ODFS Clinical Evaluation

Clinical Evaluation Report
ODFS® Pace (XL)

V1.2
Paul Taylor
Tamsyn Street
March 2018
QF 095
Review date August 2019
Hardware versions: V1.0 & V1.1

Stimulator software version: V1.3.xx and V1.4
LINQ hardware version: V1.0
Expansion board software version (ODFS® Pace XL only): V1.0.01X (W)
Wireless footswitch software version: V1.2.00F
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Clinical Evaluation Report March 2018 v1.2QF 095
Contents
Revision History .................................................................................................................... 6
Section 1: Summary ................................................................................................................... 7
Section 2: Scope for the Clinical Evaluation of the ODFS® Pace (XL) .................................... 8
Scope of the clinical evaluation ............................................................................................. 8
................................................................................................................................................ 9
Physical description and differences between the devices .................................................... 9
Device group ........................................................................................................................ 10
Positioning in relation to available treatment/management /diagnostic options. ................ 10
Exact description of intended purposes as described in the devices instructions for use: ... 11
Patient population. Definition of intended users - Referral criteria ................................ 11
Clinical Procedure ............................................................................................................ 12
Contraindications, Warnings and precautions identified in the v1.3 software release
instructions for use ............................................................................................................... 13
Contraindications: ............................................................................................................ 13
Warnings: ......................................................................................................................... 13
Precautions stipulated in the user manual include: .......................................................... 14
Additions planned for the v1.4 software release instructions for use .............................. 15
Claims on clinical performance as outlined in instructions for use ..................................... 17
Intended Use statement for v1.4 manual.......................................................................... 18
Regulatory Status of the Devices ......................................................................................... 18
Section 3 Clinical background, current knowledge, state of the art .................................. 19
Introduction .......................................................................................................................... 19
Literature Search Strategy and Search Terms ...................................................................... 19
National Guidelines ............................................................................................................. 20
Description of natural course and consequences of the medical conditions concerned. ..... 21
Multiple sclerosis ............................................................................................................. 21
CVA (stroke) .................................................................................................................... 21
Cerebral Palsy .................................................................................................................. 22
Spinal Cord injury ............................................................................................................ 22
Parkinson’s Disease ......................................................................................................... 22
State of the Art ..................................................................................................................... 23
Description of available therapeutic/management/diagnostic options ................................ 23
Hazards due to substances and technologies that could be relevant to the device under
evaluation ............................................................................................................................. 24
Critical Risks.................................................................................................................... 24
Minor Risks...................................................................................................................... 24
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Definition of intended users. ................................................................................................ 25
Section 4: Device under evaluation ......................................................................................... 26
Section 4.1: Type of evaluation ........................................................................................... 26
4.1.1 State of the art. ................................................................................................... 26
Section 4.2 Demonstration of equivalence .......................................................................... 31
Part 1: Clinical Assessment of the ODFS® Pace ................................................................. 31
Pre-market clinical report ................................................................................................ 31
Purpose............................................................................................................................. 31
Relevant standards ........................................................................................................... 31
Pre Clinical Assessment ................................................................................................... 31
Demonstration of Equivalence ............................................................................................. 31
ODFS® III [Odstock Dropped Foot Stimulator] and the ODFS® Pace................................ 31
Clinical Comparison ........................................................................................................ 32
Technical Comparison ..................................................................................................... 32
Biological comparison ..................................................................................................... 35
Discussion ........................................................................................................................ 35
Assessment of device efficacy ......................................................................................... 37
Method ............................................................................................................................. 37
Procedure ......................................................................................................................... 37
Outcome measures ........................................................................................................... 38
Analysis............................................................................................................................ 38
Results .............................................................................................................................. 39
Conclusion ....................................................................................................................... 42
References ........................................................................................................................ 43
Part 2: Clinical effectiveness comparison between the ODFS® III benchmark device and
the ODFS® Pace functional electrical stimulation device. .................................................. 44
Post Market Clinical Follow-up. ...................................................................................... 44
Background: ..................................................................................................................... 44
Methodology: ................................................................................................................... 44
Results .............................................................................................................................. 44
Discussion ........................................................................................................................ 46
Conclusion ....................................................................................................................... 47
References ........................................................................................................................ 47
Part 3: Clinical Comparison of the ODFS® Pace and ODFS® Pace XL .............................. 48
Purpose............................................................................................................................. 48
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Demonstration of Equivalence ......................................................................................... 48
ODFS® Pace [Odstock Dropped Foot Stimulator] and the ODFS®-Pace XL ................. 48
Foreseen differences in clinical response between the two devices ................................ 49
Parameter and Feature Comparison Discussion .............................................................. 54
Conclusion ....................................................................................................................... 55
Assessment of device efficacy post market follow-up .................................................... 56
Method ............................................................................................................................. 56
Recruitment ...................................................................................................................... 56
Procedure ......................................................................................................................... 56
Outcome measures ........................................................................................................... 57
Analysis............................................................................................................................ 57
Results .............................................................................................................................. 57
Conclusion ....................................................................................................................... 58
Part 4: Comparison of the ODFS® Pace XL V1.3 software & V1.0 Hardware with the
ODFS® Pace XL V1.4 software & V1.1 Hardware ............................................................. 59
Purpose............................................................................................................................. 59
Demonstration of Equivalence ......................................................................................... 59
ODFS® Pace [Odstock Dropped Foot Stimulator] and the ODFS®-Pace XL ................. 59
Foreseen differences in clinical response between the two devices ................................ 60
Parameter and Feature Comparison Discussion .............................................................. 66
Conclusion ....................................................................................................................... 67
Required further evaluation ............................................................................................. 67
Section 4.3 Clinical data held by the manufacture ........................................................ 68
Section 4.4 Clinical data from the literature .................................................................. 69
Literature Search Strategy................................................................................................ 69
Section 4.5 Summary and appraisal .............................................................................. 72
Section 4.5.1 Evidence for clinical benefit of the ODFS® family of devices................... 72
Study weighting method .................................................................................................. 72
Randomized Controlled Clinical Trials of the ODFS® .................................................... 77
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Post Market follow up ...................................................................................................... 79
National Guidelines ......................................................................................................... 92
Limitations of data, gaps, uncertainties or unanswered questions ................................... 93
Conclusions ...................................................................................................................... 94
Cited references ............................................................................................................... 94
Other references relating to the ODFS®........................................................................... 99
Review articles featuring the ODFS® ............................................................................ 102
Section 4.5.2 Evidence for the clinical risks associated with the use of the ODFS® family
of devices. 103
Part 1. Reports of adverse and serious adverse events reported to regulatory bodies
103
Implication to OML device and approach taken to mitigate risk .................................. 104
Summary ........................................................................................................................ 105
Part 2. Adverse and serious adverse events reported in the literature ..................... 113
Purpose........................................................................................................................... 113
Method ........................................................................................................................... 113
Results ............................................................................................................................ 113
Discussion ...................................................................................................................... 114
Conclusion ..................................................................................................................... 114
References ...................................................................................................................... 115
Section 4.6 Analysis of clinical Data........................................................................... 116
Review of incidence of risks identified in the risk analysis and instructions for use. ... 116
Purpose........................................................................................................................... 116
Method ........................................................................................................................... 116
Discussion ...................................................................................................................... 121
Conclusion ..................................................................................................................... 121
4.6.1 Requirement on Safety (MDD ER1)..................................................................... 122
4.6.2. Acceptability of the benefit/risk profile (MDD ER1/ AIMDD ER1) .................. 124
Summary of the total experience with the devices ........................................................ 124
Nature, extent/severity, probability/frequency, duration of benefits to the patients and of
undesirable side-effects and other risks. ........................................................................ 124
The benefit/risk profile in relation to the manufactures intended purpose. ................... 125
4.6.3 Requirement on performance (MDD ER3/AIMDD ER2) .................................... 127
4.6.4 Requirement on acceptability of side-effects (MDD ER6)................................... 127
Section 5. Conclusions .......................................................................................................... 130
Compliance with Essential Requirements ..................................................................... 130
Adequacy of available data ............................................................................................ 130
Suitability of the devices and instructions for use ......................................................... 130
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Consistency between the manufactures claims for the device, clinical data and risk
management documentation .......................................................................................... 130
Continuing post market surveillance and post market clinical follow-up ..................... 130
Section 6: Date of Next Report ......................................................................................... 132
Section 7: Dates and signatures ........................................................................................ 132
Section 8: Qualification of the responsible evaluators and declaration of competing
interests 133
Revision History
Version 1.0 July 2017 Covers up to ODFS® Pace 1.3

Version 1.1 August 2017 Extended to cover ODFS® Pace 1.4 and LINQ®
Version 1.2 April 2018 Includes revisions following BSI audit 6/9/17
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Section 1: Summary
This report was compiled using the template outlined in appendix 9A of MEDDEV 2.7/1
revision 4.
The report describes how equivalence is demonstrated between the bench mark device,
the ODFS®III and the ODFS® Pace V1 and its variant, the ODFS® Pace XL V1 (V1.3
software) and their planned replacement devices ODFS® Pace V1.1, ODFS® Pace XL V1.1
both with v1.4 software. The report then describes the clinical evidence for the efficacy,
effectiveness and safety for the devices and compares this evidence with the “sate of the
art” derived from an examination of national guidelines, relevant standards and
published literature.
Based on an examination the ODFS® Pace (XL) family of devices complies with the
following Essential Requirements (ER):
 ER1: It is demonstrated that the risk associated with the use of the ODFS® Pace (XL)
is outweighed by the benefit received.
 ER3: It is demonstrated that the ODFS® Pace (XL) meets its claim that the device
alleviates disability and handicap by improving the mobility of those who use it.
 ER6: It is demonstrated that the side effects from use of the ODFS® Pace (XL) are
acceptable.
While the overall evidence for safety and efficacy is good and procedures in place for
post market surveillance and post market follow-up are effective, it is recommended
that further evidence be collected for the use of the ODFS® Pace (XL) in conditions such
as cerebral palsy, head injury and Parkinson’s disease. Additionally further evidence
should be collected for the use of the ODFS® Pace (XL) for stimulation of other group
both in exercise and gait applications.
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Section 2: Scope for the Clinical Evaluation of the ODFS® Pace
(XL)
Dr Paul Taylor BSc, MSc, PhD, C.Eng C.Sci, MIPEM

Consultant Biomedical Engineer
The National Clinical FES Centre, Salisbury District Hospital, Salisbury, Wiltshire. SP2
8BJ, UK
Tel: 0044 1722 429119
E-mail: p.taylor@salisburyfes.com
Relevant standards
MEDDEV 2.7/1 revision 4 June 2016: Appendix A9, Section 2

MDD - 93/42/EEC
BS EN ISO 60601-1:2006 + A12:2014
BS EN 60601-1-2:2015
BS EN 60601-1-11:2015
BS EN 60601-2-10:2015 + A1:2016
BS EN 62304:2006 + A1:2015
BS EN 62366-1:2015
BS EN ISO 13485:2016.
BS EN ISO 14971:2012
BS EN ISO 15223-1:2016
Scope of the clinical evaluation
The current report is an evaluation of the Odstock Dropped Foot Stimulator ODFS® Pace
and ODFS® Pace XL devices.
Hardware versions: V1.0 & V1.1

Stimulator software version: V1.3.xx and V1.4
LINQ hardware version: V1.0
Expansion board software version (ODFS® Pace XL only): V1.0.01X (W)
Wireless footswitch software version: V1.2.00F
The device and accessories are CE marked.
Manufacturer:
Odstock Medical Limited, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ
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ODFS® Pace and
ODFS® Pace XL
LINQ
Physical description and differences between the devices
The ODFS® Pace (XL) devices are Functional Electrical Stimulation (FES) devices
primarily intended to correct dropped foot for people with upper motor neurone
neurological dysfunction. This is achieved by stimulations of the common peroneal
nerve using skin surface self-adhesive electrodes placed over the skin where the nerve
is closest to the surface. To time the stimulation to the correct phase of the gait cycle, a
pressure sensitive footswitch is placed in the shoe, under the heel of the foot on the
same leg that is receiving the stimulation. Stimulation begins when weight is taken
from the switch and ends at or soon after weight is returned to the switch.
The ODFS® Pace device is supplied in two versions. The ODFS® Pace is controlled using
a footswitch connected to the device using a fixed wire connection. The ODFS® Pace XL
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use the same pressure sensor but replaces the fixed wired link with a radio telemetry
connection.
Both devices allow adjustment of a range of timing parameters that allow the devices to
be optimised for a variety of walking styles or disabilities. In addition to the primary
function of correction of dropped foot, the devices can stimulate alternative muscles
and nerves to assist different functions in gait such as hip extension, knee extension or
extension, push-off and arm swing. As for the correction of dropped foot, the
stimulation is timed using the footswitch. The devices also have an exercise mode that
provides cyclic stimulation using the devices internal timer. To monitor device usage,
both devices provide a data log, which records the number of steps taken, the time the
device is in walk or exercise mode and the number of walking or exercise sessions
completed.
The devices are a direct development of the ODFS® III, O2CHSII and MS2 devices
previously produced by OML. They combine the walking functions of the ODFS®III and
O2CHSII with the exercise function of the MS2. It is an incremental development of this
technology, replacing the earlier analogue control circuitry with a digital controller and
LCD display. However, its principle of operation and interaction with the body remains
the same.
There are a number of innovative aspects of the ODFS® Pace device including the
adjustment of clinical parameters has been adapted reducing the chance of the patient
accidentally adjusting the stimulation parameters set by their clinician. A further
addition is an activity log enabling the patient and clinician to monitor the frequency
and time spent using the stimulator.
The ODFS® Pace XL is designed as variant of the ODFS® Pace and has the exactly the
same intended use. Hence all stimulation parameters are identical. The aspects that
differ between the devices are features of usability.
Device group
The devices are Functional Electrical Stimulation devices and fall under the FDA
categories: IPF (Stimulation, muscle, powered); GZI (Stimulator, neuromuscular,
External Function.)
Positioning in relation to available treatment/management /diagnostic

options.
Treatments for drop foot include physiotherapy, orthotic devices, medical therapy,
electrical stimulation of the affected nerves and surgery. These options can be used
alone or in combination with one another. The most commonly used treatment for foot
drop next to the use of FES is an ankle foot orthosis (AFO). An AFO is a device, usually
made of polypropylene or other material. It is usually used to hold the foot in place in a
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fixed position at a 90 degree angle to prevent the foot from dropping and dragging and
provide lateral stability and improve gait. There is limited research on the use of AFOs
for foot drop.
(reference NICE IPG278).
Exact description of intended purposes as described in the devices

instructions for use:
“The Odstock Dropped foot stimulator Pace (ODFS® Pace) is a single channel,
Footswitch controlled stimulator designed to correct dropped foot in the upper motor
neurone conditions. These conditions include stroke, multiple sclerosis, incomplete
spinal cord injury (T12 and above), head injury, cerebral palsy, Parkinson’s disease and
hereditary spastic paraparesis.”
“Skin surface electrodes are placed, typically over the common peroneal nerve as it
passes over the head of the fibula and over the motor point of tibialis anterior.
Stimulation produces dorsiflexion and eversion of the foot and in certain electrode
configurations produces a withdrawal reflex, adding knee flexion and hip flexion.
Electrical stimulation feels like “pins and needles” and most people quickly become
used to the sensation.”
“The ODFS® Pace (XL) is also designed for more general rehabilitation use. An exercise
mode provides cyclic stimulation for muscle conditioning prior to walking or
strengthening other muscle groups. Stimulation programmes are also provide for early
gait re-training of other muscle actions such as hip extension, knee flexion and
extension and push-off in terminal stance.”
Patient population. Definition of intended users - Referral criteria
Cause and functional deficit

 Neurological deficit due to an upper motor neurone lesion. An upper motor neurone
lesion is defined as one that occurs in the brain or spinal cord at or above the level of
T12. This is normally but not exclusively associated with spasticity.
 Upper motor neurone lesion resulting in dropped foot occur in conditions such as
stroke, multiple sclerosis, incomplete spinal cord injury at T12 or above, cerebral
palsy, familial / hereditary spastic paraparesis, head injury and Parkinson's disease.
Nature of functional deficit:
 Dropped foot defined as a deficit of dorsiflexion and / or eversion of the ankle.
While this will be frequently associated with lack of heel strike, FES can be
successfully used to correct inversion at first contact to significantly improve the
stability of the ankle in the stance phase, improving the safety of gait.
 A dropped foot can be unilateral or bilateral
 In addition to drop foot, deficits in knee flexion or extension, hip extension and
abduction and push off at terminal stance can be addressed. FES can be used to
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strengthen and / or control other muscles used in gait such as hamstrings,
quadriceps, gluteal and calf muscles or for arm swing.
Functional ability
 Able to passively achieve a neutral angle of the ankle. A resistance due to spasticity
of the calf muscles can be overcome but fixed contracture preventing plantagrade is
a contraindication
 Able to obtain standing from sitting unaided. Use of aids such as sticks, frame or
crutches is acceptable
 Able to walk a minimum distance of about 10m. Use of aids such as ankle foot
orthosis (AFO), sticks, frame or crutches is acceptable
 A reasonable exercise tolerance is required for treatment sessions. However, FES
often reduces the effort of walking therefore poor exercise tolerance is only an
exclusion criteria in extreme cases
 There is no maximum walking distance limit. FES devices have been successfully
used in cases where a dropped foot only becomes a significant problem when the
device user is tired or when the deficit is relatively mild.
Motivation, understanding and independence

 Able to understand the aims of the treatment and be motivated to comply with
treatment protocols. Where appropriate, carer support can assist in using the
equipment
 Where patients live alone and do not have carer assistance, they must be able to
place electrodes and operate the equipment independently. If family or carer
support is present, less independence is required.
Clinical Procedure
The patient is first assessed for suitability for FES at the initial assessment clinic. The
above referral criteria are checked. An additional acceptance criterion is the ability to
tolerate the sensation of electrical stimulation. An FES device is tried and in most cases
an improvement in gait is immediately apparent. Following discussion with the patient
a decision whether to proceed with treatment is made. In some cases the clinician may
judge that a period of electrical stimulation training is required in order to strengthen
muscles, reduce spasticity or to accustom the patient to the sensation of electrical
stimulation. Stimulation exercises may be started at this appointment if time permits.
Otherwise exercises will be set up at another appointment.
The ODFS® is fitted over two clinic sessions on consecutive days. On the first day the
user is taught how to apply the device while on the second day their ability to do so is
assessed and further training given if necessary. Use of the stimulator is increased
gradually over 2 to 3 weeks until it can be used all day. Follow up is made at 6 weeks, 18
weeks, 45 weeks and 72 weeks from first use and then every 6 months or yearly
depending on the patient's condition, for as long as the device is used. If users
experience problems they are encouraged to contact the clinic so advice can be given,
equipment repaired or extra clinic sessions arranged if necessary.
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In the case of more complex movement problems where more than one muscle group
are stimulated, treatment is often started with a single channel ODFS® and the second
channel introduced at the 6 or 18 week follow up assessment once the user has become
accustomed to FES.
Contraindications, Warnings and precautions identified in the v1.3

software release instructions for use
Contraindications:
 The exact contraindications as stipulated in the user manual are outlined: The
ODFS® Pace/Pace XL should not be used on patients who have a cardiac
pacemaker, implanted defibrillator, or other electronic implanted device unless
investigations demonstrate that there is no interaction between the devices.
Warnings:
 Neck stimulation. Stimulation should not be applied over the neck, because
severe spasm of the muscles may occur and the contractions may be strong
enough to close the airway or cause difficulty in breathing. Stimulation over the
neck could also have adverse effects on heart rhythm or blood pressure.
 Open or infected wounds. Stimulation should not be applied over open

wounds or over swollen, infected, or inflamed areas or skin eruptions, eg.
phlebitis, thrombophlebitis, varicose veins. Stimulation should only be applied
to normal intact, clean skin.
 Cancer. Stimulation should not be applied over, or in proximity to, cancerous

tumours.
 Electronic monitoring equipment. Stimulation should not be applied in the

presence of electronic monitoring equipment, such as cardiac monitors and ECG
alarms. Monitoring equipment may not operate properly when the electrical
stimulation device is in use.
 Transcerebral stimulation. The effects of stimulation of the brain are

unknown. Therefore, stimulation should not be applied across the head and
electrodes should not be placed on opposite sides of the head.
 Sleeping. Stimulation should not be applied when sleeping.
 Chest stimulation. Stimulation should not be applied across the chest because
the introduction of current into the chest may cause rhythm disturbances to the
patient’s heart, which could be fatal.
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Precautions stipulated in the user manual include:
 The handling of electrodes. Do not handle electrodes while the stimulation is

on. Always make sure that the ODFS® Pace/Pace XL is paused before adjusting
the electrodes.
 Electrodes/leads: Use this device only with the leads, electrodes, and
accessories recommended by the manufacturer. Replace leads if they become
stiff or damaged in any way.
 Skin irritation: Some people may experience skin irritation due to electrical
stimulation or the electrodes. The irritation can usually be reduced by using an
alternative type of electrode, different device settings or a new electrode
position. A slight reddening of the skin under the electrode is normal and this
should clear within 1 hour of stopping stimulation. If stimulation causes long-
term marking of the skin, discontinue use and seek medical advice.
 Skin care: Do not shave the skin under the electrodes. If long hairs require
removal, cut the hairs using scissors or a beard trimmer. If skin moisturisers are
required, use overnight and remove residual using warm water with a mild soap
before applying electrodes in the morning.
 Spasticity: If stimulation causes increased spasticity (involuntary, exaggerated

muscle stiffness and spasm), discontinue use and consult your clinician.
 Machinery Operation and Driving: Stimulation should not be used when

driving, operating machinery, or during any activity in which electrical
stimulation could distract or put the user at risk of injury.
 Bathing/ showering: Do not use the stimulator, or any part of the stimulator
system in the bath or shower.
 Shortwave therapy: Do not use the stimulator within three metres of

physiotherapy short wave therapy equipment.
 Epilepsy: Patients with suspected or diagnosed epilepsy should follow

precautions recommended by their physicians. The ODFS® Pace (XL) should not
be used by people who have poorly controlled epilepsy.
 Autonomic Dysreflexia: ODFS® Pace (XL) users who have high level spinal cord
injuries (T6 and above), may experience symptoms of autonomic dysreflexia
(increased blood pressure or sweating in response to stimulation). If affected,
discontinue use and consult your physician.
 Cardiac: Patients with suspected or diagnosed heart disease should follow the
exercise precautions recommended by their physicians.
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 Haemorrhage: Electrical stimulation should not be carried out in areas of the
body affected by recent injury, fracture or surgery.
 Pregnancy: The safety of using electrical stimulation during pregnancy has not
been established.
 Children: The ODFS® Pace (XL) is not a toy! Only use as instructed by the
clinician.
 Latex Allergies: Caution: The elasticated tubular stocking contains natural

rubber latex which may cause allergic reactions. This item is provided as an
accessory to the ODFS® Pace (XL) device. Do not use if sensitive to products that
contain latex.
 Long-term Effects: The long-term effects of electrical stimulation are unknown.

Odstock devices have been successfully used by individuals for in excess of 20
years.
 Wireless Footswitch Insole: If the user has poor sensation in the feet we advise
regular inspection of the condition of the feet as poor fitting Wireless Footswitch
Insole(s) may lead to areas of increased pressure. If this is the case we would
advise the user to contact the clinician who set up the system.
 Air Travel: Like all radio telemetry devices the ODFS® Pace XL Wireless
Footswitch should not be used while flying. We recommend that the ODFS® Pace
XL is used with a wired Footswitch for air travel. The Wireless Footswitch
should be carried in luggage with its battery removed.
 Batteries: We advise to only use batteries recommended by Odstock Medical

Limited. All battery technologies carry a very small risk of explosion. Ensure you
follow the instructions for installing, using and disposing of the battery. Please
read the information supplied with the batteries.
 Biological cross contamination: Electrodes are single person use (electrode

care section)
Additions planned for the v1.4 software release instructions for use
 Footswitch and lead failure: The device may fail if leads or footswitch become
worn. Check regularly for defect.
 Skin marking and pressure sores: Where pressure may be placed over leads
and connectors next to the skin, there is a risk of skin marking which if left
uncorrected may lead to skin break down. Visually check the skin regularly,
taking particular care in non-sensate areas.
15
 Electro-surgery: Do not use the ODFS® Pace (XL) while undergoing surgery
using high frequency electro-surgery equipment.
 Chest stimulation
Stimulation should not be applied between the chest and upper back or crossing
over the heart because the introduction of electrical current into the chest may
cause rhythm disturbances to the patient’s heart, which could be fatal.
 Strangulation
There is a risk of strangulation with wires of the system. Use appropriate length
of lead.
 Choking
Small parts of the system could be a choking hazard.
 Flammable cleaning products

Do not use flammable cleaning products to clean the device.
 Oxygen rich environments

Do not use stimulation within oxygen rich environments such as a hyperbaric
oxygen chamber or in close proximity to an oxygen mask.
 External orthopaedic metal fixation

Stimulation should not be applied in the area of exposed orthopaedic metal work.
 Prescribed user
The device should only be used by the user that the system has been prescribed
to. Keep out of reach of non-intended users. Only use as instructed by the
clinician.
 Exposed electrode pins

Ensure that the pins of the electrode wire are fully inserted into each electrode
before use.
 Accessories and consumables

Only use accessories and consumables recommended by Odstock Medical
Limited. Do not connect with equipment other than that intended to be used with
this system as defined within this instruction manual or that of the other
equipment.
 Battery change and battery cover

Do not operate the stimulator with the battery cover removed. Disconnect the all
leads prior to opening the battery cover. The clinician/carer should not be in
contact with the patient when changing the battery.
 Equipment modification
Do not tamper with or modify the equipment.
16
 Shelf life
Do not use the consumables if their expiry date has expired
 Equipment re-use
Electrodes, elasticated tubular stocking and insoles are single patient use only. If
re-using other parts of the system ensure a thorough clean using anti-bacterial
wipes.
 Storage temperature
Do not store outside of the temperature limits as detailed in the specification on
page zz. Time may be required following system removal from storage for the
screen on the stimulator to reach full brightness. If the ODFS® Pace (XL) or
accessories (excluding electrodes) have been stored at the minimum (-20 ˚C) or
maximum (70 ˚C) storage temperatures, allow 10 minutes in ambient
temperature before use.
 Use of small electrodes

The use of small electrodes (less than 32mm diameter) may result in higher
current density especially when using high output settings (current, pulse width,
frequency) and may lead to an increase in the chances of skin irritation or
thermal burns. When possible use larger electrodes or monitor skin condition
closely.
 Residual risk
Even though Odstock Medical Limited have taken all foresseable steps, through
design and testing, to ensure this device is safe and reliable, there remains a
small risk of stimulation not being delivered when required. This could lead to a
stumble or trip and consequent injury or harm. Performance of the system may
be affected by the condition of the accessories (i.e. battery, leads, electrodes and
footswitch). Please refer to troubleshooting.
Claims on clinical performance as outlined in instructions for use
The manufactures make the following claim for both devices:
“By provision of dorsiflexion and eversion, the foot clears the ground in the swing phase
of gait more easily. This increases the safety and speed and also reduces the effort of
gait, reducing compensatory mechanisms such as hip hitching and circumduction.
Reduction in effort can lead to a reduction of associated reactions and result in a general
lowering of spastic tone.
Safety in weight bearing is also improved because initial floor contact is made with the
heel and then loading is along the mid line of the foot, correcting the tendency to weight
bear on the lateral border.
17
Contraction of the tibialis anterior muscle and the hamstrings via the withdrawal reflex
may, by reciprocal inhibition, reduce antagonist activity in the calf and quadriceps
muscle groups leading to a more normal modulation of tone. Repeated use of the
stimulator may, by long term potentiation of the required pattern of synapse activity in
the spinal cord and brain, lead to the pattern of more “normal” movement being
relearned.
However, a more immediate benefit from the orthotic use of the device is that walking is
easier and safer and therefore confidence is increased, leading to an extension of
mobility range and an overall improvement in quality of life.”
Intended Use statement for v1.4 manual
The ODFS® Pace (XL) is intended to be used for the alleviation of neurological injury or
handicap due to upper motor neurone disease or injury including stroke, multiple
sclerosis incomplete spinal cord injury (T12 and above), head injury, cerebral palsy,
Parkinson’s disease and hereditary spastic paraparesis. Electrical stimulation is
triggered from a switch input or cyclic during an exercise program. Gait events are
detected by a wired or wireless footswitch.
The primary application is as a long term orthotic aid for the correction of dropped foot
for both adult and paediatric individuals. Other gait deficits can be addressed by
stimulation of additional muscle groups, singularly or in conjunction with the correction
of dropped foot, for the purpose of functional gait training and / or gait assistance.
The ODFS® Pace (XL) may also strengthen muscles, reduce spasticity, increase range of
movement, reduce oedema and increase local blood flow.
The ODFS® Pace (XL) is designed for use in home healthcare / residential and hospital /
healthcare environments.
The ODFS® Pace (XL) should be supplied and setup by a clinician who has attended an
Odstock Medical Limited training course.
Regulatory Status of the Devices
The ODFS® Pace was CE marked in November 2008 and has subsequently been
approved for use in the USA, Canada, Australia, Germany, South Africa and New Zealand.
The ODFS® Pace XL was CE marked in 2012 using the Wireless Footswitch Insole.
The LINQ footswitch for use as part of the ODFS® Pace XL system was CE marked in
April 2016
18
Section 3 Clinical background, current knowledge, state of the art
Introduction
The intervention is intended to provide a practical assistive device enabling daily
mobility for people who have dropped foot due to upper motor neurone neurological
conditions or trauma. These most commonly include multiple sclerosis, stroke, motor
incomplete spinal cord and cerebral palsy. Dropped foot is characterised by weakness
or paralysis in the lower limb leading to an inability to lift the foot. The intervention
provides electrical stimulation to the common peroneal nerve causing dorsiflexion and
eversion of the foot through the swing phase of gait.
Literature Search Strategy and Search Terms
The literature search strategy for this clinical evaluation formed an update of a previous
document (The Case for the Odstock Dropped Foot Stimulator (ODFS®) A summary of
the published evidence for the Odstock Dropped Foot Stimulator. Paul Taylor,
Consultant Biomedical Engineer, National Clinical FES Centre). The sources used to
complete the search included Embase, Medline, Cinahl and Pedro. The primary search
question was very broad: “What is the evidence base for the last 30 years for the
effectiveness of Functional electrical stimulation (FES) of the peroneal nerve for the
treatment of weakness or paralysis in the lower limb/leg for foot drop/dropped
foot/drop foot. Specifically interested in single channel drop foot/dropped foot
stimulators NOT multi-channel/4 channel, 8 channel etc.” Patient characteristics
included Multiple Sclerosis, Stroke, Spinal Cord Injury and Cerebral Palsy. A secondary
further question examined any research in the above area that had examined
“risks/adverse events/injury/skin irritation associated with the use of FES for foot
drop/dropped foot.” The date range included all dates, both male and female gender of
participants, only human studies, all publication types, all language types.
Selection criteria for studies was to include studies that examined the independent
home use of a foot drop stimulator using the outcome measure of walking speed, PCI,
balance, energy cost efficiency of walking, perceived exertion, falls, fear of falling,
distance. Studies were excluded if they were implanted stimulators; used more than a
single channel for stimulation; used other devices such as Brain Computer Interfacing
(BCI) technologies, robotics, video gaming; studies which used a tilt sensor foot drop
stimulator were also excluded for examining effectiveness due to the different
mechanism in how stimulation is achieved compared to a foot-switch. A different
triggering mechanism for stimulation may produce varying results dependent on type
of gait. Studies were further excluded that included novel technologies presenting a new
operating system e.g. use of motion sensory driven systems. Studies which included an
additional intervention to be used alongside FES were also excluded e.g. physiotherapy
or transcranial direct current stimulation (tDCS). Small case studies of five participants
or less were excluded.
19
Studies were organised according to high quality randomised controlled trials and
observational studies. The CASP Checklists were used to critically appraise the selected
studies (1).
National Guidelines
NICE have issued full guidelines on the treatment of drop foot of central neurological
origin (IPG278)1. NICE have stated that "current evidence on the safety and efficacy (in
terms of improving gait) of functional electrical stimulation (FES) for drop foot of
central neurological origin appears adequate to support the use of this procedure
provided that normal arrangements are in place for clinical governance, consent and
audit". NICE have also recently completed a device specific Medtech Innovation briefing
for the ODFS® Pace and Pace XL functional electrical stimulation devices for treating
drop foot.2 The Medtech briefing summarises that the devices can be used “…as an
alternative or adjust to orthotic devices or other walking aids, or to provide a longer
term therapeutic effect”.2
Scottish Interventional Guidance Network also supports the use of FES: The Scottish
Interventional Guidance Network (SIGN 118) report (2010); Management of patients
with stroke: Rehabilitation, prevention and management of complications, and
discharge planning. A national clinical guideline38, 39, concludes:
“Functional electrical simulation may be considered as a treatment for drop-foot, where

