Powered Prosthesis for Use With TF Osseointegration Recipients

Description

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

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Study Overview

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Study Details

Study overview

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.

Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients

Powered Prosthesis for Use With TF Osseointegration Recipients

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Chicago

Shirley Ryan AbilityLab, Chicago, Illinois, United States, 60611

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shirley Ryan AbilityLab,

Levi Hargrove, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan AbilityLab

Study Record Dates

2028-10