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Research Report

KJ Sullivan, PT, PhD, is Associate Effects of Task-Specific Locomotor and


Professor of Physical Therapy, Di-
vision of Biokinesiology and Phys-
ical Therapy at the School of Den-
Strength Training in Adults Who Were
tistry, University of Southern
California, 1540 E Alcazar St, CHP- Ambulatory After Stroke: Results of
155, Los Angeles CA 90089 (USA).
Address all correspondence to Dr
Sullivan at: kasulliv@usc.edu.
the STEPS Randomized Clinical Trial
DA Brown, PT, PhD, is Associate Katherine J Sullivan, David A Brown, Tara Klassen, Sara Mulroy, Tingting Ge,
Professor, Department of Physical Stanley P Azen, Carolee J Winstein; for the Physical Therapy Clinical Research
Therapy and Human Movement Network (PTClinResNet)
Sciences, The Feinberg School of
Medicine, Northwestern Univer-
sity, Chicago, Ill. Background and Purpose
T Klassen, PT, MS, NCS, is Clinical A phase II, single-blinded, randomized clinical trial was conducted to determine the
Instructor, Department of Physical effects of combined task-specific and lower-extremity (LE) strength training to im-
Therapy, University of British Co-
lumbia, Vancouver, British Colum-
prove walking ability after stroke.
bia, Canada.
Subjects
S Mulroy, PT, PhD, is Director,
Pathokinesiology Laboratory, Ran- The participants were 80 adults who were ambulatory 4 months to 5 years after a
cho Los Amigos National Rehabil- unilateral stroke.
itation Center, Downey, Calif.

T Ge, MS, is Doctoral Student, De- Method


partment of Preventive Medicine, The exercise interventions consisted of body-weight–supported treadmill training
Keck School of Medicine, Univer- (BWSTT), limb-loaded resistive leg cycling (CYCLE), LE muscle-specific progressive-
sity of Southern California.
resistive exercise (LE-EX), and upper-extremity ergometry (UE-EX). After baseline
SP Azen, PhD, is Professor, Depart- assessments, participants were randomly assigned to a combined exercise program
ment of Preventive Medicine, that included an exercise pair. The exercise pairs were: BWSTT/UE-EX, CYCLE/UE-
Keck School of Medicine, Univer-
sity of Southern California.
EX, BWSTT/CYCLE, and BWSTT/LE-EX. Exercise sessions were 4 times per week for
6 weeks (total of 24 sessions), with exercise type completed on alternate days.
CJ Winstein, PT, PhD, FAPTA, is Outcomes were self-selected walking speed, fast walking speed, and 6-minute walk
Professor, Division of Biokinesiol-
ogy and Physical Therapy at the
distance measured before and after intervention and at a 6-month follow-up.
School of Dentistry, and Depart-
ment of Neurology, Keck School Results
of Medicine, University of South- The BWSTT/UE-EX group had significantly greater walking speed increases compared
ern California.
with the CYCLE/UE-EX group; both groups improved in distance walked. All BWSTT
Physical Therapy Clinical Research groups increased walking speed and distance whether BWSTT was combined with LE
Network (PTClinResNet) (see list strength training or not.
of investigators on page 1598).

[Sullivan KJ, Brown DA, Klassen T, Discussion and Conclusion


et al; for the Physical Therapy Clin-
ical Research Network (PTClinRes-
After chronic stroke, task-specific training during treadmill walking with body-weight
Net). Effects of task-specific loco- support is more effective in improving walking speed and maintaining these gains at
motor and strength training in 6 months than resisted leg cycling alone. Consistent with the overtraining literature,
adults who were ambulatory after LE strength training alternated daily with BWSTT walking did not provide an added
stroke: results of the STEPS ran- benefit to walking outcomes.
domized clinical trial. Phys Ther.
2007;87:1580 –1602.]

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1580 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

I
mpaired walking ability is a hallmark documenting gait speed (eg, self- climbing and single-limb heel raises
residual deficit following stroke. Al- selected or fast speeds, distance for exercise produced moderate in-
though approximately 70% to 80% walked, with or without assistive de- creases in walking speed that were
of adults who have survived a stroke vices or orthoses).7,11–14 Studies that significantly correlated with in-
will recover the ability to walk short have compared multiple muscle creased strength in the paretic hip
distances on flat surfaces, only 50% groups most frequently have identi- flexors, knee extensors, and ankle
achieve even limited community fied strength in the hip flexors15 and plantar flexors.28 None of these stud-
ambulation1 and fewer than 20% have ankle plantar flexors7,12 as the stron- ies compared effects of muscle-
unlimited ambulation in the communi- gest predictor of walking speed after specific strengthening protocols or
ty.2 In the early period following a stroke, although strength in the knee interventions that used resisted
stroke, lower-extremity (LE) paresis extensors,14,16,17 hip extensors,13 locomotor-like activities such as a
from impaired muscle activation limits and ankle dorsiflexors18 was identi- loaded cycling task. In addition, no
the ability to advance the limb for fied as being significantly related to studies have combined task-specific
swing and to support body weight gait speed. The contribution of the locomotor training with various
during stance.3,4 As time from stroke hip flexors and ankle plantar flexors types of LE strength training such as
increases in the early poststroke pe- to maximizing walking speed has these.
riod, motor control, muscle strength been related to their large bursts of
(force-generating capacity), and walk- power generation late in the stance Task-specific training is the repeti-
ing ability begin to improve.5 In- phase of the gait cycle.7,15,19,20 tive practice of a task that is specific
complete recovery and development to the intended outcome. Repeti-
of secondary impairments, however, Muscle strength training may lead to tive stepping on a treadmill is an ex-
may contribute to continued gait dys- improvement in both lower-limb ample of task-specific gait training
function.4,6,7 In addition to paresis, strength and gait speed, although that appears to be critical to the
stroke disrupts selective voluntary controlled studies that isolate this in- achievement of improved walking
control and can leave the patient with tervention are lacking. Programs that speeds.23,25,29,30 Visintin et al31 dem-
primitive patterns of muscle action combined muscle strength training onstrated that treadmill training with
and spasticity.8 Disuse muscular atro- with stretching, balance training, 40% body-weight support (BWS)
phy compounds the initial neuro- and aerobic conditioning have dem- provided in early training that was
logical injury, and muscle weakness onstrated significant improvements progressively decreased over train-
remains prevalent despite some in walking function.21–23 However, ing sessions resulted in better walk-
functional recovery during the acute because the protocols were multi- ing outcomes after stroke than tread-
phase.9 The net effect of these impair- faceted, it is not possible to deter- mill training without BWS.
ments on walking is reduced speed mine the precise role that the
and endurance, with impaired stability strength training component may A recent Cochrane meta-analysis32
and asymmetry, during gait. Conse- have played in improving walking and an evidence-based systematic re-
quently, self-selected walking speed is function. Interventions of muscle view conducted by Foley et al33 of
a strong overall indicator of both strengthening for a single muscle the Canadian Stroke Network both
stroke severity10,11 and community group after stroke have demon- concluded that there is conflicting
ambulation status.2 strated increased muscle strength, (level 4) evidence that treadmill
but little or no improvement in walk- training with or without BWS im-
Impairment in muscle strength is ing speed.24 Several studies21,25–27 proves walking activity after stroke.
thought to be an important limiting demonstrated that strength training Across these 2 reviews, 9 random-
factor in determining walking speed of multiple LE muscle groups pro- ized clinical trials (RCTs) specifically
after stroke. There is a positive cor- duced significant increases in investigated treadmill training with
relation between muscle strength strength, resulting in modest func- BWS. There were large disparities
and maximum gait speed.7,11–14 Spe- tional changes in walking distance or among the trials in terms of the ex-
cific muscle groups that demonstrate improved balance or sit-to-stand abil- ercise parameters specified in the in-
the strongest relationship with walk- ity, but did not increase walking tervention protocols (ie, frequency,
ing speed vary greatly among stud- speed. In a study of individuals with intensity, and duration). Frequency
ies, depending on the number of mild stroke severity (ie, baseline (the number of sessions in a week)
muscles investigated, the parameter walking speeds of approximately varied from 3 times per week34,35 to
used to quantify strength (ie, hand 0.80 m/s), a program of progressive 4 times per week31 to 5 times per
dynamometer force, isometric or iso- LE strengthening using functional week.36 – 40 Training intensity can be
kinetic torques), and the method of weight-bearing activities such as step quantified by measuring within-

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Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

session attributes such as walking as muscle groups, the effectiveness dent or within synergy movement
time and treadmill speed. Actual of a resisted cycling task to improve patterns, as determined by the motor
walking time was reported in only 5 walking after stroke is an important tasks of the lower-extremity Fugl-
of the 9 RCTs and varied from 14 to and relevant clinical question be- Meyer (LE-FM) motor assessment.
30 minutes of total walking time, cause the cost of additional person-
with or without rest nel and workload demands on the Finally, we designed an upper-
breaks.31,32,35,38,40 Treadmill walking clinician of body-weight–supported extremity (UE) ergometry exercise
speed varied from 0.22 to 1.1 m/s treadmill training (BWSTT) are high. that was to serve as a “sham” task to
(0.5–2.5 mph) across the RCTs, with If a resisted cycling task can achieve be combined with the BWSTT and
only one RCT that specified speeds the same walking outcomes in indi- resisted cycling exercise. Previous
closer to functional walking viduals after stroke, then a more studies that have used low-intensity
speeds.35 The duration across all cost-effective treatment option may UE exercise as a comparison control
RCTs ranged from 10 to 68 sessions. be identified. have demonstrated that there is no
Recent studies35,41,42 have consis- effect of low-intensity UE exercise
tently shown that treadmill training Second, we wanted to determine on walking outcomes.23,25 There is
(with or without BWS) at higher whether walking outcomes after substantial evidence that physical
speeds (ie, higher intensity) is more stroke would be enhanced if a therapy interventions that include in-
effective at improving walking after high-intensity, task-specific locomo- tensive, task-specific strength or en-
stroke than training at slower tor training program was combined durance training are more effective
speeds. Therefore, a major limitation with a moderately high progressive- than standard care or no care.44 – 47
to the conclusions from the system- resistive LE exercise program. There- Therefore, there is little value in
atic reviews of treadmill training af- fore, we developed 2 intervention comparing interventions with a no-
ter stroke that were conducted prior programs that combined the BWSTT treatment control. In contrast, the
to these more recent studies is the protocol with resistive exercise pro- design of meaningful rehabilitation
lack of consistency and intensity in grams that are representative of op- clinical trials requires the use of a
the intervention and specified proto- tions physical therapists may have in parallel trial paradigm.48 A parallel
cols. Due to this conflicting evi- the clinic. One intervention program trial design includes the random as-
dence, we specifically designed this combined BWSTT with the resisted signment of study participants into 2
study to address the evidence related cycling task described above. The or more intervention groups that are
to treadmill training with BWS as our other intervention program com- equated for exposure both to the
intervention of task-specific training. bined BWSTT with a muscle-specific therapeutic intervention as well as to
progressive-resistive exercise proto- the therapist. This design discrimi-
The design of our poststroke walking col designed to strengthen the pa- nates between the positive changes
rehabilitation study was influenced retic hip flexors and extensors, knee in behavior that occur when a per-
by the literature on LE strength flexors and extensors, and ankle dor- son is being observed49 and the hy-
training and task-specific locomotor siflexors and plantar flexors. This re- pothesized treatment effect50 and
training. We posed 2 distinct clini- sisted exercise program used the 10- can result in clinical trials that have
cal questions, each with a specific repetition maximum (RM), with practical clinical relevance.51,52
hypothesis. First, we wanted to de- loading provided by equipment typ-
termine whether a resisted cycling ically present in the clinic such as The Strength Training Effectiveness
program that incorporated some of elastic bands of varying resistance Post-Stroke (STEPS) RCT was de-
the weight-bearing and task-related and cuff weights, and included signed to make specific comparisons
demands of walking in a cyclical muscle-specific exercises that clini- among 4 intervention groups that
leg cycling task as described by cians use with their patients. were equated for frequency (4 ses-
Brown et al43 was as effective in sions per week), intensity (1 hour of
improving walking outcomes in The challenge for using a muscle- moderate-intensity, task-specific gait
adults with chronic stroke who specific resistive exercise program in training or strengthening exercise),
had walking disability (ie, walking individuals with stroke is the motor and duration (6 weeks for a total of
speeds at ⬍33% of adult norms) as a control problem associated with loss 24 sessions) and included interven-
high-intensity, task-specific treadmill of movement selectivity. Therefore, tions that are available and gaining
training protocol with BWS. As this we designed an exercise program in- popularity in the clinic despite the
cycling exercise uses whole-limb cy- corporating movement activation lack of strong evidence of their ef-
clic locomotor-like movements that based on the individual’s movement fectiveness. The use of this design
emphasize LE extensors and flexors capability that was either indepen- should provide valuable compari-

