RECRUITING

Powered Prosthesis for Use With TF Osseointegration Recipients

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AmputationTransfemoral Amputation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Evaluation of Powered Prosthesis for Use With Transfemoral Osseointegration Recipients

Quick Facts

Study Start:2024-01-01
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06160882

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral lower limb amputation at the transfemoral level
  2. * Existing prosthesis wearer
  3. * K2/K3/K4 level ambulation
  4. * 18-70 years old
  5. * Mini-Mental State Exam (MMSE) score greater than 17
  6. * Ability to demonstrate proper safety with passive prosthesis
  7. * Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes
  8. * Candidate for OI surgery as verified by surgical team or has previously received OI
  9. * Candidate for TMR surgery as verified by surgical team or has previously received TMR
  1. * Unable to successfully receive osseointegration and TMR
  2. * 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
  3. * 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.
  4. * Visually impaired
  5. * Proximal nerve injury that prevents TMR
  6. * Individuals who smoke: may interfere with OI process from both bone healing and soft tissue standpoints
  7. * Individuals with active implants.
  8. * Significant comorbidity that would preclude completion of the study, use of prostheses, or would otherwise prevent data acquisition by researchers

Contacts and Locations

Study Contact

Suzanne Finucane, MS, PTA
CONTACT
312-238-0937
sfinucane@sralab.org

Principal Investigator

Levi Hargrove, PhD
PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab

Study Locations (Sites)

Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

  • Levi Hargrove, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-01-01
Study Completion Date2028-10

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • Transfemoral Amputation

Additional Relevant MeSH Terms

  • Amputation