Stroke Gait Rehabilitation Using Functional Electrical Stimulation
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The study is a prospective interventional study to assess the changes in corticospinal
      excitability and spinal reflex excitability of in response to rehabilitative strategies and
      protocols that are commonly used during physical therapy treatment of gait disorders among
      post-stroke subjects. As part of this protocol, 55 individuals with chronic stroke will be
      assigned to either Cohort 1 or Cohort 2, and will participate in 1-18 gait training sessions.
      If interested, study participants can also complete both study cohorts sequentially (with at
      least 3-weeks duration between switching from one cohort to the second). The study examines
      the effects among two cohorts of post stroke patients. Cohort 1 will participate in 18
      sessions of fast treadmill walking plus Functional Electrical Stimulation (FastFES) and
      Cohort 2 will participate in 1-3 sessions of FastFES and fast walking without FES.
    

Detailed description: 
      Stroke is the number one cause of disability. Difficulty with walking affects most stroke
      survivors. Walking deficits (e.g. reduced ankle flexion during swing phase, decreased forward
      propulsion during terminal stance) can cause risks of falls, slow walking speed, increased
      effort of walking, and difficulties with activities of daily living. Restoration of walking
      ability can improve quality of life, and is perceived as a major goal of rehabilitation by
      stroke survivors. Examples of interventions that are used to rehabilitate walking post-stroke
      are functional electrical stimulation, fast treadmill walking, and bio- feedback. While
      recent research has focused on comparing the effectiveness of different gait rehabilitation
      interventions, the neural and biomechanical mechanisms underlying different gait
      rehabilitation strategies are unknown. FastFES is a novel gait training intervention that
      combines the beneficial effects of two independent interventions: Fast treadmill walking and
      FES. The FastFES intervention incorporates principles of physiology, biomechanics, motor
      control and learning, and predictions of forward-dynamic gait simulations to improve
      post-stroke gait.

      The overall purpose of this protocol is to assess the biomechanical and neurophysiologic
      effects of rehabilitative strategies and protocols that are commonly used during physical
      therapy treatment of gait disorders post-stroke among two cohorts of people. Aim 1 of the
      study will assess the changes in gait biomechanics, corticospinal excitability, and walking
      function during 18 sessions of gait retraining, with participants in Cohort 1. Aim 2 of the
      study assesses the effect of parameters such as walking speed (slow, fast, variable,
      split-belt walking), functional electrical stimulation parameters (short-term changes induced
      by fast versus FastFES, stimulation intensity, number of muscles stimulated), and
      bio-feedback on within-session changes in gait biomechanics, walking function, and
      corticospinal excitability, among participants in Cohort 2.

      Within Cohort 1, participants will receive identical treatment throughout the 18 training
      sessions (i.e. FastFES training). Within Cohort 2, participants will participate in 3
      training sessions of both FastFES and fast walking training, with a 3-week break between the
      two types of training.
    

Intervention name(s): Fast Walking with Fast Functional Electrical Stimulation (FES) Training; Fast Walking
Intervention type(s): Device; Other
Intervention description(s): Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction. The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle. FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking). The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can. For safety, a physical therapist will walk with and guard the subject during over ground walking.; Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.
Other intervention name(s): FastFES
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment to either Cohort 1 or Cohort 2 will occur simultaneously and will be based on the lab/personnel and subject schedules. Participants in Cohort 1 receive only FastFES. Participants in Cohort 2 will receive 3 sessions of FastFES and 3 sessions of fast walking without FES.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Rehabilitation; Gait disorders; Chronic stroke