RecruitingNot Applicable

Powered Prosthesis for Use With TF Osseointegration Recipients

United States6 participantsStarted 2024-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 st…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Amputee Mobility Predictor with Prosthesis (AMPPRO)

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

Amputee Mobility Predictor with Prosthesis (AMPPRO)

Timeframe: Completion of study, an average of 1 year from enrollment

Six Minute Walk Test (6MWT)

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

Six Minute Walk Test (6MWT)

Timeframe: Completion of study, an average of 1 year from enrollment

Timed Up and Go (TUG)

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

Timed Up and Go (TUG)

Timeframe: Completion of study, an average of 1 year from enrollment

Single Leg Stance Test (SLS)

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

Trial details

NCT IDNCT06160882

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Suzanne Finucane, MS, PTA

312-238-0937 sfinucane@sralab.org

View on ClinicalTrials.gov More Amputation trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Amputee Mobility Predictor with Prosthesis (AMPPRO)

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

Amputee Mobility Predictor with Prosthesis (AMPPRO)

Timeframe: Completion of study, an average of 1 year from enrollment

Six Minute Walk Test (6MWT)

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

Six Minute Walk Test (6MWT)

Timeframe: Completion of study, an average of 1 year from enrollment

Timed Up and Go (TUG)

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

Timed Up and Go (TUG)

Timeframe: Completion of study, an average of 1 year from enrollment

Single Leg Stance Test (SLS)

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