the aim of treatment is the immediate improvement of walking speed and/or
efficiency,”
Evidence Note 46 - The use of functional electrical stimulation (FES) in adults with
dropped foot. Quality Improvement, also from SIGN:
“There is evidence, mainly from uncontrolled observational studies, to support the use
of surface-applied FES for the orthotic improvement of walking speed and reduction in
walking effort in patients with dropped foot. Patient acceptability of their treatment
appears to be high. There are few major safety concerns.”
Intercollegiate working party for stroke, (2012) National clinical guidelines for stroke
London, Royal College of Physicians 4th edition contains the following statement on
FES:
“Functional electrical stimulation can be used for drop foot of central neurological
origin provided normal arrangements are in place for clinical governance, consent and
audit.”
Finally the MS guidelines from NICE, Multiple sclerosis: Management of multiple

sclerosis in primary and secondary care. CG186 (2014) aligns itself with the IPG278
NICE guidelines.
20
Description of natural course and consequences of the medical conditions
concerned.
Lower limb paralysis or weakness, consisting of a reduced ability to dorsiflex,

commonly referred to as drop foot is associated with an increased likelihood to trip and
fall along with a reduction in walking speed and increase in effort of walking. Drop foot
is commonly seen in a number of upper neuron neurological disorders including
multiple sclerosis (MS), cerebral vascular incident (CVA), motor-incomplete spinal cord
injury (SCI) and cerebral palsy amongst others. The current clinical evaluation will focus
on data from people with MS and CVA as these are the two most common diagnoses that
are treated.
All patients with an upper motor neuron diagnosis respond similarly to the device in
terms of the immediate biomechanical and neuromodulation effect (NICE Guidelines
IPG 278). The predominant users of multiple sclerosis and stroke have been found to
follow a similar time course for overall use of the device of five years (Taylor et al.,
2013, Street and Singleton 2017).
Multiple sclerosis
There are currently approximately 100,000 people in the UK that are affected by MS. It
is the commonest cause of serious physical disability in adults of working age in the UK
(NICE guidelines QS108). Generally, the pattern of disease is relapsing-remitting MS
(RRMS), which is characterised by periods of stability or remission and periods of
relapse when MS related symptoms become worse. Two-thirds of people who start with
RRMS will develop secondary progressive MS (SPMS) which is characterised by a
reduction or absence in relapses and a gradual decline in symptoms with increased
disability. Primary progressive MS (PPMS) is characterised by an absence of relapses
and a gradual increase in disability over a long period of time. PPMS is experienced by
around 10-15% of people with MS (NICE Guidelines, QS108). The predominant
population treated for lower limb paralysis or weakness and foot drop are those with
SPMS. The MS prevalence ratio of women to men has increased markedly during the
last decade (2.3–3.5:1), which indicates an increase in MS amongst women but not men
(Harbo et al., 2013). The cause of MS is unknown but it is thought that there are genetic
and environmental factors involved in the development of the disease. A modest
increased risk of MS has been associated with the Epstein–Barr virus (EBV), low levels
of vitamin D and smoking (Harbo et al., 2013).
CVA (stroke)
CVA occurs approximately 152,000 times a year in the UK (State of the Nation National
Stroke Statistics, 2016). More than 900,000 people in England are living with the effects
of a CVA (NICE Clinical guideline CG162). Over a third of CVA survivors in the UK are
dependent on others, of those 1 in 5 are cared for by family and/or friends. CVA is one
of the largest causes of disability half of all CVA survivors have a disability (State of the
Nation Stroke statistics, 2016). The most common cause of a CVA is an ischemic stroke.
21
Despite improvements in mortality and morbidity, people with stroke need access to
effective rehabilitation services. Stroke rehabilitation is a multidimensional process,
which is designed to facilitate restoration of, or adaptation to the loss of, physiological
or psychological function when reversal of the underlying pathological process is
incomplete. Rehabilitation aims to enhance functional activities and participation in
society and thus improve quality of life. “(NICE Guidelines [CG162]
Cerebral Palsy
Cerebral palsy (CP) is the most common motor disability in childhood. 1 Population-based
studies from around the world report prevalence estimates of CP ranging from 1.5 to more
than 4 per 1,000 live births or children of a defined age range.
Cerebral palsy mainly affects how the brain controls muscles and movement. Sometimes it
can also affect other ways the brain works, such as how we see, hear, communicate, feel,
understand and think. Cerebral palsy is caused when a problem occurs in the development of
a baby's brain before, during or soon after they are born. The brain can't send messages to
different parts of the body properly, and this causes problems with balance, movement and
coordination, talking, chewing and swallowing. Everyone with cerebral palsy is affected
differently – symptoms vary widely and the effects can range from minor problems to severe
disability. (NICE guidelines Cerebral palsy in under 25s: assessment and management.
NICE guidelines [NG62] Published date: January 2017)
Spinal Cord injury

In the UK there is a prevalence of 40,000 people living with a traumatic spinal
cord injury (SCI), with approximately 1100-1200 new cases per year. In the US, there
is a prevalence of 270,000 people, with approximately 17,000 people sustaining a SCI
every year. It is estimated that 50% of SCI is incomplete3 and the number of people
with incomplete SCI relative to complete is steadily increasing. Despite a positive
prognosis for many people with motor-incomplete SCI returning to a level of functional
walking,5 a number of limitations with walking ability may persist leading to a greater
risk of falls, a decreased ability to engage in the community and likelihood of injury.6
Parkinson’s Disease
Parkinson’s disease (PD) affects about 127,000 people in the UK and is the 2nd most
prevalent neurodegenerative condition after Alzheimer’s disease. Difficulty in walking
has been identified as a major factor in reduced quality of life for people with
Parkinson’s Disease (pwPD). The studied intervention is most likely to be effective in
those people moderately affected (Hoehn and Yahr stage II and III, 36% of people with
PD (pwPD36) and in those who are younger (80% are under the age of 80) indicating a
target UK population of about 38,000.
Parkinsonian gait is characterized by bradykinesia (slowness of movement),

hypokinesia (reduced movement size), festination (rapid but very short strides) and
akinesia (difficulty in initiation of movement leading to freezing in gait). Walking is
often unsafe with falls being a significant problem. It is reported that 39% of pwPD are
recurrent fallers, experiencing a mean of 20.8 falls per year. These issues can lead to
pwPD reducing their overall activity, which can lead to reduction in fitness levels and
22
reduced health status4. Reduced mobility also leads to reduced participation and it is
common for pwPD to become socially withdrawn5.
State of the Art

The state of the art for foot drop can be defined using the existing NICE guidelines
available for foot drop of central neurological origin (IPG278, 2009) which pertain to
functional electrical stimulation. The first CE marked drop foot stimulator (September
1998) was an ODFS®III stimulator. Between the years of 1998 and 2008 it was used
almost exclusively as the drop foot stimulator of choice within the NHS. The only
existing NICE guidelines available for foot drop of central neurological origin (IPG278,
2009 ref) were largely developed using research conducted with the ODFS®III. The
NICE guidelines summarise a review of the safety and efficacy of foot drop stimulation:
“Current evidence on the safety and efficacy (in terms of improving gait) of functional
electrical stimulation (FES) for drop foot of central neurological origin appears
adequate to support the use of this procedure provided that normal arrangements are
in place for clinical governance, consent and audit.”
For further justification of the decision to use the ODFS®III as the comparator device,
please see section 4.1.1
Description of available therapeutic/management/diagnostic options
Treatments for drop foot include physiotherapy, orthotic devices, medical therapy,
electrical stimulation of the affected nerves and surgery. These options can be used
alone or in combination with one another. An ankle foot orthosis (AFO) is a device,
usually made of polypropylene or other material. It is usually used to hold the foot in
place in a fixed position at a 90 degree angle to prevent the foot from dropping and
dragging and provide lateral stability and improve gait. A description of AFO, benefits,
risks (nature, extent, probability, duration, frequency,) acceptability of undesirable side-
effects and other risks (including the nature, severity, probably and duration of
acceptable harm for stroke has been reviewed in an NHS Scotland best practice
statement (2009) (SIGN118). The literature for using AFO to treat foot drop in MS is
limited. Other treatments include orally administered drugs such as baclofen,
dantrolene or tizanidine. More recently, botulinum toxin type A (Botox) injections into
the most affected muscles have been used to treat spasticity. For a description of Botox,
benefits, risks (nature, extent, probability, duration, frequency,) acceptability of
undesirable side-effects and other risks (including the nature, severity, probably and
duration of acceptable harm for stroke has been reviewed by Wilkenfield (2013). A
further treatment involves surgery which uses selective tendon release of these
muscles, selective dorsal rhizotomy and intrathecal delivery of baclofen (also called
Baclofen pump). Surgery is rarely used to treat foot drop.
23
Hazards due to substances and technologies that could be relevant to the
device under evaluation
Hazards due to use of the device, foreseeable misuse of the devices, single fault
conditions and the materials used in the devices that could be relevant to the ODFS®
Pace/ODFS® Pace XL were identified in the Risk Management file for the ODFS® Pace
and ODFS® Pace XL. The following clinical risks were identified:
Critical Risks
1. Ectopic heart beat or atrial fibrillation due to current passing through the heart.
2. Autonomic dysreflexia in Pace users with Spinal Cord Injuries
Minor Risks
1. Skin allergy/reaction to long-term use of electrodes effects
2. Allegenicity/Biocompatibility
3. Discomfort due to high stimulation level
4. Unintended activation caused by inadvertent selection of the wrong operating

mode
5. Unintended adjustment of output level
6. Foot-switch fails to trigger the device at the relevant part of the gait cycle
7. Incorrect battery insertion (polarity) causing damage to the circuit
8. Footswitch and electrode lead coming un-plugged
9. Mechanical Forces
10. Batch to batch inconsistency
11. Device susceptible to environment influences –EMI
12. Device susceptible to environment influences – Temperature
13. Device susceptible to environment influences – Water
14. Shelf life – data retention
24
15. The electrical stimulation may under certain conditions produce a muscle spasm
or other unpredicted movement which would be hazardous if the user was
operating dangerous machinery or driving
16. Increased spasticity
17. Induced increase risk of epileptic fit
18. Unknown effects of electrical stimulation on the unborn foetus
Definition of intended users.
Device users can be divided into the following categories with the following
characteristics:
 Device wearers (patients)

o Will vary in physical and mental ability across a large range
o Will be trained to use the device by the treating clinician
o May relay on carers for daily use of the device
 Clinical staff
o Can be assumed to be of normal physical and mental ability with good
dexterity and will have specialised background knowledge.
o Will have received training in the use of the device in accordance with the
policy of OML
 Carers
dexterity but with no specialised knowledge
 Technicians
dexterity
o Will have expertise on medical device maintenance.
25
Section 4: Device under evaluation
Section 4.1: Type of evaluation
The evaluation is presented in the following sections:

1. Choice of Comparator and definition of “state of the art”
2. Part 1 takes the original pre-market clinical evaluations, revised to comply with
MEDDEV 2.7/1 revision 4 and aims to demonstrate the equivalence of the ODFS®
Pace to the first CE marked dropped foot stimulator, the ODFS®III.
3. Part 2 is a post market clinical follow-up study and takes published clinical data
for the clinical performance of the ODFS® Pace with people who have MS and
compares this internal clinical data. Using data from 331 individuals, the effect
of the ODFS® Pace is demonstrated with improved precision over the pre market
evaluation.
4. Part 3 is an equivalence study to demonstrate the equivalence of the ODFS® Pace
with its variant ODFS® Pace XL.
4.1.1 State of the art.
1. The ODFS®III is considered as the bench mark for the following reasons:
• It was the first device in the UK to be used routinely in the NHS
• The pivotal studies that established the technique into clinical service were
completed with the ODFS®III.
• Published clinical data on the long term use of ODFS®III is available and is
not available for any other device.
• Much of the data used in the evaluation by NICE (IPG278) was from the
ODFS®III
• While other dropped foot stimulator devices have joined the market since the
introduction of the ODFS, they differ in several important details and this
limits the cohort for whom they are suitable;
o Firstly the electrodes are cuff mounted. This limits the available electrode
positions and hence limits the range of gait deficits that can be addressed using
the device
o Secondly some devices use a motion sensor to synchronise the stimulation to
the gait cycle. This limits the use of the device to people with mild to
moderate gait deficits
o Thirdly the adjustable range and resolution of the stimulation and timing
parameters of these devices is less than the Odstock devices, meaning they
cannot be adjusted with the precision available in the ODFS® Pace.
• In all other respects the devices have similar parameters to the ODFS®III although
stimulation parameters. The devices therefore do not have clinical advantages over
the ODFS®III. Device features are summarised in following table.
26
At the time of writing 4 rival manufacture devices are available on the market; Bioness L300, Bioness L300 Go, Innovative Neurotronics
Walkaide and XFT 2001D G3 Foot Drop. The following table summarises their key features in relation to the OML devices.
Table 1. Feature comparison of currently marketed dropped foot stimulators and the bench mark device (ODFSIII)
Feature ODFS®III ODFS®-Pace L300 L300-GO Walkaide XFT

Compact device 111x61x31 mm 72x62x26mm 71x46x17.5m 82x47x15mm 82x61x21mm 75x70x10(m
143gm 112gm m 60gm 87.9gm m)
45gm 75gm
Device mounting Belt clip or Detachable belt, Leg cuff Leg cuff Leg cuff Leg cuff
pocket leg strap, cuff or
pocket
battery type PP3 PP3 1xAAA Internal 1xAA Internal
lithium ion lithium ion
rechargeable rechargeable
Device configuration: PC, Direct on device Direct on device Dedicated Dedicated Lap top, PC or Lap top, PC or
Tablet or other tablet tablet tablet tablet
Stimulation output
adjustable for:
 Rising ramp for 0 to 2 seconds 0 to 2 seconds in 0 to 2 seconds 0 to 0.5 s in 0-2 seconds n/k
comfort and to Analogue 50ms steps 0.1 steps
avoid spastic co-
contraction
 Stimulation Pulse width 0 to Pulse width 0 to Current 0- 0 – 100mA in 0 -90mA
intensity adjusted 365μs analogue 360μs in 3.6μs 80mA 1mA steps
by user steps
 Stimulation 0 to 2 seconds 0 to 2 seconds in 0-100% of 0-100% of no n/k
extension to avoid analogue 50ms steps heel strike to heel strike to
27
foot ‘slap’ heel lift time heel lift time
10% steps 10% steps
 Falling ramp for 0 to 2 seconds 0 to 2 seconds in 0-2 seconds 0 to 0.5 s in 0 – 0.5 n/k
comfort and analogue 50ms steps 0.1 steps seconds
control of ankle in
early stance
phase.
 Limit to maximum 20 to 100 mA 10 to 100mA in 3 pulse width 5 pulse width 25 - 300 µs 25-300µs
intensity available analogue increments of settings – 100, settings – 100,
4% 200, 300µs 150, 200, 250,
300µs
Trigger type. Adaptive Adaptive Adaptive Adaptive Movement Adaptive
Footswitch Footswitch, wireless wireless sensor wireless
wired or footswitch footswitch or (Footswitch footswitch or
wireless movement for testing) movement
sensor sensor
Test button Yes Yes no No yes n/k
Display of user output position of Yes – Percentage Single digit Single digit position of Single digit
setting rotary knob of maximum numerical numerical rotary knob numerical
shown on LCD display on display on display on
remote remote remote
control control control
Output setting locked to Friction based Output adjust No No Friction based No
avoid unintended auto disabled
adjustment
Indicator of stimulation LED LED and LCD LED LED LED n/k
output bar display
Battery life indication LED turns red at 4 levels of LED, low LED, low LED n/k
near end life battery level battery battery
indicated on the indicator indicator
LCD
28
Battery life 2- 4 weeks 3 – 6 weeks Charge daily Charge daily 3 – 6 weeks
Stimulation Frequency 40 Hz 10 to 60Hz 20-45 5Hz 20-45 5Hz 16.7 to 33Hz 16-33 Hz
In 5Hz steps steps steps
Default 40Hz
Stimulation waveform Asymmetrical or Asymmetrical or Asymmetrical Asymmetrical Asymmetrical n/k
symmetrical symmetrical or or
biphasic biphasic symmetrical symmetrical
biphasic biphasic
Stimulation Modes Adaptive timing Adaptive timing, Adaptive Adaptive Adaptive n/k
& fixed timing fixed timing & no
time out
Foot Switch Control Heel rise & heel Heel rise & heel Rise Rise or strike n/a n/k
strike strike
Safety shrouded Yes Yes Yes Yes Yes n/k
electrode lead connector
Audio feedback of Yes Yes -- In remote In connect n/k
stimulation output Plug in sounder Integral sounder unit
module
Audio feed back of Paused or Active Paused, active, -- In remote N0 n/k
device status indicated on, off, low
battery and
stimulation level
indicated
Electrodes Pals platinum Pals platinum Own brand Own brand Own bran gel Own bran gel
blue 50 x 50mm blue 50 x 50mm gel or fabric gel or fabric
#901220 or #901220 or
similar similar
Electrodes freely Yes Yes Limited by Limited by Limited by Limited by
adjustable for position cuff cuff cuff cuff
in order to cater for all
clinical presentations.
29
Device carries CE mark Yes Yes Yes Yes Yes Yes
to show compliance with Class IIa, type BF Class IIa type BF Class IIa type Class IIa type Class IIa type Class IIa type
European Medical BF BF BF BF
Device Directive and
applicable harmonised
standards.
Exercise mode no yes yes yes yes yes
Device instruction Clinician Manual Clinician Manual Clinician Clinician Clinician Not known
manuals User Manual User Manual Manual Manual Manual
Clinician Quick User Manual User Manual User Manual
Start Guide, User
Quick Start
Guide –
improved
description of
clinical
application
Published clinical Very large large large small large Very small
evidence
Examining the characteristics of the 5 devices, it can be concluded that the Bioness L300, Bioness L300 Go, Innovative Neurotronics Walkaide
and XFT 2001D G3 Foot Drop all share similar characteristics but the clinical application of these devices is limited by use of the cuff to contain
the electrodes and reduced choice of and adjustability of stimulation parameters. Lack of long term clinical follow up data also limits the
assessment of clinical effectiveness. The choice of comparator device is therefore the ODFSIII because it is closest to the ODFS Pace in design
and has the greatest published clinical evidence.
30
Section 4.2 Demonstration of equivalence
Part 1: Clinical Assessment of the ODFS® Pace

Pre-market clinical report
Dr Paul Taylor BSc, MSc, PhD, C.Eng, C.Sci, MIPEM

The National Clinical FES Centre, Salisbury District Hospital, Salisbury, Wiltshire.
SP2 8BJ, UK
Tel: 0044 1722 429119
Purpose
To compare the performance of the ODFS® Pace with its predecessor, the ODFS®III
Relevant standards
MEDDEV 2.7/1 revision 4 June 2016
Pre Clinical Assessment
The stimulation parameters of the ODFS®III and ODFS® Pace were compared. The table
below compared the parameters of the devices. This information was obtained from the
device manuals
Demonstration of Equivalence
ODFS® III [Odstock Dropped Foot Stimulator] and the ODFS® Pace
Reference document
MEDDEV 2.7/1 revision 4 June 2016. Appendix A1
To demonstrate equivalence a comparison will be made between the devices in three domains;
Clinical, Technical and Biological
31
Clinical Comparison
Table 2. Comparison of the clinical aspects of the ODFS®III and the ODFS®Pace
Feature ODFS® III ODFS®-Pace

Target clinical condition Paralyse or paraparesis due Paralyse or paraparesis due
to an upper motor neurone to an upper motor neurone
lesion lesion
Intended purpose 1. Correction of dropped 1. Correction of dropped
foot foot
2. Production of a 2. Production of a
contraction of any muscle contraction of any muscle
involved in walking at an involved in walking at an
appropriate time in the appropriate time in the
gait cycle gait cycle
3. Exercise of any muscles
Area of the body the device 1. Lower limb 1. Lower limb

is used in 2. Upper limb 2. Upper limb
3. Abdomen 3. Abdomen
4. Not for use on the chest 4. Not for use on the chest
or neck or neck
Population characteristics 1. Adults 1. Adults
2. Children 2. Children
3. Not for use in proximity 3. Not for use in proximity
to tumours, active to tumours, active
implanted devices implanted devices
(without additional (without additional
investigation), adjacent investigation), adjacent
to open wounds, to open wounds,
pregnancy, poorly pregnancy, poorly
controlled epilepsy controlled epilepsy
Technical Comparison
Table 3. Summary of the technical aspects of the device:
Feature ODFS®III ODFS®-Pace

Compact device Yes Yes –
111x61x31 72x62x26mm
mm 112gm
143gm
Belt clip fitted Yes Detachable
belt clip on
custom pouch
Uses commonly available battery – Yes Yes
alkaline or rechargeable 9 volt PP3/MN1604
32
Device configured without use of PC or other Yes Yes
additional equipment
Stimulation output adjustable for:

 Rising ramp for comfort and to avoid spastic Yes Yes
co-contraction 0 to 2 seconds 0 to 2 seconds
Analogue in 50ms steps
 Stimulation intensity adjusted by user Yes Yes
Pulse width 0 Pulse width 0
to 365μs to 360μs in
analogue 100 3.6μs
steps
 Stimulation extension to avoid foot ‘slap’ Yes Yes
0 to 2 seconds 0 to 2 seconds
analogue in 50ms steps
 Falling ramp for comfort and control of Yes Yes
ankle in early stance phase. 0 to 2 seconds 0 to 2 seconds
analogue in 50ms steps
 Limit to maximum current available Yes Yes
20 to 100 mA 10 to 100mA in
analogue increments of
4%
Trigger by adaptive footswitch to prolong Yes - analogue Yes
reliability of switches and automatically adapt to digital +
different user body weights. analogue
Test button to imitate footswitch action for use Yes Yes
while setting outputs and adjusting electrode
positions
Display of user output setting Yes – position Yes –
of rotary knob Percentage of
maximum
shown on LCD
Output setting locked to avoid unintended Friction based Output adjust
adjustment auto disabled
Indicator of stimulation output Yes – LED Yes – LED and
LCD bar
display
Battery life indication Yes Yes
LED turns red 4 levels of
at near end life battery level
indicated on
the LCD
Battery life 2- 4 weeks 3 – 6 weeks
Stimulation Frequency 40 Hz 20 to 60Hz
In 5Hz steps
Default 40Hz
Stimulation waveform Asymmetrical Asymmetrical
or symmetrical or symmetrical
33
biphasic biphasic
Stimulation Modes Adaptive Adaptive
timing timing,
& fixed timing fixed timing &
no time out
Foot Switch Control Heel rise & Heel rise &
heel strike heel strike
Safety shrouded electrode lead connector Yes Yes
Footswitch connector 2.5mm jack 2.5mm jack
Electrode and footswitch extension leads Extra flexible Extra flexible
tinsel wire tinsel wire
Audio feedback of stimulation output Yes Yes
Plug in Integral
sounder sounder
module
Audio feed back of device status Paused or Paused, active,
Active on, off, low
indicated battery and
stimulation
level indicated
Electrodes Pals platinum Pals platinum
blue 50 x blue 50 x
50mm 50mm
#901220 #901220
Electrodes freely adjustable for position in order to Yes Yes
cater for all clinical presentations.
Device carries CE mark to show compliance with Yes Yes
European Medical Device Directive and applicable Class IIa, type Class IIa type
harmonised standards. BF BF
Device instruction manuals Clinician Clinician
Manual Manual
User Manual User Manual
Clinician Quick
Start Guide,
User Quick
Start Guide –
improved
description of
clinical
application
34
Biological comparison
Neither device uses active biological agents.
Table 4 Summary of the materials that are in contact with the body
Material ODFS®III ODFS®-Pace

Pals stimulation Component CAS-No. Component CAS-No.
electrode Glycerin, non-tallow 56-81-5 Glycerin, non-tallow 56-81-5
Water 7732-18-5 Water 7732-18-5
Poly(acrylate) Poly(acrylate)
Co-polymer 28062-44-4 Co-polymer 28062-44-4
Pals Platinum blue and Component CAS-No. Component CAS-No.
Covidien s-series Uni- Polyethylene Glycol 25322-68-3 Polyethylene Glycol 25322-68-3
patch Water 7732-18-5 Water 7732-18-5
Polyvinylpyrrolidone 9003-39-8 Polyvinylpyrrolidone 9003-39-8
Magnesium Acetate 16674-78-5 Magnesium Acetate 16674-78-5
Stimulator enclosure ABS ABS

Stimulator pouch PVC, leather
Electrode and PVC PVC
footswitch leads
insulation
Foot switch covering acetate acetate
The two systems use the same materials. Please refer to document ‘Assessment of parts that
can contact the patient (incl. bio assessment)’ located in the Risk Management File. This
includes further details of biological assessments.
Discussion
The parameters and features of the ODFS®III are duplicated by the ODFS® Pace.
However, the ODFS®III is an analogue device while the ODFS® Pace is digital. This
means the parameters are adjusted in discrete steps instead of being continually
variable. Testing the device on my self, the individual steps in timing, current and pulse
width parameters appeared gradual with no abrupt changes. The degree of adjustment
was appropriate for clinical use and this was confirmed by later clinical use. Step
changes in Frequency are more noticeable but this is acceptable as this parameter is not
used to determining precise contraction strength. Contraction strength is always fine
tuned using the current or pulse width adjustment. Its default value of 40Hz is the same
as the ODFS®III; however the extra flexibility of being able to modify the frequency is a
welcome addition as it allows modulation of reflex responses and control of muscle
fatigue.
Adjustment of clinical Parameters

A significant difference between the ODFS® Pace and the ODFS®III is the way the device
parameters are adjusted. In the ODFS®III all the device controls could be viewed at one
35
time and this meant it was possible to see how the device was set up at a glance. It is
not possible to display all the device parameters at the same time due to the limitations
of the LCD. While initially this appeared to be a disadvantage, because when setting the
ODFS® Pace the stimulation parameters are set to standard default values, appropriate
to an “average” device user, only small adjustments are usually required and the
clinician quickly learns to adjust the parameters one at a time. Once use to the menu
structure, the device takes about the same time to set up as the ODFS®III. The setup
process is aided by the order of presentation of the parameters, the most commonly
adjusted parameters of rising ramp and extension being offered first while less often
adjusted parameters being shown later. The default setting makes it harder to make
mistakes while setting up the device and if the inexperienced clinician does get lost, the
default settings are easily reset. The button sequence used to enter the setup mode
ensures that the mode is not accidently entered by users. While not a significant
problem with the ODFS®III, clinician controls were occasionally accidently moved by
users and this problem has been eliminated.
Exercise mode
It is common in clinical practice to use exercise stimulation (cyclic stimulation
controlled by a timer) to prepare patients for walking with FES. The exercise is used to
increase the strength of the dorsiflexion muscles and increase the range of motion of the
ankle. When using the ODFS®III, it was necessary to use a separate device for this
function as the ODFS®III did not have an exercise facility. Inclusion of this function in
the ODFS® Pace means that an additional stimulator is not required. The range of
parameters available in the exercise mode are common to many commercially available
exercise devices, including OML’s Microstim 2V2.
Usage Log
This feature allows the recording of device usage, enabling treatment compliance and
progress to be monitored.
36
Assessment of device efficacy
The ODFS® Pace was introduced to the National Clinical FES Centre clinic in August
2009. Since that time all new dropped foot patients have received the ODFS® Pace and
approximately 100 existing ODFS®III users have transferred to the ODFS® Pace.
As part of our standard clinical procedure, the walking speed and physiological cost
index of all patients is recorded at the initial device set up and again at a follow up
appointment 18 week later. This report examines the changes in these parameters of
24 new users of the ODFS® Pace and compares the response with previously published
data of users of the ODFS®III1.
Method
Recruitment
All patients were referred to the Nation Clinical FES Centre for improvement in walking
using FES by General Practitioners or Medical Consultants. Patients were funded by the
UK’s National Health Service.
Selection Criteria
 A single dropped foot due to an upper motor neuron condition
 Able to walk a minimum of 10m. Use of any appropriate mechanical aid was
permissible
 Able to obtain standing from sitting without assistance from another person
 18 years of age or over
 No significant medical conditions that would affect the response to stimulation.
 Able to tolerate the sensation of electrical stimulation
Exclusion Criteria
 Poorly controlled epilepsy
 Poor skin condition preventing toleration of self adhesive electrodes
 Pregnancy
 Implanted active medical devices (unless information could be obtained from the
device manufacture indicating no interaction between the device and the ODFS®
Pace)
Procedure
The same clinical procedure was used as outlined in the paper Taylor P et. al 19991 was
used. Following referral, patients were asked to attend an assessment clinic. At an
appointment lasting approximately 40 minutes, the suitability of FES as an intervention
was assessed. The device was tried and if a suitable response could be obtained and
walking improved, the patient was recommended for treatment. The patient was asked
to return to the clinic to begin treatment at separate date. The device was set up over
37
two days using 2 one hour clinic appointments. At the first appointment the patient was
taught how to use the ODFS® Pace. The device and instruction manuals were issued
together with a printed digital photograph of the electrode positions. The next day, at
the second appointment, the patients’ ability to use the device was checked and extra
training given if appropriate. The outcome measures of walking speed and
Physiological Cost Index (PCI) were then taken. The patient was then asked to return to
the clinic 6 weeks later for follow up and again three months later, 18 weeks after first
receiving the device. The outcome measures were repeated at these follow up
appointments. Patients were encouraged to contact the clinic if they experienced any
problems.
Outcome measures
Walking speed over 10m: The method described by Barrett C. et al 20102 was used.
Walking speed was recorded with and without stimulation over 10 meters. The total
distance walked each time was 12m, allowing 1m at either end for acceleration and
deceleration. Walking test protocol involved a warm-up 10 meter walk without
electrical stimulation (walk 1), followed by a second walk without stimulation (walk 2),
and finally a walk with electrical stimulation (walk 3). Walks 2 and 3 were used to
produce the clinical data.
Physiological Cost Index (PCI): The PCI was recorded co currently with walking speed.
Heart rate was recorded using a Polar Heart Rate monitor. This consists of an ECG
detector warn around the chest that uses telemetry to communicate with a display unit
warn on a wrist strap. PCI derives a measure of the energy used while walking from the
change in heart rate from resting heart rate and relates this to the walking speed.
PCI (Bt/m) = Change in Heart Rate (Bt/min)

Walking speed (m/min)
PCI makes the following assumption. The increase in energy consumption while
walking is due to the extra work performed by the muscles. The energy used by the
muscles is derived from oxygen circulated to the muscles by the blood. The increase in
blood circulation is related to the change in heart rate so therefore the increase in
energy use is proportional to the change in heart rate.
Adverse Incidence were recorded using the clinics standard procedures
Analysis
The data was described using summary statistics. The statistical significance of changes
in walking speed and PCI were analysed using paired T tests. A p value of 0.05 or less
was taken as statistically significant.
38
Results
24 patients completed the procedure. The demographic data is shown in table 1. 16
patients had non progressive conditions (12 stroke, 2 spinal cord injury, 1 brain Injury
and 1 Parkinson’s disease) while 8 patients had multiple sclerosis.
Table 5 Demographic data

Mean time
since
Mean age diagnosis
Condition Male Female (years) (years)
non progressive 9 7 54.1 sd 13.4 3.4 sd 3.0
progressive 1 7 47.1 sd 22.0 16.9 sd 10.9
Adverse events
No adverse events were reported.
Walking speed
Walking speed results are shown in table 2 and 3.
Table 6 Walking speed (non progressive group)

Week 0 Walk Week 0 Walk Week 18
2 No FES SPEED ms- 3 With FES SPEED Week 18 Walk 2 Walk 3 With FES
1 ms-1 No FES SPEED ms-1 SPEED ms-1
mean 0.72 0.80 0.77 0.88
sd 0.27 0.29 0.27 0.27
max 1.12 1.45 1.24 1.30
min 0.25 0.34 0.35 0.44
Change in walking speed

Training effect ms-1 Orthotic effect orthotic effect week 18 Total orthotic effect
week 0 ms-1 ms-1 ms-1
mean 0.04 0.08 0.11 0.16
sd 0.09 0.14 0.13 0.17
max 0.23 0.43 0.43 0.49
min -0.09 -0.06 -0.08 -0.09
% change in walking speed

Training effect Orthotic effect
week 0 orthotic effect week 18 Total orthotic effect
mean 8.5 15.1 (12) 18.4 (12) 29.5 (27)

sd 15.5 26.8 25.3 37.2
max 40.0 93.5 93.5 111.4
min -12.9 -7.2 -13.3 -14.8
Paired
T test
p= 0.067 0.003 0.003 0.003
39
Table 7 Walking Speed Progressive group (Multiple Sclerosis)
Week 0 Week 18
Week 0 Walk Walk 3 With FES Week 18 Walk 2 Walk 3 With FES
2 No FES SPEED ms-1 SPEED ms-1 No FES SPEED ms-1 SPEED ms-1
mean 0.60 0.67 0.62 0.81
sd 0.34 0.24 0.32 0.22
max 1.45 1.08 1.30 1.03
min 0.13 0.35 0.11 0.46
Change in walking speed

Training effect ms-1 Orthotic effect orthotic effect week 18 Total orthotic effect
week 0 ms-1 ms-1 ms-1
mean 0.08 0.01 0.13 0.18
sd 0.31 0.33 0.10 0.20
max 0.9923 0.43 0.26 0.61
min -0.58 -1 -0.02 -0.06
% change in walking speed

Training effect ms-1 Orthotic effect
week 0 orthotic effect week 18 Total orthotic effect
mean 16.9 (14) 13.3 (5) 20.2 (16) 40.4 (10)
sd 48.4 39.2 18.4 53.2
max 158.4 97.3 48.4 164.9
min -84.1 -60.2 -1.9 -5.6
Paired
T test
p= 0.382 0.008 0.008 0.035
The change in walking speed is looked at in 4 ways.

