NCT01668602

Stroke Gait Rehabilitation Using Functional Electrical Stimulation

Cortical and Spinal Correlates of Post-stroke Gait Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
DEVICE	Fast Walking with Fast Functional Electrical Stimulation (FES) Training	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.
OTHER	Fast Walking	Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.

Timeline

• Start date: 2013-08-01
• Primary completion: 2019-05-01
• Completion: 2019-05-01
• First posted: 2012-08-20
• Last updated: 2021-03-10
• Results posted: 2021-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study