Understanding post-stroke gait training with electrical stimulation
Biomechanical and Neural Mechanisms of Post-stroke Gait Training
NA · Emory University · NCT04380454
This study is testing two different ways to help stroke survivors walk better, one with just fast treadmill walking and the other with fast treadmill walking plus electrical stimulation, to see which works best for improving their movement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 35 Years to 90 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04380454 on ClinicalTrials.gov |
What this trial studies
This study investigates the biomechanical and neural mechanisms behind two gait rehabilitation treatments for stroke survivors: fast treadmill walking and fast treadmill walking combined with functional electrical stimulation. By examining how these interventions affect gait quality and function, the research aims to develop personalized gait treatments tailored to individual needs. The study addresses the complex nature of stroke-related gait deficits, which often persist after traditional rehabilitation, impacting patients' quality of life. The goal is to enhance understanding of the factors influencing gait improvements in stroke patients.
Who should consider this trial
Good fit: Ideal candidates are stroke survivors who are at least six months post-stroke, can walk 10 meters with or without assistance, and have sufficient cardiovascular health.
Not a fit: Patients with hemorrhagic stroke, significant coordination issues, or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized rehabilitation strategies for stroke survivors, improving their mobility and quality of life.
How similar studies have performed: Previous studies have shown promise in using gait training and electrical stimulation for stroke rehabilitation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
* 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
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Trisha Kesar, PT, PhD — Emory University
- Study coordinator: Trisha Kesar, PT, PhD
- Email: trisha.m.kesar@emory.edu
- Phone: (404) 712-5803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Rehabilitation, Post-stroke, Neural mechanism, Biomechanical mechanism, Electrical stimulation, Gait Training