 Training effect: the change in walking speed between week 0 and week 18 when
the device is not used
 Orthotic effect at week 0: The change in walking speed between unassisted and
FES assisted walking at week 0
 Orthotic effect at week 18: The change in walking speed between unassisted and
FES assisted walking at week 18
 Total orthotic effect: The change in walking speed comparing unassisted
walking at week 0 with FES assisted walking at week 18
The figures in brackets are the % changes taken form Taylor et al 1998.
Non Progressive group

There were statistically significant increases in walking speed when the ODFS® Pace
was used both at set up (15.1%) and at 18 weeks (18.4%). This compares with 12%
orthotic effect at both time points reported by Taylor et al. The total orthotic effect was
29.5%. This compares 27% reported Taylor et al. While the training effect did not quite
reach statistical significance, it is possible that this might be achieved with more data. A
change of 8.5% was achieved compared with 14% in the earlier study.
40
Progressive group
Again statistically significant changes were seen in both orthotic effect at 0 and 18
weeks and also total orthotic effect. The percentage changes in this study were
substantively greater than those reported by Taylor et al.
Physiological cost index (PCI)

PCI results are shown in table 4 and 5.
Table 8 Changes in PCI Non progressive group

Week 0 Week 0 Week 18 Week 18
Walk 2 No FES Walk 3 With FES Walk 2 No FES Walk 3 With FES
PCI Btm-1 PCI Btm-1 PCI Btm-1 PCI Btm-1
mean 0.51 0.48 0.52 0.42
sd 0.25 0.23 0.41 0.23
max 0.93 0.78 1.77 0.83
min 0.09 0.13 0.11 0.11
Change in PCI
Training effect Orthotic effect orthotic effect Total orthotic
Btm-1 week 0 Btm-1 week 18 Btm-1 effect Btm-1
mean 0.01 -0.02 -0.10 -0.08
sd 0.34 0.07 0.25 0.22
max 0.99 0.09 0.05 0.14
min -0.58 -0.19 -1.00 -0.58
% Change in PCI
week 0 week 18 effect
mean 12.5 -3.0 -10.0 -2.2
sd 64.2 19.6 18.2 56.6
max 158.4 41.6 20.0 158.4
min -84.1 -45.8 -56.5 -84.1
Paired T
test p= 0.890 0.139 0.139 0.138
Non Progressive group.

No statistically significant changes were seen in PCI. This is in contrast to Taylor et al
who reported statistically significant reductions in PCI in all 4 comparisons.
41
Table 9 Changes in PCI Progressive group
Week 0 Week 0 Week 18 Week 18
Walk 2 No FES Walk 3 With FES Walk 2 No FES Walk 3 With
PCI PCI PCI FES PCI
mean 0.70 0.60 0.61 0.52
sd 0.52 0.30 0.36 0.20
max 1.78 1.23 1.24 0.86
min 0.03 0.30 0.12 0.23
Change in PCI
Btm-1 week 0 Btm-1 week 18 Btm-1 effect Btm-1
mean -0.05 -0.09 -0.15 -0.34
sd 0.23 0.36 0.18 0.39
max 0.4343 0.49 0 0.03
min -0.54 -1.11 -0.52 -1.06
% Change in PCI
week 0 week 18 effect
mean 1.0 6.5 (-18) -14.9 (-15) -26.0 (-31)
sd 30.7 53.4 14.4 22.4
max 93.5 158.4 0.1 6.8
min -45.8 -84.1 -41.9 -59.6
Paired T
test p= 0.067 0.050 0.050 0.044
Progressive group
Statistically significant changes were seen in both orthotic effects at week 0 and week
18 as well as in total orthotic effect. While the orthotic effect at week 0 was
substantively lower than Taylor et al, the orthotic effect at week 18 and total orthotic
effect were in line with the earlier study.
Conclusion
This study has demonstrated that uses of the ODFS® Pace receive similar benefit from
its use in terms of improved walking speed to users of the ODFS®III device. The effect
on the energy efficiency of gait measured using the Physiological Cost Index was again
similar for those patients who had a dropped foot due to multiple sclerosis. However,
the effect on PCI was less evident in the non progressive group. The reason for this
difference is unknown but it may relate to the slight difference in measurement
technique in the two studies. In the original study three measures of walking speed and
PCI were made in a random order and the results averaged to give the reported
measure. In this study, a new technique as used that used single measurements taken
after a preconditioning 12m walk. While both techniques are non steady state
measures of PCI, it is possible that this new method gave less consistent measures of
heart rate as there was less time heart to respond to the exercise demand.
42
Overall, the ODFS® Pace has been demonstrated to be an effective orthotic device for
correction of dropped foot and its clinical impact in terms of improved walking speed is
similar or greater than its predecessor, the ODFS®III.
References
Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton C, Swain ID. Clinical
use of the Odstock Drop Foot Stimulator - its effect on the speed and effort of walking.
Archives of Physical Medicine and Rehabilitation, 80: 1577-1583, 1999.
2. Barrett C, Taylor PN. The effects of the Odstock Drop Foot Stimulator on Perceived
Quality of Life for People with Stroke and Multiple Sclerosis.
Neuromodulation 2010 13, 1, pp: 58-64
43
Part 2: Clinical effectiveness comparison between the ODFS® III benchmark
device and the ODFS® Pace functional electrical stimulation device.
Post Market Clinical Follow-up.
Tamsyn Street
February 2017
Background:
A comparison between the established ODFS® III bench mark device and the new
ODFS® Pace functional electrical stimulation (FES) device was conducted to assess the
equivalence between the two devices. Ten metre walking speed measurements were
used to assess orthotic effect after 20 weeks of using the device. This outcome measure
is considered as representative of overall gait quality and hence is representative of the
overall efficacy of the device. Orthotic effect which is the difference between walking
with FES and without FES was used as a measure of comparison as it is representative
of established users of FES and has been used as an indicator of the main presumed
benefit of using FES in terms of walking speed.[3]
Methodology:
Data for the ODFS® Pace was taken from a recent publication [3] which included 187
people with MS who had drop foot (117 female, 70 male; mean age, 55y [range, 27-80y];
mean duration since diagnosis, 11.7y [range, 1-56]), 178 presented as unilaterally
impaired with nine presenting as bilaterally impaired. A total of 166 patients were still
using FES after 20 weeks, with 153 patients completing the follow-up measures. Data
for the ODFS® III was taken from archived data of 153 FES users with MS and drop foot
(96 female, 57 male; mean age= 52 [range, 33-71], 15 were bilaterally impaired with
138 presenting as predominantly unilaterally impaired.
Ten metre walking speed data for ODFS® III users was collected using six randomly
arranged walks with three walks with FES and three walks without FES. A different
methodology was used to measure the walking speed of ODFS® Pace users which
included four walks. The first walk was used as a “warm-up walk”, the second
measured unassisted walking, and the third walk was used as a measure of the effect of
FES. The difference between the second and third walk was used to define the orthotic
effect. The method replaced the previous method used with the ODFS® pace primarily
to reduce the number of walks that participants had to do in order to manage fatigue,
enabling increased compliance with the protocol.
Results
The results revealed that both ODFS® III users and ODFS® Pace users were able to
achieve a highly significant continuing orthotic effect (Table 1). Although both users of
the ODFS® III and users of the ODFS® Pace were walking on average at a similar walking
speed after 20 weeks of using FES (0.62 m/s), participants using the ODFS® Pace
44
appeared to increase their orthotic walking speed more than those using the ODFS® III
(Figure 1). A Wilcoxon rank sum test (Mann Whitney U Test) revealed that ODFS® Pace
users walked significantly faster than the benchmark device ODFS® III users (Z=-3.43,
p=0.0006). Both ODFS® III and ODFS® Pace users achieved a clinically important
difference in walking speed.
Table 10 A comparison between ODFS® III and the ODFS® Pace device of continuing
orthotic effect (interquartile range (IQR), confidence intervals (CI))
No FES With FES
mean median mean median Z P Medians of Means of IQR CI
value the the
differences Differences
ODFS® 0.68 0.62 0.75 0.74 9.29 0.0001 0.05* 0.07* 0.02- 0.06-
III 0.11 0.08
ODFS® 0.71 0.7 0.82 0.85 9.01 0.0001 0.09* 0.11* 0.03- 0.02-
Pace 0.16 0.03
Clinically important difference*
Figure 1. A box plot comparing the continuing orthotic effect for the ODFS® III and the
ODFS® Pace. Continuing orthotic effect is measured as the difference in walking speed
between FES on and FES off after 20 weeks of using the device. Continuing orthotic is
representative of the gains made through using FES for established users.
45
Walking Speed m/s
Median=0.04 Median=0.09
0.04
Discussion
A comparison between ODFS® III users of the benchmark device and ODFS® Pace users
revealed that those using the Pace device appear to achieve a significantly faster
walking speed. Nevertheless both devices achieved highly significant changes in
walking speed, which were also found to be clinically important differences in walking
speed.
Conclusions from this data should be made tentatively due to limitations with the
design/methodology of this study. Limitations included using independent samples
from different time periods. The ODFS® III Group while slightly younger than the
ODFS® Pace group, had slightly lower average walking speed at the beginning of
treatment suggesting they may have been, on average, slightly more disabled than
ODFS® Pace group. However, this discrepancy may also relate to the different
methodologies for measuring walking speed. In the ODFS®III group walking speed was
derived from taking the mean of 3 walks with and 3 walks without FES. In the ODFS®
Pace group, walking speed was taken from two walks, one with and one without FES,
preceded by a single warm up walk. Hence it is possible there may be a greater fatigue
factor in the ODFS®II group. It is also likely that the overall clinical technique may have
progressed over the time between the collection of the two data sets. It is notable that
46
the result achieved using the ODFS® Pace had a narrower confidence interval than
achieved with the ODFS®III, indicating greater consistency of outcome. This indicates
that a high level of confidence can be given to the findings of this study.
Conclusion
The ODFS® Pace is as least as effective as the ODFS®III in terms of its effect on walking
speed and hence overall gait quality.
References
1. Street T, Taylor P, Swain I. Effectiveness of Functional Electrical Stimulation on

Walking Speed, Functional Walking Category, and Clinically Meaningful Changes for
People With Multiple Sclerosis. Arch. Phys. Med. Rehabil. 96(4), 667–672 (2015).
47
Part 3: Clinical Comparison of the ODFS® Pace and ODFS® Pace XL

SP2 8BJ, UK
Tel: 0044 1722 429119
Purpose
To compare the performance of the ODFS® Pace XL with its predecessor, the ODFS®
Pace. Both devices use v1.3.xx software series.
Relevant standards
The stimulation parameters of the ODFS® Pace and ODFS® Pace XL were compared.
Both devices use V1.3.xx software The table below compared the parameters of the
devices. This information was obtained from the device manuals
ODFS® Pace [Odstock Dropped Foot Stimulator] and the ODFS®-Pace XL
Reference document
To demonstrate equivalence a comparison will be made between the devices in three

domains; Clinical, Technical and Biological
48
Clinical Comparison
Table 11 Summarises of the clinical aspects of the two devices:
Feature ODFS®-Pace ODFS®-Pace XL

Target clinical condition Paralyse or paraparesis Paralyse or paraparesis
due to an upper motor due to an upper motor
neurone lesion neurone lesion
Intended purpose 3. Correction of dropped 4. Correction of dropped
foot foot
contraction of any contraction of any
muscle involved in muscle involved in
walking at an walking at an
appropriate time in the appropriate time in the
gait cycle gait cycle
5. Exercise of any muscles 6. Exercise of any muscles
Area of the body the 5.

Lower limb 5. Lower limb
device is used in 6.
Upper limb 6. Upper limb
7.
Abdomen 7. Abdomen
8.
Not for use on the chest 8. Not for use on the chest
or neck or neck
6. Not for use in 6. Not for use in
proximity to tumours, proximity to tumours,
active implanted active implanted
devices (without devices (without
additional additional
investigation), adjacent investigation), adjacent
to open wounds, to open wounds,
pregnancy, poorly pregnancy, poorly
controlled epilepsy controlled epilepsy
Foreseen differences in clinical response between the two devices
As the device has the same intended use in the same population, It is not foreseen that
the clinical response will different. The only aspect that may affect the clinical is the
timing of the stimulation related to the gait cycle. His is because the processing of the
signal from the footswitch, its encoding, transmission and reception adds a delay in
comparison to a wired connection. This aspect was examined and tested in detail and
described in the PhD thesis of CA Mecheraoui “Development of a wireless distributed
three-channel stimulator system used for automated triggering of stimulation to enable
coordinated task execution in stroke patients” chapter 5. It was demonstrated that a
delay of up to 75ms did not affect the clinical response of the system. The latency of the
signal was tested under normal conditions and in the presence of wireless interference.
49
Under normal conditions the median latency was 12ms with 100% of transmissions
received within 100ms. Under interference from a blue tooth device, the median
transmission increased to 13.5ms with 99.78% of transmissions received in 100ms.
These tests demonstrate that it is highly likely that the devices will deliver the same
clinical response both in normal conditions and in the presence of radio interference.
Table 12 Summarises of the technical aspects of the device:

Conditions that the device is used in 1. Yes 1. Yes
1. Indoors 2. Yes but not 2. Yes but not
2. Clinic within 2m of within 2m of
shortwave shortwave therapy
therapy devices
devices 3. No
3. Operating Theatres 3. No 4. Yes
4. Office environment 4. Yes 5. Yes
5. Industrial environment 5. Yes 6. No
6. Aircraft take off 6. No 7. No but
7. Aircraft in flight 7. Yes wired footswitch
8. Outside good weather 8. Yes may be used
9. Outside heavy rain 9. Not 8. Yes
recommended 9. Not
recommended
Compact device Yes – Yes –
72x62x26mm 72x62x26mm
112gm 112gm
Belt clip fitted Detachable belt Detachable belt
clip on custom clip on custom
pouch pouch
Uses commonly available battery – Yes Yes but sold with 2
alkaline or rechargeable 9 volt PP3/MN1604 rechargeable
lithium polymer
batteries.
Increased power
consumption
makes primary
cells uneconomic
for regular daily
use
Device configured without use of PC or other Yes Yes

additional equipment

 Rising ramp for comfort and to avoid Yes Yes
50
spastic co-contraction 0 to 2 seconds in 0 to 2 seconds in
50ms steps 50ms steps
 Stimulation intensity adjusted by user Yes Yes
Pulse width 0 to Pulse width 0 to
360μs in 100 3.6μs 360μs in 100 3.6μs
steps steps
 Stimulation extension to avoid foot ‘slap’ Yes Yes
0 to 2 seconds in 0 to 2 seconds in
 Falling ramp for comfort and control of Yes Yes
ankle in early stance phase. 0 to 2 seconds in 0 to 2 seconds in
 Limit to maximum current available Yes Yes
10 to 100mA in 10 to 100mA in
increments of 4% increments of 4%
Trigger by adaptive footswitch to prolong Yes Yes
reliability of switches and automatically adapt digital + analogue digital + analogue
to different user body weights.
Test button for use while setting outputs and Yes Yes
adjusting electrode positions
Display of user output setting Yes – Percentage Yes – Percentage of
of maximum pulse maximum pulse
width (360µs) width (360µs)
shown on LCD shown on LCD
Output setting locked to avoid unintended Output adjust auto Output adjust auto
adjustment disabled after 4 disabled after 4
seconds (default) seconds (default)
adjustable 1 to 10 adjustable 1 to 10
seconds or seconds or
disabled. disabled.
Indicator of stimulation output Yes – LED and LCD Yes – LED and LCD
bar display bar display
4 levels of battery 4 levels of battery
level indicated on level indicated on
the LCD (GOOD, the LCD (GOOD,
OK, POOR, OK, POOR,
REPLACE) REPLACE)
Battery life 3 – 6 weeks using 3-6 weeks if wired

an alkaline footswitch used
battery. (alkaline or
4-8 days using Lithium Polymer).
MiMH 1-2 days if wireless
rechargeable footswitch used.
MiMH not
recommended for
wireless operation
Stimulation Frequency 20 to 60Hz 20 to 60Hz
51
In 5Hz steps In 5Hz steps
Default 40Hz Default 40Hz
Stimulation waveform Asymmetrical or Asymmetrical or
symmetrical symmetrical
biphasic biphasic
Stimulation Modes Adaptive timing, Adaptive timing,
fixed timing & no fixed timing & no
time out time out
Foot Switch Control Heel rise & heel Heel rise & heel
strike strike
Safety shrouded electrode lead connector Yes Yes
Electrode and footswitch extension leads Extra flexible Extra flexible tinsel
tinsel wire wire
Wireless footswitch No Wireless
footswitch insole
or OML LINQ
Integral sounder Integral sounder
Audio feed back of device status Paused, active, Paused, active,
(walking) Paused, (walking) Paused,
active, (exercise) active, (exercise)
on, off, low on, off, low battery,
battery, user menu user menu entry
entry and exit and and exit and stim
stim mode, heal mode, heal rise and
rise and heel strike heel strike and
and stimulation stimulation level
level indicated indicated
Additional low
battery warning
for wireless
module low
battery
Exercise Mode Yes Yes
Exercise mode parameters Enabled / not Enabled / not
enabled enabled
Exercise time 5- Exercise time 5-
100min + 100min +
unlimited unlimited
Current 10 – Current 10 –
100mA, Waveform 100mA, Waveform
SYMM or ASYM SYMM or ASYM
Frequency 20 – Frequency 20 –
60Hz (5Hz steps) 60Hz (5Hz steps)
On time 0 – 10s On time 0 – 10s
Off time 0-100s Off time 0-100s
Ramp time 0 -6s Ramp time 0 -6s
Electrodes Pals platinum blue Pals platinum blue
52
50 x 50mm 50 x 50mm
#901220. #901220.
Covidien s-series Covidien s-series
Uni-Patch Uni-Patch
51x51mm #696SS 51x51mm #696SS
silver carbon, blue silver carbon, blue
gel. gel.
Pals Plus series Pals Plus series
electrodes electrodes
Axlegaard Axlegaard
Usage Log Steps Steps
No. Walks No. Walks
Walk h:m Walk h:m
No. Exe No. Exe
EXE h:m EXE h:m
Reset in the Reset in the
parameter view parameter view
menu and menu and
clinicians menu clinicians menu
Electrodes freely adjustable for position in Yes Yes
order to cater for all clinical presentations.
Device carries CE mark to show compliance Yes Yes
with European Medical Device Directive and Class IIa type BF Class Iia type BF
applicable harmonised standards.
Device instruction manuals Clinician Manual Clinician Manual
Clinician Quick Clinician Quick
Start Guide, User Start Guide, User
Quick Start Guide Quick Start Guide –
– improved improved
description of description of
clinical application clinical application
Method of deployment Device provided Device provided
and set up by a and set up by a
clinician trained in clinician trained in
its use. Regular its use. Regular
planned follow-up planned follow-up
to ensure to ensure
continued safe and continued safe and
effective use effective use
Principle of operation Electrical Electrical
stimulation stimulation
delivered timed to delivered timed to
the gait cycle using the gait cycle using
a wired footswitch a telemetry
or independent of footswitch or
gait cycle using an independent of gait
internal timer cycle using an
internal timer
53
Neither device uses active biological agents. The following tables summarises the
materials that are in contact with the body
Table 13 Summary of materials in contact with the body.
Material ODFS®-Pace ODFS®-Pace XL

electrode Glycerin, non-tallow 56-81- Glycerin, non-tallow 56-81-5
5 Water 7732-18-5
Water 7732-18- Poly(acrylate)
5 Co-polymer 28062-44-4
Poly(acrylate)
Co-polymer 28062-
44-4
Pals Platinum blue Component CAS-No. Component CAS-No.
and Covidien s- Polyethylene Glycol 25322- Polyethylene Glycol 25322-
series Uni-patch 68-3 68-3
Water 7732-18- Water 7732-18-5
5 Polyvinylpyrrolidone 9003-
Polyvinylpyrrolidone 9003- 39-8
39-8 Magnesium Acetate 16674-
Magnesium Acetate 16674- 78-5
78-5
Stimulator enclosure UBS UBS

Stimulator pouch PVC PVC
footswitch leads
insulation
LINQ outer coating Rubberised coating
The two systems use the same materials. The exception is the coating material used on
the OML LINQ. This is not expected to cause a clinical problem. Please refer to document
‘Assessment of parts that can contact the patient (incl. bio assessment)’ located in the Risk
Management File. This includes further details of biological assessments.
Parameter and Feature Comparison Discussion
The ODFS® Pace XL is designed as variant of the ODFS® Pace and has the exactly the
same intended use. Hence all stimulation parameters are identical. The aspects that
differ between the devices are features of usability so do not directly impact of the clinic
54
outcome achieved. The ODFS® Pace XL has an additional feature that allows
replacement of the footswitch lead with a radio telemetry link. This feature is optional
as connection of a wired footswitch disables the telemetry unit and returns the device
to the same function as a non-wireless ODFS® Pace. Removal of the wired connection is
likely to make dressing easer and may remove the risk of the wire catching on fixed
objects while walking, causing disconnection of connection. Hence the safety as well as
the cosmesiss of the system may be improved. However the addition of telemetry has a
significant effect on power consumption and for this reason the device is supplied with
rechargeable lithium polymer batteries. These give 1 to 2 days use from a single charge.
Changing the battery every 2 days rather than monthly may have a minor negative
impact on the users experience, particularly if hand ability is affected.
Conclusion
In conclusion the ODFS® Pace and ODFS® Pace XL can be considered functionally and
clinically equivalent and any differences between the devices considered as usability
aspects only.
55
Assessment of device efficacy post market follow-up
The ODFS® Pace XL and LINQ wireless foot switch was introduced to the National
Clinical FES Centre clinic in April 2016. .
As part of our standard clinical procedure, the walking speed of all patients is recorded
at the initial device set up and again at a follow up appointment 18 week later. In our
previous report comparing the ODFS® Pace and ODFS®III we compared the effect of
using the devices over the first 18 weeks of FES treatment. Such an approach is not
appropriate for examining the effect of the ODFS® Pace XL because it is normal for
device users to use the wired ODFS® Pace at first and progress to using the ODFS® Pace
XL once it has been demonstrated to the user that FES is useful intervention to them.
Hence the comparison is restricted examining the immediate orthotic effect from using
the devices
Method
Recruitment
All patients were referred to the Nation Clinical FES Centre for improvement in walking
using FES by General Practitioners or Medical Consultants.
Selection Criteria
 A single dropped foot due to an upper motor neuron condition
 Able to walk a minimum of 10m. Use of any appropriate mechanical aid was
permissible
 Able to obtain standing from sitting without assistance from another person
 18 years of age or over
 No significant medical conditions that would affect the response to stimulation.
 Able to tolerate the sensation of electrical stimulation
Exclusion Criteria
 Poorly controlled epilepsy
 Poor skin condition preventing toleration of self adhesive electrodes
 Pregnancy
 Implanted active medical devices (unless information could be obtained from the
device manufacture indicating no interaction between the device and the ODFS®
Pace)
Procedure
The same clinical procedure was used as outlined in the paper Taylor P et. al 19991 was
used. Following referral, patients were asked to attend an assessment clinic. At an
appointment lasting approximately 40 minutes, the suitability of FES as an intervention
was assessed. The device was tried and if a suitable response could be obtained and
56
walking improved, the patient was recommended for treatment. The patient was asked
to return to the clinic to begin treatment at separate date. The device was set up over
two days using 2 one hour clinic appointments. At the first appointment the patient was
taught how to use the ODFS® Pace. The device and instruction manuals were issued
together with a printed digital photograph of the electrode positions. The next day, at
the second appointment, the patients’ ability to use the device was checked and extra
training given if appropriate. The outcome measure was walking speed. The patient
was then asked to return to the clinic 6 weeks later for follow up and again three
months later, 18 weeks, 42 weeks and then yearly for as long as the device was used.
The outcome measure was repeated at each follow up appointments. Patients were
encouraged to contact the clinic if they experienced any problems.
Outcome measures
Walking speed over 10m: The method described by Barrett C. et al 20102 was used.
Walking speed was recorded with and without stimulation over 10 meters. The total
distance walked each time was 12m, allowing 1m at either end for acceleration and
deceleration. Walking test protocol involved a warm-up 10 meter walk without
electrical stimulation (walk 1), followed by a second walk without stimulation (walk 2),
and finally a walk with electrical stimulation (walk 3). Walks 2 and 3 were used to
produce the clinical data.
Adverse Incidence were recorded using the clinics standard procedures
Analysis
Data from users of the ODFS® pace XL and LINQ was compared with data taken from the
original acceptance testing of the ODFS® Pace. The data was described using summary
statistics. The statistical significance of changes in walking speed and PCI were
analysed using paired T tests. A p value of 0.05 or less was taken as statistically
significant.
Results
Data was available for 15 users of the ODFS® pace XL and link LINQ. This was compared
with date taken from 16 users of the ODFS® Pace. The results are shown in table 1
Table 14 Walking speed with and without FES. Wired v telemetry footswitch
ODFS® Pace ODFS® Pace XL + LINQ
No FES With Orthotic No With Orthotic
FES effect FES FES effect
mean 0.77 0.86 0.11 0.54 0.66 0.12
sd 0.27 0.27 0.13 0.23 0.28 0.10
+/- 0.15 0.14 0.07 0.14 0.15 0.05
confidence
interval
median 0.66 0.91 0.09 0.45 0.54 0.11
25th 0.56 0.62 0.02 0.33 0.49 0.09
57
percentile
75th 1.06 1.11 0.17 0.73 0.88 0.16
percentile
paired t-test 0.00344 0.00025
Wilcoxon 0.00348 0.00121
t-test 0.818
Mann Whitney u 0.552
Despite difference in walking speed between the two devices the data shows that both
devices produce the same orthotic benefit. This indicates that both devices produce the
same clinical effect
Conclusion
The ODFS® pace and ODFS® Pace XL are clinical equivalent.
58
Part 4: Comparison of the ODFS® Pace XL V1.3 software & V1.0 Hardware
with the ODFS® Pace XL V1.4 software & V1.1 Hardware
Pre-release evaluation.