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Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

sons that reveal the practical benefits mography, magnetic resonance im- move out of the area within the next
of task-specific training or combined aging, or clinical criteria; (3) able to year or no transportation to the
programs to improve walking out- ambulate at least 14 m with an as- study site for all evaluations and
comes after stroke. Thus, we pro- sistive or orthotic device and assis- intervention sessions.
posed 2 separate a priori hypothe- tance of one person (minimum of
ses. First, we hypothesized that a Functional Ambulation Classification
resisted limb-loaded cycling task that level II) with a self-selected walking Study Design and
incorporated locomotor-like move- speed of ⱕ1.0 m/s; (4) voluntarily Outcome Measures
ments would be as effective at im- provided informed consent; and (5) Informed consent was approved by
proving walking outcomes (ie, speed approval of their primary care physi- the institutional review board of
and distance) as a high-intensity, cian to participate. each institution. After informed con-
task-specific intervention of treadmill sent was obtained and baseline as-
training with BWS. Second, we hy- Exclusion criteria included health sessments were completed, partici-
pothesized that intervention programs conditions that would interfere with pants were balanced for walking
that combine moderate-intensity safe participation in a moderately severity based on self-selected over-
strengthening (ie, resisted cycling or high exercise program or recent ex- ground walking speed (severe: ⬍0.5
muscle-specific strengthening) with ercise study participation that might m/s or moderate: ⱖ0.5 m/s but ⬍1.0
task-specific training (ie, BWSTT in interfere with the treatment effects m/s) and randomly assigned to 1 of 4
this study) would be more effective at of our protocol. Specific exclusions comparison exercise groups that in-
improving walking outcomes than included: serious medical condi- cluded 4 treatment sessions per
task-specific training alone. tions; resting systolic blood pressure week for 6 weeks (total of 24 treat-
greater than 180 mm Hg, resting di- ment sessions). Severity strata cut-
Method astolic blood pressure greater than offs were determined a priori based
Participants 110 mm Hg, or resting heart rate on a previous pilot study.35 Severity
Eighty participants with chronic greater than 100 bpm*; lower-limb was balanced within groups to en-
stroke were recruited for this phase orthopedic conditions such as prior sure that numbers of participants at
II, single-blinded, multisite, random- joint replacement or limitations in moderate and severe levels were not
ized intervention trial from stroke range of motion; spasticity manage- disproportionate between groups;
groups and outpatient clinics in ment that included botulinum toxin stroke severity is a factor that has
the greater Los Angeles, Calif, and injection (⬍4 months earlier) or been demonstrated to affect respon-
Chicago, Ill, communities. Three phenol block injection (⬍12 months siveness to locomotor training.29,35
study sites participated: (1) Univer- earlier) to the affected LE and intra-
sity of Southern California (USC), Di- thecal baclofen or oral baclofen Baseline measures of patient demo-
vision of Biokinesiology and Physical (within the past 30 days); Mini- graphics, stroke characteristics
Therapy, Los Angeles, Calif; (2) Ran- Mental State Exam score of ⬍24; cur- (including onset), and outcome
cho Los Amigos National Rehabilita- rently receiving LE strengthening measures were assessed prior to ran-
tion Center (RLANRC), Pathokinesiol- exercises or gait training; past partic- domization to treatment group. All
ogy Lab, Downey, Calif; and (3) ipation in any study examining the measurements were performed by
Northwestern University (NU), De- effects of long-term BWSTT (⬎4 physical therapists who were trained
partment of Physical Therapy and Hu- weeks of training); limb-loaded ped- to perform standardized assessment
man Movement Sciences, Chicago, Ill. aling or LE strengthening; or plans to procedures and blinded to group as-
signment; these therapists did not
Participants who were beyond the provide the interventions. Consis-
* Cardiovascular exclusions and preexercise
period of spontaneous neurologic re- and postexercise tolerance guidelines were tent with the health impact of dis-
covery and who were ambulatory based on findings of a previous study of exer- abling conditions adopted by the
but had significant walking disability cise training in individuals with stroke53 and Physical Therapy Clinical Research
are consistent with the American College of
that limited their community ambu- Sports Medicine Guidelines for Exercise Test- Network (PTClinResNet), outcome
lation were screened for eligibility ing and Prescription.54 In addition, because measures were selected to measure
based on the following a priori in- graded exercise testing with an electrocardio- relevant poststroke outcomes at the
graph was not conducted in our study, medi-
clusion criteria: (1) age 18 years or cal clearance was required by a primary care primary body function, activity, and
older; (2) 4 months to 5 years after physician or cardiologist for each participant. participation levels of the Interna-
first-time onset of a ischemic or hem- If indicated by the personal physician, more tional Classification of Functioning,
conservative cutoffs for systolic blood pres-
orrhagic cerebrovascular accident sure and diastolic blood pressure were used Disability and Health.55 Outcome
(CVA) confirmed by computed to- for exercise termination. measures were selected based on

December 2007 Volume 87 Number 12 Physical Therapy f 1583


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

their known reliability and validity in dynamometer,† with test positions ual muscle torques because the
the population of adults with stroke. selected based on optimal anatomi- strengthening interventions tested in
cal muscle length (ankle plantar flex- this study target either whole-limb
The primary outcome measure was ion at 5°, ankle dorsiflexion at 15° of activities (limb-loaded cycling and
overground self-selected walking dorsiflexion, knee flexion and exten- treadmill training) or specific muscle
speed.2,56 Secondary walking out- sion at 45° of knee flexion, hip flex- groups but are individualized based
come measures were fast-walking ion at 60° of hip flexion, hip exten- on each participant’s initial pattern
speed and 6-minute walk distance.57,58 sion at 90° of hip flexion) and body of weakness. We separated compos-
Walking speed was determined by stability considerations. Hip torque ite scores into extensor and flexor
the therapist as the participant’s was measured with participants in a scores because these muscles tend
time (measured in seconds with a supine position, and knee and ankle to work together both in function
stopwatch) to walk the middle 10 m torque were measured in the seated and in the whole-limb exercises.
of a 14-m walkway with the assistive position with both the knees and Moreover, the magnitude of torque
device or ankle-foot orthosis typi- hips flexed to 90 degrees. Prior to production is greater in the exten-
cally used for community ambula- each measurement, the weight of sors than in the flexors, and separate
tion. Data for 2 trials were collected the limb due to gravity was mea- composites would prevent the
for the self-selected pace followed sured and subtracted from the re- changes in extensor torques from
by collection of data for 2 trials for corded measurement. Participants obscuring the changes in the flexor
the fast pace. Measurements for both were instructed to perform the iso- values.
trials were averaged for each re- metric muscle contractions as hard
spective walking speed. Six-minute as they could and then rest for about Interventions
walk distance was determined by the 1 minute between the 3 efforts. The goal of the treatment sessions
therapist as the distance that the par- Three peak torque measurements was to have each participant engage
ticipant walked in 6 minutes with were taken from each muscle group in a 1-hour physical therapy program
the typically used assistive device or and averaged for data analysis. that included a moderate-intensity
ankle-foot orthosis on an oval walk- progressive exercise protocol that is
way between 2 chairs positioned The primary and secondary walking representative of what therapists
18 m apart. Standardized encourage- outcome measurements were col- may do in a usual treatment session.
ment was provided at each minute, lected at baseline, after 12 treat- Intervention consisted of physical
and participants could stop and rest ment sessions, after 24 treatment therapist–supervised exercise con-
at 1 of 4 chairs positioned on the sessions, and at the 6-month follow- ducted in 1-hour sessions, 4 days per
walkway. up. All other outcomes were mea- week, for 6 weeks. Protocol varia-
sured at baseline, after treatment, tions for missed visits were accept-
Additional secondary outcome mea- and at a 6-month follow-up, except able if the total 24 visits were accom-
sures included the LE-FM motor for SIS scores, which were obtained plished within an 8-week period.
score59; Berg Balance Scale60; the 16- only at baseline and at the 6-month
item Stroke Impact Scale (SIS-16), follow-up. Four exercise interventions were
version 3.061,62; Medical Outcomes used. Three exercise interventions
Study 36-Item Short-Form Health Only the primary and secondary were designed to improve gait speed
Survey (SF-36), version 2.0 (physical walking outcomes from the activity- or LE strength, and one UE exercise
health and mental health compo- level measures related to walking intervention was designed as a sham
nents)62,63; and LE isometric peak speed and endurance will be pre- intervention, not to include any ac-
torque (bilateral hip flexors, hip ex- sented in this article, along with tive component that would improve
tensors, knee flexors, knee exten- composite extensor and flexor iso- gait speed or LE strength. The exer-
sors, and ankle dorsiflexion and metric muscle torque measurements cise interventions were: (1) BWSTT,
plantar flexion).64 (ie, the sum of the 3 extensor torque (2) limb-loaded resistive leg cycling
values and the sum of the 3 flexor (CYCLE), (3) LE muscle-specific
We decided to measure isometric torque values) as an explanatory vari- progressive-resistive exercise (LE-
torque due to the known deficits in able from the body function level. EX), and (4) UE ergometry (UE-EX).
movement selectivity after stroke We elected to analyze composite (For video clips of these exercises,
and the range of motor severity we strength scores rather than individ- visit this article online at www.
expected to observe in our partici- ptjournal.org). After baseline assess-
pants. Isometric torque was mea- †
Biodex Medical Systems Inc, 20 Ramsay Rd, ments, participants were randomly
sured, bilaterally, on a Biodex Shirley, NY 11967-4704. assigned to a combination exercise

