Powered Prosthesis for Use With TF Osseointegration Recipients

NARecruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 1, 2024

Primary Completion Date

October 31, 2027

Study Completion Date

October 31, 2028

Conditions
Amputation
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."

Trial Locations (1)

60611

RECRUITING

Shirley Ryan AbilityLab, Chicago

All Listed Sponsors
collaborator

Northwestern University

OTHER

collaborator

Northwestern Memorial Hospital

OTHER

lead

Shirley Ryan AbilityLab

OTHER