RecruitingNot ApplicableNCT06160882

Powered Prosthesis for Use With TF Osseointegration Recipients

Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients

Sponsor

Shirley Ryan AbilityLab

Enrollment

6 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Amputation

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

Unilateral lower limb amputation at the transfemoral level
Existing prosthesis wearer
K2/K3/K4 level ambulation
-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 Criteria8

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

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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.