Powered Prosthesis for Use with TF Osseointegration Recipients

March 13, 2025 updated by: Levi Hargrove, Shirley Ryan AbilityLab

Evaluation of Powered Prosthesis for Use with Transfemoral Osseointegration Recipients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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) signals will be higher quality and more robust than signals measured from within a socket, potentially allowing for improved pattern recognition driven prostheses in future device design and studies.

Prior to surgical intervention, amputee participants will visit the lab up to 3 times for socket fitting, and at most 7 times to practice using the powered prosthesis and collect experimental data. There is no time limitation between sessions and each session will last a maximum of 4 hours.

Aim 1: Pre-Surgery Fitting and Powered Leg Prosthesis Training:

Participants will be fit for a custom instrumented socket that allows for collection of surface EMG signals and for use with the powered lower limb prosthesis. The socket that is fabricated is solely for the purpose of this study, will be used only in the research lab. The participant will continue to use their clinically prescribed socket and prosthesis when not attending study visits. EMG control sites over the semitendinosus, biceps femoris, tensor fasciae latae, rectus femoris, vastus lateralis, and adductor magnus 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. The walkway, ramps and stairs are equipped with handrails and the amputee with be wearing either an overhead harness or gait belt for safety. Additionally, a non-weight bearing independent control system will be configured. The participant will be instructed to attempt to move their 'phantom' limb through knee flexion/extension and ankle plantarflexion/dorsiflexion range movements while EMG data are collected. 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 then complete functional, biomechanical, metabolic, and qualitative patient reported outcome measures using the instrumented socket and the powered leg prosthesis. The investigator will use an extensive list of standard clinical assessments and participant-reported measures that assess physical function, mobility, balance, fall risk, quality of life, and metabolic expenditure.

OI TMR surgery 1 and recovery: participants will undergo the first osseointegration (OI) and targeted muscle reinnervation (TMR) surgery at Northwestern Memorial Hospital.

OI surgery 2 and recovery: Participants will undergo the second OI surgery where the abutment will be connected to the fixture with in the femur. The participant will again be monitored for full recovery (typically 4-6 weeks). No outcome measures or assessments will be performed prior to 12 weeks' post-surgery

Aim 2: Post-Surgery Fitting and Powered Leg Prosthesis Training:

After osseointegration and TMR surgery and recovery, the study participant no longer requires a standard prosthetic socket. EMG signals can now be measured using a custom fit electrode band on the residual limb that is tethered to the prosthesis. Participants will be fit with the powered prosthesis using their OI interface and trained on its use. Participants will receive instruction on use of the powered prosthesis, now attached via their OI interface with the electrode band. The participants will walk under the supervision of a clinician while device parameters are configured as prior to OI/TMR surgery. The participant will progress to walking over slopes, perform stairclimbing with a reciprocal gait and sit to and from standing transitions. The clinician will provide verbal instruction and cues on how to best make use of the power and how to safely perform all activities. The investigators will repeat the same measures as previously performed to evaluate the functional, metabolic, and biomechanical benefits conferred by OI over a traditional socket when using a powered leg device. At the end of each visit, the study participant will return to their clinically prescribed prosthesis.

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Shirley Ryan Abilitylab
        • Contact:
        • Contact:
          • Levi Hargrove, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amputee Mobility Predictor with Prosthesis (AMPPRO)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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)
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
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)
Time Frame: Completion of study, an average of 1 year from enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Completion of Aim 1:approximately 10-12 weeks (10 in lab visits) from enrollment
A non-weight bearing independent control system will be configured. The participant will be instructed to attempt to move their 'phantom' limb through knee flexion/extension and ankle plantarflexion/dorsiflexion range movements while EMG data are collected. 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
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.
Time Frame: Completion of study, an average of 1 year from enrollment
A non-weight bearing independent control system will be configured. The participant will be instructed to attempt to move their 'phantom' limb through knee flexion/extension and ankle plantarflexion/dorsiflexion range movements while EMG data are collected. 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
Completion of study, an average of 1 year from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

Northwestern University
Northwestern Memorial Hospital

Investigators

  • Principal Investigator: Levi Hargrove, PhD, Shirley Ryan Abilitylab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00215805

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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