NCT06433648 Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait
| NCT ID | NCT06433648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2023-05-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees. Aim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg/Ottobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle. Aim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only. Aim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle). Our hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06433648 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 95 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06433648 currently recruiting?
Yes, NCT06433648 is actively recruiting participants. Contact the research team at sfinucane@sralab.org for enrollment information.
Where is the NCT06433648 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06433648 clinical trial?
NCT06433648 is sponsored by Shirley Ryan AbilityLab. The trial plans to enroll 20 participants.