Recruiting

Powered Prosthesis

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT06160882

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Powered Prosthesis Training and EMG data collection

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

Study Details

Brief 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.

Conditions

Amputation

Study ID

NCT06160882

Start date

Jan 1, 2024

Status verified date

Mar, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 ]
  • Amputee Mobility Predictor with Prosthesis (AMPPRO) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Six Minute Walk Test (6MWT) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Six Minute Walk Test (6MWT) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Timed Up and Go (TUG) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Timed Up and Go (TUG) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Single Leg Stance Test (SLS) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Single Leg Stance Test (SLS) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Berg Balance Scale (BBS) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Berg Balance Scale (BBS) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Four Square Step Test (FSST) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Four Square Step Test (FSST) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Prosthetic Limb Users Survey of Mobility (PLUS-M) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Prosthesis Evaluation Questionnaire (PEQ) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Prosthesis Evaluation Questionnaire (PEQ) [ Time Frame: Completion of study, an average of 1 year from enrollment ]
  • Patient Reported Outcome Measure Information System (PROMIS) [ Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment ]
  • Patient Reported Outcome Measure Information System (PROMIS) [ Time Frame: Completion of study, an average of 1 year from enrollment ]

Central Contacts and Locations

Central contacts

Suzanne Finucane, MS, PTA

312-238-0937sfinucane@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Suzanne Finucane

3122380937sfinucane@sralab.org

Principal Investigator:

Levi Hargrove, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Keywords

  • Transfemoral Amputation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-03-18.