1584 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

program that consisted of the follow- utes of treadmill walking time over cles the participant was able to suc-
ing exercise pairs: BWSTT/UE-EX, the 1-hour intervention session. De- cessfully pedal with the seat base lo-
CYCLE/UE-EX, BWSTT/CYCLE, and tails of the BWSTT protocol have cated in the “exercise region.” The
BWSTT/LE-EX. Participants engaged been described in a previous publica- number of successful revolutions
in the exercise 4 days per week. Ex- tion.35 As part of the task-specific train- completed by the paretic limb deter-
ercise type was on alternate days (eg, ing session, the participant received mined the load setting for the next
BWSTT session on one day followed gait instruction in an overground set- set. After each set, the number of
by CYCLE session on the alternate ting over a 50-ft (15-m) distance, im- successful revolutions on the paretic
day). Based on participant prefer- plemented specifically to reinforce the limb was recorded. A successful rev-
ence, a rest day was provided on gait training that transpired while on olution was defined as the comple-
Wednesday or Friday, with no exer- the treadmill. The BWSTT session was tion of one extension phase with the
cise on the weekend. provided on either a Robomedica‡ seat base remaining in the “exercise
(USC, RLANRC) or a Biodex† (NU) un- region.” The load settings were ad-
All participants received the same weighting system. justed using this guideline for the
number of treatment sessions and remaining sets in each session, as
contact time with a physical thera- The CYCLE training protocol re- described in the Appendix.
pist in order to minimize the Haw- quired the participant to cycle with
thorne effect.49 Two separate com- the LEs on a modified Biodex† semi- The LE-EX protocol required each
parisons were conducted: (1) recumbent cycle. The apparatus has participant to isotonically exercise
BWSTT/UE-EX and CYCLE/UE-EX a releasable seat, enabling it to slide the affected LE using external resis-
and (2) BWSTT/UE-EX, BWSTT/ along a linear track where up to ten tance (eg, gravity, resistive tubing,
CYCLE, and BWSTT/LE-EX. The first 10-lb bungee cords can be attached cuff weights of various incre-
comparison examined the efficacy of to produce extensor muscle resis- ments). The therapist followed an
task-specific treadmill training with tance similar to a leg press machine. exercise algorithm that accounted
BWS compared with a resistive cy- Therefore, in addition to the regular for the participant’s strength as
cling program that emphasized LE crank-based resistance encountered well as movement synergy level to
strengthening of muscle groups used during pedaling exercise, the limb determine a 10-RM for 6 specific
in gait. The second comparison al- extensor muscles primarily are re- muscle groups (hip flexors, hip ex-
lowed for an analysis of the efficacy quired to overcome resistance to tensors, knee flexors, knee exten-
of an exercise program that com- maintain a stable body position sors, ankle dorsiflexors, and ankle
bines task-specific treadmill training against the sliding seat. The goal of plantar flexors). For example, the
with BWS with a progressive- the exercise is for the participant to starting position against gravity for
resistive exercise program (either pedal while keeping the sliding seat the ankle dorsiflexors was the
resistive LE cycling or LE muscle- from moving forward out of the tar- LE-FM position for testing ankle
specific progressive-resistive exer- get “exercise region.” If the forces movements independent of syn-
cise) compared with task-specific generated by the legs are not suffi- ergy (ie, standing, knee extended,
treadmill training with BWS alone. cient to overcome the pull of the with foot dorsiflexed against grav-
seat, the seat will move forward out ity). If the participant could isolate
A brief description of each interven- of the target region and the partici- ankle dorsiflexion in this position,
tion is provided below and in the pant will be cued to “push out” back the typical procedure to determine
Appendix. A detailed description into the “exercise region.” a 10-RM was used, and the dorsi-
of methods, progression algorithms, flexor would be loaded with resis-
and response to treatment will fol- Participants were asked to complete tance typically used by a therapist
low in subsequent publications. 10 sets of 15 to 20 revolutions in (in this case, resistive tubing). If
each session. Participants were the participant could not isolate
During the BWSTT protocol, the par- given at least 2 minutes to rest be- the dorsiflexors in the standing po-
ticipant was fitted with a harness at- tween sets, during which heart rate, sition, then dorsiflexion against
tached to an overhead suspension blood pressure, and signs of distress gravity in a sitting position was
system positioned over a treadmill. were monitored. The initial load set- used (ie, the less difficult position
The BWSTT session required the par- ting was determined through a limb to activate the dorsiflexors in the
ticipant to walk on a treadmill for load test that counted how many cy- LE-FM test). If the participant could
four 5-minute training bouts at not activate the dorsiflexors in a
speeds within the range of 1.5 to 2.5 ‡
Robomedica, One Technology Park, Suite sitting position, then the partici-
mph to achieve 20 accumulated min- C-511, Irvine, CA 92618. pant was positioned supine and

December 2007 Volume 87 Number 12 Physical Therapy f 1585


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

used hip and knee flexion to acti- and, with standing, systolic blood Adverse Event Monitoring
vate the dorsiflexors. pressure could not drop more than During the study, adverse events
20 mm Hg. Immediately after exer- were reported to the PTClinResNet
Progression included moving to a cise, the participant’s systolic blood Administrative Core at USC, the Data
more isolated movement position or pressure had to be less than 200 mm Management Center (DMC) at USC,
increasing resistance within a posi- Hg and diastolic blood pressure had and the institutional review board at
tion where activation occurred. Dur- to be below 110 mm Hg. Exercise each site. An adverse event was de-
ing the LE-EX session, each muscle intensity was no greater than 80% of fined as an unexpected health-
group was exercised for 3 sets of 10 age-predicted maximum heart rate; a related incident that occurred during
repetitions at 80% of the 10-RM. A rest was provided if the individual the course of the study, regardless of
progression algorithm was used to perceived a high rate of exertion.㛳 If its severity or potential relationship
increase the workload across the 12 any of the previous cardiovascular to the study. Adverse events were
treatment sessions. The therapist guidelines were not met, the exer- coded on the severity and potential
progressed the exercise by either in- cise session was not started or, if relationship to the STEPS protocol.
creasing the load within an exercise already started, was stopped imme-
type or progressing the participant diately. The participant’s primary Data Analysis
to the more difficult exercise-type care physician was contacted if there Because of concern that a simple
level. were abnormal responses to exer- randomization might yield notice-
cise or if heart rate or blood pressure able imbalance with respect to
The UE exercise protocol required was higher then what was typical for treatment assignment and baseline
the participant to cycle with the UEs the participant at rest. Medication walking severity, a blocked random-
on an Endorphin EN-300 Hand adjustment was provided by the phy- ization treatment allocation proce-
Cycle.§ The therapist adjusted the re- sician, if needed. If the physician or dure was used to ensure that 20 par-
sistance on the cycle to a level where the investigators felt that the exer- ticipants were assigned to each of
the participant could complete 20 cise intensity was too high for an the 4 intervention groups and that
revolutions, but no more (ie, 20-RM). individual, the participant was with- severity (moderate or severe walking
The exercise session consisted of the drawn from the study. impairment) was balanced within
participant completing 10 sets of a each group (BWSTT/UE-EX, CYCLE/
maximum of 20 revolutions. For- Each therapist passed a rigorous UE-EX, BWSTT/CYCLE, and BWSTT/
ward and backward cycling were al- standardization procedure on his or LE-EX). Allocation sequence was
ternated for each set of exercise, and her respective protocol before eval- generated and intervention group as-
the therapist assisted the partici- uating or intervening with a par- signed after baseline assessments by
pant’s hemiparetic UE with the cy- ticipant in the STEPS study. The the DMC.
cling motion, as needed. standardization process included at-
tendance at training sessions to de- The primary outcome measure for
During intervention sessions, cardio- velop psychomotor skills, video- the preplanned hypotheses (hypoth-
vascular response was monitored by taped performance of the therapist esis 1: BWSTT/UE-EX versus CYCLE/
heart rate and blood pressure mea- conducting the protocol on an indi- UE-EX; hypothesis 2: BWSTT/UE-EX
surements prior to exercise, immedi- vidual with stroke, and 90% compe- versus BWSTT/CYCLE versus
ately after each exercise bout, and at tency rating by peer review on a BWSTT/LE-EX) was 10-m self-
the end of the exercise session. Prior standardized assessment rating scale selected walking speed. Due to the
to the start of exercise and at the end assessed by the research coordinator nature of this phase II study, in
of the exercise session, each partici- from a cooperating site other than which we were interested in the
pant’s heart rate and blood pressure the therapist’s “home” site. dose-response between intervention
needed to be within the following effects and long-term functional ef-
cardiovascular tolerance guidelines: fects of our interventions, we de-
while sitting at rest, systolic blood 㛳
Cardiovascular guidelines established for cided to complete the analysis on the
pressure had to be less than 180 mm this trial were developed prior to the 2004 evaluable participants (ie, those par-
Hg, diastolic blood pressure had to American Heart Association scientific state- ticipants who received the full dose
ment on exercise guidelines for people who
be less than 110 mm Hg, and heart had survived a stroke.65 Based on this more of therapy). However, we also report
rate had to be less than 100 bpm, recent evidence, we would recommend a sub- the results of the more conservative
maximal training heart rate of 70% of age- intention-to-treat analysis of all ran-
predicted maximum heart rate when an exer-
§
Endorphin Corp, 6901 90th Ave, North cise tolerance test has not been done in an domized subjects using a carry-
Pinellas Park, FL 33782. individual after stroke. forward method by imputing the last

