Diana Suciu

Title: Restoring Mobility Confidence in Amputees, a literature review of Integrated Lower Limp Sensory Prosthetics

Abstract:
Background: Individuals with lower limb loss experience a significant decline in their mobility and confidence in
navigating varied terrain after amputation. New advancements in commercially available products have made
prosthetics lighter, and more reliable; with the advent of microprocessor knees, and powered ankles to help ambulation.
However, these new devices have done little to improve amputee reliance on their prosthesis, as knee, ankle, and hip
surgeries of the intact limb are still common, due to amputees putting excessive pressure and strain on their intact side.
For lower-limb amputees the critically important aspect for displaying integrated reliance on their prosthesis and
ensuring confidence in maintaining balance, preventing falls, and responding to unexpected agitations, is sensory input.
Objective: In this work, we will report and review the peer-reviewed literature available on the latest advancements in
integrated lower limb sensory prosthesis. Results: The papers included in this review describe the design of the novel
systems, their users, length of usage time, functionality, and progress in ambulatory tasks the users experienced with
the integrated lower limb prosthetic systems. Publications on integrated sensory prosthetic legs mainly focus on the
development of new technologies, and acute studies with participants operating in mainly lab settings. Significance: This
review provides information on the methods for sensory feedback systems in lower limb prosthetics. Integrated lower
limb prosthesis receive very little attention and have low appreciation in literature when compared to integrated hand
prosthesis, or brain computer interfaced robotic limbs. Integrated sensory prosthetic leg units are shown to be useful to
many unilateral amputees and should receive more attention and higher acceptance.

Introduction:
Lower limb loss results in a substantial disturbance of sensorimotor coordination. Despite centuries of prosthetic
innovation lower limb amputees constantly face challenges during ambulation. Lower limb amputees experience a
decreased sense of balance and ambulation confidence (SITE), an increased risk of falling (SITE), and an increased
cognitive burden when accomplishing simple ambulatory tasks when compared to able bodied individuals (SITE). As a
result of this loss of coordination confidence, and increased mental load, many amputees adapt an asymmetrical gait
(SITE). This unbalanced gait leads to chronic back pain, as well as injury in their intact knees, hips which can require
surgery(SITE). The causes for these ongoing issues and challenges for lower limb amputees has been attributed to the
stiff mechanical properties of their prosthetic limbs. Commercially available prosthetics do not provide the users with
the ability to adjust their locomotion based on sensory information. The main method amputees receive any
somatosensory feedback from their prosthetic limb is via interactions between the prosthetic limb socket and their
residual limb.
Recent studies have suggested that incorporating somatosensory feedback into the prosthesis of lower limb amputees
would allow an increased in confidence, and thus allow for a more naturalistic gait, thus decreasing injury risk. These
new studies have begun to investigate the potential of integrating sensory feedback into lower limb prosthetics in two
main modalities: implanted sensory feedback systems, and external feedback systems.
Implanted sensory feedback systems rely on the subject to undergo a surgery in which an electrode is placed on the
sciatic within the residual limb. Once the subject has recovered they are trained to distinguish sensation in their
phantom limb when the nerve is excited through the electrodes. There are two implanted modalities which will be
discussed in this review C-FINES (cuff or flat interface nerve electrode) and TIMES (Transversal intrafascicular
multichannel electrodes).
External sensory feedback systems are less common than implanted systems, they rely on noninvasive methods for
eliciting environmental awareness to the prosthetic user. The non-invasive nature of these systems make them a
desirable possibility for individuals who cannot or do not wish to undergo surgery for increased prosthetic ambulation
ability. However, due to the rare nature of these somatosensory feedback systems only one external sensory method
will be reviewed in this paper, the Vibrotactile Feedback System. The Vibrotactile Feedback System is a relatively
lightweight wearable system which delivers provides vibrations on the prosthetic users’ residual limb to alert them of
balance perturbations and balance changes.
In the present review, we focus on the latest emerging technologies in the field of integrated neuroprotheses. We depict
the different existing approaches for providing sensory feedback, the experimentation process in which improvements in
confidence and ambulatory ability are classified, and look at the future prospects of integrated sensory lower limb
neuroprosthesis.

Methods:
Implanted Electrodes for Integrated Neuroprothesis

Directly interfacing with the remaining nerves within the residual limbs of amputees can be an effective method in
eliciting useful sensations in people with different levels of amputation. There are multiple studies that investigate the
feasibility of restoring sensation in lower limb amputees via implanted electrodes. In this review we will focus on the
two most recent immerging implant technologies, the C-FINES and TIMES systems.

