Metabolic Costs of Walking Post Stroke
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This will be a randomized, matched-group study to compare the cardiopulmonary / metabolic
      benefits for persons post stroke that learn to walk utilizing early treadmill training
      post-acute stroke to persons post stroke that learn to walk utilizing non-treadmill based
      gait training during the same time period. Participants (n=30) will be adults who have
      completed acute rehabilitation following a stroke. Random assignment will be to either the
      ESTT or traditional gait training protocol during the outpatient rehabilitation phase.

        1. Group A: Traditional outpatient therapy (n = 15)

        2. Group B: Treadmill training (ESTT) outpatient therapy (n = 15)
    

Detailed description: 
      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.
    

Intervention name(s): ESTT; Traditional outpatient
Intervention type(s): Other; Other
Intervention description(s): ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke; Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; gait; cardiovascular