1586 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

collected value for the posttreatment detect these effect sizes is larger comparisons were conducted using
value for the primary outcome mea- than 80%. the Tukey adjustment procedure.
sure. Consistent with our prespeci-
fied analytic plan, an intent-to-treat Demographics, stroke history, and Similar analyses were conducted for
analysis was completed between: baseline functional assessments were the extensor and flexor composite
(1) BWSTT/UE-EX and CYCLE/ compared across the 4 randomized torque scores. However, due to non-
UE-EX (40 randomized participants) groups using an ANOVA for compari- normality, the Wilcoxon rank-sum
and (2) BWSTT/UE-EX, BWSTT/ son of means and chi-square and and Kruskal-Wallis nonparametric
CYCLE, and BWSTT/LE-EX (60 ran- Fisher exact tests for comparison of tests were used to evaluate the treat-
domized participants) for the pri- proportions. Variables found to be sta- ment effect of BWSTT/UE-EX versus
mary outcome measure and second- tistically significant were used as co- CYCLE/UE-EX after 24 sessions and
ary walking outcome measures. variates in the subsequent intention-to- the effects across all 3 BWSTT
Secondary outcome measures were treat analyses. groups, respectively. The Wilcoxon
10-m fast walking speed and signed-rank test was used to com-
6-minute walking distance. In addi- For hypothesis 1, one-way ANCOVA pare within-treatment differences in
tion, paretic and nonparetic exten- was used to compare the postinter- the torque measurements. Statistical
sor and flexor composite torque vention change in primary and sec- analyses were conducted using SAS,
scores (ie, the sum of the 3 extensor ondary outcomes between the version 9,# at the .05 level of
torque values and the sum of the 3 BWSTT/UE-EX and CYCLE/UE-EX in- significance.
flexor torque values) were used to tervention groups. Severity (moder-
characterize strength gains as a result ate, severe) was the preplanned co- Results
of the interventions. variate. Paired t tests also were Recruitment and Retention
conducted within each of the inter- To achieve the planned sample size
Power calculations were conducted vention groups to evaluate changes of 72 participants (18 per inter-
for the expected posttreatment after 24 sessions. Effect sizes were vention group), a total of 284 indi-
change (post–session 24 value ⫺ calculated as the between-treatment viduals were screened by telephone
baseline value) in the primary out- difference in mean change scores di- or chart review. Of these individuals,
come measure for each of the 2 pre- vided by the pooled standard devia- 127 were evaluated for an in-person,
planned hypotheses. For hypothesis tion. Similar analyses were con- physical screening examination (Fig. 1).
1, with a sample size of 18 in each ducted to evaluate the persistence of A total of 80 participants (28%) were
of the 2 groups, a one-way analysis the treatment effects at 6 months. In recruited and randomly assigned to
of variance (ANOVA) will have 80% this case, the dependent variable the 4 exercise pairs between June
power to detect a between-group ef- was the 6-month change in the pri- 2002 and April 2005. Of the 204 par-
fect size of 0.23 at the .05 level of mary and secondary walking out- ticipants who were not recruited, 173
significance. For hypothesis 2, when come measures (6-month follow-up (85%) did not meet the inclusion cri-
the sample size in each of the 3 value ⫺ post–session 24 value). teria, and 31 (15%) declined due to
groups is 18, a one-way ANOVA will personal reasons. Table 1 summarizes
have 80% power to detect a the reasons for exclusion by clinical
between-group effect size of 0.19 at For the primary outcome measure, a site.
the .05 level of significance. With an 2-way repeated-measures ANOVA
expected attrition rate of 10%, our model was used to determine the Of the 80 randomized participants,
recruitment goal was 80 partici- interaction effects of group (BWSTT/ 71 (89%) completed the full exercise
pants, with an expectation that 72 UE-EX, CYCLE/UE-EX) and time protocol (Fig. 1). Reasons for drop-
participants (n⫽18 per group) with (baseline, after 12 sessions, after 24 ping out during the intervention
both baseline and posttreatment sessions, and after 6 months), with phase included abnormal cardiac
measures of comfortable walking time as the repeated measure. response to exercise, musculoskele-
speed would provide enough power tal injury, medical illness, and per-
to detect significant group differ- For hypothesis 2, similar analyses sonal reasons. Of the 71 participants
ences for each of the hypotheses. were conducted to compare out- from the intervention phase, 63
Because our preplanned analytic comes among the BWSTT/UE-EX, (89%) were evaluated at the 6-month
strategy (see below) was to adjust for BWSTT/CYCLE, and BWSTT/LE-EX follow-up examination. Reasons for
the severity level (moderate, severe) intervention groups. When signifi-
using an analysis of covariance cant differences across the 3 inter- #
SAS Institute Inc, PO Box 8000, Cary, NC
(ANCOVA), in theory, our power to vention groups were found, multiple 27513.

December 2007 Volume 87 Number 12 Physical Therapy f 1587


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Enrollment
STEPS Prescreened-Telephone screen (n=284)
Summary of ineligbility
(n=204)
Personal reasons
Eligible for in-person physical screen (n=127) (n=31)
Did not meet inclusion
criteria
(n=173)
Randomized (n=80)
Randomized proportionally
by
initial gait speed to 1 of
4 treatment groups
Randomized

Allocated to Allocated to Allocated to Allocated to


BWSTT/UE-EX group CYCLE/UE-EX group BWSTT/CYCLE group BWSTT/LE-EX group
(n=20) (n=20) (n=20) (n=20)
10 moderate 12 moderate 11 moderate 10 moderate
10 severe 8 severe 9 severe 10 severe

Withdrawn by Withdrawn by Withdrawn by Withdrawn by


Evaluable

administration administration administration administration


(n=1) (n=2) (n=1) (n=4)
Refused (n=0) Refused (n=0) Refused (n=1) Refused (n=0)
Analyzed (n=19) Analyzed (n=18) Analyzed (n=18) Analyzed (n=16)
10 moderate 10 moderate 10 moderate 9 moderate
9 severe 8 severe 8 severe 7 severe

Withdrawn by Withdrawn by Withdrawn by Withdrawn by


Follow-up

administration administration administration administration


(n=0) (n=0)
6-mo

(n=1) (n=0)
Refused (n=0) Refused (n=3) Refused (n=2) Refused (n=2)
Analyzed (n=19) Analyzed (n=14) Analyzed (n=16) Analyzed (n=14)
10 moderate 8 moderate 9 moderate 9 moderate
9 severe 6 severe 7 severe 5 severe

Figure 1.
CONSORT diagram. Flow of participants through trial. STEPS⫽Strength Training Effectiveness Post-Stroke study, BWSTT/
UE-EX⫽combined body-weight–supported treadmill training and upper-extremity ergometry intervention group, CYCLE/
UE-EX⫽combined resistive leg cycling and upper-extremity ergometry intervention group, BWSTT/CYCLE⫽combined body-weight–
supported treadmill training and resistive leg cycling intervention group, BWSTT/LE-EX⫽combined body-weight–supported tread-
mill training and lower-extremity progressive-resistive exercise intervention group.

loss to follow-up included personal Table 2 summarizes the demo- 60.7) months, respectively. Stroke
reasons and inability to locate the graphic and clinical characteristics characteristics included 42 left CVA
participant. Chi-square analysis re- for the 80 randomized participants and 38 right CVA. Stroke type in-
vealed that participant follow-up by treatment assignment. No signifi- cluded 48 infarcts, 17 hemorrhages,
rates (BWSTT/UE-EX group⫽0.95, cant differences in baseline charac- and 15 not specified because these
CYCLE/UE-EX group⫽0.70, BWSTT/ teristics were found across the inter- strokes were determined by clinical
CYCLE group⫽0.80, and BWSTT/ vention groups. Overall, 45 (56%) presentation. Baseline clinical out-
LE-EX group⫽0.70) were not sig- of the participants were men. The comes, including the primary and
nificantly different across the 4 average⫾SD (range) age and time af- secondary walking outcomes, stroke
intervention groups (P⫽.17). ter stroke were 60.9⫾12.4 (32.0 – impairment severity (LE-FM motor
83.2) years and 25.0⫾16.2 (4.3– score, Berg Balance Scale score), and

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Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Table 1.
Summary of Ineligibility by Site: Strength Training Effectiveness Post-Stroke (STEPS) Study Recruitment Efforts Summary, June
2002 to April 2005, Composite Across Sitesa

Reason Code
Site TF SS TL TG MS OP OR SI CS TP MP CP Total STEPS
Contacts Subjects
USC 4 5 5 2 2 12 3 0 2 2 4 2 78 35
RLANRC 3 0 1 1 1 11 5 0 1 0 1 0 42 18
NWU 75 2 3 12 0 8 2 6 0 20 0 9 164 27
Total 82 7 9 15 3 31 10 6 3 22 5 11 284 80
a
TF⫽too far poststroke (⬎5 y); SS⫽second/multiple strokes; TL⫽too low on ambulation criteria; TG⫽free walking speed exceeded 1.0 m/s; MS⫽mental
status (Mini-Mental State Exam score ⬍24); OP⫽other problems (participant did not show or return telephone call, personal reasons for not participating,
no reason for not participating, not able to participate 3– 4 times per week); OR⫽orthopedic limitations (hip, knee, or ankle contracture; prior hip or knee
replacement; leg-length discrepancy ⬎5 cm; or premorbid gait disorder); SI⫽spasticity issues (receiving intrathecal baclofen, botulinum toxin injection
within past 4 mo to affected lower extremity); CS⫽cerebellar stroke; TP⫽transportation problems; MP⫽medical problems (diagnosis other than stroke, other
medical issues); CP⫽current participation in formal physical therapy program/clinical program or past participation in body-weight–supported training for
⬎4 weeks; USC⫽University of Southern California; RLANRC⫽Rancho Los Amigos National Rehabilitation Center; NU⫽Northwestern University.

quality-of-life (SF-36 physical health that occurred in 18 participants. In addition to participant adverse
and mental health scores, SIS-16 There were 17 adverse events during events, there were 11 instances of
score) variables, are presented in Ta- the intervention period, 8 of which unanticipated protocol variations. A
ble 2 by treatment assignment. No were not study related (4 falls in committee of PTClinResNet and
significant differences were found home, 1 report of low back pain, 1 STEPS investigators assessed each
across the intervention groups. controlled seizure, 1 participant unanticipated protocol variation to
diagnosed with colon cancer, 1 par- determine whether the participant
Comparison by severity level (data ticipant diagnosed with congestive should be included in the evaluable
not shown) revealed that, as ex- heart failure after randomization but data set. The investigators deter-
pected, the moderate group had prior to starting intervention). Study- mined that 8 were minor variations,
higher values compared with the se- related events associated with the and 3 were major variations. Minor
vere group for all of the primary following intervention pairs includ- variations included missing one ses-
and secondary outcome measures ed: (1) in the BWSTT/UE-EX group, sion of exercise (for a reduced total
(self-selected overground walking minor hand abrasion and foot pain; of 23 out of 24 exercise sessions) and
speed: 0.71⫾0.20 m/s versus 0.25⫾ (2) in the BWSTT/CYCLE group, foot completing a total of 24 exercise ses-
0.12 m/s, fast walking speed: pain, reduced blood pressure, and sions but not an equal number of
1.00⫾0.30 m/s versus 0.34⫾0.18 increased blood pressure (twice in 1 each of the 2 exercises (eg, 11 ses-
m/s, and distance walked in 6 min- participant); and (3) in the BWSTT/ sions of one exercise and 13 sessions
utes: 258.07⫾86.71 m versus 93.94⫾ LE-EX group, gluteus medius muscle of the other exercise). Major varia-
60.52 m), LE-FM scores (26.14⫾3.45 pain and toe pain, with later diag- tions were protocol deviations that
versus 20.89⫾5.46), and Berg Bal- nosis of toe stress fracture (2 oc- were beyond the tolerances deter-
ance Scale scores (49.61⫾7.26 versus currences in 1 participant). Four mined a priori, such as prolonged
33.94⫾10.20). All differences were participants were withdrawn from absences and doubling of exercises
statistically significant at P⬍.0001. the study by the administration due on single days. Data for participants
Stratification by severity was equiva- to the adverse events. Two adverse with major protocol variations were
lent between all groups at baseline, as effects were adjudicated as related to included in the baseline analysis but
indicated by no significant differences the study (foot pain, toe stress frac- were excluded from the final evalu-
in severity by group for all variables ture), and 2 adverse effects were able data analysis. Of the 71 evalu-
(P⬎.05). considered not related to study but able participants, 8 were lost to the
due to cardiac conditions (conges- 6-month follow-up (1 died, 1 had sus-
Adverse Events and tive heart failure, high blood pres- tained a myocardial infarction, and 6
Protocol Variations sure not responsive to medication). refused to attend or could not be
Across the intervention and 6 month The participant with colon cancer located).
follow-up period, there were 21 cu- withdrew from the study.
mulative adverse events reported

