Improving gait symmetry in stroke patients using cycling and biofeedback
Cycling Intervention With Biofeedback of Power Symmetry for Patients With Stroke in an Inpatient Rehabilitation Facility: Pilot Randomized Controlled Trial.
NA · University of Utah · NCT06857916
This study is testing if cycling with real-time feedback can help stroke patients improve their walking balance and overall movement during their rehabilitation.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Utah (other) |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06857916 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a cycling intervention with power biofeedback on gait symmetry and functional outcomes in stroke patients undergoing inpatient rehabilitation. Participants will engage in cycling sessions that provide real-time feedback on their power output, which is expected to help address gait asymmetry, a common issue following stroke. The study will measure changes in cycling power, gait symmetry, and overall mobility before and after the intervention. By quantifying power production, the research seeks to enhance rehabilitation strategies for individuals with hemiparesis post-stroke.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have experienced a confirmed ischemic or hemorrhagic stroke and exhibit lower extremity hemiparesis.
Not a fit: Patients with severe cognitive impairments, significant contractures, or unstable medical conditions may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve gait symmetry and functional mobility in stroke patients, enhancing their rehabilitation outcomes.
How similar studies have performed: While the specific approach of using cycling with biofeedback is novel, similar interventions targeting gait improvement in stroke rehabilitation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. they have a confirmed MCA or ACA ischemic or intracerebral hemorrhagic stroke, confirmed by CT/MRI or clinical documentation -AND demonstrating lower extremity hemiparesis \[\< 100 on lower limb Motricity Index24\] 2. 18 to 70 years of age 3. a Functional Ambulation Category of 2 (Dependent Level II) through 5 (Independent Level surfaces only) 4. medical clearance to participate Exclusion Criteria: 1. contractures that limit lower limb range of motion 2. cardiovascular, respiratory or metabolic instability, including unstable angina or hypertension above 200/110 at rest 3. uncontrolled diabetes 4. severe respiratory disorders that limit exercise 5. inability to ambulate \> 150 feet prior to stroke 6. prior history of peripheral or central nervous system injury 7. moderate to severe hemispatial neglect according to the Kessler Foundation Neglect Assessment 8. major cognitive impairment preventing the capability to understand training instructions; identified by inability to follow 3-step command 9. severe aphasia preventing communication with the therapist.
Where this trial is running
Salt Lake City, Utah
- University Health, Neilsen Rehabilitation Hospital — Salt Lake City, Utah, United States (RECRUITING)
Study contacts
- Principal investigator: Heather A Hayes, PhD — University of Utah
- Study coordinator: Heather A Hayes, PhD
- Email: heather.hayes@hsc.utah.edu
- Phone: 801-587-9249
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, cycling, power, inpatient rehabilitation, biofeedback, gait symmetry