A new approach to help stroke survivors improve their walking
A Novel, Comprehensive Approach to Post-stroke Gait Rehabilitation
This study is testing a new walking training program for stroke survivors to see if it can help them walk better and improve their overall movement.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04411303 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the feasibility and effectiveness of a comprehensive gait training program for individuals who have experienced a chronic stroke. The program combines biofeedback-based gait training, which addresses walking pattern impairments, with aerobic exercise intensity-based training, which targets walking activity limitations. The study will assess how well participants can reduce gait deviations while walking at different aerobic intensities. The ultimate goal is to develop a more effective rehabilitation strategy for improving walking in stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are individuals who are more than six months post-stroke, independently ambulatory, and able to walk for at least five minutes.
Not a fit: Patients with significant neurological damage to specific brain areas or uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance walking ability and overall mobility for stroke survivors.
How similar studies have performed: While there have been studies on individual components of gait rehabilitation, this comprehensive approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>6 months post stroke, affecting 1 hemisphere of the brain * Independently ambulatory (including use assistive devices) * Able to walk for 5 minutes without stopping * Demonstrates readiness for exercise based on responses to the PAR-Q+ * Participants enrolled in Aim 2 will require medical clearance from physician to participate Exclusion Criteria: * Damage to the pons or cerebellum on MRI or signs of cerebellar involvement * Damage to the basal ganglia or extrapyramidal symptoms * Uncontrolled hypertension (\>160/100mmHg) * Montreal Cognitive Assessment score \< 25 * Orthopedic or pain conditions * Note\*: Pregnant women are excluded from this study to avoid any potential harm to the fetus from the harness used during treadmill walking.
Where this trial is running
Los Angeles, California
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Kristan Leech, PT, DPT, PhD — University of Southern California
- Study coordinator: Kristan Leech, PT, DPT, PhD
- Email: kleech@pt.usc.edu
- Phone: (323) 442-1583
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.