December 2007 Volume 87 Number 12 Physical Therapy f 1589


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Table 2.
Baseline Demographics, Stroke History, Primary Outcomes, and Participation Measures by Intervention Group (N⫽80)a

BWSTT/ CYCLE/ BWSTT/ BWSTT/ Pb


UE-EX UE-EX CYCLE LE-EX
(nⴝ20) (nⴝ20) (nⴝ20) (nⴝ20)
Demographics
Sex: male 10 (50%) 11 (55%) 13 (65%) 11 (55%) .81
Age (y) 60.6 (13.7) 63.4 (8.6) 58.2 (15.2) 61.4 (11.2) .63
Race/ethnicity
Hispanic or Latino 2 (10%) 1 (5%) 2 (10%) 2 (10%) .92
African American 6 (30%) 6 (30%) 2 (10%) 4 (20%) .77
Asian 2 (10%) 4 (20%) 4 (20%) 2 (10%)
White 12 (60%) 9 (45%) 13 (65%) 13 (65%)
Undeclared 0 (0%) 1 (5%) 1 (5%) 1 (5%)
Education level
College: graduate 3 (15%) 10 (50%) 9 (45%) 9 (45%) .13
College: postgraduate 6 (30%) 3 (15%) 4 (20%) 4 (20%)
High school or less 11 (55%) 7 (35%) 7 (35%) 7 (35%)
Stroke characteristics
Time since stroke (mo) 27.5 (16.1) 28.4 (19.0) 23.1 (15.0) 20.7 (14.4) .40
Right-sided weakness 12 (60%) 10 (50%) 11 (55%) 9 (45%) .80
Right-hand dominance 19 (95%) 17 (85%) 19 (95%) 19 (95%) .54
Type of stroke
Hemorrhage 4 (20%) 4 (20%) 4 (20%) 5 (25%) 1.00
Infarct 12 (60%) 12 (60%) 13 (65%) 11 (55%)
Clinical criteria 4 (20%) 4 (20%) 3 (15%) 4 (20%)
Stroke severity
LE-FM motor score 24.5 (5.5) 24.4 (4.5) 24.2 (4.0) 22.1 (6.3) .49
(maximum score⫽34)
Berg Balance Scale 42.1 (9.8) 42.6 (11.4) 45.2 (10.1) 40.4 (15.0) .72
(maximum score⫽56)
Primary and secondary
outcomes at baseline
Comfortable gait speed (m/s) 0.49 (0.24) 0.48 (0.28) 0.53 (0.28) 0.52 (0.35) .93
Fast gait speed (m/s) 0.69 (0.38) 0.65 (0.42) 0.71 (0.38) 0.76 (0.50) .88
6-min walk distance (m) 189.3 (99.9) 170.0 (115.2) 187.6 (99.9) 190.0 (135.4) .93
Participation measures
SF-36 (n⫽14) (n⫽16) (n⫽13) (n⫽16)
Physical health 39.3 (9.0) 41.9 (5.8) 41.5 (9.0) 37.4 (8.1) .38
Mental health 52.3 (8.9) 55.4 (9.7) 49.9 (13.0) 55.7 (9.7) .40
Stroke Impact Scale (n⫽19) (n⫽20) (n⫽18) (n⫽19)
SIS-16 73.8 (14.0) 79.5 (10.9) 76.2 (13.0) 76.3 (14.7) .60
a
Values are mean⫾SD for continuous variables, frequency (%) for categorical variables. BWSTT/UE-EX⫽combined body-weight–supported treadmill training
and upper-extremity ergometry intervention group, CYCLE/UE-EX⫽combined resistive leg cycling and upper-extremity ergometry intervention group,
BWSTT/CYCLE⫽combined body-weight–supported treadmill training and resistive leg cycling intervention group, BWSTT/LE-EX⫽combined body-weight–
supported treadmill training and lower-extremity progressive-resistive exercise intervention group, LE-FM⫽lower-extremity Fugl-Meyer motor score,
SF-36⫽Medical Outcomes Study 36-Item Short-Form Health Survey, SIS-16⫽16-item Stroke Impact Scale.
b
Chi-square test for categorical variables, one-way analysis of variance for continuous variables.

1590 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Table 3.
Primary and Secondary Gait Outcomes at Baseline, After 24 Treatment Sessions, and Change From Baseline by Groupa

BWSTT/ CYCLE/ BWSTT/ BWSTT/ Pb Pc


UE-EX UE-EX CYCLE LE-EX
(nⴝ19) (nⴝ18) (nⴝ18) (nⴝ16)
10-m comfortable
gait speed
(m/s)
Baseline 0.50 (0.23) 0.43 (0.25) 0.54 (0.28) 0.57 (0.35)
Postintervention 0.63 (0.32) 0.44 (0.26) 0.63 (0.33) 0.67 (0.37)
Changed 0.13 (0.14) 0.01 (0.07) 0.09 (0.12) 0.10 (0.07) ⬍.004 .70
P .001* .67 .004* ⬍.0001*
10-m fast gait
speed (m/s)
Baseline 0.71 (0.37) 0.57 (0.36) 0.73 (0.39) 0.80 (0.51)
Postintervention 0.81 (0.43) 0.58 (0.39) 0.81 (0.44) 0.90 (0.51)
Change 0.10 (0.14) 0.01 (0.09) 0.08 (0.13) 0.10 (0.08) ⬍.03 .81
P .008* .79 .032* .0002*
6-min walk
distance (m)
Baseline 196.96 (96.4) 149.00 (99.6) 192.33 (102.3) 199.28 (137.87)
Postintervention 219.46 (106.0) 164.52 (118.6) 217.79 (122.6) 244.60 (144.57)
Change 22.5 (34.8) 15.5 (31.0) 25.5 (37.6) 45.3 (33.5) .50 .17
P .011* .049* .011* ⬍.0001*
a
Values are mean⫾SD. BWSTT/UE-EX⫽combined body-weight–supported treadmill training and upper-extremity ergometry intervention group, CYCLE/UE-
EX⫽combined resistive leg cycling and upper-extremity ergometry intervention group, BWSTT/CYCLE⫽combined body-weight–supported treadmill training
and resistive leg cycling intervention group, BWSTT/LE-EX⫽combined body-weight–supported treadmill training and lower-extremity progressive-resistive
exercise intervention group. *P⬍.05 for baseline-postintervention comparison using paired t test.
b
P value is comparison of BWSTT/UE-EX and CYCLE/UE-EX data using analysis of covariance (covariate⫽severity).
c
P value is comparison of BWSTT/UE-EX, BWSTT/CYCLE, and BWSTT/LE-EX data using analysis of covariance (covariate⫽severity).
d
Postintervention change calculated by subtracting baseline value from post–session 24 value.

Posttreatment and 6-Month means and standard deviations for group comparison are provided in
Follow-up Outcomes each of the walking outcome mea- Table 3.
In order to avoid bias in the primary sures for session 24 and the 6-month
analyses or initial interpretations, the follow-up as well as the change Group analysis confirmed that the
principal investigators (KJS, DAB, scores calculated from the posttreat- BWSTT/UE-EX intervention in-
SM) were blinded to group assign- ment measurement to 6-month creased self-selected and fast walking
ment until the final primary analyses follow-up for each intervention speeds to a significantly greater ex-
were completed for the primary and group. tent than the CYCLE/UE-EX interven-
secondary walking outcome mea- tion. The ANCOVA with walking se-
sures for both the BWSTT/UE-EX and BWSTT/UE-EX compared with verity as the covariate revealed
CYCLE/UE-EX comparisons and the CYCLE/UE-EX. Self-selected and significantly greater increases in self-
BWSTT/UE-EX, BWSTT/CYCLE, and fast walking speeds and walking selected walking speed (P⬍.004, ef-
BWSTT/LE-EX comparisons. Table 3 distance increased significantly after fect size⫽0.99) and fast walking
presents the means and standard de- the BWSTT/UE-EX intervention. In speed (P⬍.03, effect size⫽0.68) for
viations for each of the walking out- contrast, the CYCLE/UE-EX interven- the BWSTT/UE-EX group compared
come measures at baseline and for tion resulted in improvements in with the CYCLE/UE-EX group. Treat-
session 24 as well as pretest-posttest walking distance but not in self- ment group differences were nonsig-
change scores by experimental inter- selected or fast walking speed. nificant for the 6-minute walk test
vention group. Table 4 presents the Paired t-test values for each within- (P⫽.50, effect size⫽0.21). Figure 2

December 2007 Volume 87 Number 12 Physical Therapy f 1591


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Table 4.
Primary and Secondary Gait Outcomes Change Scores From Post–Session 24 Assessment to 6-Month Follow-up Assessment
(n⫽63)a

BWSTT/ CYCLE/ BWSTT/ BWSTT/ Pb Pc


UE-EX UE-EX CYCLE LE-EX
(nⴝ19) (nⴝ14) (nⴝ16) (nⴝ14)
10-m comfortable
speed (m/s)
Post–session 24 0.63 (0.32) 0.44 (0.28) 0.63 (0.35) 0.72 (0.36)
6-mo follow-up 0.65 (0.33) 0.43 (0.26) 0.64 (0.32) 0.77 (0.03)
Changed 0.02 (0.11) ⫺0.01 (0.11) 0.01 (0.10) 0.05 (0.09) .35 .53
P .38 .61 .68 .06
10-m fast gait
speed (m/s)
Post–session 24 0.81 (0.43) 0.61 (0.42) 0.81 (0.47) 0.98 (0.49)
6-mo follow-up 0.82 (0.44) 0.60 (0.42) 0.83 (0.43) 0.94 (0.69)
Change 0.01 (0.10) ⫺0.01 (0.17) 0.02 (0.12) ⫺0.04 (0.37) .57 .65
P .52 .76 .54 .70
6-min walk
distance (m)
Post–session 24 219.46 (105.95) 170.52 (122.80) 221.58 (128.53) 265.69 (141.87)
6-mo follow-up 219.50 (116.85) 165.54 (116.13) 233.61 (131.31) 266.40 (133.03)
Change 0.04 (55.54) ⫺4.98 (55.40) 12.03 (24.70) 0.71 (32.64) .81 .65
P 1.00 .74 .07 .94
a
Values are mean⫾SD. BWSTT/UE-EX⫽combined body-weight–supported treadmill training and upper-extremity ergometry intervention group, CYCLE/UE-
EX⫽combined resistive leg cycling and upper-extremity ergometry intervention group, BWSTT/CYCLE⫽combined body-weight–supported treadmill training
and resistive leg cycling intervention group, BWSTT/LE-EX⫽combined body-weight–supported treadmill training and lower-extremity progressive-resistive
exercise intervention group. *P⬍.05 for baseline-postintervention comparison using paired t test.
b
P value is comparison of BWSTT/UE-EX and CYCLE/UE-EX data using analysis of covariance (covariate⫽severity).
c
P value is comparison of BWSTT/UE-EX, BWSTT/CYCLE, and BWSTT/LE-EX data using analysis of covariance (covariate⫽severity).
c
Six-month follow-up change calculated by subtracting post–session 24 value from 6-mo follow-up value.

