Backward walking training for stroke recovery
Brain and Behavioral Responses to Backward Walking Training Post-Stroke
This study tests whether backward walking training can help veterans who have had a stroke improve their walking and balance.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT04928482 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of backward walking training on gait and balance in post-stroke veterans. Participants, who are between 2 to 4 months post-stroke, will be randomly assigned to receive either 18 or 27 sessions of training. The study will also utilize magnetic resonance imaging to assess brain activity before and after the intervention, aiming to identify predictors of rehabilitation response. The trial is designed to enhance personalized rehabilitation approaches for stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are veterans diagnosed with unilateral stroke who are 2 to 4 months post-stroke and have specific mobility limitations.
Not a fit: Patients with other neurological conditions, serious cardiac issues, or severe orthopedic problems may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve gait and balance in post-stroke patients, enhancing their quality of life.
How similar studies have performed: Previous studies have shown positive outcomes with similar rehabilitation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Berg Balance Scale \< 45 * Self-selected 10 meter gait speed \< 0.8 m/s * Diagnosis of unilateral stroke * \> 2 months \< 4 months post-stroke * Able to ambulate at least 10 feet with maximum 1 person assist * Medically stable Exclusion Criteria: * Presence of neurological condition other than stroke * Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) * Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded * Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of -10 degrees, knee flexion ROM \< 90 degrees, hip flexion contracture \> 25 degrees, and ankle plantar flexion contracture \> 15 degrees) * Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest * Pain upon ambulation * Receiving physical therapy services for mobility and/or gait * Living in a skilled nursing facility * Any MRI contraindication, including but not limited to the presence of metal, MR sensitive implanted medical devices, or claustrophobia
Where this trial is running
Gainesville, Florida and 1 other locations
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville, Florida, United States (Recruiting)
- Brooks Rehabilitation — Jacksonville, Florida, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Dorian Kay Rose, PhD MS BS — North Florida/South Georgia Veterans Health System, Gainesville, FL
- Study coordinator: Dorian K Rose, PhD MS BS
- Email: Dorian.Rose@va.gov
- Phone: (352) 273-8307
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.