Powered Prosthesis for Use With TF Osseointegration Recipients

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT06160882
Status
Recruiting
Apply to this trial

Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Powered Prosthesis Training and EMG data collection — OTHER
    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.
  • Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR) — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Mar 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients
    Perform Osseointegration (OI)Surgery and Targeted Muscle Reinnervation (TMR) and evaluate powered prosthesis training and use. The participant will complete non-weightbearing neural control tasks along with functional, biomechanical, metabolic and qualitative patient-reported outcome measures using the OI interface and the powered leg prosthesis.

Primary Outcome Measure

Amputee Mobility Predictor with Prosthesis (AMPPRO) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilityLabChicagoIllinois60611
Suzanne Finucane
[email protected]
3122380937
Levi Hargrove, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
Shirley Ryan AbilityLab· Chicago, IL

Related Studies