Powered Prosthesis for Use With TF Osseointegration Recipients

NCT06160882 | Recruiting

• 1 other identifier: STU00215805
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Transfemoral Amputation

Outcome Measures

Primary Outcomes (18)

• Amputee Mobility Predictor with Prosthesis (AMPPRO)

  A questionnaire that measures the ambulatory potential of lower limb amputees. It requires the amputee to complete various tasks. Including sitting balance, reaching, transfers, sit to stand, and standing balance.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Amputee Mobility Predictor with Prosthesis (AMPPRO)

  A questionnaire that measures the ambulatory potential of lower limb amputees. It requires the amputee to complete various tasks. Including sitting balance, reaching, transfers, sit to stand, and standing balance.

  Completion of study, an average of 1 year from enrollment

• Six Minute Walk Test (6MWT)

  The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Six Minute Walk Test (6MWT)

  The 6 minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.

  Completion of study, an average of 1 year from enrollment

• Timed Up and Go (TUG)

  The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Timed Up and Go (TUG)

  The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults.

  Completion of study, an average of 1 year from enrollment

• Single Leg Stance Test (SLS)

  The Single Leg Stance (SLS) Test is used to assess static postural and balance control. The SLS Test is a balance assessment that is widely used in clinical settings to monitor neurological and musculoskeletal conditions.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Single Leg Stance Test (SLS)

  The Single Leg Stance (SLS) Test is used to assess static postural and balance control. The SLS Test is a balance assessment that is widely used in clinical settings to monitor neurological and musculoskeletal conditions.

  Completion of study, an average of 1 year from enrollment

• Berg Balance Scale (BBS)

  The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Berg Balance Scale (BBS)

  The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

  Completion of study, an average of 1 year from enrollment

• Four Square Step Test (FSST)

  The Four Square Step Test (FSST) is used to assess dynamic stability and co-ordination. It looks at the ability of the subject to step over low objects forward, sideways, and backward.\[

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Four Square Step Test (FSST)

  The Four Square Step Test (FSST) is used to assess dynamic stability and co-ordination. It looks at the ability of the subject to step over low objects forward, sideways, and backward.\[

  Completion of study, an average of 1 year from enrollment

• Prosthetic Limb Users Survey of Mobility (PLUS-M)

  The Prosthetic Limb Users Survey of Mobility™ is a self-report instrument for measuring mobility of adults with lower limb amputation.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Prosthetic Limb Users Survey of Mobility (PLUS-M)

  The Prosthetic Limb Users Survey of Mobility™ is a self-report instrument for measuring mobility of adults with lower limb amputation.

  Completion of study, an average of 1 year from enrollment

• Prosthesis Evaluation Questionnaire (PEQ)

  The PEQ is a self-evaluating instrument consisting of nine validated scales: ambulation, appearance, frustration, perceived response, stump health, social burden, noise, utility, and well-being.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Prosthesis Evaluation Questionnaire (PEQ)

  The PEQ is a self-evaluating instrument consisting of nine validated scales: ambulation, appearance, frustration, perceived response, stump health, social burden, noise, utility, and well-being.

  Completion of study, an average of 1 year from enrollment

• Patient Reported Outcome Measure Information System (PROMIS)

  The PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Patient Reported Outcome Measure Information System (PROMIS)

  The PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.

  Completion of study, an average of 1 year from enrollment

Secondary Outcomes (2)

• Determine changes in EMG signal quality and neural information resulting from OI and TMR as compared to an instrumented socket for control of a powered leg prosthesis.

  Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment

• Determine changes in EMG signal quality and neural information resulting from OI and TMR as compared to an instrumented socket for control of a powered leg prosthesis.

  Completion of study, an average of 1 year from enrollment

Study Arms (1)

Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients

OTHER

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.

Other: Powered Prosthesis Training and EMG data collection; Procedure: Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)

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.

Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients

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.

Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Northwestern University: collaborator
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Levi Hargrove, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Finucane, MS, PTA

CONTACT

312-238-0937; sfinucane@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Scientific Chair, Center for Bionic Medicine

Model Details: The primary endpoint will be to evaluate the functional, biomechanical, metabolic outcomes, and user satisfaction while using a powered prosthesis suspended by an OI interface compared to their prescribed traditional socket The secondary endpoint will be to determine changes in EMG signal quality and neural information resulting from OI and TMR as compared to an instrumented socket for control of a powered leg prosthesis.

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: December 7, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)