CompletedNot Applicable

Biomechanical and Neural Mechanisms of Post-stroke Gait Training

United States55 participantsStarted 2021-03-16

Plain-language summary

The study seeks to develop an understanding of how, why, and for whom fast treadmill walking (Fast) and Fast with functional electrical stimulation (FastFES) induce clinical benefits, allowing future development of cutting-edge, individually-tailored gait treatments that enhance both gait quality and gait function.

Who can participate

Age range

35 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * at least 6 months since stroke * single cortical or subcortical ischemic stroke * able to walk 10-meters with or without assistive device * sufficient cardiovascular health and ankle stability to walk on treadmill for 2-minutes at self-selected speed without orthosis * resting heart rate 40-100 bpm Exclusion Criteria: * hemorrhagic stroke * cerebellar signs (ataxic ("drunken") gait or decreased coordination during rapid alternating hand or foot movements * score of \>1 on question 1b and \>0 on question 1c on NIH Stroke Scale * inability to communicate with investigators * musculoskeletal conditions or pain that limit walking * neglect/hemianopia, or unexplained dizziness in last 6 months * neurologic conditions or diagnoses other than stroke * lack of sensation in lower limb affected by stroke * any medical diagnosis that would hinder the participant from completing the experimental trial * diabetes not controlled by medication or causing risk for participation in exercise programs * additional exclusion criteria due to contra-indications to TMS (measurement of corticospinal excitability) 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 6 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Gait Propulsion Symmetry

Timeframe: Baseline, after 3 training sessions (Week 1), after 6 training sessions (Week 2), after 12 training sessions (Week 4), 3 Week Follow-up (3 weeks post-intervention), 6 Week Follow-up (6 weeks post-intervention)

Change in 10-Meter Walk Test at Self-selected Walking Speed

Timeframe: Baseline, after 3 training sessions (Week 1), after 6 training sessions (Week 2), after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)

Change in 10-Meter Walk Test at Fast Walking Speed

Timeframe: Baseline, after 3 training sessions (Week 1), after 6 training sessions (Week 2), after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)

Change in Paretic Soleus TMS Motor Evoked Potential (MEP) Amplitude

Trial details

NCT IDNCT04380454

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

35 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Gait Propulsion Symmetry

Change in 10-Meter Walk Test at Self-selected Walking Speed

Timeframe: Baseline, after 3 training sessions (Week 1), after 6 training sessions (Week 2), after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)

Change in 10-Meter Walk Test at Fast Walking Speed

Timeframe: Baseline, after 3 training sessions (Week 1), after 6 training sessions (Week 2), after 12 training sessions (Week 4), 6 Week Follow-up (6 weeks post-intervention)

Change in Paretic Soleus TMS Motor Evoked Potential (MEP) Amplitude