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Procedure

Powered Prosthesis for Amputation

N/A

Recruiting

Led By Levi Hargrove, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Unable to successfully receive osseointegration and TMR

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of study, an average of 1 year from enrollment

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates how well people with above-knee amputations walk with a powered prosthesis after OI & TMR surgery.

Who is the study for?

This trial is for individuals aged 18-70 with an above-knee amputation who currently use a prosthesis and can safely operate it. They must be able to walk at various levels (K2/K3/K4), produce detectable muscle signals, and either are candidates for or have had osseointegration (OI) and targeted muscle reinnervation (TMR) surgeries.

What is being tested?

The study tests how well people with above-knee amputations can move, control, and feel satisfied using a powered knee and ankle prosthesis after receiving OI and TMR surgeries. It involves training on the new prosthesis as well as collecting muscle activity data.

What are the potential side effects?

Potential side effects may include discomfort from adapting to the powered prosthesis, skin irritation around electrode sites, surgical risks associated with OI/TMR procedures such as infection or poor bone integration, but specific device-related side effects aren't detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a candidate for or have had orthopedic implant surgery.

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I am a candidate for or have had TMR surgery as confirmed by my surgical team.

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I am between 18 and 70 years old.

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I can walk with little to no assistance.

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I have had one leg amputated above the knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have certain bone and nerve integration surgeries.

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I understand and can follow the study's requirements.

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I have a nerve injury near my body's center that stops me from getting TMR.

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I can wear a prosthesis and do daily tasks without major new injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of study, an average of 1 year from enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of study, an average of 1 year from enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of study, an average of 1 year from enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Amputee Mobility Predictor with Prosthesis (AMPPRO)

Berg Balance Scale (BBS)

Four Square Step Test (FSST)

+6 more

Secondary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Evaluation of Powered Prosthesis for use with Transfemoral Osseointegration RecipientsExperimental Treatment2 Interventions

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.

0 / 9Eligibility criteria met