SP2 8BJ, UK
Tel: 0044 1722 429119
Purpose
To show equivalence between ODFS® Pace XL (software V1.4 & v1.1 hardware) with its
predecessor, the ODFS® Pace XL (software V1.3 hardware V1.0).
Relevant standards
The stimulation parameters of the devices were compared. The table below compared
the parameters of the devices. This information was obtained from the device manuals
ODFS® Pace [Odstock Dropped Foot Stimulator] and the ODFS®-Pace XL
Reference document
To demonstrate equivalence a comparison will be made between the devices in three

domains; Clinical, Technical and Biological
59
Clinical Comparison
Table 15. Summary of the clinical aspects of the two devices:
Feature ODFS®Pace XL ODFS®Pace XL

Software V1.3 Software V1.4
Hardware V1.0 Hardware V1.1
Target clinical condition Paralyse or paraparesis Paralyse or paraparesis
due to an upper motor due to an upper motor
neurone lesion neurone lesion
Intended purpose 1. Correction of 1. Correction of
dropped foot dropped foot
contraction of any contraction of any
muscle involved in muscle involved in
walking at an walking at an
appropriate time in appropriate time in
the gait cycle the gait cycle
3. Exercise of any 3. Exercise of any
muscles muscles
Area of the body the 1. Lower limb 1. Lower limb

device is used in 2. Upper limb 2. Upper limb
3. Abdomen 3. Abdomen
4. Not for use on the 4. Not for use on the
chest or neck chest or neck
3. Not for use in 3. Not for use in
proximity to proximity to
tumours, active tumours, active
implanted devices implanted devices
(without additional (without additional
investigation), investigation),
adjacent to open adjacent to open
wounds, pregnancy, wounds, pregnancy,
poorly controlled poorly controlled
epilepsy epilepsy
Foreseen differences in clinical response between the two devices
Both versions of the device have the same clinical purpose, indications and target group.
It is not foreseen that the clinical response will be effected by the device used.
60
Table 16. Summary of the technical aspects of the devices

Conditions that the device is used in 1. Yes 1. Yes
1. Indoors 2. Yes but not 2. Yes but not
2. Clinic within 2m of within 2m of
shortwave shortwave therapy
therapy devices
devices 3. No
3. Operating Theatres 3. No 4. Yes
4. Office environment 4. Yes 5. Yes
5. Industrial environment 5. Yes 6. No
6. Aircraft take off 6. No 7. No but wired
7. Aircraft in flight 7. Yes footswitch may be
8. Outside good weather 8. Yes used
9. Outside heavy rain 9. Not 8. Yes
recommended 9. Not
recommended
Compact device Yes – Yes –
72x62x26mm 72x62x26mm
112gm 112gm
Belt clip fitted Detachable belt clip on Detachable belt clip on
custom pouch custom pouch
Uses commonly available battery – Yes but also sold with Yes but also sold with
alkaline or rechargeable 9 volt 2 rechargeable lithium 2 rechargeable lithium
PP3/MN1604 polymer batteries. polymer batteries.
Increased power Increased power
consumption makes consumption makes
primary cells primary cells
uneconomic for uneconomic for
regular daily use regular daily use
Device configured without use of PC or Yes Yes

other additional equipment

 Rising ramp for comfort and to Yes Yes
avoid spastic co-contraction 0 to 2 seconds in 50ms 0 to 2 seconds in 50ms
steps steps
 Stimulation intensity adjusted Yes Yes
by user Pulse width 0 to Pulse width 0 to
360μs in 100 3.6μs 360μs in 100 3.6μs
steps steps
 Stimulation extension to avoid Yes Yes
foot ‘slap’ 0 to 2 seconds in 50ms 0 to 2 seconds in 50ms
steps steps
 Falling ramp for comfort and Yes Yes
61
control of ankle in early stance 0 to 2 seconds in 50ms 0 to 2 seconds in 50ms
phase. steps steps
 Limit to maximum current Yes Yes
available 10 to 100mA in 10 to 100mA in
increments of 4% increments of 4%
 Delay Yes Yes
0 to 2s in 50ms 0 to 2s in 50ms
increments increments
 Period time Yes Yes
300 to 6000ms in 300 to 6000ms in
50ms increments 50ms increments
Trigger by adaptive footswitch to Yes Yes
prolong reliability of switches and digital + analogue digital + analogue
automatically adapt to different user
body weights.
Test button for use while setting Yes Yes
outputs and adjusting electrode
positions
Display of user output setting Yes – Percentage of Yes – Percentage of
maximum pulse width maximum pulse width
(360µs) shown on (360µs) shown on
LCD LCD
Output setting locked to avoid Output adjust auto Output adjust auto
unintended adjustment disabled after 4 disabled after 4
seconds (default) seconds (default)
adjustable 1 to 10 adjustable 1 to 10
seconds or disabled. seconds or disabled. A
lock symbol is
displayed when the
control is locked.
Output intensity (pulse width %) at The clinician can The clinician can
switch on choose 0% or 50%. choose 0%, 50% or
last used value.
Indicator of stimulation output Yes – LED and LCD bar Yes – LED and LCD bar
display display
4 levels of battery 4 levels of battery
level indicated on the level indicated on the
LCD (GOOD, OK, LCD (GOOD, OK,
POOR, REPLACE) POOR, REPLACE)
Battery life 3-6 weeks if wired 3-6 weeks if wired

footswitch used footswitch used
(alkaline or Lithium (alkaline or Lithium
Polymer). 1-2 days if Polymer). 1-2 days if
wireless footswitch wireless footswitch
used. used.
MiMH not MiMH not
recommended for recommended for
62
wireless operation wireless operation
Stimulation Frequency 20 to 60Hz 10 to 60Hz
In 5Hz steps In 5Hz steps
Default 40Hz Default 40Hz
Stimulation waveform Asymmetrical or Asymmetrical or
symmetrical biphasic symmetrical biphasic
Stimulation Modes Adaptive timing, Adaptive timing,
fixed timing & no time fixed timing & no time
out out
Foot Switch Control Heel rise & heel strike Heel rise & heel strike
Safety shrouded electrode lead Yes Yes
connector
Electrode and footswitch extension Extra flexible tinsel Extra flexible tinsel
leads wire wire
Wireless footswitch Wireless footswitch Wireless footswitch
insole or OML LINQ insole or OML LINQ
Integral sounder Integral sounder
Audio feed back of device status Paused, active, Paused, active,
(walking) Paused, (walking) Paused,
active, (exercise) on, active, (exercise) on,
off, low battery, user off, low battery, user
menu entry and exit menu entry and exit
and stim mode, heal and stim mode, heal
rise and heel strike rise and heel strike
and stimulation level and stimulation level
indicated Additional indicated Additional
low battery warning low battery warning
for wireless module for wireless module
low battery low battery
Exercise Mode Yes Yes
Method choosing mode Selectable in user Wired version –
accessible menu Exercise selectable by
removing footswitch
jack from the
stimulator
Wireless version -
Selectable in user
accessible menu
Exercise mode parameters Enabled / not enabled Enabled / not enabled
Exercise time 5- Exercise time 5-
100min + unlimited 100min + unlimited
Current 10 – 100mA, Current 10 – 100mA,
Waveform SYMM or Waveform SYMM or
ASYM ASYM
Frequency 20 – 60Hz Frequency 10 – 60Hz
(5Hz steps) (5Hz steps)
On time 0 – 10s in 1s On time 0 – 20s in 0.5s
63
steps steps
Off time 0-10s in 1 s Off time 0-20s in 1s
steps steps
Ramp time 0 -6s Ramp time 0 -6s
Electrodes Pals platinum blue 50 Pals platinum blue 50
x 50mm #901220. x 50mm #901220.
Covidien s-series Uni- Covidien s-series Uni-
Patch 51x51mm Patch 51x51mm
#696SS silver carbon, #696SS silver carbon,
blue gel. blue gel.
Pals Plus series Pals Plus series
electrodes Axlegaard electrodes Axlegaard
Usage Log Steps (incremental Total Steps
count of number of (previously steps)
steps taken)
No. Walks (number of No. Walks (as

times the pause previous but only
button is pressed to counted if at least one
begin walking) step taken)
Walk h:m (agaragate Walk h:m (as previous

time between pause but only counted if at
button presses to start least one step taken)
and stop walking)
Does h:m (total time
No. Exe (Total number of stimulation (bottom
of time exercise mode of rising ramp to
is entered) bottom of falling
ramp)
EXE h:m (Total time
spent in exercise No. Exe (as previous
mode) but only counted if at
least one exercise
The above logs can be envelope delivered)
reset in the parameter
view menu and EXE h:m (as previous
clinicians menu but only counted if at
least one exercise
envelope delivered)
The above logs can be

reset in the parameter
view menu and
clinicians menu
My Steps (an
incremental count of
steps intended for use
64
by the device user. It
is reset from the User
Accessible Menu Only)
Σ Steps (an
incremental count of
steps intended to
record the total use of
the device over its life
time. It is viewed in
the parameter view
mode and cannot be
reset.
Flight safe mode Wireless operation Flight safe mode

disabled by plugging accessed by using the
in a wired footswitch user accessible menu.
Aeroplane symbol
displayed on screen
when in flight safe
mode.
Electrodes freely adjustable for Yes Yes
position in order to cater for all clinical
presentations.
Device buttons Rubber buttons As before but with
activating pause and improved sensitivity
test functions
Battery clips Bent mild steal clips As before but with
improved stiffness
Device carries CE mark to show Yes --
compliance with European Medical Class IIa type BF Class IIa type BF
Device Directive and applicable
harmonised standards.
Device instruction manuals Clinician Manual Clinician Manual
Clinician Quick Start Clinician Quick Start
Guide, User Quick Guide, User Quick
Start Guide – Start Guide –
improved description improved description
of clinical application of clinical application
Method of deployment Device provided and Device provided and
set up by a clinician set up by a clinician
trained in its use. trained in its use.
Regular planned Regular planned
follow-up to ensure follow-up to ensure
continued safe and continued safe and
effective use effective use
Principle of operation Electrical stimulation Electrical stimulation
delivered timed to the delivered timed to the
65
gait cycle using a gait cycle using a
wired footswitch or telemetry footswitch
independent of gait or independent of gait
cycle using an internal cycle using an internal
timer timer
Differences marked using filled boxes and are discussed below.
Neither device uses active biological agents. The following tables summarises the
materials that are in contact with the body:
Table 17 Materials in contact with the human body

Material ODFS®-Pace ODFS®-Pace XL
electrode Glycerin, non-tallow 56-81-5 Glycerin, non-tallow 56-81-5
Water 7732-18-5 Water 7732-18-5
Poly(acrylate) Poly(acrylate)
Co-polymer 28062-44-4 Co-polymer 28062-44-4
Pals Platinum blue Component CAS-No. Component CAS-No.
and Covidien s- Polyethylene Glycol 25322-68-3 Polyethylene Glycol 25322-68-3
series Uni-patch Water 7732-18-5 Water 7732-18-5
Polyvinylpyrrolidone 9003-39-8 Polyvinylpyrrolidone 9003-39-8
Magnesium Acetate 16674-78-5 Magnesium Acetate 16674-78-5
Stimulator enclosure ABS ABS

Stimulator pouch PVC PVC
footswitch leads
insulation
LINQ outer coating Rubberised coating Rubberised coating
The two systems use the same materials.
Parameter and Feature Comparison Discussion
The two versions of the device are intended for the same purpose and for use by the
same clinical groups. The changes made between the devices does not effect this. The
changes are intended to improve the usability of the device and increase its flexibility
when addressing clinical problems. The following changes are identified:
Control lock: A lock symbol is displayed whe the control ok is active. This will aid the
users understanding of the device.
Output intensity at switch on: The addition of switching on at the last used setting will
increase the convenience for some users. However, this feature will not suit all users
66
and the clinicians will need to judge which users this feature is suitable for. Guidelines
are given in the instruction manual.
Stimulation frequency range: The lower frequency range has been lowered from 20 to
10Hz. This useful for applications where fatigue is a concern or in applications to
increase blood flow. As with all parameters there is a need to choose this option only
where appropriate and additional guidance has been added to the instruction manual.
Method of choosing Walk & Exercise mode: The v1.4 software reverts back to the
method used in earlier versions of the device, i.e., pulling out the footswitch jack to
enter exercise mode. This follows feedback that this method was simpler for device
users.
Exercise mode parameters: The ON time range has increased from 0s – 20s to 0s – 20s
and is now adjustable in 0.5s increments instead of 1s. Similarly the OFF time range has
been changed from 0 to 20s from 0 to 10s but remains in 1s increments. This will allow
greater flexibility of clinical application.
Usage Log: Additional parameters have been added, increasing the information on how
the device has been used and the accuracy of the existing ones improved. The addition
of MY STEPS will allow users to set themselves daily activity targets and may improve
adherence to device use
Flight Safe mode: The addition of a aeroplane symbol will improve the usability of thie
feature.
Hardware changes. Buttons and battery clips: The new buttons are easier to press than
the previous version and the more robust clips should improve reliability.
Conclusion
In conclusion the ODFS® Pace XL Change from 1.3 to 1.4 versions of the software and
from 1.0 to 1.1 version of the hardware do not change the main clinical purpose of the
device. The changes are restricted to the areas of usability and reliability.
Required further evaluation
The differences between the new and old version of the ODFS® Pace XL are insufficient
to require a formal clinical investigation. However, a clinical assessment of the usability
of the changes should be performed to verify there is no negative impact on device
usability.
67
Section 4.3 Clinical data held by the manufacture
Clinical data held by the manufacture has been included in the preceding and following
sections and has not been treated separately.
68
Section 4.4 Clinical data from the literature
Literature Search Strategy

The literature search strategy for this clinical evaluation formed an update of a previous
document (The Case for the Odstock Dropped Foot Stimulator (ODFS®) A summary of
the published evidence for the Odstock Dropped Foot Stimulator. Paul Taylor,
Consultant Biomedical Engineer, National Clinical FES Centre). This document
summarises the evidence for the ODFS and has been updated approximately every two
years. For this review it has been incorporated into this document to compile with the
new standard (MEDDEV 2.7/1 revision 4.) The searches to inform this document have
been updated using the search method described below.
The sources used to complete the search included Embase, Medline, Cinahl and Pedro.
The primary search question was very broad, search terms are highlighted and in bold:
“What is the evidence base for the effectiveness of Functional electrical stimulation
(FES) of the peroneal nerve for the treatment of weakness/ paralysis in the lower
limb/leg for foot drop/dropped foot/drop foot.”
Search terms included:

Functional Electrical stimulation
FES
Electrical stimulation
Neuromuscular electrical stimulation
NMES
Dropped foot
Foot drop
Drop foot
Stroke
CVA
Multiple sclerosis
MS
Cerebral Palsy
CP
Head injury
Traumatic Brain injury
TBI
Familial Spastic paraparesis
Hereditary Spastic Paraparesis
HSP
FSP
Spinal cord injury
SCI
Peroneal nerve stimulation
Additionally, alerts are received from online media and journals of current publications
and these are continually collected and incorporated into the review at its next revision.
69
Studies were first reviewed on their titles and then if believed to be relevant, reviewed
on their abstract. If still judged to be relevant full versions of the articles were obtained
and a final decision made as its inclusion in the review made. The article was then
scored (see section 4.5.1) and a narrative description summarising its findings written.
Where there was strong evidence for the technique from studies that used either the
ODFS®III or the ODFS®Pace, for example in stroke or multiple sclerosis, this evidence is
presented alone. Where there is less evidence from studies that used these devices but
studies that used other devices supports the technique, for example in cerebral palsy,
this additional evidence is presented.
Two reviewers read through each study and excluded studies that did not use FES while
walking, used implanted stimulators; studies that that stimulated additional muscle
groups; studies that used other devices such as Brain Computer Interfacing (BCI)
technologies, robotics, video gaming. Studies were further excluded that included novel
technologies presenting a new operating system e.g. use of motion sensory driven
systems. Studies which included an additional novel intervention to be used alongside
FES were also excluded e.g. transcranial direct current stimulation (tDCS). Small case
studies of five participants or less were excluded. Studies that used other FES devices
such as a tilt sensor were weighted accordingly affording a higher weighting to devices
that used a similar mechanism to the device under review (see next section) Studies not
in English or reporting non-human use were also excluded.
The intended purpose of FES for the correction of dropped foot.
The intervention is intended to provide a practical assistive device enabling daily mobility for
people who have dropped foot due to upper motor neurone neurological conditions.
Specifically, electrical stimulation of the common peroneal nerve causes dorsiflexion and
eversion of the foot through the swing phase of gait.
By convention, the effects on the user are described in two ways. The orthotic effect is the
direct effect of using the FES when the device is used (FES switched on). The second effect is the
training or therapeutic effect and relates to changes in walking ability when not using FES (FES
switched off) that can be attributed to using FES for a period of time. This is sometimes also
referred to as carry-over effect, which is the short term improvement in walking immediately
following use of FES.
The ODFS® has the following practical orthotic effects:

 The foot is prevented from catching the ground as it is brought forward. This
improves the safety of gait.
 The foot contacts the ground at the end of the swing phase with the heel and
with slight eversion. This ensures weight bearing through the centre or slightly
medially to the centre line of the foot leading to greater ankle stability in stance
improving the safety of weight bearing.
 Walking speed is increased
 The effort of walking is reduced.
 The walking range (distance) is increased
 The above affects lead to a greater confidence when walking, greater
independence and participation and an overall improvement in quality of life.
70
In addition to the direct orthotic effect of using the device as an orthosis there can also be
therapeutic effects.
 Most FES users with dropped foot due to stroke and spinal cord injury and 1/3
of people with MS improve their walking without the device after using the
device for several months.
 The effect of electrical stimulation on improving muscle strength, fatigue
resistance, muscle bulk, local blood supply and skin condition are well
established.
While the therapeutic effects of FES are of benefit to many FES users, the primary use of the
device is as an orthosis, providing practical and effective gait assistance in everyday life.
71
Section 4.5 Summary and appraisal
This section is divided in to two parts. The first part examines the evidence for clinical
benefit of the ODFS® family of devices (4.5.1). The second part examines the evidence
for the severity of the risks associated with their use (4.5.2).
Section 4.5.1 Evidence for clinical benefit of the ODFS® family of

devices
This review
Functional Electrical Stimulation (FES) for correction of dropped foot due to an upper motor
neuron lesion was first evaluated by Liberson3. Salisbury District Hospital developed the
Odstock Dropped Foot Stimulator (ODFS®) based upon the device first used and described by
Liberson. To date (2017), around 20,000 ODFS® units have been produced and the ODFS® has
been the subject of multiple clinical investigations. There are over fifty published peer reviewed
journal articles relating to the ODFS® and many additional reports, articles and abstracts. A
summary of the primary clinical trials, case series and retrospective studies relating to the
ODFS® are presented here. While there is a growing body of literature relating to other FES
devices, this is not included in this review except where directly relevant.
Study weighting method
The selected studies were rated using the following methods. First they were scored using the
van Tuldar assessment method61. This method is primarily intended to rate randomised control
trials (RCTs). Hence the van Tuldar score is almost always higher for RCTs than for case-series
or post-market clinical follow-up. This can give an impression that the latter studies are of
poorer quality than the RCTs and hence should be considered less important. However, this
fails to take into account that the studies are designed for different purposes and provide
different information. It is increasingly accepted that the once afforded status of RCT’s as the
“gold standard” is limited by the context of the reserach62, 63, 64, 65. RCTs, in an effort to control
confounding variables to ensure scientific rigour, can sometimes be performed in an artificial
environment, perhaps providing considerably more clinical input than would be available in
standard clinical practice or use a comparator that is not standard care. This can limit their
relevance to standard clinical practice. Well-designed post market clinical follow-up studies
can often provide much more realistic information, reporting the “real life” effect, and hence can
be considered more ecologically valid. This is particularly the case where the underlying
condition is either stable (stroke, spinal cord injury, cerebral palsy) or declining (multiple
sclerosis, Parkinson’s Disease or hereditary spastic paraparesis) enabling the assumption that
any treatment effect observed is very likely to due to the intervention and not spontaneous
recovery. To address these concerns the studies were therefore given an ecological validity
score 1 to 4, where 1 indicated a laboratory based design, 2 indicated a clinical procedure
substantially modified by experimental design and / or nonstandard care comparator, 3
indicated standard clinical practice with some modification by experimental design and 4
indicated a standard clinical practice. To address the issue that evidence is not available for
various aspects of the clinical effect of FES from the ODFS Pace, a relevance score was also
devised as follows: ODFS Pace 5, ODFSIII 4, Other footswitch controlled dropped foot
stimulators 3, Tilt sensor controlled dropped foot stimulators 2, Other dropped foot stimulator
1. Where sufficient evidence is available directly from ODFS devices alone, only this evidence is
72
provided. Where there is insufficient evidence from ODFS devices, evidence from similar
devices is presented. The assessment form is presented below.
Table 18 Study assessment form

Ref no. Study
Van Tuldar Criteria Yes =1 No =0

1. Were the eligibility criteria specified?
2. Was a method of randomization performed?
3. Was treatment allocation concealed?
4. Were prognostic indicators similar for groups at baseline?
5. Were the index and control interventions explicitly described?
6. Was the care provider blinded to the intervention?
7. Were co-interventions avoided or comparable?
8. Was the compliance reported in all groups?
9. Was the patient blinded to the intervention?
10. Was the outcome assessor blinded to the intervention?
11. Were the outcome measures relevant?
12. Were adverse effects described?
13. Was the withdrawal/dropout rate described?
14. Was a short-term follow-up measurement performed? (<1year)
15. Was a long-term follow-up measurement performed? (>1year)
16. Was timing comparable for outcome assessment in both groups?
17. Was the sample size for each group described?
18. Did the analysis include an intention to treat analysis?
19. Was the variability given for primary outcome measures?
Total
Relevance score: ODFS Pace 5, ODFSIII 4, Footswitch controlled DFS 3,

Tilt sensor controlled FES 2, Other dropped foot stimulator 1
Ecological validity score.
1. Lab based design
2. Clinical procedure substantially modified by experimental
design and / or nonstandard care comparator
3. Standard clinical practice with some modification by
experimental design
4. Standard clinical practice.
Size
(total n)
Condition
Design (RCT, Case series, Case-control, PMCF)
The following table summarises the scoring of the studied used in this review. Additionally the
study size, design and main findings are also presented. Main findings are presented as orthotic
effects (OE) where outcome measures are recorded while using the device and therapeutic
effects (TE) where outcome measures are recorded without FES being used. The latter indicates
the training effect from FES.
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Table 19 Summary of reviewed studies scores
Ref 1st Author + Van Relevance Ecological Number of Condition Design Main findings
No. date Tuldar score validity participants
score score
1 Esnouf 2010 13 4 3 54 MS RCT OE-TE 72% fewer falls, improved ADL
3 Liberson 1961 6 3 1 7 CVA CS Improved muscle activity TE
4 Burridge 1997 11 4 3 32 CVA RCT Increased OE speed, reduced PCI
5 Burridge 1997 11 4 3 32 CVA RCT Reduced TE Quadriceps spasticity
6 Wright 2004 12 3 3 22 CVA acute RCT Faster improvement in TE speed. Same as AFO for
OE
7 Johnson 2004 13 4 3 21 CVA RCT Improved TE + OE speed, PCI and Rivermead motor
assessment
8 Sheffler 2013 13 4 2 110 CVA acute RCT Improved TE mEFAP, SSQOL improved but no dif
with AFO. No effects on FMA
9 Sheffler 2015 13 4 2 110 CVA acute RCT TE improved speed, cadence, stride length, hip and
ankle power and hip flexion. No dif with AFO
group
10 Barrett 2009 10 4 3 53 MS RCT OE speed and distance, no TE Control group had
TE
11 Taylor 2013 12 3 2 28 MS RCT FES TE and OE improvements in ROGA, Speed and
MSIS29 Compared to Exercise
12 Taylor 1999 8 4 4 160 CVA, MS, PMCF TE and OE increase in Speed and PCI
SCI
13 Taylor 2002 5 4 4 47 CVA, MS PMCF OE speed maintained long term both groups, TE
speed CVA only. FES cost-effective
14 Swain 2004 7 4 4 158 CVA, MS PMCF OE speed maintained long term both groups, TE
speed CVA only
15 Taylor 2013 10 4 4 127 CVA, MS, PMCF Mean time of FES use 4.9years. FES cost effective.
SCI
16 Street 2015 8 5 4 187 MS PMCF OE speed increase
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17 Barrett 2010 8 4 4 41 CVA, MS PMCF Improved QoL
18 Burridge 2007 6 4 4 20 CVA, MS PMCF OE Increased reduction of effort walking on
uneven surfaces
19 Paul 2008 6 4 3 12 MS PMCF OE Reduce O2 consumption with FES
20 Scott 2013 7 4 1 12 MS CS OE Improved dorsiflexion and knee flexion.
Reduce knee hyperextension. Increased speed
21 Van Der Linden 6 4 1 22 MS CS-C OE FES improved gait kinematics, except push off
2014
22 Mann 2008 8 4 2 10 PD CS TE+OE FES improved speed, step length, distance
and freezing. OE only reduced falls
23 Popa 2013 9 5 3 11 PD CS TE Increase speed, step length and QoL. Reduced
PD symptoms.
24 Taylor 1999 9 4 4 121 CVA, MS, PMCF FES improved confidence, reduces falls and effort.
SCI Device used full time by 50%, and part tome by
remainder.
25 Taylor 2004 8 4 4 211 MS, CVA PMCF FES improves, Independence, confidence and QoL,
and reduces effort.
26 Malone 2002 5 4 4 12 CVA, MS PMCF FES has a big impact on device users and their
carers.
27 Bully 2001 7 4 4 9 CVA PMCF 8/9 users preferred FES to AFO. Ankle freer,
walking more normal, safer and more
independent. FES more comfortable.
28 Wilkie 2011 5 4 4 13 CVA PMCF See ref 27.
29 Street 2015 7 5 4 31 MS PMCF FES users less concerned about falling and
achieved more ADL
31 Swain 1996 12 4 4 32 CVA RCT FES is cost effective.
32 Taylor 2007 12 4 4 32 CVA RCT FES cost effective over 5 years
33 Street 2015 6 5 4 27 MS PMCF EQ-5D-5L value for QALY gain = 0.114
42 Street 2014 5 5 4 40 MS PMCF Improved walking speed with FES compared to
AFO.
43 Salisbury 2013 12 4 3 16 CVA acute RCT FES is feasible with sub-acute stroke patients.
44 Wilkinson 2014 13 4 3 20 CVA acute RCT FES is feasible with sub-acute stroke patients. OE
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speed increase.
45 Van der Linden 8 4 3 9 MS CS FES improved OE kinematics.
2014
47 Taylor 2014 10 4 4 39 MS PMCF Mean FES use 5.5 years and cost effective
51 Singleton 2015 5 5 4 257 MS PMCF OE speed at 18 weeks and 4 years. No TE
52 Khurana 2013 4 1 1 20 MS RCT FES OE reduces energy expenditure compared to
AFO.
54 Taylor 2017 5 5 4 71 MS, CVA PMCF EQ-5D-5L value for QALY gain = 0.114. FES V cost
effective
55 Durham 2004 9 4 3 12 CP CS OE improved gait kinematics.
56 Bailes 2016 8 3 2 12 CP CS OE improved speed and 6m distance. TE
improvement in obstacle avoidance.
57 Pool 2016 13 2 3 32 CP RCT OE on dorsiflexion, stance time and step length.
58 Pool 2016 13 2 3 32 CP RCT Improved ADL with FES use
59 El-Shamy 2016 9 2 3 34 CP RCT OE improved general gait parameters
60 Marsden 2012 6 4 4 11 HSP CS-C OE improved speed, ground clearance and
dorsiflexion.
Abbreviations
CS case series, CS-C case series with matched (non-randomised) control group, CP cerebral palsy, CVA cerebral vascular accident (stroke), HSP
hereditary spastic paraparesis, MS multiple sclerosis, OE orthotic effect, PD Parkinson’s disease, PMCF post market clinical follow-up (study using
prospective data from standard clinical practice) RCT randomised controlled trial, TE training effect.
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Randomized Controlled Clinical Trials of the ODFS®
Stroke
A randomized controlled clinical trial was conducted to evaluate the effect of the Odstock
Dropped Foot Stimulator (ODFS®) on effort and speed of walking in hemiplegic patients with
dropped foot4, 5. Thirty- two chronic post-stroke (>6 months) subjects were randomized to
either a treatment group receiving stimulation with the ODFS® and concurrent physical therapy
or a control group receiving physical therapy alone. During the first month of the trial, all
subjects received 10 sessions of physical therapy. Each session was approximately one hour.
Measurements of walking speed over a distance of 10 metres were collected at baseline, 4
weeks, and 12 weeks following the initial device set-up. Comparisons were made between
mean walking speed at baseline and at the conclusion of the study for each group. At 12-weeks
follow-up, a mean increase in walking speed of 20.5% was observed for the treatment group
(when the stimulator was in use) and 5.2% in the control group. The Physiological Cost Index
(PCI), a measure of walking efficiency, was also evaluated in this study. Improvement was
demonstrated via a reduction in PCI at the conclusion of the study compared to baseline. The
treatment group had a 24.9% reduction of PCI (when the stimulator was in use) whereas the
control group had a 1% reduction. During the course of this trial, no significant carryover effect
of stimulation with the ODFS® device was observed since there were no significant
improvements in walking speed in the treatment group without the use of stimulation.
Wright et al. compared the use of FES or AFO on the gait of 22 participants who were in the
recovery stage following a stroke within the last 6 months6. They were randomly assigned to
use either an Orthomerica Supra-Lite AFO or an Odstock Dropped Foot Stimulator (ODFS®) to
manage their dropped foot and followed over a 24 week period. Both groups demonstrated
significant improvements in walking speed and physiological cost index (t-test, p<0.05). Both
groups showed significantly increased endurance in their walking range (t-test, p<0. 05). This
general recovery was also demonstrated by significant improvements in the Rivermead Mobility
Index (t-test, p<0.05). No significant changes in spasticity were observed measured using the
Ashworth scale. No significant differences between the groups were observed by ANCOVA on
any of these measurements. However, further analysis of the original data examining the
change in walking speed over the first 12 weeks, the period that common peroneal stimulation
alone was used, showed that the FES improved unassisted walking speed by a mean of 0.14ms-1
compared with an increase of 0.09 ms-1 in the AFO group a statistically significant difference (p
=0.004) shown using a Mann Whitney U test, suggesting that FES had a better training effect
than AFO use. This study can be criticised for the relatively small sample size in a population
that was changing through natural recovery.
In an RCT, Johnson et al. investigated the effect of combined botulinum toxin type A (BTX) with
functional electric stimulation (FES) treatment on spastic drop foot in stroke and compared it
with a control group receiving physiotherapy7. 21 ambulant adults who were within 1 year of
stroke with a spastic drop foot were randomly assigned to the two groups. 18 research
volunteers completed the study. The treatment group received BTX injections (Dysport) on 1
occasion into the medial and lateral heads of the gastrocnemius (200U each) and tibialis
posterior (400U each) muscles and FES, used on a daily basis for 16 weeks to assist walking.
Both groups continued with physiotherapy at the same rate. Outcome measures were walking
speed over 10m, Physiological Cost Index (PCI) and Rivermead Motor Assessment (RMA). It
was shown that walking speed increased over 12 weeks in both control (P_.020) and treatment
groups (without stimulation, p=.004; with stimulation, p=.042). The baseline corrected (analysis
77
of covariance) increase in mean walking speed at 12 weeks, relative to controls, was .04m/s
(95% confidence interval [CI], .003–.090) without stimulation, and .09m/s (95% CI, .031– .150)
with stimulation. Statistically significant improvements in PCI and RMA were found in the
treatment group but were not seen in the control group. It was concluded that the combined
treatment effectively improved walking and function. BTX is a useful adjunct to FES where high
calf tone may reduce effective range of movement.
Sheffler et al. performed a randomised controlled trial to investigate the effect on