C-FINES
In the study conducted by Charkar et al (CHECK SPELLING), two individuals with unilateral transtibial amputations were
implanted with high-density composite flat interface nerve electrodes (C-FINES). During the outpatient implantation
procedure each participant received three 16 contact C-FINES along their sciatic nerves. The C-FINES are flexible and
allow for gentle reshaping around the sciatic nerve with little to no pressure to the nerve itself, resulting in high
electrode contact and no agitation to the participants. This method allows for a minimally invasive electrode however it
may result in lower selectivity during neural excitation. After implantation the C-FINE’s leads were routed through a
percutaneous incision on the subject’s upper thigh, out of the area of disturbance from the prosthetic socket. Once the
incisions were healed the electrical stimulation trials began. The participants underwent tests weekly for upwards of
seven months, and intermittent tests for up to three years after initial implantation. Elicited sensations are perceived
immediately and are interpreted by the participants as originating from the missing limb. Subject’s reported sensations
included tactile and proprioceptive sensations.

TIMES

-Transversal intrafascicular multichannel electrodes (TIMEs)

-single electrodes implanted intra-neurally
-neural interfaces for selective and minimally invasive use
-implanted with 14 channels
-sensitive on the facile level
- inserted along the nerve larger diameter

External stimulators:
-Vibration feedback studies
-vibration feedback to four motors worn on the thigh. The electronics for driving the vibrating tactors
are contained in a waist pack worn by the user.

- Sensation Tests methods/results

-C-Fines: (chronic tests)
 - Sensation in the foot during sitting and standing trials:
- changes in phantom limb perception and sensation in the residual limb were assessed initially with
questionnaires
- After the first 3 months of experiments, reported sensation locations became more consistent
- the charge densities at threshold values were calculated on a monthly basis for the ALL contacts
(not just contacts associated with the foot and ankle after the 3 month initiation period)

TIME
-subjects participated in ‘Passive Tasks’
-the users were asked to discern the location of the pressure executed by an experimenter over
different foot sensory sole locations.
- distribution of the sensation type for each subject was recorded over the course of months

Vibration: (acute tests)

-Control groups wore a Ski boot, to simulate wearing a prosthetic ankle.
-Both control and amputee groups wore the Haptic feeback system
-Both groups conducted balance test through several stationary rhythmic weight shifting exercises
-Elicited Sensation results
C-Fines:
-good for chronic readings, however sensation appears to travel initially, but does stabilize.
-Perceived modalities included tactile and proprioceptive sensations

TIME
-The participants achieved a performance of around 90% of identifying locations pressed on their sensory insole
- When asked to identify touch or flexion events without stimulation rates dropped down to a chance level

Vibration:
-It wasn’t an elicited sensation map as the previous two, however an increase in the ability to navigate unseen
objects was reported.

-Walking/mobility tests methods/results -C-Fines:

-Subjects were blindfolded and asked to cross a randomized ladder course
-Able bodied and amputee subjects were used.
-Amputees were tested with and without sensory feedback
-All trials were videotaped and later reviewed for the number of missed steps, slips, trips or falls subjects made
during the blind searching ambulation task

TIME
-To verify if the neuroprosthesis could boost walking capacity, the participants performed three functional tests:
-climbing and descending stairs, completing an obstacle course, and walking over a straight line.
-Glasses were worn that obscured inferior view of the subjects
- Subjects were tested without neural feedback, with sensory foot sole tactile feedback
-The subjects’ integration of the prosthesis was assessed through objective and subjective measures
- A cognitive load assessment where the subjects EEG activity with and without sensory feedback was preformed

Vibration: (acute tests)

 -Control groups wore a Ski boot, to simulate wearing a prosthetic ankle.
-Both control and amputee groups wore the Haptic feedback system
-Both groups participated in foot placement activities such as walking up and down stairs,
and placing their foot when their view was obstructed, thus relying only on the feedback system

-Walking/sensing mobility tests

C-Fines:
-Improved confidence in subjects
-(xx%), showed greater balance through fewer slips/trips
-amputee subjects were more comfortable searching and feeling with their midfoot even with feedback on
-able bodied subjects were more likely to search with their forefoot

TIME
-Sensory feedback-improved walking performance of amputees
-Sensory feedback-improved embodiment and cognitive burden.

Vibration:
-Prosthesis users responded favorably to the use of vibrotactile feedback.
-Both prosthesis users had a baseline without-feedback performance that was considerably lower than that of
the control group.
-Participants with low ability to discern foot placement without vibrotactile feedback showed the greatest
increases in performance in the stair stepping task.

