Metabolic Costs of Walking Post Stroke

At the time of enrollment, participants will be randomly assigned to one of the two groups
depending on the severity of impairment in the hemiparetic lower extremity. Groups will be
matched based on high functioning vs. low functioning (STREAM scores). Group assignment will
be done by random drawing from concealed envelopes with red or blue chips for assignment to
ESTT or non-treadmill based outpatient therapy services. For the next participant who is
screened with a similar STREAM impairment level, he/she will be placed in the alternate group
to match the group assignments. Enrollment will proceed in this fashion. All outpatient
therapy services will be provided at the UT Southwestern School of Health Professions School
of Physical Therapy Gait Disorders Clinic (UTSW GDC). The groups will be as follows:

1. Group A: Traditional outpatient therapy (n = 15)

2. Group B: Treadmill (ESTT) outpatient therapy (n = 15) Therapy for the purposes of the
study will be discontinued after a maximum of 24 training sessions or 8 weeks. It is
anticipated, based on the research concerning AFO use in persons with stroke, that all
participants will require an AFO for safe gait training in the outpatient setting.

Traditional outpatient therapy: For persons in Group A, gait training will consist of 30
minutes of walking training. The program may include a variety of interventions that are
commonly done to rehabilitate gait after stroke (excluding treadmill training). Walking may
include the use of various assistive devices such as rolling walkers, gait trainers, canes
and crutches. Other tools that may be utilized include visual cues (tape, lasers) and
auditory cues (metronome). Other activities such as single limb stance and stair climbing may
be included to facilitate limb stability. Functional electrical stimulation (FES) may be used
to facilitate muscle activation in the hemiparetic lower extremity during gait training for
all participants. Stimulation may be applied to muscles of the upper and/or lower leg gait
training. Use of electrical stimulation will be documented, including all parameters (make
and model of unit, rate of stimulation [pulses per second], waveform, and duration of use).
Appropriate exercises from a bank of exercises will be selected for each participant. The
bank of exercises will include: standing heel cord stretches, single leg stance, sit to
stand, timed standing, marching in place, tap ups, step ups, step throughs, standing ball
roll, stair climbing, standing Theraband exercises, wall squats. They will be advised to
complete the exercises daily (5 days/week total) for a total of 30 minutes per day. In
addition, they will be instructed to wear the AFO for all upright mobility tasks, in
combination with the prescribed assistive device.

Treadmill (ESTT) outpatient therapy: For persons in Group B, study-related outpatient gait
training will be initiated on the treadmill with partial body weight support. The initial
body weight support will be set between 30% and 50% of patient's body weight. During
progressive training sessions, the amount of body weight support will attempt to be reduced
and the researcher will assess the response to the increased body weight on the gait pattern.
The initial speed of the treadmill will be 0.7 mph (minimum initial speed) and will be
increased progressively as tolerated until a speed of 1.8 mph is reached. Subject tolerance
to the intervention will be monitored closely. Gait training on the treadmill will be
scheduled in 30-minute sessions. The subjects will be allowed to take rest breaks as needed
during the treadmill training.

During gait training on the treadmill, ankle control will be facilitated by means of an ankle
foot orthosis (AFO) with a double adjustable joint. For over ground gait, participants will
also use an AFO with a double adjustable joint Functional electrical stimulation (FES) may be
used to facilitate muscle activation in the hemiparetic lower extremity during gait training
for all participants. Over ground gait will not be initiated until the subject is able to
walk on the treadmill with no more than 10% body weight support and with no more than minimal
assist to advance the hemiparetic leg at a speed of 0.8 mph or greater for at least 3 minutes
for two consecutive bouts. (Subjects can also have assistance with weight shift.) Once over
ground gait is initiated, either bilateral or unilateral support will be used, depending on
upper extremity control and general upright stability. If the quality of the gait
deteriorates significantly from the gait observed on the treadmill, over ground gait will be
halted for that session. Treadmill training will continue to progress to over ground gait.
Once over ground gait training is initiated, 20 minutes of the 30 total therapy minutes will
be spent on treadmill training and 10 minutes will be spent on over ground gait training.
Treadmill training will continue until subjects are able to walk 10 minutes without resting
with no body weight support, but with vest on for safety, without upper extremity support
without assist for weight shift or lower extremity control at a speed of 1.8 mph. If this is
prior to the conclusion of study-related therapy, the entire 30 minute session will be spent
practicing over ground gait.

Appropriate exercises from a bank of exercises will be selected for each participant. The
bank of exercises will include: standing heel cord stretches, single leg stance, sit to
stand, timed standing, marching in place, tap ups, step ups, step throughs, standing ball
roll, stair climbing, standing Theraband exercises, wall squats. They will be advised to
complete the exercises daily (5 days/week total) for a total of 30 minutes per day. In
addition, they will be instructed to wear the AFO for all upright mobility tasks, in
combination with the prescribed assistive device.

The Step Program: To introduce this component of the study, the participant and
caregiver/support person will be given a 15-minute presentation entitled Step it Up. This
program was developed by the research team and it addresses the critical need and benefits of
exercise for persons post stroke, methods of safe exercise monitoring and information on
progression of exercise intensity and duration to improve cardiorespiratory function. The
presentation will include an explanation of the Borg Rate of Perceived Exertion (RPE, 6-20
scale) and directions on how to utilize a pedometer for daily walking measurement. Following
the presentation, participants will meet with an investigator and demonstrate competency with
the application of the pedometer and utilization of the RPE scale. Each participant will be
provided written material that covers the salient points of the presentation. They will also
receive a notebook that has the instructions along with 16 weekly logs for recording walking
data. The training should take approximately 30 minutes and will take place following the
final gait treatment.

The walking program will continue until T4 and T4a. Each participant will be scheduled for
this testing within 10 calendar days of the 24-week anniversary of the commencement of
outpatient therapy. At this testing time (T4 & T4a) all outcome measures will be repeated.
The final testing time (T5 and T5 a) will be completed within 10 calendar days of 288-day
anniversary of commencement of outpatient physical therapy. All outcome measures will be
repeated at this testing time. This will be the termination point of the study.

Inclusion Criteria:

- confirmed diagnosis of recent cerebrovascular accident (CVA) (less than 6 weeks post
at the time of admission to inpatient rehabilitation)

- able to give informed consent independently or have family member or other authorized
surrogate available to give consent

- first time stroke OR complete gait recovery from prior stroke

- sufficient support at home to participate in home-based fitness training program

- transportation to University of Texas Southwestern Medical Center Gait Disorders
Clinic (UTSW GDC) for therapy and testing

- ability to follow one-part commands

Exclusion Criteria:

- non-ambulatory before onset of stroke (at time of admission to inpatient
rehabilitation)

- bilateral stroke

- presence of severe cardiac problems (heart failure [New York Heart Association > Class
2], unstable or exercise-induced angina)

- other co-morbidities which could affect gait training (i.e. amputation, spinal cord
injury, traumatic brain injury, etc.)

- recent myocardial infarct (within 4 weeks of date of inpatient rehabilitation
admission)

- any uncontrolled health condition for which exercise is contraindicated

- severe lower extremity joint disease/pathology that would interfere with gait training

- subjects -with body mass index (BMI) greater than 40

- significant cognitive impairment (less than 2 on the Functional Independence Measure
[FIM] cognitive sub-scale)

- age greater than 80 years or less than 18 years

- able to complete 5 or more full heel raises with the affected ankle in standing with
the knee extended with no more than one or two fingers on support surface for balance