neuroplasticity by comparing the training effect between AFO (ankle foot orthosis) and FES
users8,9. 110 stroke survivors were randomly allocated to either a group who use the ODFS® or
a group who used a custom made AFO. Subjects were treated for 12 weeks and followed up for
6 months post treatment. Both groups received 2 sessions per week of physiotherapy gait
training over the first 5 weeks of the study reducing to 1 session a week in the following weeks.
After the intervention period the participants returned to using an AFO if they had used one
prior to the study. The principal outcome measure was the Fugl-Meyer Assessment (FMA), an
impairment level test designed to detect change in motor function. Secondary measures were
the modified Emory Functional Ambulation Profile (a test that derives a score based on
measurement of walking speed in 5 different scenarios) recorded without FES (training effect
only) and the Stroke Specific Quality of Life (SSQOL) scale. Overall there was no significant
change in FMA in either group over the course of the study. However, significant improvements
in both mEFAP and SSQOL both at 12 and 24 weeks were seen in both groups. The
improvement in walking speed (mEFAP) is consistent with the previous RCTs and suggests that
there was a reduction in impairment that the FMA was insufficiently sensitive to measure. Only
one of the 16 items in the lower limb section of the FMA relates to ankle dorsiflexion and the
three level scoring system allows only fully (2) partial (1) or absent (0) for each tested
movement. It was noted that participants in the FES group who had no active dorsiflexion prior
to treatment had some active movement after the intervention. This was not seen in the AFO
group. The study concluded that there was no evidence of a motor relearning effect on lower
limb motor impairment in either FES or AFO groups. However, both the FES and usual-care
groups demonstrated significant improvements in functional mobility and quality of life during
the treatment period, which were maintained at 6-month follow-up. The study design can also
be criticised for being somewhat removed from standard clinical practice as participants
received considerably more physiotherapy gait training than is common.
Two small RCTs have investigated the feasibility of using the ODFS® in early gait training
following stroke43, 44. While neither was adequately powered to give statistically meaningful
between group results, both demonstrated that it was feasible to use FES in sub-acute stroke. In
the study by Wilkinson et al. both FES and control groups showed significant improvements
(FES turned off) in 10m walking speed, 6 minute walking distance, Rivermead Mobility Index
and Canadian Occupational Performance Measure with no difference between groups. The FES
group had improved Rivermead Observational Gait Analysis scores, a measure of the quality of
gait indicating fewer deviations from normal gait which was not seen in the control group. The
FES group walked faster when FES was used. For an adequately powered study 125 participants
would be required.
Multiple Sclerosis
A randomised controlled clinical trial was conducted with people who have a dropped foot due
to secondary progressive multiple sclerosis (SPMS)2, 10 . A group of 54 people with SPMS were
randomly allocated to a treatment group who received the ODFS® for daily use to correct
78
dropped foot or a control group who received a home based self-administered, physiotherapy
exercise programme. Both groups used the intervention for 18 weeks and attended the clinic
for follow up support and assessment once every 6 weeks. Uses of the ODFS® walked faster at
each assessment after week 0 when the device was used, measured over 10m (percentage mean
difference at 18 weeks of 10 % p=0.001). However, there was no training effect from the device.
The physiotherapy group did show a training effect over 18 weeks (percentage mean difference
at 18 weeks of 13 % p=0.001). Walking distance over 3 minutes was also consistently greater
when the device was used (percentage mean difference at 18 weeks of 12 % p=0.004) but again
no training effect was seen. In the control group a training effect was seen over 18 weeks
(percentage mean difference at 18 weeks of 15 % p=0.005) but this was less than the overall
benefit seen by the FES walkers who were able to walk 25% further in 3 minutes when FES was
used at the end of the trial compared to the beginning unaided. The effect of using the ODFS® on
activities of daily living (ADL) measured using the Canadian Outcome Performance Measure
(COMP). At the end of the study it was found that there was no significant effect of ADL in the
group who received physiotherapy (Median change = 0 for performance and 0 for satisfaction)
while significant improvements in ADL were seen in the ODFS® group (Median change = 1.1 for
performance p=0.038 and 1.7 for satisfaction p=0.001). Significant improvements seen were a
reduction of tripping and falls and an increase in the distance that could be walked. In the same
study the ODFS® users also reported 72% fewer falls than a control group (p=0.035), recorded
using a falls diary.
While the above trial showed that FES had a beneficial orthotic effect in terms of improved
walking speed and reduced incidence of falls, physiotherapy exercises were demonstrated to
have a beneficial training effect, while FES did not have this effect. It is common in MS that
dropped foot does not present in isolation but is often associated with more proximal weakness
in the hip, lower back, and abdominal muscles. The authors suggested that an improved effect
may be obtained if FES for dropped foot was combined with core stability exercises. This was
tested in a following study where twenty-eight people with secondary progressive multiple
sclerosis and unilateral dropped foot participated in a randomized crossover trial11. Group1
received FES for correction of dropped foot for six weeks with the addition of hip extension for a
further six weeks. In weeks 12–18, FES was continued with the addition of eight sessions of core
stability physiotherapy with home-based exercise. FES and home-based exercise were
continued until weeks 19–24. Group 2 received the same physiotherapy intervention over the
first 12 weeks, adding FES in the second 12 weeks. It was found that FES for dropped foot
correction alone improved walking speed and Rivermead Observational Gait Analysis (ROGA)
score, whereas physiotherapy had no effect. Adding gluteal stimulation further improved ROGA
score. Both interventions reduced falls (72% for FES alone), but adding FES to physiotherapy
reduced them further. FES had greater impact on the Multiple Sclerosis Impact Scale (MSIS-29),
indicating improved quality of life. The change in MSIS-29 was equivalent to 1 point fall in EDSS
score, suggesting mobility may be returned to the level experienced by a participant on average
3 to 4 years earlier. The study concluded that adding gluteal stimulation to common peroneal
stimulation was feasible and that FES for dropped foot can improve mobility and quality of life
and reduce falls. Adding gluteal stimulation further improved gait quality. Adding
physiotherapy may have enhanced the effect of FES, but FES had the dominant effect.
Post Market follow up
Case series data
Outcome measures used in the original RCT continued to be collected after the ODFS® was
introduced into clinical service at Salisbury District Hospital in 1996. A prospective audit study
reported on 151 patients with a dropped foot who had been using the device for 18 weeks12. All
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subjects had a dropped foot resulting from an upper motor neuron lesion, including stroke, MS,
or incomplete spinal cord injury. Changes in walking speed and walking effort over a 10-metre
distance, as measured by the Physiological Cost Index (PCI), were reviewed and collected from
patient charts. Comparisons were made between the walking speed and PCI at the initial device
set-up and after the device had been in use for 4.5 months (both with and without stimulation).
In a subset of 111 stroke patients, a mean increase in walking speed of 27% (p<0.01) and a 31%
reduction in PCI (p<0.0l) was observed with the ODFS® stimulator in use. These results were
based upon a comparison of baseline data without stimulation against 4.5 month follow-up data
using the ODFS® device. Without stimulation at the 4.5 month follow-up visit, stroke subjects
had 14% increase (p<0.0l) in walking speed and a 19% reduction in PCI (p<0.0l) compared to
their baseline measures without stimulation. These results suggest some carryover effect of
stimulation. A smaller subset of multiple sclerosis patients had a similar orthotic benefit but
demonstrated no carry-over effect of stimulation. In a subgroup of 27 ODFS® users who had
had a stroke, walking speed both with and without the device was observed to improve over the
first 18 weeks and thereafter remain unchanged7. As the ODFS® users were an average of 5.4
years post stroke this supports the hypothesis that the carryover observed was due to use of the
stimulator rather than natural recovery following the stroke.
In a study published in 2008 Paul et al measured the oxygen consumption of 12 people with MS
while walking with and without the ODFS®19. It was found that the oxygen consumption fell
from 0.46 mL min-1 kg-1 m-1 to 0.41 mL min-1 kg-1 m-1 indicating a statistically significant
increase in gait efficiency when the ODFS® was used. This result is in line with a questionnaire
survey of 43 ODFS® users who had MS, 88% of whom reported that walking was less effort
when walking with the ODFS®11. It is also in line with the 1999 audit paper that showed that
the physiological cost index, an index derived from the change in heart rate and walking speed
indicating the effort used in walking, was reduced by 24%12.
A number of smaller studies have supported the findings of the larger study12. In a group of 78
MS subjects, users walked 20% faster when using the device. Although no overall carryover
effect was observed, one third showed an improvement in unaided walking speed of more than
10%13. In a subgroup of 20 MS users, this improved walking speed with the device was shown
to also peak at 18 weeks with no significant change from initial values after that time. 18 MS
users of the bilateral dropped foot stimulator showed a 48% increase in walking speed at 18
weeks but again no significant carryover effect although a strong trend was observed. In an
audit study by Swain and Taylor 2004 it was shown that in a cohort of 113 people who have had
a stroke walking speed increased over the first 18 weeks of FES use and then was maintained at
that level over the next 12 months14. In a group of 41 MS users, walking speed also increased
over the first 18 weeks of FES use. While overall walking speed declined over the next 12
months, the difference between speed with and without was maintained indicating continued
orthotic benefit from FES (Figure 1). A sub group of 44 people with a dropped foot due to
stroke were followed over an extended period. It was demonstrated that the improvement in
walking speed due to FES was maintained 42 months after first using the device14.
80
Figure 1
Median % change in walking speed for CVA (n=113) and MS (n=41)

over 72 weeks
% change in walking speed compaierd with
25.0
20.0 Stroke FES on

Stroke FES off
15.0 MS FES on
NS week 0
MS FES off
10.0
5.0
0.0
0 10 20 30 40 50 60 70 80
-5.0
-10.0
Weeks
A recently published study by Street et al. also examined the effect of FES use on FWC and
clinically meaningful changes in walking speed for people with multiple sclerosis (pwMS) who
have dropped foot16. Perry et al. related walking speed to functional independence defining
people with a walking speed of less than 0.4ms-1 as household walkers, between 0.4 and 0.58
ms-1 as most restricted community walkers, between 0.58 and 0.8 ms-1 as least limited
community walkers and over 0.8ms-1 as non-limited community walkers49 This case series used
a consecutive sample of patients collected between 2008 and 2013 at Salisbury District
Hospital. One hundred and eighty seven (117 females, 70 males, mean number of years since
diagnosis 11.7, median 9, range 1 - 56 years, age range 27-80, average 55 years) pwMS with
dropped foot received FES of the common peroneal nerve (178 unilateral, 9 bilateral patients).
One hundred and sixty-six pwMS (89%) continued to use FES after 20 weeks with 153 pwMS
completing the follow up measures. A minimal clinical meaningful change was defined as a
change in walking speed of between ≥0.05 and 0.1ms-1 and a substantial meaningful change
defined as 0.1ms-1 or greater50. The study found that walking speed was increased by a mean of
0.07ms-1 (p<0.001), on the first day FES was used increasing to 0.11ms-1 (p<0.001) after 20
weeks, which is a mean average increase of 27% and a substantial clinically meaningful change.
71% of pwMS achieved a clinical meaningful change in walking speed at 20 weeks. Overall 90
pwMS were in the lower groups for FWC at the start of treatment with 49 (54%) improving
their FWC after 20 weeks while 8 (5%) pwMS experienced a decline in FWC. While no overall
significant training effect was found, 31% did experience an increase in walking speed and 38%
a decline. The number of pwMS who achieved a meaningful change in walking speed is
summarized in figure 2. The authors concluded that despite the likely deterioration in walking
performance over the study period due to the progression of MS, FES is highly effective as an
orthotic aid for improving or maintaining mobility.
81
120
100
80
60
40
20
0
Improvement Decline Improvement Decline Improvement Decline
Minimum Substantial Total
Initial Continuing Total Unassisted Walking
Figure 2
In the same clinical audit, 67 people with multiple sclerosis (pwMS) were asked about their use
of an AFO immediately prior to starting FES use26, 42. Twenty five were using AFOs while 27 had
used and rejected AFOs and 15 had never used an AFO. Walking speed was measured, both
with and without the AFO and FES at the beginning of treatment for 20 of the 25 who were
using an AFO27. No significant difference was found in walking speed between wearing an AFO
and walking unassisted However, walking was 0.08 ms-1 (p<0.001) faster with FES. It is likely
that in the majority of cases the motivation for referral for FES was to improve walking more
effectively than had been possible using a splint. Hence while this may result in selection bias in
this data, it also indicates that there is a significant number of people with dropped foot who are
dissatisfied with the gait assistance provided by AFOs.
Singleton and Street used a similar approach to one used in the above study to analyse data
collected from the West Midlands Rehabilitation Centre51. 257 pwMS who used FES were
followed over the first 6 months of their use of FES. A statistically significant orthotic effect in
walking speed was found at base line, 0.08ms-1 (p<0.001) and at six months, 0.09ms-1 (p<0.001).
No overall training effect was found (0.01ms-1 p=0.43). 58% achieved a clinically meaningful
change in walking speed when walking with FES at six months and 32% walked faster without
FES, experiencing a training effect. However, 29% had a reduced walking speed without FES.
Long term prospective audit data
The long term use of FES was examined in a study by Taylor et al (2013)15. The study aimed to
determine how long the intervention is of benefit and the total cost of its provision. From a
retrospective review of medical records one hundred and twenty-six people with spastic
dropped foot (62 stroke, 39 multiple sclerosis, 7 spinal cord injury, 3 cerebral palsy, 15 others)
who began treatment in the year 1999, were followed for the duration of the FES use. Device
usage, reasons for discontinuing treatment, 10 m walking speed and Functional Walking
Category (FWC) were recorded. The median time of FES use was 3.6 years (mean 4.9, standard
deviation 4.1, 95% confidence interval 4.2–5.6) with 33 people still using FES after a mean of
11.1 years. People with stroke walked a mean of 45% faster overall, including a 24% training
effect with 52% improving their FWC. People with multiple sclerosis did not receive a
82
consistent training effect but walked 29% faster when FES was used with 40% increasing their
FWC.
Singleton and Street also conducted a long term audit on a cohort of 50 FES users who were
followed for 4 years51. The mean orthotic effect at set up was 0.10ms-1 (p<0.001) and at 4 years
was 0.12ms-1 (p<0.001) indicating that the benefit from FES had been maintained. However,
unassisted walking declined over the period from 0.59 ms-1 to 0.40ms-1 p<0.001 due to the
progression of MS. Walking speed with FES at 4 years was 0.56ms-1 and not statistically
different from unassisted walking speed at the start of FES use (p=0.38). The finding was
similar to that found by Taylor et al. in their 10 year audit of ODFS® users and indicates, in
terms of walking speed, FES had provided a means of achieving the mobility experienced before
4 years of deterioration due to the progression of MS, therefore adding 4 years of improved
mobility to their lives.
Quality of Life
The main outcome measure used to indicate the effect of FES for dropped foot has traditionally
been walking speed. It has been seen as a proxy measure for change in gait quality. However,
Barrett and Taylor described a study that measured the effect of the ODFS® use on device
related quality of life measured using the Psychosocial Impact of Assistive Devices Scale (PIADS)
in a group of 20 people who had MS and 21 who had had a stroke17. The PIADS score was taken
after 18 weeks of ODFS® use. Additionally, walking speed was measured both at the beginning
of treatment and at 18 weeks. A statistically significant improvement was recorded in PIADS
score in both MS and stroke groups with no statistically significant difference between the
groups tested using Fourier’s Analyses (F-tests). A similar effect on walking speed was seen as
previously shown in published papers12, 13, 14, 15. However, it was found that there was no
correlation between change in walking speed and the quality of life measure. This indicates that
walking speed while indicating an overall improvement in gait does not necessarily reflect the
perceived benefit to the user of FES. In a study by Burridge et al. it was shown that the
improvement in walking speed and PCI was greater when walking with FES over uneven ground
than over smooth surfaces18. Study participants completed a 7 item questionnaire about their
perception of the effect of the ODFS®. It was found that there was a significant correlation
between the reduction in PCI when walking on uneven surfaces and the perception score, with a
weaker association when walking over smooth surfaces. No relationship was found between
change in speed and perception score.
Recent research on 4516 people with multiple sclerosis using the EQ5D has found a large gap
between quality of life for people with multiple sclerosis (mean health state score 59.7 ± 22.4)
and the general population (86).53 Twenty-seven (mean age 53, range 44-70) people with
multiple sclerosis completed the EQ5D-5L questionnaire at baseline and after 18 weeks of using
FES. 33. A significant improvement in quality of life was found between baseline (51.0 ± 22.3)
and after using FES for 18 weeks (58.4 ± 22) (p=0.02) and an improvement of 15 points on the
VAS was also found (p<0.05). The study suggests that pwMS who have mobility problems have
a reduced quality of life compared to the general cohort of pwMS, which includes a wider range
of disease progression and that FES improves their quality of life.
The effect of FES on quality of walking: gait kinematics
Scott et al investigated the kinematic effect of FES in 12 pwMS with relapsing remitting multiple
sclerosis who were new users of functional electrical stimulation20. Gait kinematics were
83
recorded using 3D gait analysis. Walking ability was assessed through the 10-metre and the 6-
minute walk tests. All assessments were performed with and without the assistance of
functional electrical stimulation. Ankle dorsiflexion at initial contact (p=0.026) increased by 5.9º
reducing the risk of the toe dragging on the ground. Knee flexion was also increased at initial
contact by 2.4º (p=0.044) reducing knee hyperextension and hence helping to protect the knee
joint. The peak knee flexion during swing increase by 8.9º (p = 0.011) increasing ground
clearance through swing, again reducing the risk of the toe catching the ground. The increased
peak dorsiflexion in swing of nearly 4 degrees during functional electrical stimulation assisted
walking approached significance (p=0.069). The 10-m walk time was significantly improved by
functional electrical stimulation (p=0.004) but the 6 min walk test was not. It was concluded
that the acute application of functional electrical stimulation resulted in an orthotic effect
through a change in ankle and knee kinematics and increased walking speed over a short
distance in people with multiple sclerosis who experience foot drop.
A study by van der Linden et al. compared the gait characteristics of people with Multiple
Sclerosis (pwMS) to those of healthy controls walking at the same average speed and assessed
the effects of the acute application of FES for dropped foot correction21. Twenty-two pwMS
(mean age 49 years), who were new FES users, and 11 age matched healthy controls
participated. Three dimensional gait kinematics were assessed whilst pwMS and healthy
controls walked at self-selected walking speeds (SSWS). Healthy controls also walked at the
average walking speed of the pwMS group and pwMS also walked using FES. Compared to
healthy controls walking at their SSWS, pwMS walked slower and showed differences in nearly
all gait characteristics (p<0.001). Compared to healthy controls walking at the same average
speed, pwMS still exhibited significantly shorter stride length (p=0.007), reduced dorsiflexion at
initial contact (p=0.002), reduced plantar flexion at terminal stance (p=0.008) and reduced knee
flexion in swing (p=0.002). However, no significant differences were seen between groups in
double support duration (p=0.617), or hip range of motion (p=0.291). Acute application of FES
resulted in a shift towards more normal gait characteristics, except for plantar flexion at
terminal stance which decreased. In conclusion, compared to healthy controls, pwMS exhibit
impairment of several characteristics that appear to be independent of the slower walking
speed of pwMS. The acute application of FES improved most impaired gait kinematics.
In a second study by van der Linden et al nine pwMS were assessed on four occasions; four
weeks before baseline, at baseline and after six weeks and twelve weeks of ODFS® use45. Joint
kinematics and performance on the 10 meter and 2 minute walk tests (10WT, 2 minWT) were
assessed with and without FES. Participants also completed the MS walking Scale (MSWS10),
MS impact scale (MSIS29), Fatigue Severity Score (FSS) and wore an activity monitor for seven
days after each assessment. Compared to unassisted walking, FES resulted in statistically
significant improvements in peak dorsiflexion in swing (p = 0.006), 10MWT (p = 0.006) and 2
minWT (p = 0.002). Effect sizes for the training effect, defined as the change from unassisted
walking at baseline to that at 12 weeks, indicated improved ankle angle at initial contact (2.6º,
95% CI 21º to 4º, d = 0.78), and a decrease in perceived exertion over the 2 min walking tests
(21.2 points, 95% CI 25.7 to 3.4, d =20.86). Five participants exceeded the Minimally Detectable
Change (MDC) for a training effect on the 10mWT, but only two did so for the 2 minWT. While
the MSWS12 improved at 6 weeks, no effects of the use of FES were found for MSWS, MSIS29,
FSS or step count at 12 weeks. .
Shefler et al. investigated the training effect of FES use on the kinematic parameters of gait in a
group of 110 stroke survivors who used the ODFS® or an AFO for a period of 12 weeks9. Both
groups received physiotherapy. Kinematic gait analysis was performed at the beginning and end
of treatment and 12 and 24 weeks after the intervention was removed. All measurements were
taken without FES. Both groups demonstrated a significant improvement in cadence, stride
length, walking speed which were found to be associated with increased peak hip and ankle
push off power at terminal stance and increased hip flexion at heel strike. Improvements were
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maintained at follow up. The study indicates that gait training with either FES or AFO is
effective at improving the kinematic parameters of gait in chronic stroke.
Mann et al. investigated the use of the ODFS® for prevention of freezing of gait in Parkinson’s
Disease22. Seven subjects with idiopathic Parkinson’s Disease received single channel electrical
stimulation for 8 weeks to the common peroneal nerve to improve heel strike and provide
sensory stimulus during the swing phase of gait. Stride length, time and number of steps to
complete a 20 metre walk and distance completed in 3 minutes were assessed. Episodes of
freezing and incidence of falls were recorded. Walking tests showed an immediate orthotic
effect on distance and average stride length at some assessments during the treatment period
but not on number of steps and walking speed. A training effect was observed for all parameters
of gait measured. Fewer falls (72% fewer) and episodes of freezing occurred during the
treatment period. The number of falls returned to pre-treatment levels when treatment was
stopped.
In a second observational study in Parkinson’s disease, Popa and Taylor investigated the effect
of combined upper and lower limb Functional Electrical Stimulation (FES) to improve hand
function and gait23. Eleven people with Parkinson’s and Hoehn and Yahr score 2-3 used FES to
assist dorsiflexion while walking and hand opening or fine hand movements for 2 weeks. The
outcome measures were; the 9-Hole Peg Test, the box and block test, 10m Walking Test, the
Tinetti Balance scale, the Modified Parkinson’s Disease Quality of Life questionnaire (PDQL),
SPES/SCOPA scale (Short Parkinson’s Evaluation Scale/Scales for Outcomes in Parkinson’s
disease) and adherence to treatment. All tests were carried out without FES. Nine participants
completed the protocol with two dropping out of the study due to difficulty in using the
equipment. A mean increase in walking speed of 0.29ms-1 (p = 0.002), step length of 0.09 m
(p=0.007) and cadence of 19.8 steps min-1 (p = 0.045) were recorded using the 10m walking
test. There was an improvement in balance demonstrated by an increased by 2.9 (p = 0.006 in
the Tinetti Balance score. There was an increase in the number of blocks moved in the Box and
Block Test of 5.1 (p=0.025) indicating a clinically meaningful change in hand function. A
significant change in the Parkinson’s symptoms score of the PDQL of 4.9 (p = 0.013) and a
reduction in the SPES/SCOPA score of -5.7 (p=0.005) indicating a reduction in the impact of
Parkinson’s. Overall it was concluded that FES produced significant improvements in gait and
upper limb function after a relatively short treatment period, indicating that FES may be a
practical therapeutic intervention for bradykinesia.
Incomplete Spinal Cord Injury
Two case series studies from independent centres have reported the effect of using the ODFS®
with people who have incomplete spinal cord injury (ISCI) and found similar effects for the
orthotic and training effects of FES. Taylor et al. followed a group of 8 people with ISCI over 18
weeks of FES use12. A substantial clinical increase in walking speed was achieved with FES at
week 18 in comparison to walking without FES at the beginning of treatment, 0.1ms-1 (p < 0.05),
an increase of 19%. There was also a trend towards a significant training effect of 0.06ms-1 (p=
0.09), an increase of 12%. The second case series study was performed by Street and Singleton.
22 people with ISCI were followed over 6 months of FES use. The orthotic effect on walking
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speed at 6 months was found to be 0.12ms-1 (p=0.004), a mean change of 18%. A training effect
of 12% or 0.08ms-1 (p=0.04) was also found.
Neurodevelopmental Disorders and FES
There is less research for the use of FES for the lower limb in neurodevelopmental disorders,
however the available research has been largely supportive of the effectiveness, acceptability
and safety of using FES with neurodevelopmental disorders such as cerebral palsy (CP) and
Hereditary and spontaneous spastic paraparesis (HSP).
Cerebral Palsy
The term cerebral palsy (CP) is used to describe a group of disorders caused by non-progressive
brain damage. CP is often accompanied by secondary musculoskeletal impairments which are
characterised by a combination of gastrocnemius muscle spasticity, contracture, ankle
dorsiflexion, weakness and poor ankle selective motor control. There are few studies that have
been conducted on the effectiveness of FES for the lower limb in CP. One of the first studies
examined the effect of FES applied to the anterior tibial muscles in a group of 10 children with
CP who walked with a toe stepping gait (mean age 9.1 years). The main outcome measure was
heel-toe interval measured using gait analysis. Outcome measures were taken at set-up, after
three months of using the device and three months after discontinuing. A significant benefit in
heel-toe interval and immediate significant orthotic effect in walking speed was found at set-up.
No training or therapeutic effect was found. The sample size for the study was small and the
design did not allow comparison with alternative treatments. No adverse events or other
complications were reported from the study. The study suggests that the ODFS® III is effective
for children with CP and provides support for further work. (Durham et al., 2004,
physiotherapy)
The study by Durham et al., 2004 conducted using the ODFS® III can be used to support the
acceptability of using the device with CP, however, due to the lack of studies examining the
ODFS® III, further studies using other commercially available devices are included here to
further assess effectiveness, acceptability and any residual risks associated with the device. The
Ness L300 works in a very similar way to the ODFS® Pace using a footswitch to trigger
stimulation timed to the swing phase of the gait. A recent case series including 11 children with
CP (mean age 9 years 11 months) required participants to use the device during an
accommodation period of 4 weeks followed by 12 weeks of treatment. Interestingly, no
significant initial orthotic effect was found in this study but a total orthotic effect was found for
walking speed, six minute walk test. A significant therapeutic or training effect was only found
on a Standardized Walking Obstacle Course (SWOC). The authors suggest that children with CP
should be provided with a period of time to accommodate to using FES before deciding on the
long term benefits (Bailes et al., 2016). Although there are a lack of studies conducted with CP
using an ODFS® III or ODFS® Pace, there have been some recent randomised controlled trials
examining the effectiveness of FES with this population using the Walkaide FES system.
Electrical stimulation from the Walkaide FES device is triggered using a tilt sensor rather than a
footswitch which the ODFS® Pace uses, therefore the results from these studies should be
interpreted with caution.
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One randomised controlled trial (Pool et al., 2015) included 32 children with CP (average age
10 yrs 3 months). The intervention group received eight weeks of daily FES with the Walkaide
system (four hours per day, six days per week), while the control received standard care. The
participants were assessed at baseline and after eight weeks of treatment followed by six weeks
of follow-up without FES. The treatment group had an increased ankle angle at initial contact
(mean difference 11.9°, 95 % CI 6.8° to 17.1°; p < 0.001; d = 0.6), increased ankle angle in
maximum dorsiflexion in swing (mean difference 8.1°, 95 % CI 1.8 to 14.4°; p = 0.007; d = 0.4),
increased normalized time in stance (mean difference 0.27, 95 % CI 0.05 to 0.49; p = 0.011;
d = 0.4) and increased normalized step length on the affected side (mean difference 0.06, 95 %
CI 0.003 to 0.126; p = 0.035; d = 0.4) post treatment compared to the control group while using
FES. No significant therapeutic effect was found for any of the above measures apart from a
borderline significant effect for increased normalized time in stance (mean difference 0.23,
95 % CI − 0.001 to 0.47; p = 0.050; d = 0.4). Potentially, the study intervention period of eight
weeks was too short to see the full benefits of FES. Further randomised controlled trials should
consider providing a period of several weeks as the case series by Bailes et al., (2016) suggests
to accommodate to using the device and have a longer intervention period. In terms of risk
there were no reported unintended effects or adverse events from using the device in this study.
Another recent randomised controlled trial (n=34) examined the effects of FES on gait pattern
and energy expenditure over a period of three months. The intervention group received
functional electrical stimulation for two hours a day three days a week, while the control group
participated in physiotherapy for the duration of the study. The Gaitrite system was used to
evaluate gait parameters and an indirect calorimeter was used to assess energy expenditure.
Researchers found an overall significant improvement in gait parameters (p<0.005) (El Shamy e
and Abdelaal, 2016, abstract only accessed 12/04/2017, full text requested also include details
of any adverse events once identified the full text).
There has also been some qualitative work using the Canadian Occupational Performance
Measure (COPM) examining whether FES is effective in improving self-perceptions of
individually identified mobility performance problems. The study included 32 children with CP
(average age: 10 years, 8 months). Participants were randomly assigned to the intervention
group which consisted of daily FES, or the control which was standard care. After eight weeks
of intervention or control, participants were again assessed after a six week follow-up during
which they received no treatment. The results found significantly higher performance scores
(mean difference 1.6, 95 % CI 0.1 to 3.2, p = 0.034) and satisfaction scores post treatment (mean
difference 2.4, 95 % CI 0.5 to 4.2, p = 0.004) compared to the control group. However no
significant difference was found between groups after the six week follow up for performance
but there was a small but significant difference for satisfaction (mean difference 1.9, 95 % CI 0.1
to 3.8, p = 0.03). In terms of risk, there were no reported adverse effects from using the FES
device in this study. The study suggests that FES is useful for improving self-perceptions of
individually identified mobility performance problems.
Familial Spastic Paraplegia
HSP is a heterogeneous degenerative condition associated with a dying back axonal

