Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients
Shirley Ryan AbilityLab
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.
Description
The objective of this study is to evaluate functional mobility, non-weight-bearing neural control, and user satisfaction from individuals with unilateral transfemoral amputation who have received osseo-integration (OI) and targeted muscle reinnervation (TMR), while ambulating with a fully powered prosthesis. The hypothesis is that OI will show perceived benefits for participants including: 1) lower perceived weight of the prosthesis due to the more secure OI interface over a traditional socket, 2) decreased energy expenditure during ambulation and transitions, and 3) electromyographic (EMG) s…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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: *…
Interventions
- OtherPowered 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.
- ProcedurePerform 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.
Location
- Shirley Ryan AbilityLabChicago, Illinois