Understanding the impact of powered prosthetics on walking for transfemoral amputees
Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
This study is testing whether powered knee and ankle prosthetics can help transfemoral amputees walk better, especially when combined with special training.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06433648 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how powered knee and ankle prosthetics affect the walking ability of K2-level transfemoral amputees. Participants will use either a commercially available passive microprocessor knee prosthesis or a powered knee and ankle prosthesis, with assessments focused on functional performance. The study will also explore the effects of intensive clinical gait training on these powered devices. The hypothesis is that powered componentry will enhance ambulation and that training will further improve outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-95 with a unilateral transfemoral amputation who can walk independently with a prosthesis.
Not a fit: Patients who weigh over 250 pounds or have significant new injuries that prevent prosthesis use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for transfemoral amputees.
How similar studies have performed: Other studies have shown promising results with powered prosthetics, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ages 18-95 * A unilateral transfemoral amputation * At least 6 months since definitive prosthesis fitting * Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person. * Medically cleared by physician to participate in study * English speaking Exclusion Criteria: * Weight greater than 250 pounds * Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions. * Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. * Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Suzanne Finucane, MS, PTA
- Email: sfinucane@sralab.org
- Phone: 312-238-0937
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.