degeneration affecting the corticospinal tracts, dorsal columns and spinocerebellar tracts. HSP
is characterised by weakness, spasticity and stiffness predominantly experienced in the lower
limbs which result in difficulties with walking and balance. Similarly to other causes of foot
drop people with HSP are at a greater risk of tripping and falling due to impaired dorsiflexion.
There is only one study which has examined the effectiveness of FES in people with HSP which
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compared 11 long term users (average 2.6 years +/-1.6) of FES with healthy controls (n=11).
Researchers examined ankle muscle strength, stiffness and walking speed along with lower limb
kinematics. FES resulted in a small but significant increase in walking speed p<0.05), a
significant difference was also found for improved toe clearance and maximal dorsiflexion. The
study design was limited in only examining the orthotic effect following the use of FES in a
group of people with HSP who had used FES in the past. Therefore, the study design did not
allow the examination of a training or therapeutic effect and the size of the orthotic effect may
have been masked by not using a true baseline. The study was also potentially underpowered
due to the small sample size (Marsden et al., 2012). In terms of risk the study did not report on
any adverse events or complications following the use of FES.
FES users’ experience
There is also published literature on the patient’s experience of using FES. Taylor et al. (1999)
reported the results of a questionnaire survey sent out to 291 users of the FES service in
Salisbury24. The questionnaire was returned by 64% of devices users. The mean time of use
was 19.5 months. The mean time since CVA was 5.5 years while for those who had MS the mean
time since diagnosis was 12 ½ years. The most commonly reported reasons for using the device
were:
 Increased confidence while walking 78.5%
 Reduced effort of walking 77.6%
 Increased walking distance 70.1%
 Reduced risk of tripping while walking 69.2%
 Increased walking speed 61.7%
 Increased independence 51.4%
Of those who used a wheelchair prior to using FES, 32% had reduced their use of the chair while
18% had stopped using it altogether. Of those who required assistance from a carer while
walking 46% had reduced their requirement for assistance while 14% no longer required
assistance.
A second questionnaire survey was sent to 286 FES users from which 211 replies were received.
The survey found similar results to the above study for how and why the ODFS® was use25.
Additionally questions were asked about the users attitudes to FES use. The questionnaire gave
a series of statements and the respondent was asked if they agreed or disagreed with the
statement. 92% of CVA and 98% of MS were glad that they had the ODFS® and 91% of CVA and
90% of MS would recommend it to another person. 70% of CVA and 73% of MS agreed that its
use increased their independence and 85% of CVA and 83% of MS agreed that they were more
confident when using the ODFS®. 69% of CVA and 71% of MS agreed that it improved their
quality of life.
In a study by Malone et al., structured interviews were conducted with 12 users of the ODFS®,
six were people with MS and 6 had experienced a stroke26. Their partners / carers were also
interviewed. They were asked to describe their lives before and after receiving FES. The users
reported that the ODFS® had changed their lives. The users were more socially confident with
the device, as it reduced the risk of tripping and / or falling. Partners felt more confident
leaving the ODFS® user alone at home. Overall, the participants wished more people were
aware of the device and able to get access to it.
A second qualitative study, Bulley et al. also explored the experiences, preferences and choices
relating to the use of functional electrical stimulation (FES) for foot-drop and compared it with
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the experience of ankle foot orthoses (AFOs) by people who have suffered a stroke and their
carers27, 28. Semi-structured interviews were used to explore individual experiences using
interpretative Phenomenological Analysis (IPA). Nine participants who had used both FES and
several types of AFO were recruited from a single FES clinic. Participants described experiences,
preferences and choices relating to AFO and FES use. All but one person expressed a preference
for FES, relating FES use to being able to move the ankle more freely; walk more normally,
safely and independently; and experience greater comfort. Several people used AFOs when the
FES equipment failed, when travelling and near water. One person rationed their use of FES on a
daily basis due to allergic reactions.
The above studies have frequently found that the safety of gait is an important factor in why
people chose to use FES. To explore this further, Street et al. used the Falls Efficacy Scale-
International (FES-I) to explore the effect on fear of falling29. The FES-I asks how concerned a
person is about falling in 16 different activities/situations and asks to rate their concern on a 4
point scale where 1 = not concerned and 4 = very concerned. If an activity is not done by the
person, for example if someone else does their shopping for them, they are asked to imagine
how concerned they would be if they did that activity. As an addition to the questionnaire, they
were asked to say if they did participate in each activity on the FES-I and rate their participation
on a 4 point scale where 1 = regularly, 2 = sometimes, 3 occasionally and 4 = never. The
responses to each question were summed (range 16 to 64) and the change in the 2 scores
calculated. 31 pwMS complete the questionnaires before starting FES and after 18 weeks of FES
use. The median reduction in FES-I score was 6, IQR 1-10 (p<0.001) indicating a reduced fear of
falling. The participation score also fell by 4.5, IQR 1-9 (p<0.001) indicating that FES lead to an
increase in participation in activities of daily living. The activities that were most commonly
improved by FES were cleaning the house, walking around the neighbourhood, using stairs,
shopping, answering the telephone and visiting friends or relatives.
Street et al. examined the effect of FES on patients centres outcome measures using the Goal
Attainment Scale (GAS) and perceived level of effort using the Borg scale42 + unpublished data. 56
pwMS and 21 stroke survivors used the ODFS® Pace for a period of 18 weeks. Three GAS goals
were set at the start of FES use through discussion between the treating clinician and the FES
user. The achievement of the goals was reassessed at the second follow up clinic appointment;
18 week after FES was started. Stroke survivors achieved or exceeded 86% of their chosen goal.
The most frequently chosen goal areas were Increasing walking distance (n=15), reduced fear of
falling (n=11), increased level of independence (n=6), improved quality of walking (n=5) and
reduced effort of walking (n=4). In the MS group, 67% of goals were achieved or exceeded. The
most frequently chosen gaol areas for pwMS were increasing walking distance (n=37),
improvement in social / functional activities (n=24), reduced fear of falling (n=18), increased
level of confidence while walking (n=18) and reduced effort of walking (n=18). The Borg rate of
perceived effort scale consist of an 11 point scale were 0 indicates compete rest, 1 very easy, 2
easy, 3 moderate, 4 somewhat hard, 5 hard , 7 very hard and 10 extremely hard. The test is
administered at the same time as the 10m walking test with the FES user asked to rate the effort
of walking after each 10m walk. The median score reduced from 4 (IQR 3 to 5) to 3 (IQR 2 to 3)
when FES was first used. The reduction in effort was maintained at 18 weeks. The perception
of reduced effort while walking is in line with the observation of reduced oxygen consumption19,
52 and physiological cost index4, 12 both reduce when FES is used.
Singleton and Street used Visual Analogue Scales (VAS) with a range of 0 to 10 to assess the
perceived impact of FES on various aspects of walking and quality of life51. 50 pwMS who used
FES for 4 years recorded VAS outcome measures at set up and each follow up clinic
appointment. In all but two cases the VAS score change recorded at 6 months was maintained
at 4 years. The perceived frequency of trips and falls changed from a VAS of 8 to 2, confidence
while walking from a VAS of 4 to 8, the effort of walking from a VAS 8 to 5 and quality of life
from a VAS of 7 to 8. The other two VAS assessments continued to improve between 6 months
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and 4 years. The Perceived level of Spasticity VAS reduced from 7 to 5 at six months and
reduced further to 3 at 4 years. The level of perceived pain reduced from 5 to 3 at six months
and reduced to 1 at 4 years. The study indicates that the perceived benefit from FES is
maintained throughout its use, despite the progressive nature of MS.
Adverse Effects and Summary
Only minor adverse effects have been reported from use of the ODFS system, and they are common
adverse effects associated with any powered muscle stimulator. In a survey of 107 device users, 22%
had experienced some skin irritation from electrodes on some occasion over an average of 19.5
months24. However, these problems had been overcome enabling continued use of the device. Since
the survey the Salisbury clinic has changed the type of electrodes used and reduced the maximum
period for which electrodes are used for. In a six month period from June 2005 every occurrence of
skin irritation occurring in the Salisbury FES clinic was recorded30. In that time 585 individual
patients were seen in the clinic. 13 cases of irritation were reported. An appeal for honesty to the
clinicians working in the clinic indicated some under reporting, estimated to be about 25%. This
therefore results in prevalence in the clinic of between 3 and 4%. However, 8 cases were
reoccurrence and 5 first time cases, 3 of whom developed skin reaction in the first 6 months and the
other 2 between 12 and 18 months of ODFS® use. This means the prevalence of new cases was
around 1 to 1.5%. There were no cases of discontinued treatment due to skin irritation in this period.
Further, in the randomised controlled trial of the ODFS with people who have secondary progressive
MS, there were no reports of skin irritation in the period of the 18 week trial10.
Out of a survey of 56 people who had discontinued use of the ODFS®, three (3) discontinued due to
skin irritation24. Five out of the 56 survey respondents discontinued use of the device due to
increased spasticity. While the overwhelming majority tolerated the sensation of stimulation well,
one (1) out of the 56 discontinued because they found the sensation to be painful. Other reasons for
discontinuation were due to convenience and functional issues not associated with adverse effects.
The most commonly cited reason for discontinuation was improvement in mobility such that the
device was no longer required. In the 10 year audit of 126 FES users, only 1 person discontinued due
to skin irritation15.
Cost effectiveness
There are 4 reports that estimate the QALY gain associated with use of FES.
The first report was from the Development and Evaluation Committee of the South and West
Regional Health authority 199631, 32. It was this report that was submitted to the NHS to justify the
establishment of the first clinical service for FES drop foot. The report was reviewed and accepted
by the Health Authority and is available at http://www.salisburyfes.com/dec.htm. The report used
data from the randomised controlled trial of the ODFS performed between 1993 and 1995 with 32
people who had had a stroke. The trial compared the effect of using the device with a standard
treatment consisting of physiotherapy. The QALY gain was calculated using a combination of data
including change in walking speed and physiological cost index, change in Hospital Anxiety and
Depression Index (HAD) and change in a mobility score derived from a custom designed
questionnaire closely aligned with the Health Related Quality of Life (IHQL). After 12 weeks of
intervention it was calculated that the FES group received a QALY gain of 0.065 while the
physiotherapy group had a gain of 0.023, a difference of 0.042. At 1996 prices this gave a cost per
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QALY of £19,821 for one year’s FES use and £10,037 over 5 years. In 2007 the report was re-
examined and costs per QALY calculated for current prices32. This gave a cost per QALY of £39,047
at one year and between £13,524 and £19,237 at five years depending on the number of follow up
clinic appointments received. However, this analysis assumes that a comparison is made with an
individual who receives physiotherapy. In clinical practice the ODFS is used as a long term aid while
physiotherapy is rarely received for more than a few weeks. It may therefore be fair to attribute the
whole of the QALY gain seen by FES users rather that the difference between FES and Physiotherapy
interventions. This gives a cost per QALY gain of £25,230 at 1 year and between £8,738 and
£12,431 at 5 years.
From an audit of patients who began FES use in 1999, it is now known that the average length of
time FES was used for was 4.9 years and that the average cost per patient was £2,965 (based on an
average of 10.9 hospital appointments per patient)15. It can therefore be calculated that for this
cohort of 127 patients and assuming the same QALY gain calculated above, the mean cost per QALY
was £9,658, well within the willingness to pay threshold of £30,000 used by NICE. It is not
appropriate to apply discounting to the QALY gain as FES is a continuing intervention. This is
supported by records of the difference in walking speed recorded with and without FES and VAS
assessments of the impact of FES on various aspects of walking and quality of life showing it they
maintained over the whole period that FES was used for15, 51.
A further economic report was produced by the Purchasing and Supply Agency in February 201034. It
took a different approach to calculating QALY gain. Its main indicator of effect was walking speed.
The mean gain in walking speed due to FES was calculated by averaging the results from four
published studies, two of which used the ODFS. It was found that the mean increase in walking
speed was 0.18 ms-1. The change in walking speed was compared to Perry’s criteria for mobility
based on walking speed. Perry calculated that the mean threshold for becoming a moderate
community walker was 0.58 ms-1 and for becoming a functionally independent walker was 0.80 ms-1.
By examining the range of walking speeds it was possible to calculate the proportion of FES users
who would cross these thresholds and this could be corresponded to changes in the HUI3 (Health
Utility Index v3) scale. The other input to the model was the number of FES users who received dis-
benefit due to skin reaction to the electrodes. This was the only reported adverse effect of FES. 22%
of FES users were reported as having minor skin irritation while 3% received a major skin reaction
sufficient to cause discontinued use of FES. Using this technique an overall QALY gain of 0.041 was
calculated. This compares with a QALY gain of 0.042 in the earlier study. A cost per QALY was found
at 1 year of £52,336 and at 5 years of £19,238.
The Purchasing and Supply Agency report which examined data on skin irritation due to electrodes
from the 1999 clinical rehab paper on patient’s perceptions of use of the ODFS may have been
exaggerated24. As described above in the section on adverse effects, the types of electrodes used
and clinical procedures have since been improved since 1999 and this means the prevalence of new
cases in the clinic significantly reduced to around 1 to 1.5%. Further, in the randomised controlled
trial of the ODFS® with people who have secondary progressive MS, there were no reports of skin
irritation in the period of the trial10. Also, in the audit of patients who began use of FES in 1999, only
one FES user discontinued FES due to skin reactions in the whole 10 year follow up period15. These
results suggest that the dis-benefit effect of skin irritation has been significantly exaggerated in the
Purchasing and Supply Agency report, resulting in a smaller QALY gain than might otherwise have
been expected.
The latest study to examine the cost – utility of FES used the EQ-5D-5L questionnaire, the standard
health economics instrument, to estimate the health utility index from using the ODFS® Pace33. 45
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pwMS and 27 pwCVA completed the questionnaire before beginning FES and again after 20 weeks
use. The study showed a QALY gain of 0.114 (p=0.02) in both groups. Justified by the observation
that the mean increase in walking speed due to FES remains steady throughout the time FES was
used, the QALY gain was extrapolated over 4.9 years giving a total gain of 0.542 after sicounting at
3% per year. From the long term audit the mean cost was £3095, giving a mean cost per QALY of
£5,705.
Possible cost savings to the NHS due to reduction in falls
Two studies have shown a 72% reduction in the incidence of falls when FES has been used2, 10. No
published data on the incidence of falls requiring medical treatment for people with MS could be
found. However, data does exist for a general elderly population. Nurmi and Luthje (2002)
performed an audit of falls amongst the elderly in institutional care35. They reported an incidence of
falls of 1398 falls per 1000 person years and that one third of falls resulted in injury. The average
cost per injury was €944. The average cost per fall per year was therefore €440. If falls that resulted
in injury were reduced by the same proportion as in the ODFS trial, there would be an annual saving
of €329 or €1650 over five years. Allowing for an inflation rate of 44% (retail price index) between
2002 and 2014 the annual saving would be €474 (£374) or €2376 (£1877) over 5 years at 2014 prices
(exchange rate 14th July 2014). From an individual perspective, the mean time between injuries
would increase from 2.15 years to over 7 years.
National Guidelines
NICE IPG278 (2009)
The Interventional Procedure Guidelines (IPG) number 27836 produced by the National Institute
for Health and Clinical Excellence states:
1.1 Current evidence on the safety and efficacy (in terms of improving gait) of functional
electrical stimulation (FES) for drop foot of central neurological origin appears adequate
to support the use of this procedure provided that normal arrangements are in place for
clinical governance, consent and audit
In the public information document that accompanies IPG27837 summarises the guidelines as
follows:
This procedure can be offered routinely as a treatment option for people with drop foot
caused by damage to the brain or spinal cord, provided that doctors are sure that:
• The patient understands what is involved and agrees to the treatment,
and
• The results of the procedure are monitored.
Scottish Interventional Guidance Network
The Scottish Interventional Guidance Network (SIGN 118) report (2010); Management of
patients with stroke: Rehabilitation, prevention and management of complications, and
discharge planning. A national clinical guideline38, 39, concludes:
92
“Functional electrical simulation may be considered as a treatment for drop-foot, where
the aim of treatment is the immediate improvement of walking speed and/or efficiency,”
Evidence Note 46 - The use of functional electrical stimulation (FES) in adults with dropped
foot. Quality Improvement
“There is evidence, mainly from uncontrolled observational studies, to support the use
of surface-applied FES for the orthotic improvement of walking speed and reduction in
walking effort in patients with dropped foot. Patient acceptability of their treatment
appears to be high. There are few major safety concerns.”
Intercollegiate working party for stroke, (2012) National clinical guidelines for
stroke London, Royal College of Physicians 4th edition
Functional electrical stimulation can be used for drop foot of central neurological origin
provided normal arrangements are in place for clinical governance, consent and audit40.
Multiple sclerosis: Management of multiple sclerosis in primary and secondary

care. CG186 (2014)
This standard aligns itself with the IPG278 NICE guidelines41.
Limitations of data, gaps, uncertainties or unanswered questions
Cyclic Exercise Stimulation

There is limited data available on the use of the ODFS® Pace (XL) device for cyclic exercise
stimulation, however the use of cyclic exercise stimulation for muscle strengthening, increasing
range of joint motion, reduction of spasticity and increasing local blood flow is well established.
Additional muscles in walking

Studies investigating the use of the additional muscles in gait have been restricted to another
OML device, the O2CHSII. While the ODFS® Pace (XL) uses the same principles to activate these
muscles in gait, device specific data would strengthen the efficacy and safety case for the ODFS®
Pace (XL).
Ankle Foot Orthotics (AFO) compared to FES

There is a lack of studies that have compared the ODFS® and ODFS® Pace device to ankle foot
orthotics (AFO) with only one study (Write et al) comparing FES and AFO in sub-acute stroke.
As the AFO is the most common traditional alternative to the Pace device this is a limitation of
the data.
93
Conclusions
A review of the published evidence relating to the Odstock Dropped Foot Stimulator (ODFS®)
indicates that the device is an effective orthosis for people with dropped foot due to an upper
motor neurone lesion. This is shown by clinically meaningful increases in walking speed
leading to improvements in functional walking category and hence indicating a positive impact
on quality of life.
FES users experience a reduction in the effort of walking indicated by a reduction of the
physiological cost index and oxygen consumption while walking. For people who have a stroke,
a significant training effect is also observed. For pwMS, FES can provide approximately 4 years
extra mobility in the context of a progressive condition. Kinematic analysis shows that FES
causes improvements in ankle knee and hip movement improving efficiency, reducing knee
hyperextension and enabling greater ground clearance. Three studies have reported that FES
use leads to a 72% reduction in falls.
The device is well accepted with a mean time of use as an orthosis of 4.9 years for stroke and 5.5
years for MS. Users of the device report that their walking is less effort; that they are less likely
to trip and fall; that they feel more confident while walking, that they can walk further and that
they experience less pain and spasticity. Improvements in activities of daily living and quality
of life are also demonstrated. Partners of ODFS® users report that they are less concerned for
the safety of their FES using partners when left alone, resulting in an improvement in their own
independence. Finally, use of the device is supported by national guidelines.
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94
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672
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67, 2007
95
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Feasibility of Electrical Stimulation to Assist Gait in Parkinson’s Disease. Neuromodulation
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pp. 296-298, Bournemouth, UK, September 2004.
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29. Street T, Taylor P, Swain I. Impact of Functional Electrical Stimulation on Fear of Falling
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96
30. Salisbury FES Newsletter Summer 2006, available at
http://www.salisburyfes.com/summer2006.htm#7
31. Swain ID, Taylor PN, Burridge JH, Hagan SA, Wood DE. Report to the development
evaluation committee Common peroneal stimulation for the correction of drop-foot (1996)
http://www.salisburyfes.com/dec.htm
32. Taylor P, Mann G, Jolley C, Swain I. Economic Justification for the Odstock Dropped Foot
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33. Street T, Taylor P, Swain I. Quality of Life following the use of Functional Electrical
Stimulation for Multiple Sclerosis. International FES Society UK and Ireland chapter scientific
meeting, Sheffield, UK 8th-9th May 2015
34. Economic Report. Functional Electrical Stimulation for dropped foot of central
neurological origin. CEP10012. Published by the NHS Purchasing and Supply Agency Feb 2010
www.dh.gov.uk/cep
35. Nurmi I, Lüthje P. Incidence and costs of falls and fall injuries among elderly in
institutional care. Scand J Prim Health Care. 2002 Jun;20(2):118-22.
36. http://www.nice.org.uk/Guidance/IPG278 Functional electrical stimulation for drop

foot of central neurological origin N1733 1P ISBN 84629-846-6 Jan 09
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stimulation N1734 1P ISBN 1-84629-847-4 Jan 09
38. Evidence Note 25 - The use of functional electrical stimulation (FES) in adults with
dropped foot. Quality Improvement Scotland, 2008
http://www.nhshealthquality.org/nhsqis/files/ClinicalGovernance_TheUseOfFunctionalElectric
alStimulation(FES)inAdultsWithDroppedFoot_OCT08.pdf
39. Scottish Interventional Guidance Network (SIGN 118) The Scottish Interventional
Guidance Network report (2010); Management of patients with stroke: Rehabilitation,
prevention and management of complications, and discharge planning. A national clinical
guideline. www.sign.ac.uk ISBN 978 1 905813 63 6
40. Intercollegiate working party for stroke, (2012) National clinical guidelines for stroke
London, Royal College of Physicians 4th edition ISBN 978–1–86016–492–7 eISBN 978–1–
86016–493–4
41. Multiple sclerosis: Management of multiple sclerosis in primary and secondary care.
CG186 (2014) ISBN: 978‑1‑4731‑0778‑6 http://www.nice.org.uk/guidance/cg186/
42. Street, T, Taylor P, Swain I. A comparison between ankle assisted orthotics and
Functional Electrical Stimulation: a feasibility study. Multiple Sclerosis Journal 2014;20:(7)
1001
43. Salisbury L, Shiels J, Todd I, Dennis M. A feasibility study to investigate the clinical
application of functional electrical stimulation (FES), for dropped foot, during the sub-acute
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phase of stroke – A randomized controlled trial. Physiotherapy Theory and Practice.
2013;29(1):31-40.
44. Wilkinson IA, Burridge J, Strike P, Taylor P. A randomised controlled trial of integrated
electrical stimulation and physiotherapy to improve mobility for people less than 6 months post
stroke. Disabil Rehabil Assist Technol, Early Online: 1–7, 2014 Informa UK Ltd. DOI:
10.3109/17483107.2014.917125
45. van der Linden ML, Hooper JE, Cowan P, Weller BB, Mercer TH (2014) Habitual
Functional Electrical Stimulation Therapy Improves Gait Kinematics and Walking Performance,
but Not Patient-Reported Functional Outcomes, of People with Multiple Sclerosis who Present
with Foot-Drop. PLoS ONE 9(8): e103368. doi:10.1371/journal.pone.0103368
46. Evidence Note 46 - The use of functional electrical stimulation (FES) in adults with
dropped foot. Quality Improvement Scotland, 2012
http://www.healthcareimprovementscotland.org/our_work/medicines_and_technology/shtg_-
_evidence_notes/evidence_note_46.aspx
47. Taylor P, Humphreys L, Swain I. A 15 year cost-effectiveness study of the use of FES for
the correction of dropped foot in Multiple sclerosis. Multiple Sclerosis Journal 2014;20:(7)
1001-2
48. Scherer MJ. Outcomes of assistive technology use on quality of life. Disabil Rehabil
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49. Perry J, Garrett M, Gronley JK, Mulroy SJ. Classification of walking handicap in the stroke
population. Stroke 1995;26:982-9.
50. Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness
in common physical performance measures in older adults: meaningful change and
performance. J Am Geriatr Soc 2006;54:743-9.
51. Singleton C and Street T. The effect of dropped foot stimulation on walking speed for
People with Multiple Sclerosis – a longitudinal study. International FES Society UK and Ireland
chapter scientific meeting, Sheffield, UK 8th-9th May 2015
52. S. Khurana, T. Ference, A. Beranger. Comparison of functional electric stimulation

neuroprosthesis and ankle foot orthosis in persons with multiple sclerosis. 26th ECTRIMS
congress &15th RIMS meeting 2013
53 Jones KH, Ford DV, Jones PA, et al. How People with Multiple Sclerosis Rate Their Quality
of Life: An EQ-5D Survey via the UK MS Register. Reindl M, ed. PLoS ONE. 2013;8(6):e65640.
doi:10.1371/journal.pone.0065640
54 Taylor P, Street T, Swain I. Quality Adjusted Life Years (QALY) Gain From The Use Of
FES For The Correction Of Dropped Foot Due To Stroke And Multiple Sclerosis Derived Using
The Eurool EQ-5L-5D. IFESS 2017
55 S Durham S, Eve L, Stevens C, Ewins D. Effect of Functional Electrical Stimulation on

asymmetries in gait of children with hemiplegic cerebral palsy. June 2004Volume 90, Issue 2,
Pages 82–90
56 Bailes AF, Caldwell C, Clay M, Tremper M, Dunning K, Long J.
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57 Pool D, Valentine J, Bear N, Donnelly CJ, Elliott C, Stannage K.

The orthotic and therapeutic effects following daily community applied functional electrical
stimulation in children with unilateral spastic cerebral palsy: a randomised controlled trial.
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58 Pool D, Valentine J, Blackmore AM, Colegate J, Bear N, Stannage K, et al. Daily functional
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60 Marsden J., Stevenson V., McFadden C., Swain I., Taylor P. 2012. The Effects of
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1403.2012.00494.
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from the History of RCTs. June 2, 2016 N Engl J Med 2016; 374:2175-2181 DOI:
10.1056/NEJMms1604593
Other references relating to the ODFS®
1. Sheffler LR, Hennessey MT, Knutson JS, Chae J. Neuroprosthetic effect of peroneal nerve
stimulation in multiple sclerosis: a preliminary study. Arch Phys Med Rehabil. 2009
Feb;90(2):362-5.
2. Sheffler LR, Hennessey MT, Naples GG, Chae J. Improvement in functional ambulation as a
therapeutic effect of peroneal nerve stimulation in hemiplegia: two case reports.
Neurorehabil Neural Repair. 2007 Jul-Aug;21(4):366-9. Epub 2007 Mar 16.
99
3. Sheffler LR, Hennessey MT, Knutson JS, Naples GG, Chae J. Functional Effect of an Ankle Foot
Orthosis on Gait in Multiple Sclerosis: A Pilot Study. 87(1):26-32, January 2008
4. Burridge JH, Taylor PN, Hagan SA, Swain ID. Experience of the clinical use of the Odstock
Drop Foot Stimulator. Artificial Organs 21(3): 254-260, 1997.
5. Taylor P, Johnson M, Mann G, Swain I. Patterns of use and users’ perceptions of the Odstock
Dropped Foot Stimulator following stroke and multiple sclerosis. 9th Annual Conference of
the International FES Society and 2nd FESnet Conference, (ISBN 1-85899-191-9), pp. 296-298,
Bournemouth, UK, September 2004.
6. Johnson CA, Tromans AM, Wood DE, O’Keeffe D, Buhrs D, Swain ID, Burridge JH. A pilot
study to investigate the combined effect of (Botulinum Neurotoxin Type A) BoNTA and
functional electrical stimulation (FES), with physiotherapy, in the treatment of spastic
dropped foot in subacute stroke. Artificial Organs, 26(3): 293-294, 2002.
7. Finn SM, Mann GE, Taylor PN. Using functional electrical stimulation in Parkinson’s disease.
Artificial Organs, 26(3): 290-291, 2002.
8. Burridge JH, McLellan DL. Relation between abnormal patterns of muscle activation and
response to common peroneal nerve stimulation in paraplegia. Journal of Neurology,
Neurosurgery and Psychiatry, 69: 353-361, 2000.
9. Burridge JH, Wood DE, Taylor PN, McLellan DL. The relationship between abnormal patterns
of muscle activation and response to common peroneal nerve stimulation in hemiplegia. 4th
Annual Conference of the International Electrical Stimulation Society, (ISBN 4-9980783-0-5),
pp. 189-192, Sendai, Japan, August 1999.
10. Kinsella SM, O’Keefe D, Wood DE, Lyons GM. A case study of the effects of functional
electrical stimulation for drop foot in a subject with hemiplegia. Physiotherapy Ireland,
20(1): 9-13, 1999.
11. Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton, C, Swain ID. Clinical
audit of five years provision of the Odstock Drop Foot Stimulator. Artificial Organs, 23(5):
440-442, 1999.
12. van der Linden ML,. Hazlewood E, , Hillman SJ and Robb JE. Functional Electrical
Stimulation to the Dorsiflexors and Quadriceps in Children with Cerebral Palsy. Pediatr
Phys Ther 2008;20:23–29)
13. Sheffler LR, Hennessey MT, Naples GG, Chae J. Peroneal nerve stimulation versus an ankle
foot orthosis for correction of footdrop in stroke: impact on functional ambulation.
Neurorehabil Neural Repair. 2006 Sep;20(3):355-60.
14. Falkonakis A. (2009) Use of functional electrical stimulation (FES) in the treatment of drop-
foot in patients with upper motor neuron lesions. Themata Fysikotherapeias, 5 (7): 48-54.
15. Sheffler LR, Bailey SN, Chae J. Spatiotemporal and kinematic effect of peroneal nerve
stimulation versus an ankle-foot orthosis in patients with multiple sclerosis: a case series.
PM R. 2009 Jul;1(7):604-11
100
16. Taylor P, Dropped Foot Stimulator: From the first idea to a patient satisfactory device. 15th
International Functional Electrical Stimulation Society Conference. Vienna 2010.
17. Street, T, Taylor P, Swain I. The practical use of Functional Electrical stimulation in the
treatment of people with multiple sclerosis. Multiple Sclerosis Journal 2014;20:(7) 1000
18. Linda Miller, Danny Rafferty, Lorna Paul, and Paul Mattison A comparison of the orthotic
effect of the Odstock Dropped Foot Stimulator and the Walkaide functional electrical
stimulation systems on energy cost and speed of walking in Multiple Sclerosis. 2015 Disabil
Rehabil Assist Technol, Early Online. ISSN 1748-3107 print/ISSN 1748-3115 online, DOI:
10.3109/17483107.2014.898340
101
Review articles featuring the ODFS®
1. Burridge JH, Taylor PN, Swain ID. A review of the literature published for the correction of
peroneal nerve stimulation for the correction of dropped foot. Reviews in Clinical
Gerontology, 8: 155 161, 1998.
2. Lyons, GM; Sinkjaer, T; Burridge, JH; et al (2002) A review of portable FES-based neural
orthoses for the correction of drop foot. IEEE Transactions on Neural Systems and
Rehabilitation Engineering, 10(4): 260-279.
3. Kottink, AL.; Oostendorp, LJ.; Buurke, JH.; et al (2004) The orthotic effect of functional
electrical stimulation on the improvement of walking in stroke patients with a dropped foot:
a systematic review. Artificial Organs, 28(6):577-86.
4. Robbins SM, Houghton PE, Woodbury G, Brown JL, The Therapeutic Effect of Functional and
Transcutaneous Electric Stimulation on Improving Gait Speed in Stroke Patients: A Meta-
Analysis Arch Phys Med Rehabil Vol 87, June 2006
5. Roche A, O´ Laighin G and Coote S Surface-applied functional electrical stimulation for

orthotic and therapeutic treatment of drop-foot after stroke – a systematic review Physical
Therapy Reviews 2009 VOL 14 NO 2 63-80
6. Stevens P, Hunsaker RB. Recent Findings Regarding the Efficacy of functional electrical
stimulation in patients with chronic hemiplegia and multiple sclerosis: a narrative literature
review. J Prosthet Orthot. 2010;22:166-171
7. Buyers Guide. Functional Electrical Stimulation for dropped foot of central neurological
origin. CEP10010. Published by the NHS Purchasing and Supply Agency Feb 2010
www.dh.gov.uk/cep
8. Market Review. Functional Electrical Stimulation for dropped foot of central neurological
origin. CEP10011. Published by the NHS Purchasing and Supply Agency Feb 2010
www.dh.gov.uk/cep
9. Schuhfried O, Crevenna R, Fialka-Moser V, Paternostro-Sluga T.on-invasive neuromuscular

electrical stimulation In patients with central nervous system lesions: An educational
review. J Rehabil Med 2012; 44: 99–105
10. Pereira S, Mehta S, McIntyre A, Lobo L, Teasell RW. Functional electrical stimulation for
improving gait in persons with chronic stroke. Top Stroke Rehabil. 2012 Nov-
Dec;19(6):491-8. doi: 10.1310/tsr1906-491.
11. Graham J The management and treatment of foot drop in stroke. British Journal of
Neuroscience Nursing March 2013 Vol 9 No 1
12. Wening J, Ford J, Jouett D. Orthotic and FES for maintenance of walking in patients with MS.
Disease-a-Month 59 (2013) 284-2894
102
Section 4.5.2 Evidence for the clinical risks associated with the use of
the ODFS® family of devices.
Part 1. Reports of adverse and serious adverse events reported to

regulatory bodies
8th February 2017
Paul Taylor and Tamsyn Street.
Purpose
To identify reports of adverse and serious adverse effects that have been reported to
the regulatory authorities regarding the ODFS® family of devices and similar devices.
Method
The American Food and Drugs administration (FDA) and the Medicines and Healthcare
Products Regulatory Agency (MHRA) were asked for all reports of adverse events and
serious adverse events that had been reported for the ODFS® family of devices and
similar devices. These two regulatory authorities cover over 90% of the territory that
the ODFS® devices have been sold into.
Results
FDA
The FDA online data base was interrogated for adverse events reported for electrical
stimulators between 2012 1and 2016. Electrical stimulation device are covered by two
codes; IPF (Stimulation, muscle, powered); GZI (Stimulator, neuromuscular, External
Function.
No adverse events had been reported for any OML FES device.
Devices with similar characteristics to OML devices
IPF Stimulation, muscle, powered (table 1)

In total 61 adverse events had been recorded in this category. The individual listings
were reviewed for the similarity of stimulation parameters or technology used by the
devices. Five devices had similar characteristics to OML products and thirteen may
have had similar characteristics. The uncertainty was because they were multimodal
devices capable of producing stimulation parameters similar to OML devices and other
parameters that were significantly different. The on-line reports did not provide
103
enough information to identify which mode was used when the adverse event occurred.
The remain 42 listings were for devices that were significantly different to OML devices.
These used high frequency outputs or interferential waveforms.
Eighteen adverse events were reported. Eleven related to skin irritation or burns, three
to faulty equipment, one to user error, one to bleeding from a recent wound, one to a
cardiac event and one was a non-specific injury.
GZI Stimulator, Neuromuscular, External Functional (table 2)

In total 8 adverse reported. Four were from devices similar to OML devices. All four
reported adverse events were skin irritation to the electrodes.
The results from the FDA data base are summarised in the table at the end of this
reposrt
MHRA
The MHRA was asked to provide a list of adverse events that have been reported from
the 01/01/2006 to the current day for peroneal nerve electrical stimulators used to
assist with walking for people with foot drop/dropped foot/lower limb paralysis/drop
foot. Additionally information was requested on neuromuscular electrical stimulation
devices used for exercise or therapeutic stimulation to improve strength in muscles or
treatment of pain.
The MHRA gave the following response:
Over the last three years MHRA has received eight adverse incidents reports
regarding TENS machines. In summary, two incidents concerned an allergic
reaction to the electrode pads, whilst three reported 'burn' markings left by the
electrode pads. One report concerned an electrical failure that caused the device to
emit smoke. One report alleged a TENS machine caused an episode of atrial
fibrillation, whilst another claimed that a TENS machine caused a respiratory
effect. MHRA has not issued any advice or alerts on the use of TENS machines.
From the above response we can conclude that no adverse events involving OML
devices had been reported. However, TENS machines generally have similar output
characteristics to OML devices so these adverse events are relevant to OML as a class of
devices.
Implication to OML device and approach taken to mitigate risk

