RECRUITING

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

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

This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).

Official Title

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

Quick Facts

Study Start:2023-01-30
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05695911

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
  2. * ≥ 18 years old
  3. * History of severe socket-related skin or residual limb problems
  4. * Schedule for OI prosthesis implantation surgery
  1. * Vascular amputation etiology
  2. * Substance abuse
  3. * Unstable heart condition
  4. * Acute systemic infection
  5. * Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24)
  6. * Active cancer treatment

Contacts and Locations

Study Contact

Cory Christiansen, PT PHD
CONTACT
303 724 9101
CORY.CHRISTIANSEN@CUANSCHUTZ.EDU
Brecca Gaffney, PHD
CONTACT
303 315 7559
BRECCA.GAFFNEY@UCDENVER.EDU

Principal Investigator

Cory Christiansen, PT PHD
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

CU Physical Therapy
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Cory Christiansen, PT PHD, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

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 Date2023-01-30
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2023-01-30
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • amputation
  • osseointegration
  • rehabilitation
  • biofeedback

Additional Relevant MeSH Terms

  • Amputation
  • Transfemoral Amputation
  • Osseointegration