shows the post–session 24 ⫺ base- speed from the posttreatment mea- ment sessions (baseline, post–session
line change scores for self-selected surement to the 6-month follow-up in 12, and post–session 24 measures) and
and fast walking speeds and distance the CYCLE/UE-EX group adds validity the 6-month follow-up measure. Data
walked for the BWSTT/UE-EX and to intervention effects rather than for 33 participants (19 in the BWSTT/
CYCLE/UE-EX groups. Group differ- other factors such as natural recovery UE-EX group, 14 in the CYCLE/UE-EX
ences were the same when the more or individual experience. Group group) were included in this analysis.
conservative intention-to-treat analy- differences after treatment persisted Figure 3 illustrates the longitudinal pat-
sis of all 40 randomized subjects us- for all walking outcome measures at tern of change for the primary out-
ing the carry-forward method was 6 months (Tab. 4, between-group come measure across the baseline,
used for the primary outcome mea- comparisons). post–session 12, post–session 24, and
sure (P⫽.01). 6-month follow-up measures. For self-
To better understand changes over selected walking speed, the repeated-
At the 6-month follow-up, gains in the course of treatment (ie, effects measures ANOVA revealed significant
walking speed and distance walked of treatment duration) and for the main effects of group (P⫽.03) and
for the BWSTT/UE-EX group and in 6-month follow-up, a 2-way repeated- time (P⫽.004) and a significant
distance walked for the CYCLE/ measures ANOVA (with group as group ⫻ time interaction (P⫽.002).
UE-EX group were maintained (Tab. 4, the between factor and session as the Multiple comparisons (using the
within-group comparisons). Addition- within factor) was conducted for the Tukey method) revealed that the
ally, the lack of change in walking participants who completed all treat- BWSTT/UE-EX group improved self-

1592 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

selected walking speed significantly A ns


more than the CYCLE/UE-EX group by
session 24 (P⫽.01) and sustained this
0.15

Self-selected Walking Speed (m/s)


improvement 6 months later (P⫽.02).

BWSTT combined with strength-


ening regimens. Consistent with 0.10
the BWSTT/UE-EX intervention, the
BWSTT/CYCLE and BWSTT/LE-EX
interventions resulted in significant 0.05
increases in self-selected and fast
walking speeds and walking distance
(Tab. 3, within-group comparisons).
Group analysis of the 3 BWSTT train-
ing interventions revealed that the B ns
addition of an LE strengthening pro- 0.15
tocol on alternate days to task- Fast Walking Speed (m/s)
specific training did not result in ad-
ditional gains in walking-related 0.10
outcomes, including walking speed
or walking distance. An ANCOVA
with walking speed severity as the 0.10
covariate comparing the BWSTT/UE-
EX, BWSTT/CYCLE, and BWSTT/
LE-EX groups revealed no significant
group differences for any of the
walking outcomes (Tab. 3, between-
ns
group comparisons). Figure 2 shows C
ns
the change scores for self-selected
and fast walking speeds and distance 50
6-min Walk Distance (m)

walked for the BWSTT/UE-EX,


40
BWSTT/CYCLE, and BWSTT/LE-EX
groups. Group differences were the
30
same when the more conservative
intention-to-treat analysis of data for 20
all 60 subjects randomly assigned to
the 3 BWSTT groups using the carry- 10
forward method was used for the
primary outcome measure (P⫽.43).
BWSTT/ CYCLE/ BWSTT/ BWSTT/
UE-EX UE-EX CYCLE LE-EX
Table 4 summarizes the long-term
beneficial effects of BWSTT on walk- Figure 2.
ing improvements. At 6 months, Bar graphs of change (post–session 24 – baseline) by group (combined body-weight–
walking improvements were sus- supported treadmill training and upper-extremity ergometry [BWSTT/UE-EX], solid blue
bars; combined resistive leg cycling and upper-extremity ergometry [CYCLE/UE-EX],
tained regardless of whether the sub- white bars; combined body-weight–supported treadmill training and resistive leg cy-
jects were trained in the BWSTT/UE- cling [BWSTT/CYCLE], lined bars; combined body-weight–supported treadmill training
EX, BWSTT/CYCLE, or BWSTT/ and lower-extremity progressive-resistive exercise [BWSTT/LE-EX], hatched bars) for the
LE-EX protocol, as demonstrated by primary and secondary walking outcomes (mean⫾SEM): (A) self-selected walking
nonsignificant differences in the speed, (B) fast walking speed, and (C) 6-min walk distance. Significant baseline to
postintervention changes (paired t test, P⬍.05) indicated by asterisk above bar. Analysis
change scores between the post–ses- of covariance (ANCOVA) for between-group differences for BWSTT/UE-EX and CYCLE/
sion 24 and 6-month follow-up mea- UE-EX comparisons indicated by lower horizontal bar; ANCOVA group differences for
sures (Tab. 4, within-group compar- BWSTT/UE-EX, BWSTT/CYCLE, and BWSTT/LE-EX comparisons indicated by top hori-
isons). An ANCOVA comparing the 3 zontal bar; significant group difference (P⬍.05) indicated by asterisk above lower
groups that received BWSTT re- horizontal bar; ns⫽not significant.

December 2007 Volume 87 Number 12 Physical Therapy f 1593


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

0.80 Endurance improvements were evi-


dent for both the BWSTT-trained and
Self-selected Walking Speed (m/s)

resisted cycling–trained groups. Fur-


thermore, our findings indicate that
0.60 a moderate-intensity program of LE
progressive-resistive exercise alter-
nated daily with task-specific train-
ing did not provide an added benefit
to walking outcomes after stroke. Re-
0.40
gardless of whether treadmill train-
ing with BWS was combined with
resistive LE exercise, an intense,
task-specific walking program re-
0.20 sulted in improvements in walking
speed and endurance that were sus-
tained at the 6-month follow-up.
Baseline After 12 Sessions After 24 Sessions 6-mo Follow-up
Specificity and Intensity of
Figure 3. Training
Time series plot comparing combined body-weight–supported treadmill training and The primary finding from the STEPS
upper-extremity ergometry (BWSTT/UE-EX) (●) and combined resistive leg cycling and trial, that treadmill training with
upper-extremity ergometry [CYCLE/UE-EX] (Œ) group means (⫾SEM) at baseline, after
12 sessions, after 24 sessions, and at 6-month follow-up for the primary outcome of BWS was more effective than re-
self-selected walking speed. sisted cycling in improving walking
speed after stroke, may be ex-
plained, in part, by considering the
vealed that there were no group dif- torque for the paretic flexors combination of specificity of training
ferences in 6-month follow-up (P⫽.01). There were no significant intrinsic to walking on a treadmill
change scores (Tab. 4, between- postintervention increases in and intensity of walking at challeng-
group comparisons). This analysis strength for either the BWSTT/ ing speeds. Several recent systematic
confirmed that, for all of the BWSTT CYCLE or BWSTT/LE-EX interven- reviews of physical therapy interven-
groups, posttreatment walking gains tion (Tab. 5). tions have concluded that there is
persisted at 6 months. strong evidence that task-specific
Group analysis revealed no significant gait training can improve poststroke
Changes in isometric torque mea- group differences in composite torque walking outcomes.33,45,46 Treadmill
surements. Composite torques changes between the BWSTT/UE-EX training with BWS at challenging
for the extensors (sum of hip exten- and CYCLE/UE-EX groups (Mann- speeds is a primary example of a
sor, knee extensor, and plantar- Whitney U and Wilcoxon tests, P⬎.05 high-intensity, task-specific gait train-
flexor measurements) and flexors for all composite torque comparisons, ing intervention because it requires
(sum of hip flexor, knee flexor, and Tab. 5). Similarly, group differences the participant to engage in repeti-
dorsiflexor measurements) were cal- were not significant for the BWSTT/ tive walking practice with high de-
culated for the nonparetic and pa- UE-EX, BWSTT/CYCLE, and BWSTT/ mand during the training session.
retic LEs. Medians (⫾1 interquartile LE-EX groups (Kruskal-Wallis test, Consistently, long-term changes in
range) for each group are shown in P⬎.05 for all composite torque com- performance are achieved when the
Table 5. In the BWSTT/UE-EX group, parisons, Tab. 5). conditions of task practice are simi-
there was a significant increase in lar to the task and conditions in
postintervention torque for the non- Discussion which retention or transfer perfor-
paretic extensors (P⫽.004) and the The major finding of this study was mance is expected.66 In addition,
paretic flexors (P⫽.02). Although that task-specific training using tread- task specificity effects are particu-
not statistically significant, the in- mill walking with BWS was more ef- larly strong for highly practiced
crease in postintervention torque for fective in increasing walking speed skills, where motor abilities acquired
the paretic extensors approached than a less task-specific, resisted cy- with practice are specific to the task
significance (P⫽.06). For the cling training program in individuals that is performed.67 Keetch et al67
CYCLE/UE-EX group, there was a sig- with chronic stroke who have lim- demonstrated this with a highly prac-
nificant increase in postintervention ited community ambulation ability. ticed skill, free-throw shooting, in

1594 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Table 5.
Composite Flexor and Extensor Torques (in Newton-Meters) for the Paretic and Nonparetic Lower Extremities at Baseline and
Postintervention Change (Median, Range) by Group (n⫽69)a

BWSTT/ CYCLE/ BWSTT/ BWSTT/ Pb Pc


UE-EX UE-EX CYCLE LE-EX
(nⴝ19) (nⴝ18) (nⴝ18) (nⴝ16)
Flexors, nonparetic
Baseline 39.70 (30.93–50.23) 42.12 (33.23–53.47) 47.90 (38.63–62.73) 47.10 (32.20–56.73)
Change d
⫺0.70 (⫺2.90–7.10) ⫺0.21 (⫺3.67–2.37) 0.47 (⫺6.93–6.17) 0.10 (⫺3.77–3.50) .92 .72
P 1.00 .81 1.00 1.00
Flexors, paretic
Baseline 20.97 (10.27–32.07) 23.63 (13.93–32.13) 29.13 (14.67–33.30) 28.13 (20.63–34.50)
Change 3.43 (1.53–7.63) 1.53 (0.57–7.33) 0.70 (⫺2.33–3.10) ⫺1.60 (⫺4.27–4.70) .28 .07
P .02* .01* .63 .61
Extensors, nonparetic
Baseline 87.97 (54.30–119.67) 96.97 (79.03–109.70) 95.30 (74.40–137.07) 107.93 (87.63–146.13)
Change 9.17 (1.87–16.47) 1.48 (⫺11.83–15.53) ⫺0.20 (⫺6.67–16.23) 5.83 (⫺14.37–11.10) .07 .16
P .004* .81 1.00 1.00
Extensors, paretic
Baseline 49.87 (36.17–67.10) 56.07 (35.07–82.47) 64.93 (47.60–83.67) 64.80 (49.43–91.13)
Change 9.10 (⫺1.17–18.30) 3.02 (⫺8.80–16.83) 2.10 (⫺2.70–11.43) 7.67 (⫺15.07–12.43) .35 .46
P .06 .48 .33 .30
a
BWSTT/UE-EX⫽combined body-weight–supported treadmill training and upper-extremity ergometry intervention group, CYCLE/UE-EX⫽combined resistive
leg cycling and upper-extremity ergometry intervention group, BWSTT/CYCLE⫽combined body-weight–supported treadmill training and resistive leg cycling
intervention group, BWSTT/LE-EX⫽combined body-weight–supported treadmill training and lower-extremity progressive-resistive exercise intervention
group. * P⬍.05 for baseline-postintervention comparison using the Wilcoxon signed-rank test.
b
P value is comparison of BWSTT/UE-EX and CYCLE/UE-EX data using the Wilcoxon rank-sum test.
c
P value is comparison of BWSTT/UE-EX, BWSTT/CYCLE, and BWSTT/LE-EX data using the Kruskal-Wallis test.
d
Postintervention change calculated by subtracting baseline value from post–session 24 value.

