AmputationNCT06160882
Powered Prosthesis for Use With TF Osseointegration Recipients
A study testing Powered Prosthesis Training and EMG data collection and Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR) in people with Amputation, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Amputation
- What is being tested?
- Powered Prosthesis Training and EMG data collection and Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Suzanne Finucane, 3122380937, sfinucane@sralab.org
Levi Hargrove, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Powered Prosthesis Training and EMG data collection, Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)
- Keywords
- Transfemoral Amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Prosthesis Training and EMG data collectionOther
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 or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Powered Prosthesis Training and EMG data collection; Procedure: Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.[
Measured: 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.[
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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
Measured: 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.
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
Measured: Completion of study, an average of 1 year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Northwestern Memorial Hospital
- Responsible party
- Principal investigator, Levi Hargrove, Shirley Ryan AbilityLab
- Investigators
- Levi Hargrove, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160882
- Sponsor's protocol ID
- STU00215805
- Status last verified
- Mar 2025
- First submitted
- 29 Aug 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients
- ClinicalTrials.gov ID
- NCT06160882
- Acronym / sponsor ID
- STU00215805
- Conditions
- Amputation
- Keywords
- Transfemoral Amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Northwestern University, Northwestern Memorial Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients | Other | Other: Powered Prosthesis Training and EMG data collection, Procedure: Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered Prosthesis Training and EMG data collectionParticipants 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. | Other | Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients |
| 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. | Procedure or surgery | Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration Recipients |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.[
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.[
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.
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.
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.
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.
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.
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.
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Levi Hargrove, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Prosthesis Training and EMG data collection and Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR) in people with Amputation, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Finucane, MS, PTA (312-238-0937, sfinucane@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.