Improving mobility for individuals with above-knee amputation using biofeedback
Quantifying Biofeedback Training and Retention Effects on Functional Outcomes in Above-knee Prosthesis Users
This study is testing if using haptic biofeedback can help people with above-knee amputations walk better and feel more confident while moving.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | San Jose State University Academic / other |
| Locations | 2 sites (Palo Alto, California and 1 other locations) |
| Trial ID | NCT05126485 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of haptic biofeedback in enhancing functional mobility for individuals with above-knee amputation (AKA). Participants will receive biofeedback training to improve gait symmetry and walking efficiency, addressing common issues such as discomfort and fear of falling. The research aims to quantify motion through wearable sensors and provide real-time feedback to help participants correct their movement patterns. By comparing traditional gait retraining methods with biofeedback, the study seeks to determine the potential benefits of this innovative approach in rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are individuals with unilateral above-knee amputation who have been using a prosthetic limb for at least three months and can walk for a minimum of 25 minutes.
Not a fit: Patients with significant injuries to their intact limb or those with major upper-limb loss may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance mobility and quality of life for individuals with above-knee amputations.
How similar studies have performed: While biofeedback has shown promise in other mobility impairment contexts, its specific application for above-knee amputations remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral limb amputation occurring between the knee and hip joints * Minimum of one-year post-amputation and should have at least three-months experience walking with their current prosthetic system. * Classified as K2 and K3-level community ambulators will be included in the study. * Able to walk a minimum of 25 minutes with minimal rest. For participants with vascular-related amputations, a doctor's note clearing them to participate in the study will be required. * Able to understand and speak English. Exclusion Criteria: * Previous spinal cord injury, stroke, or traumatic brain injury. * Major upper-limb loss, defined as an amputation occurring proximal to the wrist. * Previous or current injury affecting the function of their intact limb (e.g. pelvic injury, osteoarthritis, etc.) * Significant hip contracture exceeding 15° * Body-mass-index exceeding 35
Where this trial is running
Palo Alto, California and 1 other locations
- VA Palo Alto Healthcare System — Palo Alto, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Study coordinator: Matthew J Leineweber, Ph.D.
- Email: matthew.leineweber@sjsu.edu
- Phone: 4089243931
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.