Very Intensive Early Walking in Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the efficacy of intensive locomotor interventions
      early post stroke. An intensive locomotor training (LT) program will be compared to an active
      control, conventional physical therapy. It is proposed that an early and intensive stepping
      paradigm that is not typically employed early in physical therapy will lead to superior
      outcomes and improved community mobility. A randomized, blinded, controlled trial will test
      subjects with moderate to severe locomotor dysfunction in individuals post-stroke to compare
      walking-related outcomes after intensive gait training (including treadmill, overground,
      stair training, and skilled walking training) to outcomes after conventional physical
      therapy.
    

Detailed description: 
      In Aim 2, intensive gait training overground and on the treadmill using the device as
      appropriate will be provided using a randomized, controlled trial (RCT) design. Determination
      of optimal swing phase and propulsive assistance provided to subjects to maximize treadmill
      walking velocity (in Aim 1) will be necessary to assess the efficacy of this technique to
      improve walking function over prolonged LT sessions. Consistent with work from the previous
      grant cycle12, we will compare the relative improvements in impairments, activity and
      participation following 1 of 2, 8 -week interventions to improve walking ability post-stroke.
      Fifty-six (56) subjects will be recruited, stratified based on walking 10 meters [requiring
      moderate assistance (subject performing 50-74%), minimal assistance (subject performing
      greater than 75% of gait but still needing assist), with a gait speed <0.5m/s without assist,
      or with gait speed of >0.5-0.9m/s without assist. Subjects will be randomized to experimental
      (intensive gait training using aforementioned gait training principles) or control conditions
      (conventional physical therapy). The test group will receive 40, 40-minute LT sessions during
      a 60 minute time period over 8 weeks with subjects ambulating on the treadmill, overground,
      and on stairs. During the first 5 training sessions, LT will take place solely on the
      treadmill. After that time, half of the sessions will be walking overground and stairs and
      half on the treadmill. Training will be performed with a target heart rate of 70-80% of heart
      rate reserve (HRR) and subjective ratings of perceived exertion of 14-17 when patients are on
      medications to limit heart rate kinetics. Kinematics during LT will be monitored visually to
      ensure proper foot placement necessary for continuous stepping while maintaining the
      appropriate intensity, using the device as necessary. The control group will receive
      conventional physical therapy (receiving at least 3 sessions of physical therapy per week) at
      the subject's and medical teams' discretion (day rehabilitation, outpatient, or home health).
      If the subject is not receiving at least 3 sessions of physical therapy per week, control
      therapy treatments will be provided consistent with recent data detailing the amount of
      specific physical therapy activities provided during single-session outpatient visits19and
      published data21 as well as unpublished data from Moore that delineates the number of steps
      taken per conventional therapy session based on the gait speed of individual (number of steps
      during training=1500*gait speed+200). The additional 200 steps were added to this algorithm
      to allow for individuals who require assist to receive gait training during the sessions.
      Clinical and quantitative assessment of neuromuscular and cardiopulmonary impairments,
      limitations in activity and participation, assessment of corticospinal tract (CST)
      excitability and integrity will be performed prior to training, mid-training, end of 8 week
      training, and with a 2-6 month follow-up examination. Control group participants will have
      the option of participating in 4 weeks of intensive gait training (experimental protocol) at
      the end of the follow up testing and complete one more testing session at the end of those 4
      weeks. Primary outcome measures include laboratory and community measures of ambulatory
      function, including gait speed over short distances, distance walked and gait efficiency
      during the 6 min walk, and the amount of daily community stepping (using Step Activity
      Monitors [SAM]20), CST excitability measures using transcranial magnetic stimulation (TMS)
      (optional) and assessment of white matter tract integrity using MRI (optional).
    

Intervention name(s): Intensive Walking; Conventional Physical Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weeks high intensity walking training over multiple stepping tasks; Regular physical therapy for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke, rehabilitation, gait training