expert basketball players. It is con- tensor load, resulted in improve- We argue that the standardized inter-
ceivable that highly practiced func- ments in endurance but not in gait vention protocol for BWSTT used in
tional tasks such as walking also are speed. Although it has been demon- the STEPS trial incorporated suffi-
influenced by similar task specificity strated that cycling with or without cient training specificity, intensity,
effects. limb loading requires kinematic pat- and duration to achieve a significant
terns and coordinated muscle activa- change in walking speed in individ-
For individuals after stroke, walking tion patterns similar to those re- uals with chronic stroke that was
is a highly practiced functional task quired for walking,68 –70 it appears maintained at the 6-month follow-
where the learner has to reacquire that the specificity effects of this up. There were improvements in
the motor abilities associated with type of training affected distance walking speed and walking distance
gait function. In this study, all of the walked but not speed in individuals across all 3 groups whose interven-
protocols that incorporated BWSTT with chronic stroke. This partial ef- tion incorporated BWSTT. The func-
were effective in improving immedi- fect may be due to the nature of the tional walking classification devel-
ate and long-term walking ability. CYCLE protocol used in this study, oped by Perry and colleagues2 is a
Moreover, this ability transferred which involved 20 repetitions that useful way to determine whether
from the treadmill training environ- were repeated for 10 sets per ses- changes in walking speed are associ-
ment to overground walking. In con- sion. This type of training stimulus ated with clinically meaningful
trast, there was evidence that re- may be more effective in improving changes in walking outcomes at the
sisted cycling, which required the endurance that benefited walking level of participation (ie, community
participants to coordinate a lower- distance versus walking speed. ambulation). Of the 53 participants
limb cycling pattern with an LE ex- who received an intervention that

December 2007 Volume 87 Number 12 Physical Therapy f 1595


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

included BWSTT, more than 50% (27 work by Sullivan et al35 and demon- tant therapeutic factors that result in
out of 53) increased walking speed strate that both treatment intensity more intense task practice of walk-
to an extent that would classify them (ie, treadmill training speed of 2.0 ing (ie, able to achieve faster walking
at a higher functional walking level mph) and duration (ie, minimum of speeds despite severity level) than
postintervention. 12 BWSTT training sessions) are fac- would occur on a treadmill without
tors associated with BWSTT training BWS. Finally, the participants them-
Based on an analysis of data of the effectiveness. This phase II RCT can- selves reported a higher level of con-
participants who completed all 24 not address the optimal training du- fidence in their walking skills. Con-
sessions of their randomization as- ration (ie, effect of increased training sistently, participants reported that
signment, we found that BWSTT sessions) or timing (ie, early or late they felt that they were practicing
with initial BWS of 30% to 40% that after acute stroke) for this type of something meaningful and that they
was reduced across sessions, and at locomotor training after stroke. In enjoyed the walking sessions. Fur-
treadmill speeds of 1.5 to 2.2 mph order to inform clinical practice, ther study of how this type of train-
for 20 minutes of walking time (with larger-scale rehabilitation clinical tri- ing improves patient self-efficacy is
rests, as needed), for a minimum of 2 als that include a larger poststroke warranted. In addition, the BWSTT
sessions over a 6-week period re- population are required to address groups did receive 50 ft (15 m) of
sulted in functionally significant these factors. overground walking reinforcement
changes in walking outcomes in a after the treadmill session. Though
majority of the individuals after Does BWS add a critical element to possible, it is unlikely that this low-
stroke who participated. Findings the training experience? Clearly, fur- intensity activity alone could have
such as these provide information ther studies would need to be spe- accounted for the strong effects of
about an effective dosing of exercise cifically designed to adequately an- the BWSTT group or differences be-
and gait training needed to achieve swer this question. However, the tween the CYCLE and the BWSTT
functional poststroke walking out- findings of a study by Visintin et al31 groups.
comes. Additionally, it is interesting and a follow-up analysis of the ef-
to note that an intense schedule of fects of stroke severity by this same Evidence for Overtraining Effects
12 sessions of treadmill training with group71 would suggest that BWS dur- Contrary to our initial hypotheses,
BWS was enough of a training stim- ing treadmill walking appears to be strength training added to task-
ulus to increase walking speed, walk- an “active” ingredient of this inter- specific BWSTT training did not pro-
ing distance, and LE strength in indi- vention. In our experience, there are vide an additive effect to walking
viduals with chronic stroke. This was many additional benefits of BWS pro- outcomes. Our results suggest that
true when BWSTT was combined vided by an overhead suspension BWSTT alternated with a UE “sham”
with either the UE “sham” exercise system. First, the unweighting pro- exercise was more effective in in-
program or a progressive LE exercise vides added support and positive re- creasing LE strength than a com-
program. The robustness of this find- inforcement to the patients so that bined training program that included
ing is validated further by the com- they are able to practice walking in both task-specific and strength train-
parable results of the intention-to- a safe environment without fear of ing (BWSTT/CYCLE, BWSTT/LE-EX).
treat analysis for self-selected falling. Second, BWS is progressively This appears counterintuitive in a
walking speed that included all ran- decreased over the course of train- population of adults with stroke,
domized participants where we car- ing, which allows the therapist to where motor control deficits are re-
ried forward baseline or post–ses- progressively increase the biome- lated to both weakness and the tim-
sion 12 treatment data for missing chanical demand (ie, body weight ing of muscle activation needed to
post–session 24 treatment data. load to muscles) as the individual support functional tasks such as
with stroke develops improved mo- walking.72 However, evidence exists
Furthermore, the repeated-measures tor control and power during the in the exercise science literature that
analysis that compared changes in stance and swing phases of gait. In- exercise programs for young adults
walking speed over the course of deed, one of the criteria for pro- that combine high-volume and high-
training and the 6-month follow-up gression is for the therapist to de- intensity endurance and resistive ex-
(Fig. 3) suggests that the significant crease stepping assistance level as ercise programs can reduce the
change in walking speed was not ev- the patient increases motor control. strengthening effect, particularly if
ident between the BWSTT/UE-EX the muscle groups recruited are used
and CYCLE/UE-EX groups until ses- Third, the use of the harness and the during both strength and endurance
sion 24 (ie, the 12th BWSTT session). progressive manipulation of BWS training (for reviews, see Kraemer
These findings replicate the pilot and therapist assistance are impor- and Ratamess73 and Hunter et al74).

1596 f Physical Therapy Volume 87 Number 12 December 2007


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Recent investigations of the appar- 12 for our participants. For the LE-EX gait training (9 sessions over 3
ent interference of endurance train- protocol, loads were adjusted for weeks) resulted in increases in gait
ing on strength development have each muscle group such that the par- speed and torque production for a
studied older adults who were ticipants completed 8 to 10 repeti- group that received eccentric mus-
healthy, including 55- to 75-year-old tions for 3 sets at 80% of their 10-RM cle strengthening. Together, these
men75 and 60- to 84-year-old men load. For the CYCLE protocol, the studies reveal the need for further
and women.76 Both studies con- participants completed a minimum work to determine the optimal dose
trolled for frequency and duration of 12 to 20 repetitions for 10 sets response and scheduling of exercise
between exercise groups over 20 with as much load as could be toler- interventions that combine resis-
and 12 sessions of training, respec- ated. In both of the resistive exercise tance and task training to improve
tively. Endurance training, including conditions, the perceived effort re- functional walking ability in individ-
cycling or walking on a treadmill, ported by the participants was high. uals after stroke.
was in the range of 60% to 80% of For the exercise protocol used in this
estimated heart rate reserve. Upper- study, it appears that the best Study Limitations
extremity and LE resistance training strength training stimulus for the LE There are several limitations associ-
on exercise machines ranged from occurred in the BWSTT/UE-EX ated with this study. We did not
moderate (20-RM) to high (8-RM) group, where the LE muscle groups, achieve the isometric strength gains
intensity levels, as defined by the progressively loaded through de- that we projected with the CYCLE
American College of Sports Medicine creasing BWS, were provided ade- protocol. One explanation is that
guidelines.54 Both studies demon- quate rest on the alternating UE-EX the exercise repetitions selected for
strated that, in older adults, cardio- “sham” intervention days. this protocol were 12 to 20 repeti-
vascular training alone resulted in LE tions for 10 sets, which is more ef-
strength gains comparable to those Smith et al77 also reported LE fective for increasing muscle endur-
achieved through either a low- or strength gains in adults with chronic ance.73 Due to physical limits of the
high-resistance or combined program. stroke who participated in a tread- recumbent bicycle that we used,
mill aerobic exercise program ad- some participants progressed to the
The lack of a significant strength in- ministered 3 times per week over 12 highest level of resistance (ie, 100
crease in the combined exercise weeks. The results of their study and lb); therefore, the only method to
groups in our study might be ex- our study suggest that the benefit of progress the exercise was to in-
plained by a similar interference ef- task-specific training, and the associ- crease repetitions. Some individuals
fect between resistance and endur- ated increases in torque production, actually completed as many as 40
ance training. Significant increases in could be attributed to improved mo- repetitions per set. The increase in
the nonparetic extensors and paretic tor unit activation that occurs as in- repetitions rather than load likely
flexors as well as a nonsignificant dividuals after stroke actively engage further enhanced the muscle endur-
trend for the paretic extensors in functional tasks that demand mus- ance effect.
(P⫽.06) were found in the BWSTT/ cle activation that is progressed
UE-EX group and for the paretic flex- across treatment sessions. The short- Another potential limitation is that
ors in the CYCLE/UE-EX group, but term increases in torque production the hemiparetic muscles were tested
not in the combined BWSTT/CYCLE over the 6-week training program isometrically in isolated positions
and BWSTT/UE-EX groups. If there that we observed would provide ad- and potential gains in torque gener-
was no interference from the com- ditional support for improved cen- ation during full limb flexion or ex-
bined exercise groups, we would tral activation. tension synergy patterns were not
have expected the torque changes to measured by these tests. Due to lim-
be similar in all 3 BWSTT groups. Our findings need to be interpreted itations in selective movement abil-
with caution. The STEPS protocol ity, this resulted in great variability in
One possible explanation is that we combined resistive exercise and a our torque data, with some differ-
had induced an overtraining effect in moderately high intensity of training ences in baseline torque values
the combined exercise groups. The on alternate days and induced what among groups. However, the longi-
training intensities of our groups appeared to be an overtraining ef- tudinal torque comparisons were
were moderately high for the BW- fect. However, recent findings by consistent, regardless of whether
STT sessions, as validated by age- Patten et al78 suggest that a dy- parametric or nonparametric statis-
predicted maximum heart rates that namic high-intensity resistance train- tics were used (we used the more
averaged 62%⫾10.3% in session 1 ing intervention (15 sessions over 5 conservative nonparametric compar-
and 67%⫾10.1% in BWSTT session weeks) followed by clinic-based isons for this analysis), which sug-

