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RECRUITING
NCT06160882
NA

Powered Prosthesis for Use With TF Osseointegration Recipients

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.

Official title: Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-01-01

Completion Date

2028-10

Last Updated

2025-03-18

Healthy Volunteers

No

Conditions

Interventions

OTHER

Powered Prosthesis Training and EMG data collection

Participants are fit for a custom instrumented socket for collection of surface EMG signals and use with the powered lower limb prosthesis. EMG control sites will be located using clinical best practices. Once socket fit is completed, the prosthetist will attach and align the powered prosthesis. The participant will be instructed to walk with the powered prosthesis for level ground walking, incline walking, stair climbing and non-weight bearing independence control activities. A non-weight bearing independent control system will be configured. These data are used to train a pattern recognition control system which can control the leg knee and ankle joints respectively, either in a virtual environment or with the physical prosthesis The participants will complete functional, biomechanical, metabolic, and patient reported outcome measures.

PROCEDURE

Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)

Participants will undergo OI Surgery 1 +TMR and recovery. Following recovery, participants will receive OI surgery 2 where the abutment is connected to the fixture with in the femur. Participants will receive standard post-surgical care and participate in the OPRA rehab program through the Shirley Ryan AbilityLab. The participant uses their clinically prescribed prosthetic knee unit for training in the OPRA rehab program. Post-Surgery Fitting and Powered Leg Prosthesis Training: EMG signals are measured using a custom fit electrode band on the residual limb that is tethered to the prosthesis. Participants are fit with the powered prosthesis using their OI interface and trained on its use. The participant will complete non-weight-bearing neural control tasks as done prior to surgery. The participants will complete functional, biomechanical, metabolic, and patient-reported outcome measures using the OI interface and the powered leg prosthesis.

Locations (1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States