Innovative powered leg for amputees
Intuitive Control of a Hybrid Prosthetic Leg During Ambulation
NA · Shirley Ryan AbilityLab · NCT04038151
This study is testing a new lightweight powered prosthetic leg to see if it helps amputees be more active and involved in their communities compared to regular prosthetic legs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT04038151 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the clinical benefits of a lightweight powered prosthetic leg that utilizes an intent recognition framework for control during walking. The study will involve two phases: the first phase will fit participants with the Hybrid Leg and provide in-lab therapy for ambulation training, while the second phase will randomize participants to use either their own passive prosthetic leg or the Hybrid Leg in a controlled setting. The goal is to assess whether the Hybrid Leg encourages greater activity and community participation compared to traditional prosthetics.
Who should consider this trial
Good fit: Ideal candidates include individuals with unilateral or bilateral lower limb amputations who are K2, K3, or K4 ambulators and can communicate in English.
Not a fit: Patients with significant cognitive impairments or other comorbidities that prevent the use of a prosthesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this innovative prosthetic leg could significantly enhance mobility and quality of life for amputees.
How similar studies have performed: While the approach of using intent recognition in prosthetics is innovative, similar studies have shown promise in enhancing mobility for amputees.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A unilateral or bilateral lower limb amputation * K2/K3/K4 ambulator with a prosthesis * English speaking Exclusion Criteria: * 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
- Principal investigator: Levi Hargrove, PhD — Shirley Ryan AbilityLab
- Study coordinator: Suzanne Finucane
- 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.
Conditions: Amputation, Transfemoral Amputation