Stroke Gait Rehabilitation Using Functional Electrical Stimulation

Completed · Not applicable

Conditions studied: Cerebrovascular Accident

In brief

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.

Key facts

Study ID

NCT01668602

Run by

Emory University

People needed

24

Starts

2013-08-01

Expected to finish

2019-05-01

Last updated by the study team

2021-03-10

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic stroke (>6 months post stroke)
• First (single) lesion
• Able to walk with or without the use of a cane or walker
• Sufficient cardiovascular health and ankle stability to walk for 6 minutes at a self-selected speed without an orthoses
• Resting heart rate 40-100 beats per minute
• Resting blood pressure between 90/60-70/90

You may not qualify if…

• Evidence of moderate/ severe chronic white matter disease or cerebellar stroke on MRI
• Cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements
• Insulin dependent diabetes
• History of lower extremity joint replacement
• Score of >1 on question 1b and >0 on question 1c on NIH Stroke Scale
• Inability to communicate with investigators
• Neglect/hemianopia, or unexplained dizziness in last 6 months
• Neurologic conditions other than stroke
• Orthopedic problems in the lower limbs or spine (or other medical conditions) that limit walking
• Contraindications to transcranial magnetic stimulation (TMS) are: history of seizures, metal implants in the head or face, history of recurring or severe headaches/migraine, headache within the past 24 hours, presence of skull abnormalities or fractures, hemorrhagic stroke, history of dizziness, syncope, nausea, or loss of consciousness in the past 12 months

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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