Evaluation of a powered prosthesis for individuals with transfemoral amputation

Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients

This study is testing a powered knee and ankle prosthesis to see if it helps people with leg amputations move better and feel more satisfied with their mobility after special surgeries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shirley Ryan AbilityLab (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06160882 on ClinicalTrials.gov

What this trial studies

This study aims to assess the functional mobility, control, and user satisfaction of individuals who have undergone osseointegration and targeted muscle reinnervation surgeries while using a powered knee and ankle prosthesis. Participants will be fitted with a custom socket for EMG signal collection and will undergo training with the powered prosthesis. The study will evaluate perceived benefits such as reduced weight perception, decreased energy expenditure during movement, and improved EMG signal quality. Data will be collected through multiple lab visits prior to surgical intervention and during the use of the powered prosthesis.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18-70 with unilateral transfemoral amputation who are existing prosthesis wearers and are candidates for osseointegration and targeted muscle reinnervation.

Not a fit: Patients who are unable to receive osseointegration or targeted muscle reinnervation, or those with significant cognitive impairments, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance mobility and satisfaction for amputees using powered prostheses.

How similar studies have performed: While the approach of using powered prostheses is being explored, this specific combination of osseointegration and targeted muscle reinnervation in conjunction with powered devices is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Unilateral lower limb amputation at the transfemoral level
* Existing prosthesis wearer
* K2/K3/K4 level ambulation
* 18-70 years old
* Mini-Mental State Exam (MMSE) score greater than 17
* Ability to demonstrate proper safety with passive prosthesis
* Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes
* Candidate for OI surgery as verified by surgical team or has previously received OI
* Candidate for TMR surgery as verified by surgical team or has previously received TMR

Exclusion Criteria:

* Unable to successfully receive osseointegration and TMR
* Significant new injury that would prevent use of a prosthesis: Ability to consistently wear prosthesis and perform activities of daily living and specific performance tasks is necessary to properly evaluate the relative benefits of the intervention
* 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.
* Visually impaired
* Proximal nerve injury that prevents TMR
* Individuals who smoke: may interfere with OI process from both bone healing and soft tissue standpoints
* Individuals with active implants.
* Significant comorbidity that would preclude completion of the study, use of prostheses, or would otherwise prevent data acquisition 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, MS, PTA

Conditions: Amputation, Transfemoral Amputation