Discussion:

C-Fines:
Major invasive surgery, electrodes are percutaneous so has potential for infection, or breaking. Potential for re-
implantation if the CUFF electrodes reject over time. However, it does seem to be a good option for a stable, long term
system (over several years), if they could make the system wireless.

TIME
A study of this technology has not occurred for longer than 3 months, which given the nature of interfasicular
electrodes and their overall instability makes me question how viable this system would be for longer term. However it
does seem to have a higher accuracy of location with less drift over the C-Fines, so if the system can be applied long
term, and the subject is eligible for an invasive surgery it could be a fantastic option for restoring sensation in the future.
It was an informative experiment to see that the integrated system did relive cognitive load on subjects during
functional tasks. I would like to see similar studies done on the other two systems discussed in this review.

Vibration:
(was more of an initial conceptual study, so the numbers weren’t as robust as the other two) This technology
does not require a major surgery which is a plus, however it is currently quite a large and relatively unwieldy system, as
it develops it can get smaller. However, a study to compare how it fairs long term against implanted technology is to be
seen. The fact it is external means adjustments will be easier, and do you (???) have the risk of bodily rejection as
implantable devices have.

Initial Papers to be Reviewed:

Charkhkar, Hamid, et al. “High-Density Peripheral Nerve Cuffs Restore Natural Sensation to Individuals with Lower-Limb
Amputations.” Journal of Neural Engineering, vol. 15, no. 5, 2018, p. 056002., doi:10.1088/1741-2552/aac964.

Charkhkar, Hamid, et al. “Sensory Neuroprosthesis Improves Postural Stability during Sensory Organization Test in Lower-
Limb Amputees.” Scientific Reports, vol. 10, no. 1, 2020, doi:10.1038/s41598-020-63936-2.

Christie, Breanne P., et al. “Ambulatory Searching Task Reveals Importance of Somatosensation for Lower-Limb
Amputees.” Nature News, Nature Publishing Group, 23 June 2020, www.nature.com/articles/s41598-020-67032-3.

Rokhmanova, Nataliya, and Eric Rombokas. “Vibrotactile Feedback Improves Foot Placement Perception on Stairs for
Lower-Limb Prosthesis Users.” 2019 IEEE 16th International Conference on Rehabilitation Robotics (ICORR), 2019,
doi:10.1109/icorr.2019.8779518.

Rusaw, David et al. “Can vibratory feedback be used to improve postural stability in persons with transtibial limb
loss?.” Journal of rehabilitation research and development vol. 49,8 (2012): 1239-54. doi:10.1682/jrrd.2011.05.0088

Petrini, Francesco et al. “Enhancing functional abilities and cognitive integration of the lower limb prosthesis” Journal of
Science Translational Medicine.vo. 11, 2019

Papers to reference for background information:

Arzy, S., et al. “Neural Basis of Embodiment: Distinct Contributions of Temporoparietal Junction and Extrastriate Body
Area.” Journal of Neuroscience, vol. 26, no. 31, 2 Aug. 2006, pp. 8074–8081, 10.1523/jneurosci.0745-06.2006. Accessed
19 Aug. 2020.

Bach-y-Rita, Paul, and Stephen W. Kercel. “Sensory Substitution and the Human–Machine Interface.” Trends in Cognitive
Sciences, vol. 7, no. 12, Dec. 2003, pp. 541–546, 10.1016/j.tics.2003.10.013.

Charkhkar, Hamid, et al. “A Translationa

l Framework for Peripheral Nerve Stimulating Electrodes: Reviewing the Journey from Concept to Clinic.” Journal of
Neuroscience Methods, vol. 328, Dec. 2019, p. 108414, 10.1016/j.jneumeth.2019.108414. Accessed 15 Oct. 2020.

Christie, Breanne P, et al. “Visuotactile Synchrony of Stimulation-Induced Sensation and Natural Somatosensation.”
Journal of Neural Engineering, vol. 16, no. 3, 30 Apr. 2019, p. 036025, 10.1088/1741-2552/ab154c. Accessed 15 Oct.
2020.

Dhillon, G. s., et al. “Effects of Short-Term Training on Sensory and Motor Function in Severed Nerves of Long-Term
Human Amputees.” Journal of Neuropsychology, 1 May 2005, 10.1152/jn.00937.2004.

Dietrich, Caroline, et al. “Sensory Feedback Prosthesis Reduces Phantom Limb Pain: Proof of a Principle.” Neuroscience
Letters, vol. 507, no. 2, Jan. 2012, pp. 97–100, 10.1016/j.neulet.2011.10.068. Accessed 18 May 2020.