Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait

Recruiting now · Not applicable

Conditions studied: Amputation, Amputation, Traumatic, Amputation of Knee, Amputation; Traumatic, Limb

In brief

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.

Key facts

Study ID

NCT06433648

Run by

Shirley Ryan AbilityLab

People needed

20

Starts

2023-05-01

Expected to finish

2029-06-30

Last updated by the study team

2024-05-30

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.