Skin irritation is a known risk from FES devise and is addressed in our instructions for
use. Warnings regarding use with people with cardiac conditions or open wounds are
also included in our instructions for use.
104
Summary
This review of adverse events reported to regulatory bodies did not produce of any
events attributed to OML devices. Adverse events that were reported from devices with
similar characteristics to OML devices were known risks associated with FES devices
and already addressed in the design and accompanying documentation of FES devices.
It is concluded that there are no actions required in response to this report.
105
Table 20. IPF – Stimulator, Muscle, Powered
Event Date Brand Name Event text Device Type of Comment/mitigation
similar to problem
ODFS®
devices?
2015/11/1 CHATTANOOGA Event description: complaint received that alleges "once Yes Clinician No information on
0 technician believed the therapy session was completed she received device type or wave
attempted to remove the electrodes from the patient. As she stimulation form. Likely to be
was removing the electrodes she sustained an electrical shock operator error. ODFS®
that gripped her hands, wrists and elbows sustained it in a device warn the user to
flexed position. She was unable to release the electrodes until only adjust electrodes
the machine was shut off by others in the room". Device not yet when stimulation is off.
returned to manufacturer for evaluation. No indication event
caused or contributed to permanent impairment or death.
Manufacturer narrative: not yet returned.
2015/05/0 NEUROTECH Event description: patient was prescribed the left kneehab xp Yes Bleeding from ODFS® instruction
5 KNEEHAB XP from his doctor in (b)(6) 2015. Patient advised he had knee recent wound manuals instruct user
surgery on (b)(6) 2015 and used the unit 1 day 05/05/15 x 3 not to place electrodes
times. Also stated that he had a bandage over the wound but it in the vicinity of open
was not directly underneath the kneehab. The third time he wounds.
went to use it he went to the bathroom shortly afterwards and
noticed blood coming down his leg. Patient contacted his doctor
straight away. He was advised to cease using it and he stated
using the kneehab resulted in his wound reopening and he
needed his doctor to reclose the wound. Manufacturer
narrative: the returned device was functioning as expected.
Instructions for use not followed . Section 2.2 precautions of ifu
, bullet point 6, states, "caution should be used in the presence
of the following - following recent surgical procedures when
muscle contraction may disrupt the healing process;" this
patient was using the device on (b)(6) 2015 when he had
surgery on his knee on (b)(6) 2015 which is 8 days previous.
106
ODFS Clinical Evaluation Report v1.2 April 2018
2015/06/3 CONTINUUM Event description: it was reported that a patient was admitted Yes Cardiac event Empi devices have
0 to the emergency room for chest pains while using an empi similar parameters to
device. On (b)(6) 2015 the patient stated that she was using an ODFS® devices. It is not
nmes device on her right hip. She has been using this device for clear that the chest
several weeks. 15 minutes into the treatment she felt an intense pains were related to
pain in the left side of her chest, back and shoulder area. The the stimulation.
patient then went to the er, where an ekg was done at the time
she was admitted and again four hours later. She also had a
chest x-ray, and blood work. The er doctor stated to the patient
that she passed the initial test. The er doctor said that the final
interpretation of the x-ray and blood test would be in 48-72
hours. The er doctor suggested to discontinue using the device
and to follow-up with her primary physician and suggested a
stress test. The patient said she still feels lightheaded and short
of breath. On (b)(6) 2015 the patient seen her primary
physician, her physician stated that she was puzzled on why she
had this experience. The patient has no known cardiac issues
previous to this event and that the patient will continue to use
the device. Manufacturer narrative: a follow-up report will be
submitted once the evaluation is completed.
2014/11/0 ZYNEX Event description: pt reported unit burned her (lower back Yes Skin irritation Similar waveforms to
6 area). She came to the main office, dropped the unit off in ODFS® but not enough
person and showed the redness on her lower back to the qual information
mgr. See scanned pages.
2011/12/2 ZYNEX Event description: pt reported that she received multiple Yes Skin irritation Similar waveforms to
9 blisters on her skin where the electrodes were placed. ODFS® but not enough
information
2016/09/2 VECTRA GENYSIS Event description: patient was placed on electrical stimulation Insufficient Skin irritation Multi waveform device
8 for 10 min. Afterwards, the patient complained of pain in his information and no information
back area. The patient was noted to have 4 skin lesions, 2 given on type of wave
cervical area and 2 lumbar area. It appears the stim unit form used. May be a
malfunctioned causing the patient to receive more stimulation device specific
than intended. The patient has 2 small 1st degree burns just malfunction
below neck, each approx 1 cm in diameter, no drainage, no red
streaking, no blistering. The patient has another 2 small 1st
degree burns to the lower back just above the belt line, each one
is approximately 1 cm in diameter, no redness, no drainage, no
blistering manufacturer narrative: .
107
2014/06/2 ZYNEX Event description: pt burned by unit. Manufacturer narrative: Insufficient Skin irritation No information on the
0 unit was evaluated and no problem was found. Found during information device or waveform but
2015 and should have been reported. some zynex devices
provide similar
parameters to ODFS®
devices
2015/05/0 ZYNEX Event description: patient received burns to neck in (b)(6) Insufficient Skin irritation No information on the
1 2015, but wasn't report until (b)(6) 2015. Unit has not been information device or waveform but
received for evaluation. Manufacturer narrative: patient has some zynex devices
been called, and unit has not been received as of (b)(6) 2013. provide similar
Waiting for unit. Zynex believed a mdr was sent in (b)(6) 2015, parameters to ODFS®
but it was discovered it was not. devices
2015/01/1 ZYNEX Event description: patient reported burn marks on her upper Insufficient Skin irritation No information on the
7 arm. She said she took pictures and will send to us. information device or waveform but
Manufacturer narrative: unit was evaluated and no problems some zynex devices
was found. Mdr wasn't reported initially due to further provide similar
investigation and photos not being received. Photos are parameters to ODFS®
included. devices
2015/10/0 CHATTANOOGA Event description: complaint received that alleges "the unit has Insufficient Skin irritation No information about
6 burned a patient". Product not returned for evaluation. Product information the device of wave form
questionnaire received from clinician and/or patient. Event did used. Device may be
interrupt treatment, recovery was impeded. Patient received faulty.
third degree burn under 1 electrode, superficial burn under one
electrode. Patient received treatment at the time of the incident,
and was referred for follow up with doctor post event.
Manufacturer narrative: not returned. Manufacturer narrative:
product was returned for review. The product malfunctioned or
failed to meet specifications. The malfunction or failure is not
related to the event. No problems were duplicated that may
have caused or contributed to the event. All treatments were
run for full duration and no problems were duplicated.
108
2015/09/2 CHATTANOOGA Event description: complaint received that alleges "they were Insufficient Pain No information about
1 doing an e-stim treatment and the unit's intensity continued to information the device of wave form
increase without anyone turning it up. This caused pain in the used. Device may be
resident and when they tried to turn it off, they couldn't and had faulty.
to pull off the electrodes which then shocked the therapist. The
resident has experience constant pain throughout the weekend
where the pads were attached. The patient is going to see their
primary dr. For these injuries". Questionnaire was not received
from clinician and/or patient. Device not returned to
manufacturer for evaluation. No indication event caused or
contributed to permanent impairment or death. No indication
device caused or contributed to the event. Manufacturer
narrative: product was returned for review. The product met
specifications and did not malfunction. The unit and applicator
passed all functional and cosmetic testing. No accessories were
included for evaluation (leadwires, electrodes) . Additional
information does not change original not reportable decision.
Manufacturer narrative: device not returned.
2014/06/2 ZYNEX Event description: received unit with letter from law firm Insufficient Insufficient Insufficient information
1 claiming patient injury, but no specific as to type of injury information information
reported. Manufacturer narrative: zynex: unit returned through
front door, but not as a qa return. Low firm letter enclosed. No
specifics on problem other than "personal injury" unit was
tested and functioned according to spec. No problem found. Law
letter could be from a billing perspective and not necessary the
unit.
2014/08/0 ZYNEX Event description: device is shocking patient even with new Insufficient Shocks No information on
4 pads and lead wires. Manufacturer narrative: zynex: patient did information received by which device but zynex
not return ac adapter or lead wires. Unit turned on, passed final user devices have similar
testing without any problems. No problem found. parameters to ODFS®
devices. May be a device
fault
ELECTRODE GEL Event description: patient is using reusable electrode gel pads Insufficient Skin irritation Could be similar
PADS for pain management for 6-10 hours. Patient experienced, information electrodes to those used
soreness, blistering and oozing yellowish fluid from his back for by ODFS® but no
3 weeks. Patient is taking antibiotics and using betadine to information given
clean area. Patient has been using therapy for 23 years with no
problem until using reusable pads.
109
2013/01/1 DYNATRON D650 Event description: on (b)(6) 2013, dynatroincs received a Insufficient Insufficient Unable to find
1 PLUS phone call from a medical device dealer reporting that they information information information about this
were contacted by an end user facility regarding two device.
dynatronics devices (d650; d650 plus) that were involved in
two adverse events involving two different pts. The end user
facility was asked to complete an incident questionnaire for
each of the adverse events but would not provide any details as
to what had occurred with the devices. The only details that
were made known to the dealer are that one of the events
required medical intervention; the other event did not require
medical intervention. It is not known which device was involved
in the event that resulted in medical intervention. Manufacturer
narrative: there were no problems found with the operation of
the device. All outputs from the device were within
specifications. Chassis ground leakage test was within
specifications. Pt leads and lead adapters tested good. The
power cord received with the device tested good but it was not
a hospital grade power cord. The power cord was replaced with
a hospital grade power cord. The power cord was replaced with
a hospital grade cord. The overlay (user-device interface) was
evaluated and it was worn through over the up intensity key.
The worn overlay was replaced. Additional routine equipment
maintenance included a software update and calibration
verification. Labeling for the device was evaluated and the
operator's manual contains industry standard contra
indications, warnings, and precautions for all modalities
available on the device.
2012/06/3 RX-8000 Event description: used the rx-8000 from (b)(6) after (b)(6) Insufficient Skin irritation A multi-waveform
0 2012 order. I followed the manual for instructions and information device but some modes
placement of the electrodes on my laterals, abdominals and similar to ODFS®
back. First on low settings for warm-up and 1x higher setting devices. There may be
experienced shocks, burns, skin irritations, and pain. It was so an element of user error
devastating that i couldn't tolerate total time allowed. Thought
i'd try with the silver back electrodes so i did. Got the same
experience. Called (b)(6) for customer service for refund in
(b)(6). No response yet. Dates of use: (b)(6) 2012. Diagnosis or
reason for use: muscle stimulate. Event abated after use: yes.
Event reappeared after reintroduction: yes.
110
2012/01/1 ZYNEX Event description: pt reported that she received a shock and a Insufficient Skin irritation Similar waveforms to
8 blister on her skin. Manufacturer narrative: investigation: dhr information ODFS® but not enough
review revealed that the unit was mfg by zynex on (b)(4) 2011, information
with no issues. Unit passed zynex final testing with no issues.
Mode: ifc, low-high; timer: 60 min., data: 1112 mins, 29 times.
Unit tested and inspected by (b)(6), on (b)(4) 2012.
Oscilloscope test performed in all modes. All waveform levels
and timings were correct and according to specification. On-
skin test performed. Electrodes connected to underside of right
forearm. Tested in low-high mode at 8 ma output. Battery
powered using partially drained zynex battery. While treatment
was in effect, touched center conductor of ac adapter input
connector. Was not able to replicate the problem. No shocking
sensation occurred while probing around the ac adaptor
connector. Conclusion: it is inconclusive exactly how the pt
experienced a shocking sensation.
2011/11/0 INTERLECT MODEL Event description: on (b)(6) 2012 additional information was Insufficient Skin irritation Multi waveform device
1 900 received from user facility. A injury in the form of a 2nd degree information and no information
burn was reported. Manufacturer narrative: the device was given on type of wave
evaluated by djo and found to be functioning within form used.
specification. It cannot be determined if the device caused the
reported burn.
111
Table 2: GZI – Stimulator, Neuromuscular, External Functional
Event Date Brand Name Event text Device type of Comment/mitigation

similar to problem
ODFS®
devices?
2015/07/2 CHATTANOOGA Event description: complaint received that alleges "unit Insufficient Skin No information given on
9 caused 2nd degree burn on patient". Questionnaire was not information irritation device parameters
received from clinician and/or patient. Device not returned to
manufacturer for evaluation. No indication event caused or
contributed to permanent impairment or death. Manufacturer
narrative: not returned.
2014/12/1 CHATTANOOGA Event description: complaint received from clinician that Insufficient Skin No information given on
8 alleges "pt received 3rd degree burns". Questionnaire was information irritation device parameters
received from clinician and/or pt. Pt received 2nd degree burn
under one pad and a 3rd degree burn under one pad. Pt was
seen by his doctor and a burn specialist for diagnosis and
treatment, no description of treatment revealed to mfr. Device
not returned to mfr for evaluation.
CHATTANOOGA Event description: complaint received from clinic that alleges Insufficient Skin No information given on
"patient received third degree burns during stim treatment." information irritation device parameters
product not received by manufacturer for review. Product
questionnaire not received from clinician and/or patient.
Complaint alleges event caused or contributed to permanent
impairment, injury or death. Complaint alleges device caused
or contributed to the event.
LEGEND XT 4CH Event description: patient suffered a burn on the forearm from Insufficient Skin Multi-function device and no
COMBO PKG an electrode during electrotherapy treatment. The patient information irritation information about which
sought and received additional treatment from a medical mode caused the reported
facility. problem.
112
Part 2. Adverse and serious adverse events reported in the literature
Paul Taylor July 2017
Relevant standards
Purpose
Identify the prevalence of adverse and serious adverse events reported in the scientific
literature and OML internal data.
Method
Using the same literature review procedure outlined in section 4.4, papers were
identified that reported adverse events. These were then summarised.
Results
Only a minority of papers reported adverse events. Reports are restricted to larger and more
formal studies.
ODFS® studies
Only minor adverse effects have been reported from use of the ODFS® system, and they are
common adverse effects associated with any powered muscle stimulator. In a survey of 107
device users, 22% had experienced some skin irritation from electrodes on some occasion over
an average of 19.5 months1. However, these problems had been overcome enabling continued
use of the device. Since the survey the Salisbury clinic has changed the type of electrodes used
and reduced the maximum period for which electrodes are used for. In a six month period from
June 2005 every occurrence of skin irritation occurring in the Salisbury FES clinic was
recorded2. In that time 585 individual patients were seen in the clinic. 13 cases of irritation
were reported. An appeal for honesty to the clinicians working in the clinic indicated some
under reporting, estimated to be about 25%. This therefore results in prevalence in the clinic of
between 3 and 4%. However, 8 cases were reoccurrence and 5 first time cases, 3 of whom
developed skin reaction in the first 6 months and the other 2 between 12 and 18 months of
ODFS® use. This means the prevalence of new cases was around 1 to 1.5%. There were no cases
of discontinued treatment due to skin irritation in this period. Further, in the randomised
controlled trial of the ODFS® with people who have secondary progressive MS, there were no
reports of skin irritation in the period of the 18 week trial3.
Out of a survey of 56 people who had discontinued use of the ODFS®, three discontinued due to
skin irritation1. Five out of the 56 survey respondents discontinued use of the device due to
increased spasticity. While the overwhelming majority tolerated the sensation of stimulation
113
well, one out of the 56 discontinued because they found the sensation to be painful. Other
reasons for discontinuation were due to convenience and functional issues not associated with
adverse effects. The most commonly cited reason for discontinuation was improvement in
mobility such that the device was no longer required. In the 10 year audit of 126 FES users, only
1 person discontinued due to skin irritation while 3 people discontinued because they found the
stimulation uncumfortable4.
In a recent PMCF, 133 patients with stroke were followed up over a period of 20 weeks
using the ODFS® Pace5. An above average incidence of skin irritation was reported with
15/104 reporting skin irritation, 9/104 reported pain from electrodes, 7/104 reported
having a fall but did not report whether this was while using the FES device or not. In a
recent PMCF, 187 patients with MS were followed up over a period of 20 weeks using
the Pace6. A total of eight patients (4.3%) had skin irritation from using the electrodes;
five of those were able to continue with FES, while three chose to discontinue use. The
study did not report on falls or technical issues encountered by patients.
Adverse events reported in studies of other dropped foot stimulators.
The incidence of skin irritation has been identified in three other studies. Kluding
reported that from a group of 99 users of the Bioness L300 who took part in a randomised
controlled trial, 130 adverse incidence occurred of which 50% related to skin irritation in a 42
week period7. It is not reported what the other adverse events were but all were considered
minor events that did not require medical intervention. No serious device related adverse
events were reported. Bethoux reported that 33 out of 242 users of the Walkaide device
experienced skin irritation over 12 month of its use8. A total of 600 adverse events are
recorded, but with the exception of the skin irritation, it is not stated if they are related to the
device use. No serious a device related adverse events are reported. Everaert 7 out of 69
people taking part in a randomised cross over trial of the Walkaide device developed
irritation during a 12 week period of using the Walkaide. 1 fall occurred that was attributed
to Walkaide use. No device related serious adverse events occurred.
Discussion
Adverse and serious adverse event reporting is not well reported in the literature. This may
in part reflect the relative safety of the technique as where adverse events have been reported,
no serious events have occurred and non serious events have largely been restricted to skin
irritation. It is clearly the case that skin irritation is the principle clinical risk from using FES
for correction of dropped foot but for the most part it can be clinically managed and only
leading to discontinuation of FES use in a minority of cases.
Conclusion
No serious adverse events are reported for the ODFS® family of devices or similar devices.
Skin irritation is the principle clinical risk with pain in response to the stimulation being the
next most frequently reported adverse event. Long term audit data demonstrates that the
incidence of adverse events is clinically acceptable.
114
References
perceptions of the Odstock Drop Foot Stimulator. Clinical Rehabilitation, 13: 333-340,
1999.
2. Salisbury FES Newsletter Summer 2006, available at
http://www.salisburyfes.com/summer2006.htm#7
3. CL Barrett, GE Mann, PN Taylor and P Strike. A randomized trial to investigate the
effects of functional electrical stimulation and therapeutic exercise on walking
performance for people with multiple sclerosis. Mult Scler. 2009 Apr;15(4):493-504
4. Taylor P, Humphreys L, and Swain I, The long-term cost-effectiveness of the use of
functional Electrical stimulation for the correction of dropped foot Due to upper motor
neuron lesion. J Rehabil Med 2013; 45: 154–160
5. Street T, Swain I and Taylor P. Training and Orthotic Effects related to the use of
Functional Electrical Stimulation of the Peroneal Nerve in Stroke. J Rehabil Med.
2016
6. Street TD, Taylor PN, Swain ID. The Effectiveness of Functional Electrical
Stimulation on Walking Speed, Functional Walking Category and Clinically
Meaningful Changes for People with Multiple Sclerosis. Archives of Physical
Medicine. Volume 96, Issue 4, April 2015, Pages 667–672
7. Kluding PM, Dunning K, O'Dell MW, Wu SS, Ginosian J, Feld J, McBride K. Foot
Drop Stimulation Versus Ankle Foot Orthosis After Stroke: 30-Week Outcomes.
Stroke. 2013 May 2. [Epub ahead of print]
8. Bethoux F, Rogers HL, Nolan KJ, Abrams GM, Annaswamy TM, Brandstater M,
Browne B, Burnfield JM, Feng W, Freed MJ, Geis C, Greenberg J, Gudesblatt
M,Ikramuddin F, Jayaraman A, Kautz SA, Lutsep HL, Madhavan S, Meilahn J, Pease
WS, Rao N, Seetharama S, Sethi P, Turk MA, Wallis RA, Kufta C. The Effects of
Peroneal Nerve Functional Electrical Stimulation Versus Ankle-Foot Orthosis in
Patients With Chronic Stroke: A Randomized Controlled Trial. Neurorehabil Neural
Repair. 2014 Feb 13. [Epub ahead of print]
9. Everaert DG, Stein RB, Abrams GM, Dromerick AW, Francisco GE, Hafner BJ,
Huskey TN, Munin MC, Nolan KJ,Kufta CV. Effect of a foot-drop stimulator and
ankle-foot orthosis on walking performance after stroke: a multicenter randomized
controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):579- 91. doi:
10.1177/1545968313481278. Epub 2013 Apr 4.
115
Section 4.6 Analysis of clinical Data
Review of incidence of risks identified in the risk analysis and instructions for
use.
Paul Taylor
March 1st 2017
Relevant standards
Purpose
To identify the prevalence of risks that have been identified for the ODFS® Pace (XL) and
similar device.
Method
Relevant clinical risks were taken from the clinical risk analysis performed using the Qware
database system. Evidence of the prevalence and seriousness of each risk was taken from the
Source of information:
MHRA and FDA registers, published literature and OML internal data
The following table lists all the foreseen risks from using the ODFS® pace (XL) devices.
Next to each risk any reported occurrences are listed.
Table 21. Identified risk factors and reports of occurrence.

Risk MHRA or FDA Published literature Internal data
Ectopic heart beat or atrial FDA: One Non reported Non reported
fibrillation due to current incidence of a
passing through the heart cardiac event
occurring while
using non-OML
device. It is not
reported if this
included ectopic
heart beats. A
causal relationship
was not established.
116
MHRA: 1 report of
atrial fibrillation
following use of a
TENS device.
Autonomic dysreflexia in Pace Non reported Not reported for Not reported for
users with Spinal Cord Injuries OML devices but ODFS® Pace users
has been reported in but seen in complete
complete high level spinal
tetrapligics. This cord injured patients
group unlikely to in response to upper
use the ODFS® Pace limb and abdominal
(XL) FES.
Skin allergy/reaction to long- FDA 11 reports Kluding (2013) Internal audits of
term use of electrodes effects MRHA 5 reports from a group of 99 prevalence of skin
None related to users of the Bioness irritation at clinic
OML devices L300, 160 adverse appointments:
incidence occurred
of which 50% 2005: 3.1%
related to skin 2006: 4.9%
irritation in a 42 2008: 1.7%
week period. 2011: 2.4%
Bethoux (2014) 33
out of 242
experienced skin
irritation over 12
month of using the
Walkaide
Everaert (2013) 7
out of 69 had
irritation after 12
weeks of using the
Walkaide.
Street (2015) 4.5%

of ODFS® Pace
users (MS)
experienced skin
irritation after 20
week use.
Street (2017) 104

ODFS® Pace users
(stroke) over 20
Weeks. 14%
experienced skin
irritation
Taylor (2013) 1
person out of 126
discontinued use of
ODFS® due to skin
irritation. Average
device use 4.9 years.
117
Allegenicity/Biocompatibility Non reported Non reported Non reported
Discomfort due to high FDA: 1 report of Taylor (2013) 3 22/09/16 focus
stimulation level pain from over person out of 126 group. The
strong output. Non discontinued use of sensation of FES
OML device ODFS® due to was thought to be a
discomfort from disadvantage of FES
FES. Average by some
device use 4.9 years. participants.
Street (2017) 104

ODFS® Pace users
(stroke) over 20
Weeks. 8%
experienced pain
from the electrodes
Unintended activation caused by Non reported Non reported Non reported
inadvertent selection of the
wrong operating mode
Unintended adjustment of FDA: 1 report of Non reported Non reported
output level pain from over
strong output.
Non OML device
Foot-switch fails to trigger the Non reported Non reported Non reported
device at the relevant part of the
gait cycle
Incorrect battery insertion Non reported Non reported Non reported
(polarity) causing damage to the
circuit
Footswitch and electrode lead Non reported Non reported 1 report in the 2016
coming un-plugged clinic book report.
Mechanical Forces Non reported Non reported Battery tag and
transformer failure
due to mechanic al
shock reported in
repair report.
Batch to batch inconsistency Non reported Non reported Non reported
Device susceptible to Non reported Non reported Non reported
environment influences –EMI
Device susceptible to Non reported Non reported Non reported
environment influences –
Temperature
Device susceptible to Non reported Non reported Footswitch damage
environment influences – Water due to water ingress
Device malfunction
due to immersion in
water (dropped
down loo)
Shelf life – data retention Non reported Non reported Non reported
FES induce spasm interfering Non reported Non reported Non reported
with driving or operation of
dangerous machinery
Increased spasticity Non reported Non reported Non reported
118
Induced increase risk of Non reported Non reported Non reported
epileptic fit
Harm to the unborn child Non reported Non reported Non reported
Interactions with implanted Non reported Non reported A review of the
cardiac pacemakers Scientific Literature
by J Badger (2017)
showed that there
was no reported
cases of interaction
of lower limb FES
devices with Cardiac
pacemakers or IDC
devices. Paper to be
submitted to RATE
journal.
Stimulation of the neck causes Non reported Non reported Non reported
airway block
Stimulation by a wound causes FDA 1 case. Non reported Non reported
bleeding
Stimulation proximity to a Non reported Non reported Non reported
cancer causes spread of the
cancer
Interference with EMG/ECG Non reported Non reported Non reported
monitoring devices
Harm due to intracranial Non reported Non reported Non reported
stimulation
Harm from using FES while Non reported Non reported Non reported
sleeping
Harm from handling electrodes FDA: 1 report of Non reported Non reported
while stimulating being unable to
release electrodes
held while
stimulating. User
error.
Stimulator effected by Non reported Non reported Non reported
shortwave therapy devices
Use of FES with people with FDA: One Non reported Non reported
cardiac conditions incidence of a
cardiac event
occurring while
using non-OML
device. A causal
relationship was not
established.
MHRA: 1 report of
atrial fibrillation
following use of a
TENS device.
Latex allergy (Elastic bandage Non reported Non reported Non reported
used to hold electrodes in place.
Biological cross contamination Non reported Non reported Non reported
due to shared electrode use
Footswitch and lead failure Non reported Everaert (2013) one Non reported
119
leading to falls fall was attributed to
the FES device but
no details of the
exact cause are
given.
Skin marking and pressure sores Non reported Non reported Non reported
due to pressure placed on leads
and other components of the
system next to the skin
Use of FES devices while Non reported Non reported Non reported
undergoing electro-surgery by
lead to skin burns
Chocking hazard from Non reported Non reported Non reported
swallowing of small parts
Strangulation risk from use of Non reported Non reported Non reported
leads
Fire risk from use of Non reported Non reported Non reported
inflammable cleaning products
Fire or explosion risk from use Non reported Non reported Non reported
in an oxygen rich environment
such as a hypobaric oxygen
chamber or operating theatre
Pain from electrode contact on Non reported Non reported Non reported
external orthopaedic metal
bracing.
Harm due to use of the device Non reported Non reported Non reported
by a person for whom the
device was not set up
Discomfort or skin irritation Non reported Non reported Non reported
coursed by direct contact with
the electrode pins.
Electric shock risk by the Non reported Non reported Non reported
battery contacts coming into
contact with a live part while
the battery is changed or is
exposed.
Harm due to modification of the Non reported Non reported Non reported
device
Skin irritation from excessive Non reported Non reported Non reported
current density resulting from
use of electrodes of diameter
32mm or less when using high
power output.*
Harm due to use of equipment Non reported Non reported Non reported
outside its shelf life
Thermal burns from using the Non reported Non reported Non reported
device at high powers in very
high ambient temperatures (over
37°C)
* While there have been no reports of skin irritation occurring specifically due to the use of
small electrodes, it cannot be ruled out that reports of skin irritation listed above under “Skin
allergy/reaction to long-term use of electrodes effects” may have been due to the use of small
electrodes. Moreover, standard size electrodes may become partially disconnected or have reduced
contact area due to long term ware, leading to increased current density.
120
Discussion
The most frequently reported adverse event was skin irritation to the electrodes. This is
known complication of FES and is addressed in the instructions for use. Comparison with
other devices indicates the incidence of skin irritation from use of the ODFS® devices are in
line or better than similar devices. In most cases skin irritation is managed and only lead to
discontinued use of FES in one case. The reported incidence in the clinic remains acceptable
low through repeated audit. Pain from stimulation was identified as a reason for stopping
FES in three cases. Two cardiac events were reported to be associated with FES use. FES
often indicated for people who have a history cardiovascular problems that commonly
accompany stroke. Hence there this group is at higher risk of cardia events. It cannot be
concluded that the events are directly caused by FES.
Three items were reported that were related to device malfunction that stopped device use but
did not relate to harm to the device user. Mechanical shock has led to failure of the
transformer and battery tags. Design modifications are currently being implemented to
address these issues. Water ingress has been identified as an issue and it is planned to
improve this future deigns of the ODFS® Pace. Failure of the connection in the footswitch
lead is also recognised as problem and addressed in the clinic by regular renewal of the leads,
provision of a footswitch without a connector or provision of a wireless footswitch.
Conclusion
This review of the identified risks for the ODFS® Pace (XL) devices has indicated that in
most cases the mitigation put in the place in the design, accompanying documentation or FES
teaching are sufficient to prevent most envisaged risks. It is recommended that with the
exception of the above mentioned design changes, no other changes are required to the
device, its documentation or clinical teaching.
121
4.6.1 Requirement on Safety (MDD ER1)
Table 22. Summary of Conformity Assessment with requirement on safety and

acceptable benefit/risk profile MDD ER1
General Principle Harmonised and other relevant Evidence of compliance or reason
standards applied by manufacturer for no-applicability
EN: ISO; international, local This column to contain direct
standards or company procedures. reference to documents such as:
Other standard or procedures study results, test reports, design
applied by manufacturer identified outputs identified by number/title
by number/title. within the Quality System.
The devices must be designed European Medical Devices Directive -OML QF/052 Compliance with
and manufactured in such a way (MDD) 93/42/EEC + 2007 rev. Annex I MDD – Essential
that, when used under the Requirements [this document].
conditions and for the purposes BS EN 60601-1:2006 (3 Ed) Medical
rd -Intended Use / Purpose (QF102).
intended, they will not Electrical Equipment – General -Essential performance (QF/103).
compromise the clinical condition requirements for safety (incorporates
or the safety of patients, or the -Risk analysis performed and
PEMS and risk management) recorded. Design principles evolved
safety and health of users or,
where applicable, other persons, from range of stimulator products
provided that any risks which Design of OML Products OMP006 (OML that have been in production since
may be associated with their design procedure) 1996 with no adverse incidents.
intended use constitute Software package Qware now used
acceptable risks when weighed BS EN ISO 14971:2012 (Risk for risk management.
against the benefits to the patient Management for Medical Devices) -Pre market testing regime for
and are compatible with a high effectiveness and safety.
level of protection of health and ISO 13485:2013 (Quality Management -Post market surveillance conducted
safety. System for Medical Devices) on similar CE marked devices since
1998.
This shall include: -Instructions for use: two versions
— reducing, as far as directed at appropriate levels of
possible, the risk of use understanding – Clinician and
error due to the Patient
ergonomic features of -Requirement that Clinician fitting
the device and the the device is by a trained clinician or
environment in which supervised under their supervision
the device is intended to
be used (design for
patient safety), and
— consideration of the
technical knowledge,
experience, education
and training and where
applicable the medical
and physical conditions
of intended users (design
for lay, professional,
disabled or other users).
122
Analysis whether there are special design features that pose special safety concerns (e.g.
presence of medicinal, human or animal components) that were identified in the device
risk management documentation and that required evaluation from a clinical perspective,
and whether these have been adequately addressed.
There is a risk of falling from using the device if the footswitch does not trigger. This is
highlighted in the IFU. In the most recent study published including data collected from the
ODFS® Pace, 7/104 (7%) people reported having a fall but it was not reported whether they
were using the device at the time of the fall or not. Other data has found 71% overall decrease
in falls while using the ODFS® Pace device for those with MS in comparison to a physiotherapy
exercise group (Barrett et al., 2009). If the device fails to trigger while walking, the user is
returned to a level of disability that they were prior to using the device and hence there is no
additional risk. The overall reduction in the incidence of falls out ways the dis-benefit from falls
that may occur in the relatively rare event of device failure. See reference document ‘Safety case
for no or unexpected output’ located in the Risk Management File.
Whether the risks identified in the risk management documentation and literature have
been adequately addressed. Whether all the hazards and other clinically relevant
information (e.g. clinical precautions for reduction of risks, clinical management of risks)
have been identified appropriately.
The clinical risks have be extensively and exhaustively reviewed using Q-ware. No additional
risks were found from review of the literature or reports from regulatory bodies. It is therefore
concluded that he clinic risk analysis is sufficient for this family of devices.
Whether the safety characteristics and intended purpose of the device requires training of
the end-user or other precautions, if users foreseen are adequate, if training requirements
and other precautions are described in the IFU.
The manufacture require that clinicians administering FES treatment using its ODFS® devices
receives training by attending 1 day course. Procedures for training the end-user in the use of
the device are set out in the instructions for use. Nevertheless, the safety characteristics of the
device allow it to be used independent of special training as all the safety information and
precautions are contained within the IFU.
Whether there is full consistency between current knowledge/ the state of the art, the
available clinical data, the information materials supplied by the manufacturer, and the
risk management documentation for the device.
This report was prepared following a review of the manual and Qware risk analysis. At the
time of report preparation the whole risk analysis for the ODFS® Pace (XL) was under review.
Consequently risks were identified in Q-Ware that were not covered in the instruction manuals.
These additions are currently being added to the manuals to accompany the V1.4 software
release. This report has been written to reflect these updates.
A review of the literature and reports of adverse events did not find any further risks that had
not been considered in the risk analysis. It is therefore concluded that all relevant risks have
been considered.
123
4.6.2. Acceptability of the benefit/risk profile (MDD ER1/ AIMDD ER1)
Summary of the total experience with the devices
ODFS®III
The ODFS®III received the CE mark in 1998 and remained on the market until 2008. In
this time approximately 6000 devices were made and distributed.
ODFS® Pace
The device was released into the UK in November 2008 and subsequently into outside
UK (OUK) territories including Austria, Benelux, Canada, Denmark, Eire, Germany,
Iceland, Italy, India, New Zealand, Romania, South Africa and the USA over subsequent
years. OML had (to end of March 2016) sold 6,682 devices across all these territories
with the UK accounting for 85% of the sales.
The ODFS® Pace XL

Released into the UK in 2012 and subsequently into OUK territories including Austria,
Benelux, Canada, Denmark, Eire, Germany, India, New Zealand, Romania and South
Africa from 2014. We had (to end of March 2016) sold 608 devices across all these
territories with the UK accounting for 81% of the sales.
Device reuse
The above figures do not fully represent the amount of patients whom may use the
device. It is common for device to be recycled and put back out into clinical use. It is
also the case that some long term users will have used more than one device as device
life is expected to be 5 years.
Extent and length of clinical follow up

