RECRUITING

A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations

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

Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6.

Official Title

A Prosthetic Foot Test-Drive Strategy for Improving Stability and Falls-Related Outcomes in Veterans With Leg Amputations

Quick Facts

Study Start:2024-01-01
Study Completion:2024-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05473065

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 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * has a unilateral (one leg) transtibial (below-knee) amputation
  2. * has used a prosthetic limb for walking for at least six months
  3. * has a comfortably fitting prosthetic socket
  4. * has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet
  5. * be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials
  1. * contralateral limb or upper limb amputation that would interfere with completion of study activities
  2. * are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet)
  3. * unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress
  4. * current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness)
  5. * weight greater than 263lbs.
  6. * inadequate cognitive or language function to consent to participate
  7. * currently incarcerated
  8. * impaired decision-making ability or the use of a legally authorized representative

Contacts and Locations

Study Contact

David C Morgenroth, MD
CONTACT
206-277-1982
dmorgen@uw.edu
Elizabeth G Halsne, PhD, CPO
CONTACT
206-277-1217
bhalsne@uw.edu

Principal Investigator

David C Morgenroth, MD
PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System

Study Locations (Sites)

Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
United States
VA Puget Sound Health Care System
Seattle, Washington, 98108
United States

Collaborators and Investigators

Sponsor: Seattle Institute for Biomedical and Clinical Research

  • David C Morgenroth, MD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System

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 Date2024-07-31

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2024-07-31

Terms related to this study

Keywords Provided by Researchers

  • amputation
  • rehabilitation
  • balance
  • stability
  • falls
  • emulator
  • prosthetics

Additional Relevant MeSH Terms

  • Amputation