December 2007 Volume 87 Number 12 Physical Therapy f 1597


Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

gests that a larger sample size may programs that incorporate moderate- Committee are: Nancy Byl, PT, PhD, FAPTA,
have provided more power for de- to high-intensity endurance and re- Chair (University of California–San Francisco,
San Francisco, Calif), Hugh G Watts, MD
tecting group differences. sistance training are combined for (Shriners Hospital for Children–LA Unit, Los
poststroke rehabilitation. Angeles, Calif), June Isaacson Kailes, MSW
Clinical Relevance and (Western University of Health Sciences,
Conclusions Invited Commentary and Author Pomona, Calif), and Anny Xiang, PhD (Uni-
This study investigated the effects of 4 Response follow on page 1603. versity of Southern California).
standardized training protocols to im- The authors acknowledge
prove walking ability in individuals the Foundation for Physi-
Dr Sullivan, Dr Brown, Dr Mulroy, and Dr Azen
with chronic stroke. This is the first cal Therapy for funding of
provided concept/idea/research design. Dr the Physical Therapy Clin-
rehabilitation RCT to use exercise Sullivan, Dr Brown, Ms Klassen, Dr Mulroy, ical Research Network (PTClinResNet). They
control-comparison groups to report and Ms Ge provided writing. Dr Brown, Ms also acknowledge Biodex Inc, who donated
the effects of task-specific training, re- Klassen, and Ms Ge provided data collection. 3 semirecumbent cyclocentric ergometers
Dr Sullivan, Dr Brown, Ms Klassen, Dr Mulroy,
sistance training, and protocols that used in the Strength Training Effectiveness
Ms Ge, and Dr Azen provided data analysis. Dr
combined these 2 forms of exercise Post-Stroke (STEPS) study.
Brown and Ms Klassen provided project man-
on measures of walking activity out- agement. Dr Sullivan, Dr Brown and Dr Win- Primary outcome data were presented as
comes and strength after stroke. stein provided fund procurement. Dr Sullivan, part of an accepted symposium at the Com-
Dr Brown, and Dr Mulroy provided subjects bined Sections Meeting of the American
and facilities/equipment. Dr Winstein provided Physical Therapy Association; February 14 –
The results of the present investiga- institutional liaisons. All authors provided con- 18, 2007; Boston, Mass. A platform presen-
tion indicate that treadmill walking sultation (including review of manuscript be- tation of this work was given at the 17th
with BWS that uses training parame- fore submission). International Congress of the World Confed-
ters that ensure an adequate exercise eration for Physical Therapy; June 2– 6, 2007;
The authors acknowledge the STEPS clinical Vancouver, British Columbia, Cananda.
frequency, intensity, and duration research team: University of Southern Califor-
provided an important stimulus for nia: Robbin Howard, PT, DPT, NCS, Didi A case study of one participant was given as
walking speed, walking distance, Matthews, PT, DPT, NCS, Bernadette Cur- a platform presentation at the III STEP Con-
and LE strength gains in individuals rier, PT, DPT, NCS, Arlene Yang, PT, MSPT, ference: Linking Movement Science and In-
NCS, Barbara Lopetinsky, PT, BS, and Maria tervention; July 15–21, 2005, Salt Lake City,
with chronic stroke. In contrast, an
Caro, PT, DPT; Northwestern University: Utah, and was published in the September
alternative progressive-resistive cy- Nicole Furno, PT, BS, Nicole Korda, PT, BS, 2006 issue of Journal of Neurologic Physical
cling exercise program matched for Carolina Carmona, PT, BS, Allie Hyngstrom, Therapy.
intensity and duration resulted only PT, MSPT, Sheila Schindler-Ivens, PT, PhD,
Dr Brown serves as a consultant to Biodex Inc.
in changes in walking distance. and Lynn Rogers, MS; Rancho Los Amigos
National Rehabilitation Center: Craig Clinical Trials.gov Identifier: NCT00389012
Newsam, PT, DPT, Valerie Eberly, PT, NCS,
Lastly, and of special significance to JoAnne Gronley, PT, DPT, Jennifer Whitney, This article was submitted October 13, 2006,
the design of effective exercise pro- PT, MPT, Betsy King, PT, DPT, and Louis and was accepted July 19, 2007.
grams for adults who have survived a Ibarra, PTA.
DOI: 10.2522/ptj.20060310
stroke, training programs that
Physical Therapy Clinical Research Network
combined task-specific treadmill (PTClinResNet): Network Principal Investiga- References
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intensity LE progressive-resistance and Co-Principal Investigator is James Gor- gic stroke. Int Disabil Stud. 1990;12:
don, PT, EdD, FAPTA (both at University of 119 –122.
exercise training on alternate days
Southern California, Los Angeles, Calif). 2 Perry J, Garrett M, Gronley JK, Mulroy SJ.
did not achieve an additive effect on Classification of walking handicap in the
Project Principal and Co-Principal Investiga-
walking outcomes or the isometric tors include: David A Brown, PT, PhD (North- stroke population. Stroke. 1995;26:
982–989.
LE muscle torque gains that were re- western University, Chicago, Ill); Sara Mul-
3 Perry J. Gait Analysis: Normal and Patho-
alized by the task-specific treadmill roy, PT, PhD, and Bryan Kemp, PhD (Rancho
logic Function. Thorofare, NJ: Slack Inc;
training with BWS alone. Further Los Amigos National Rehabilitation Center, 1992.
Downey, Calif); Loretta M Knutson, PT, PhD,
work is necessary to determine how 4 De Quervain IA, Simon SR, Leurgans S,
PCS (Missouri State University, Springfield, et al. Gait pattern in the early recovery
exercise programs that combine Mo); Eileen G Fowler, PT, PhD (University of period after stroke. J Bone Joint Surg Am.
muscle strengthening protocols with California–Los Angeles, Los Angeles, Calif); 1996;78:1506 –1514.
task-specific training can be imple- and Sharon K DeMuth, PT, DPT, Kornelia 5 Mulroy S, Gronley J, Weiss W, et al. Use of
Kulig, PT, PhD, and Katherine J Sullivan, PT, cluster analysis for gait pattern classifica-
mented to maximize function and tion of patients in the early and late recov-
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Appendix.
Initial Intervention Training Parameters and Progressions for Each Exercise Protocol

BWSTT CYCLE LE-EX UE-EX


Exercise Task-specific walking Lower-extremity cycling Progressive-resistive exercise Upper-extremity cycle
exercise using body- with the limb loaded in program for paretic hip ergometry as sham
weight support and the extension phase of flexors and extensors, exercise condition.
therapist assistance the cycling revolution. knee flexors and
during treadmill extensors, and ankle
training. dorsiflexors and plantar
flexors.
Session 1 Training Parameters Training Parameters Training Parameters Training Parameters

TM speed: optimal Resistance: Start at Exercise selection and Resistance: Adjusted


speed 2.0 mph level 4 (40 lb of resistance: Participant to the level where
(range⫽1.5–2.5 resistance [four 10-lb attempts the baseline the participant can
mph). resistance cords]). exercise for each muscle complete 20 cycling
Determine 15- to 20- group. The baseline revolutions, but no
Trainer assistance: revolution maximum. If exercise position for each more (20-RM).
up to maximum the participant completes muscle group specifically
assist (3 trainers: fewer than 10 cycling targets the isolated Cycling rotations:
1 at each leg, 1 at revolutions, decrease one muscles and requires the Forward and
hips) to enable resistance level. If the participant to move in backward cycling
proper gait participant completes an antigravity range, revolutions are
kinematics. 10 to 18 cycling deviating from synergy. alternated for each
revolutions, maintain set of exercise.
BWS: between resistance level. If the If the participant cannot
30% and 40% of participant completes perform the baseline Trainer assistance:
participant’s weight. 19 to 20 cycling exercise movement Assistance is given
revolutions, increase one deviating from synergy, to the participant’s
Training time: 20 resistance level. a decrease in progression hemiparetic upper
total minutes is made incorporating extremity as
walking time (goal: Cycling revolutions: movement patterns necessary to
four 5-minute 15 to 20 revolutions in within synergy. If the complete the
walking periods, each set. participant can complete cycling revolution.
with additional the baseline exercise, the
rests, as needed). Sets: 10 exercise is continued or Cycling revolutions:
progressive resistive 20 revolutions in
loading is initiated until each set.
the 10-RM load is
determined. Sets: 10

Repetitions: 10

Sets: 3 (for each muscle


group).
(continued)

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Locomotor and Strength Training in Adults Who Were Ambulatory After Stroke

Appendix.
Continued

BWSTT CYCLE LE-EX UE-EX


Sessions 2–12 With the participant Resistance: Determined by Exercise selection and This intervention is
maintaining proper the number of successful resistance: Determined designed to have no
gait kinematics, the cycling revolutions the by the participant’s cardiovascular or
following training participant is able to success in completing lower-extremity
parameters are complete (maximum⫽ 10-RM. If the participant training effect.
manipulated: 20 cycling revolutions). is able to perform 10 Therefore, for
If participant completes repetitions with ease, sessions 2 to 12, the
TM speed: progressively fewer than 10 cycling then a progression is trainer always
increase to 2.0 mph revolutions, decrease applied (increase exercise ensures that there is
(if not achieved in one resistance level. If level or resistance). If the minimal physical
initial sessions) and participant completes 10 participant is able to exertion by the
above 2.0 mph, as to 18 cycling revolutions, complete only 8 participant.
tolerated by the maintain resistance level. repetitions in each set,
participant. If participant completes but can complete 10 To keep the
19 to 20 cycling repetitions with ease participant
Trainer assistance: revolutions, increase one when the load is interested in the
decrease from resistance level. decreased, then the exercise over the
assistance level current exercise level or subsequent sessions,
provided in session 1, Cycling revolutions: resistance is maintained. modifications can be
with optimal goal of 15 to 20 revolutions in If the participant is able made in: (1) the
participant walking each set. to do less than 8 trainer assistance
with no trainer repetitions in each set, given to the
assistance by Sets: 10 then the exercise is participant’s
session 12. decreased (either in hemiparetic upper
exercise level or extremity, and/or
BWS: decrease from resistance). (2) resistance on the
support provided in bicycle (to maintain
session 1, with Repetitions: 10 the 20-RM level).
optimal goal of However, the trainer
participant walking Sets: 3 must always ensure
with no BWS by that there is minimal
session 12. physical exertion by
the participant
Training time: increase when completing
walking time in each the exercise.
training bout, with
optimal goal of
participant walking 20
min continuously by
session 12.
a
BWSTT⫽body-weight–supported treadmill training, CYCLE⫽resistive lower-extremity cycling, LE-EX⫽lower-extremity progressive-resistive exercise, UE-
EX⫽upper-extremity cycle ergometry, TM⫽treadmill, BWS⫽body-weight support, RM⫽repetition maximum.

1602 f Physical Therapy Volume 87 Number 12 December 2007

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