Around 5000 of all ODFS® users have attended the clinical service in Salisbury. The
service has a policy of never discharging a patient while using FES and so a high
proportion of device users have continuous follow-up throughout their use of the
devices. Audit data exists over 11 years for general population and for 15 years for
pwMS FES use. The Salisbury clinical service therefore represents between one quarter
and one third of all experience with the devices and hence can be considered a very
representative sample for device use over the whole lifetime of its use. Other clinics in
the UK follow the same policy of continual follow-up and support, accounting for around
50% of the remaining device users. It is very likely that reported experience of adverse
events is fully representative of all the clinical experience.
Nature, extent/severity, probability/frequency, duration of benefits to the

patients and of undesirable side-effects and other risks.
124
It was demonstrated in 11 year audit by Taylor et al (2013) that the mean duration of
device use is 5 years (Taylor 2013) with 28% of device users continuing its use after 11
years. Measurement of 10m walking speed, both with and without FES showed that the
orthotic benefit from the device remained constant over the whole period of device use,
indicating that benefit was maintained for as long as it was use.
The most frequently reported risk was skin irritation from use of the electrodes.
Irritation usually clears in one to two weeks of discontinuing use if the electrodes.
Pain in response to stimulation is transitory and will end as soon as stimulation ends.
Increase spasticity resulting from FES use can have two components. The more
common effect is the immediate spastic response to a rapid contraction. This will be
transitory and have no long term effect. The more unusual effect is spasms that occur
after FES use. This effect may subside after several days of stopping FES.
Autonomic Dysreflexia in response to FES, while reported in other applications of FES

has not been reported in uses of dropped foot devices. Where it has occurred, the effect
wares off over several minutes after the stimuli is removed. Dangerously large
increases in blood pressure, while a known symptom of autonomic dysreflexia, have not
been reported as associated with FES.
Falls that cause injury can have consequences that are long lasting and in the extreme
case lead to death or permanent disability. This has not been reported associated with
FES use.
The benefit/risk profile in relation to the manufactures intended purpose.
Each section of the intended use statement is now examined.
The ODFS® Pace (XL) is intended to be used for the alleviation of neurological injury or
handicap due to upper motor neurone disease or injury including stroke, multiple sclerosis
incomplete spinal cord injury (T12 and above), head injury, cerebral palsy, Parkinson’s
disease and hereditary spastic paraparesis. Electrical stimulation is triggered from a
switch input or cyclic during an exercise program. Gait events are detected by a wired or
wireless footswitch.
Evidence exists for the alleviation handicap demonstrating improved function for
people with upper motor neurone injury and data is available for stroke, multiple
sclerosis incomplete spinal cord injury (T12 and above), cerebral palsy, Parkinson’s
disease and hereditary spastic paraparesis. While no specific evidence is offered for
head injury, it is clear that this is of the same class of condition as identified in the NICE
guidelines IPG278 as “dropped foot of central neurological origin”. Risks from using the
device are not condition specific. No serious adverse incidences are reported and
reported adverse incidences do not have lasting effects.
125
The primary application is as a long term orthotic aid for the correction of dropped foot
for both adult and paediatric individuals. Other gait deficits can be addressed by
stimulation of additional muscle groups, singularly or in conjunction with the correction of
dropped foot, for the purpose of functional gait training and / or gait assistance.
Evidence exists for the long term use of the device as an assistive device for correction
of dropped foot in adults. The average time of device use is 5 years (Taylor et al. 2013).
Studies for the devices use with children who have CP has been restricted to short term
studies of up to 3 months. These studies have not reported any serious adverse events
or adverse events. While there is no reason to expect children to respond differently or
have a different risk profile to adults over the longer period of FES use, long term follow
up studies would confirm this.
Evidence for the stimulation of additional muscle groups is restricted to small case
series studies using another OML device, the O2CHSII. Clinical benefits are
demonstrated for the addition of hamstrings (knee flexion in swing), calf muscles (push
off in stance), quadriceps (knee extension to maintain standing in stance, gluteals (hip
extension in stance) and triceps muscles (arm swing while walking). No serious
adverse events or adverse events have been reported despite these applications being
used in the clinical service in Salisbury since 2000. The expected risk profiles for these
applications are the same as that for the correction of dropped foot using the ODFS®
Pace (XL).
The ODFS® Pace (XL) may also strengthen muscles, reduce spasticity, increase range of
movement, reduce oedema and increase local blood flow.
These claims are not device specific but apply to this class of device. The manufactures
do not offer any device specific evidence for these effects as the clinical effects of
strengthening muscles, reducing spasticity, reducing oedema, increased range of motion
and increase local blood flow are well established. The choice of parameters used for
this application is based on standard texts and the user is referred to the standard text
(LA Benton, LL Baker, BR Bowman, RL Waters. Functional Electrical Stimulation - A
Practical Clinical Guide. From Rancho Los Amigos Rehabilitation Engineering Centre,
Rancho Los Amigos Hospital, Downey, California, USA. Available from Nidd Valley
Medical.) There are no additional risks associated with these claims.
The ODFS® Pace (XL) is designed for use in home healthcare / residential and hospital /
healthcare environments.
All the clinical effectiveness and safety data is collected from home use of the device
after being set up in the hospital. Use of the devices is therefore safe and effective in the
stated environments.
The ODFS® Pace (XL) should be supplied and setup by a clinician who has attended an
Odstock Medical Limited training course.
126
This has been the policy of OML since the devices received the first CE mark in 1998.
This policy is intended to assure safe and effective use of the devices and can only
improve outcomes.
4.6.3 Requirement on performance (MDD ER3/AIMDD ER2)
Table 23. Summary of Conformity assessment with requirement on performance

MDD ER3
General Principle Harmonised and other relevant Evidence of compliance or reason for
standards applied by no-applicability
manufacturer This column to contain
EN: ISO; international, local direct reference to
standards or company documents such as: study
procedures. Other standard or results, test reports, design
procedures applied by outputs identified by
manufacturer identified by number/title within the
number/title. Quality System.
The devices must achieve the ISO13485:2013 certification -> Quality -Useability feedback – clinicians QF/130
performances intended by the Assurance -Useability feedback – patients QF/132
manufacturer and be designed,
-Clinical Justifications QF/118 to back up
manufactured and packaged in Test procedure (QF/107) and claim that the ODFS® Pace (XL) “treats or
such a way that they are suitable calibration (of test equipment) alleviates a disease or handicap” by
for one or more of the functions
improving an individuals mobility.
referred to in Article 1 (2) (a), as
specified by the manufacturer. Manufacture and assembly -Patient trial reports QF/035
instructions (QF/106) -Post Market Surveillance
The clinical data presented in this report demonstrates that the ODFS® family of devices
does alleviate disability and handicap demonstrated by improved mobility. This is
demonstrated by improved walking speed, a surrogate marker for overall quality of gait
and reduced effort while walking. Evidence is presented that this is associated with
improved safety by the elimination of falls. This is also associated with greater
participation in activities of daily living and improved quality of life.
4.6.4 Requirement on acceptability of side-effects (MDD ER6)
Table 24. Summary of conformity assessment with requirement on acceptability of

undesirable side-effects (MDD ER6 / AIMDD ER5).
General Principle Harmonised and other relevant Evidence of compliance or reason for
standards applied by no-applicability
manufacturer This column to contain direct reference
EN: ISO; international, local to documents such as: study results,
standards or company test reports, design outputs identified
procedures. Other standard or by number/title within the Quality
procedures applied by System.
manufacturer identified by
number/title.
127
Any undesirable side-effect must EC MDD 93/42/EEC + 2007 revisions. Documented in:
constitute an acceptable risk when Requirements built into internal Clinical Justification QF118 &
weighed against the performances procedure:
Risk Management Plan QF100
intended.
“Construction of a Technical File.” Hazard identification and risk analysis QF101
(OMP004)
Demonstration of conformity with
the essential requirements must BS EN ISO 14971:2012 (Risk
include a clinical evaluation in Management for Medical Devices)
accordance with Annex X.
Serious Adverse Events

No serious adverse events have been reported for the ODFS® family of devices or similar
devices, either to regulatory bodies, in the scientific literature or internal data.
Adverse events
The most frequently reported adverse event is skin irritation in response to the electrodes. The
second most frequently reported adverse event is pain or discomfort in response to stimulation.
Both issues are covered by mitigation in the instruction manuals. The incidence of people
discontinuing FES use due to either issue is low at between 1 and 2 %. No long term effects after
stopping FES have been reported. It is reported that the majority of people experiencing skin
irritation can continue FES use by using conservative management techniques.
Overall acceptability of side-effects

It can be concluded that since long term audit (Taylor 2013) demonstrates continued benefit
from the devices over a period exceeding 11 years, that no serious adverse events have been
reported and that the incidence of discontinuation of FES use due to adverse events is low at
less than 5%, the overall benefit of the devices exceeds the risks associated with their use.
Data quality, limitations gaps, uncertainties and unanswered questions. Are the
undesirable side-effects acceptable?
Only a minority of published studies included reports of adverse incidences. However, as stated
above, the follow-up rate in routine clinical service is exceptionally high for a medical device of
this type. It is therefore highly likely that if adverse events occur, they will be reported to the
manufacture and/or regulatory body. Hence, adverse events occurring at a rate of 1 in 1000 or
more are likely to have been identified.
A possible shortcoming is that data is largely restricted to the use of the device with people who
have MS or stroke. While it is not expected that people with other upper motor neurone clinical
conditions would respond differently, conformation of this by collection of additional data in
these minority patient groups would add to the knowledge. Also the long term effect in
paediatric applications has not yet been demonstrated and no device specific evidence for the
efficacy and safety of the device for exercise or stimulation of muscles other than the
dorsiflexion group. These aspects should be the subject of post market surveillance and post
market clinical follow-up.
Benefits from using the device were consistently recorded in a range studies and range of
patient groups. For people with Stroke and MS, data is available over an extended period of
over 10 years indicating that benefits continue in to the long term. The proportion of device
128
users who discontinue treatment due to adverse events is low. It can therefore be concluded
that the risk benefit ratio is in favour of the benefit.
129
Section 5. Conclusions
Compliance with Essential Requirements

The ODFS® Pace (XL) (hardware versions 1.0 and 1.1 and software versions 1.3xx and 1.4)
comply with the following Essential Requirements:
 ER1: It is demonstrated that the risk associated with the use of the ODFS® Pace (XL)
is outweighed by the benefit received.
 ER3: It is demonstrated that the ODFS® Pace (XL) meets its claim that the device
alleviates disability and handicap by improving the mobility of those who use it.
 ER6: It is demonstrated that the side effects from use of the ODFS® Pace (XL) are
acceptable.
Adequacy of available data

The clinical outcomes from use of the ODFS® Pace (XL) and its equivalent predecessor, the
ODFS®III, have been studied over a period of 20 years. This has resulted in a range of
published studies both from the centre that originated the ODFS® and elsewhere, produced by
many authors. This enables confidence that the clinical effects described are well
established. Wide adherence to best practice means that a large proportion of device users
are followed up over the full duration of their use of the devices means under reporting of
serious adverse events is unlikely. It can therefore be concluded that the data provides a
realistic safety and effeteness profile for the devices.
Suitability of the devices and instructions for use

Overall satisfaction with the device is reported as high with an adherence rate that is high for
any assistive device. The instructions for use have been assessed by an external test house as
part of 60601 testing. However, since the introduction of the device, new requirements on the
assessment of usability have come into force. While past experience does not indicate that
usability is a cause for concern, it is recommended that the useably assessment be updated to
demonstrate compliance with the new home healthcare guidance.
Consistency between the manufactures claims for the device, clinical data and
risk management documentation
No risks were identified from the literature or reports to regulatory authority that were not
considered in the risk management or claims made by the manufacture. If a discrepancy
exists at all it is that many “theoretical” risks are included in the risk management that have
no report in clinical practice.
Continuing post market surveillance and post market clinical follow-up

The efficacy, effectiveness and safety of the ODFS® Pace (XL) is well established for stroke,
MS and spinal cord injury. There is less information available in for its use in other clinical
conditions such as cerebral palsy, hereditary spastic paraparesis, Parkinson’s Disease and
head injury. Also there is no device specific evidence for use of the device for stimulating
other muscle groups in either exercise or walking. It is recommended that post market
follow-up studies continue in these areas.
130
131
Section 6: Date of Next Report
This report should be reviewed and updated July 2019
Section 7: Dates and signatures
Assessors
Dr Paul Taylor Date___3rd July 2017_ Signature___
Dr Tamsyn Street Date_______________ Signature____________________________
We the above agree with the contents of this report.
Release of the document by OML
Quality Manager
Dr Steven Crook Date_______________ Signature____________________________
Managing Director
Philip Casson Date_______________ Signature____________________________
132
Section 8: Qualification of the responsible evaluators
and declaration of competing interests
Surname: Taylor
Forenames: Paul Nicholas
Date of Birth: 18th May 1963
Current Consultant Clinical Engineer, Head of Research
Position:
Address: The National Clinical FES Centre, Salisbury District Hospital, Salisbury,
Wiltshire, SP2 8BJ
Tel: Work: 01722 429119 Home 01722 782439
Email: p.taylor@salisburyfes.com
Qualifications:
C.Sci. IPEM 2008
PhD – 1997-2004 (part time) – FES based training orthosis for hand function following stroke –
University of Southampton. Supervisor Paul Chappell
State Registered Clinical Scientist – 2000
C. Eng. Biomedical Engineering - Institute of Physics and Engineering in Medicine – 1999
MBES - 1990 (now MIPEM, Member of the Institute of Physics and Engineering in Medicine)
MSc. Medical Electronics and Physics, St Bartholomew’s Medical School, London University –
1988-1990
BSc. (Hons) Physics and Electronics, Westfield College, London University – 1982-1985
Posts Held:
July 2016 – present. Visiting professor School of Health and Social Science, University of
Bournemouth
April 2006 – present. Consultant clinical Engineer. Salisbury District Hospital.
April 2000 –July 2009 - 0.1 Senior Lecturer, School of Design Engineering & Computing,
University of Bournemouth
April 1997 – October 2006 Principal Clinical Engineer Salisbury Healthcare NHS Trust, FES
Coordinator
April 1990 – March 1997 Senior Clinical Engineer, Salisbury Healthcare NHS Trust, FES
Coordinator
July 1986- March 1990 – Basic Grade Physicist, Salisbury Healthcare NHS Trust
Overview:
Paul Taylor is a Biomedical Engineer and co-ordinates the FES research and clinical service at the
National Clinical FES Centre in Salisbury. He has a broad experience in the clinical application of
FES, developing systems for gait assistance following stroke, multiple scleroses and spinal cord
injury; for standing following spinal cord injury; assisted cough for tetraplegics and improved hand
function following stroke. He has devised and / or executed clinical trials for these devices and
also devices from other centres such as the Freehand System for restoring grip in tetraplegics, the
Finetech Implanted Dropped Foot Stimulator (STIMuSTEP) and the Finetech implanted device for
hand opening following stroke (Healthy AIMS EU project). He designed and executed the
randomised controlled trial of the Odstock Dropped Foot stimulator which led to its acceptance for
use in the National Health Service and recommendation in NICE guidelines. He is active in the
training of clinicians and researches in the application of FES. His main current research interest is
the restoration of hand function following stroke and also the improvement in gait following MS,
Stroke and Pakinson’s using FES. Paul is the President of the UK and Republic of Ireland chapter
133
of IFESS.
Selected Publications:
1. Street T, Swain I and Taylor P. Training and Orthotic Effects related to the use of Functional
Electrical Stimulation of the Peroneal Nerve in Stroke. J Rehabil Med. 2016
2. Taylor PN, Wilkinson Hart IA, Khan MS, Slade-Sharman DWM. The Correction of Dropped Foot
Due to Multiple Sclerosis Using the STIMuSTEP Implanted Dropped Foot Stimulator.
International Journal of MS Care Preprint. Online First: http://ijmsc.org/doi/10.7224/1537-
2073.2015-038
3. Popa L and Taylor P. Functional electrical stimulation may reduce bradykinesia in Parkinson’s
disease: A feasibility study. Journal of Rehabilitation and Assistive Technologies Engineering
January - December 2015 2: 2055668315607836, first published on October 26, 2015
doi:10.1177/2055668315607836
4. L Venugopalan · P N Taylor · J E Cobb · I D Swain. Upper limb functional electrical stimulation
devices and their man-machine interfaces Journal of Medical Engineering & Technology
10/2015; DOI:10.3109/03091902.2015.1102344
5. Sheffler LR, Taylor PN, Bailey SN, Gunzler DD, Buurke JH, IJzerman MJ, Chae J: Surface peroneal
nerve stimulation in lower limb hemiparesis: effect on quantitative gait parameters. Am J Phys
Med Rehabil 2015;00:00Y00.
6. Street TD, Taylor PN, Swain ID. The Effectiveness of Functional Electrical Stimulation on
Walking Speed, Functional Walking Category and Clinically Meaningful Changes for People
with Multiple Sclerosis. Archives of Physical Medicine. Volume 96, Issue 4, April 2015, Pages
667–672
7. Taylor P, Mann G, Esnouf J, Luckie H, Warring K, McFadden C, Smith C Kenney L. A
Randomised controlled trial of an accelerometer triggered functional electrical stimulation
deveice for recovery of upper limb function in chronic stroke – the reach project. International
Journal of Stroke Vol 9 (Suppl 4) 2014 15 iswsn 1747-4930, issn 1747-4949
8. Wilkinson I, Taylor P, Windrup J, Burridge J. ‘Talking about walking’ – a qualative exploration
of changes in walking post-stroke from the perspective of a stroke survivor. International
Journal of Stroke Vol 9 (Suppl 4) 2014 31
9. Street T, Taylor, P, Swain I. The practical use of functional electrical stimulation (FES) in the
treatment of dropped foot for people with stroke. International Journal of Stroke Vol 9 (Suppl
4) 2014 40
10. Wilkinson IA, Burridge J, Strike P, Taylor P. A randomised controlled trial of integrated
electrical stimulation and physiotherapy to improve mobility for people less than 6 months
post stroke. Disabil Rehabil Assist Technol, Early Online: 1–7, 2014 Informa UK Ltd. DOI:
10.3109/17483107.2014.917125
11. Taylor P, Wilkinson I, Slade-Sharman D, Khan M. A comparison of external and implanted FES
for the correction of dropped foot in MS. Multiple Sclerosis Journal 2014;20:(7) 1001
12. Taylor P, Humphreys L, Swain I. A 15 year cost-effectiveness study of the use of FES for the
correction of dropped foot in multiple sclerosis. Multiple Sclerosis Journal 2014;20:(7) 1001-2
13. Street, T, Taylor P, Swain I. A comparison between ankle assisted orthotics and Functional
134
Electrical Stimulation: a feasibility study. Multiple Sclerosis Journal 2014;20:(7) 1001
14. Street, T, Taylor P, Swain I. The practical clinical use of Functional Electrical Stimulation in the
treatment of people with multiple sclerosis. Multiple Sclerosis Journal 2014;20:(7) 1000
15. Sheffler LR, Taylor PN, Gunzler DD, Buurke JH, IJzerman MJ, Chae J. Randomized Controlled
Trial of Surface Peroneal Nerve Stimulation for Motor Relearning in Lower Limb Hemiparesis.
Archives of Physical Medicine and Rehabilitation 2013;94:1007-14
16. Taylor P., Barrett C., Mann G., Wareham W., Swain I. 2013. A Feasibility Study to Investigate the
Effect of Functional Electrical Stimulation and Physiotherapy Exercise on the Quality of Gait of
People With Multiple Sclerosis. Neuromodulation 2013; e-pub ahead of print. DOI:
10.1111/ner.12048
17. Taylor P, Humphreys L, and Swain I, The long-term cost-effectiveness of the use of functional
Electrical stimulation for the correction of dropped foot Due to upper motor neuron lesion. J
Rehabil Med 2013; 45: 154–160
18. Marsden J., Stevenson V., McFadden C., Swain I., Taylor P. 2012. The Effects of Functional
Electrical Stimulation on Walking in Hereditary and Spontaneous Spastic Paraparesis.
Neuromodulation 2012; E-pub ahead of print. DOI: 10.1111/j.1525-1403.2012.00494.x
19. Mann G, Taylor P, Lane R. Accelerometer-Triggered Electrical Stimulation for Reach and Grasp
in Chronic Stroke Patients: A Pilot Study. Neurorehabil Neural Repair May 31, 2011
1545968310397200
20. JE Esnouf, PN Taylor, GE Mann, CL Barrett. Impact on falls and activities of daily living of use of
a Functional Electrical Stimulation (FES) device for correction dropped foot in people with
multiple sclerosis. Mult Scler accepted for publication Mult Scler 2010;16 1141-1147
21. Barrett CL, Taylor PN. The effects of the Odstock Drop Foot Stimulator on Perceived Quality of
Life for People with Stroke and Multiple Sclerosis. Neuromodulation 2010 13, 1, pp: 58-64
22. CL Barrett, GE Mann, PN Taylor and P Strike. A randomized trial to investigate the effects of
functional electrical stimulation and therapeutic exercise on walking performance for people
with multiple sclerosis. Multiple Sclerosis Mult Scler. 2009 Apr;15(4):493-504
23. Geraldine E. Mann, Stacey M. Finn, Paul N. Taylor. A Pilot Study to investigate the Feasibility of
Electrical Stimulation to Assist Gait in Parkinson’s Disease. 2008. Neuromodulation, 11:2 pp
143-149
24. CL Barrett, GE Mann, PN Taylor and P Strike. A randomized trial to investigate the effects of
functional electrical stimulation and therapeutic exercise on walking performance for people
with multiple sclerosis. Multiple Sclerosis Mult Scler. 2009 Apr;15(4):493-504
25. Burridge JH, Elessi K, Pickering RM, Taylor PN. Walking in an uneven surface: the effect of
common peroneal nerve stimulation on gait parameters and relationship between perceived
and measured benefits in a sample of participants with a drop foot. Neuromodulation, 10(1):
59-67, 2007
26. Swain ID, Taylor PN. The clinical use of functional electrical stimulation in neurological
rehabilitation. In: Horizons in Medicine 16 – Updates on major clinical advances. Ed. Franklyn
J. Pub. Royal College of Physicians, ISBN 1-86016-233-9, London, pp. 315-322, 2004.
135
27. Taylor PN, Esnouf JE, Hobby JA. The functional impact of the Freehand system on tetraplegic
hand function – Clinical results. Spinal Cord, 40: 560-566, 2002.
28. Taylor PN, Esnouf J, Hobby J. Pattern of use and user satisfaction of the NeuroControl Freehand
System. Spinal Cord, 39: 156-160, 2001.
29. Hobby J, Taylor PN, Esnouf J. Restoration of tetraplegic hand function by use of the
NeuroControl Freehand system. Journal of Hand Surgery, 26B(5): 459-464, 2001.
30. Taylor PN. The use of electrical stimulation for correction of dropped foot in subjects with
upper motor neuron lesions. Advances in Clinical Neuroscience and Rehabilitation, 2(1): 16-18,
2002.
31. Taylor PN. The use of electrical stimulation for correction of dropped foot in subjects with
upper motor neuron lesions. Advances in Clinical Neuroscience and Rehabilitation, 2(1): 16-
18, 2002.
32. Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton C, Swain ID. Clinical use of
the Odstock Drop Foot Stimulator - its effect on the speed and effort of walking. Archives of
Physical Medicine and Rehabilitation, 80: 1577-1583, 1999.
perceptions of the Odstock Drop Foot Stimulator. Clinical Rehabilitation, 13: 333-340, 1999
34. Taylor PN, Burridge JH, Wood DE, Norton J, Dunkerley A, Singleton, C, Swain ID. Clinical audit
of five years provision of the Odstock Drop Foot Stimulator. Artificial Organs, 23(5): 440-442,
1999.
35. Burridge JH, Taylor PN, Swain ID. A review of the literature published for the correction of
peroneal nerve stimulation for the correction of dropped foot. Reviews in Clinical Gerontology,
8: 155-161, 1998
36. Burridge JH, Taylor PN, Hagan SA, Wood DE, Swain ID. The effect of common peroneal nerve
stimulation on quadriceps spasticity in hemiplegia. Physiotherapy, 83(2): 82-89, 1997.
37. Burridge J, Taylor P, Hagan S, Wood D, Swain I. (1997) The effects of common peroneal nerve
stimulation on the effort and speed of walking: A randomised controlled clinical trial with
chronic hemiplegic patients. Clin Rehabil 11. 201-210
38. Kenney L, Bultstra G, Buschman R, Taylor P, Mann G, Hermens H et al. An implantable two
channel drop foot stimulator: initial clinical results. Artif.Organs 2002;26:267-70
39. Hart DJ, Taylor PN, Chappell PH, Wood DE. A microcontroller system for investigating the catch
effect: functional electrical stimulation of the common peroneal nerve. Medical Engineering and
Physics, 28(5): 438-448, 2006.
40. Avramidis K, Strike PW, Taylor PN, Swain ID. Effectiveness of electrical stimulation of the
vastus medialis muscle in the rehabilitation of patients after total knee arthroplasty. Archives
of Physical Medicine and Rehabilitation, 84: 1850-1853, 2003.
41. Esnouf J, Taylor PN, Hobby JA. Improvement in activities of daily living using the Freehand: a
136
system designed for people with tetraplegia. British Journal of Occupational Therapy, 66(3):
113-117, 2003
42. Taylor PN, Tromans AM, Harris KR, Swain ID. Electrical stimulation of abdominal muscles for
control of blood pressure and augmentation of cough in a C3/4 level tetraplegic. Spinal Cord,
40: 34-36, 2002
Declaration of competing interests for Paul Taylor
Paul Taylor holds stock in the company OML. At the time of revision of this report he was a
director of OML. He was the original designer of the ODFS early devices (I, II, III) and was
an investigator in many of the studies featured in this report.
Tamsyn Street (BSc, MSc, PhD)

Research Fellow
Clinical Science and Engineering, Salisbury District Hospital, Salisbury, Wiltshire, SP2 8BJ
(01722) 439 544
Tamsyn.Street@nhs.net
Qualifications
University of Nottingham PhD Neuropsychology (school 2005-2009

scholarship)
University of Birmingham MSc Forensic Psychology 2009-2011
Practice
University of Nottingham Postgraduate Certificate 2004-2005
Applied Neuropsychology (part-time)
University of Exeter BSc (hons) Psychology 2000-2003
Overview
My work primarily involves investigating functional electrical 03/06/13-

stimulation and other assistive technologies for the purpose of to the
rehabilitation of people with multiple sclerosis or who have had present
a stroke or spinal cord injury. I use both quantitative and
qualitative techniques to analyse data. My role also involves
supervision of postgraduate students in research study design
and analysis, supporting the head of research and others in
contributing to applying for grant applications and analysis of
data. Supporting external researchers in the analysis of their
data. Developing and maintaining a research seminar series.
Contributing and advising the multidisciplinary team from
research findings and area of knowledge. Disseminating
research through conferences and publications. I advise on
the scientific committee for the international functional
electrical stimulation society (IFESS) conference.
137
Publications
1. Street T, Singleton C. A five year follow-up of a longitudinal cohort study of the

effectiveness of functional electrical stimulation for people with multiple sclerosis. Int. J.
MS Care., (submitted) (2016).
2. Street T, Singleton C. A clinically meaningful training effect in walking speed using

functional electrical stimulation for incomplete spinal cord injury. J. Spinal Cord Med.
(submitted) (2016).
3. Street T, Taylor P, Swain I. Effectiveness of Functional Electrical Stimulation on

Walking Speed, Functional Walking Category, and Clinically Meaningful Changes for
People With Multiple Sclerosis. Arch. Phys. Med. Rehabil. 96(4), 667–672 (2015).
4. Street T, Ian S, Paul Taylor. Fear of falling and participation following the use of
functional electrical stimulation for the lower limb in people with multiple sclerosis. Eur.
Comm. Treat. Res. Mult. Scler. Lond. U.K.
5. Street T, Swain I, Taylor P. Training and orthotic effects related to functional electrical
stimulation of the peroneal nerve in stroke*. J. Rehabil. Med. 49(2), 113–119 (2017).
6. Street T, Taylor P, Swain I. The practical clinical use of Functional Electrical Stimulation
in the treatment of people with multiple sclerosis. Mult. Scler. J. 20(7), 1000–1001
(2014).
7. Street T, Swain I, Taylor P. Patient reported symptoms associated with activities of

daily living in upper limb impairment for people with multiple sclerosis. ECTRIMS
Online Libr. Str. T Sep 15 2016 146177. .
8. Street T, Swain I, Taylor P. Comparison of Functional Electrical Stimulation and Ankle

Foot Orthosis in Stroke. UK Stroke Forum Conf. Present. Liverp. Dec. 2015. .
9. Street T, Swain I, Taylor P. A comparison between ankle assisted orthotics and

Functional Electrical Stimulation: a feasibility study. Mult. Scler. J. 20(7), 1001 (2014).
10. Street T, Taylor P, Ian S. Quality of life and cost effectiveness following the use of
functional electrical stimulation (FES) of the peroneal nerve for people with multiple
sclerosis. ECTRIMS Online Libr. Str. T Sep 16 2016 146066. .
Declaration of competing interests for Tamsyn Street
Tamsyn Street was an investigator in some of the studies featured in this report.
138

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Clinical Evaluation Report

ODFS® Pace (XL)

Review date August 2019

Hardware versions: V1.0 & V1.1

Version 1.0 July 2017 Covers up to ODFS® Pace 1.3

Dr Paul Taylor BSc, MSc, PhD, C.Eng C.Sci, MIPEM

MEDDEV 2.7/1 revision 4 June 2016: Appendix A9, Section 2

Scope of the clinical evaluation

Hardware versions: V1.0 & V1.1

Physical description and differences between the devices

Positioning in relation to available treatment/management /diagnostic

Exact description of intended purposes as described in the devices

Patient population. Definition of intended users - Referral criteria

Cause and functional deficit

Motivation, understanding and independence

Contraindications, Warnings and precautions identified in the v1.3

 Open or infected wounds. Stimulation should not be applied over open

 Cancer. Stimulation should not be applied over, or in proximity to, cancerous

 Electronic monitoring equipment. Stimulation should not be applied in the

 Transcerebral stimulation. The effects of stimulation of the brain are

 Sleeping. Stimulation should not be applied when sleeping.

 The handling of electrodes. Do not handle electrodes while the stimulation is

 Spasticity: If stimulation causes increased spasticity (involuntary, exaggerated

 Machinery Operation and Driving: Stimulation should not be used when

 Shortwave therapy: Do not use the stimulator within three metres of

 Epilepsy: Patients with suspected or diagnosed epilepsy should follow

 Latex Allergies: Caution: The elasticated tubular stocking contains natural

 Long-term Effects: The long-term effects of electrical stimulation are unknown.

 Batteries: We advise to only use batteries recommended by Odstock Medical

 Biological cross contamination: Electrodes are single person use (electrode

 Flammable cleaning products

 Oxygen rich environments

 External orthopaedic metal fixation

 Exposed electrode pins

 Accessories and consumables

 Battery change and battery cover

 Use of small electrodes

Claims on clinical performance as outlined in instructions for use

The manufactures make the following claim for both devices:

Intended Use statement for v1.4 manual

Regulatory Status of the Devices

Literature Search Strategy and Search Terms

“Functional electrical simulation may be considered as a treatment for drop-foot, where

Finally the MS guidelines from NICE, Multiple sclerosis: Management of multiple

Lower limb paralysis or weakness, consisting of a reduced ability to dorsiflex,

Spinal Cord injury

Parkinsonian gait is characterized by bradykinesia (slowness of movement),

State of the Art

Description of available therapeutic/management/diagnostic options

2. Autonomic dysreflexia in Pace users with Spinal Cord Injuries

1. Skin allergy/reaction to long-term use of electrodes effects

3. Discomfort due to high stimulation level

4. Unintended activation caused by inadvertent selection of the wrong operating

5. Unintended adjustment of output level

7. Incorrect battery insertion (polarity) causing damage to the circuit

8. Footswitch and electrode lead coming un-plugged

10. Batch to batch inconsistency

11. Device susceptible to environment influences –EMI

12. Device susceptible to environment influences – Temperature

13. Device susceptible to environment influences – Water

14. Shelf life – data retention

16. Increased spasticity

17. Induced increase risk of epileptic fit

18. Unknown effects of electrical stimulation on the unborn foetus