RECRUITING

Improving Socket Fit in Female and Male Veterans With Transtibial and Transfemoral Amputation

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 investigators do not yet know how a prosthetic socket with adjustable panels affects the performance of people with a lower limb amputation compared to a conventional prosthetic socket. The primary objective of this study is to compare an adjustable and conventional prosthetic socket and use this information to determine the optimal socket that would improve rehabilitation and function in people with lower limb amputation.

Official Title

Improving Socket Fit in Female and Male Veterans With Transtibial and TransfemoralAmputation

Quick Facts

Study Start:2022-01-31
Study Completion:2026-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05989243

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The investigators will enroll up to 40 Veterans
  2. * 20 with unilateral transtibial amputation
  3. * 20 with unilateral transfemoral amputation who are at or above a K2 Medicare functional classification level (MFCL) and who are 18-65 years old
  4. * All participants will have no current problems with their prosthesis or residual limb, and be at least 6-months post-amputation
  5. * Participants will be at or above a K2 MFCL, defined as a person who has the ability or potential for ambulation with the ability to traverse low level environmental barriers such as curbs, stairs, or uneven surfaces, typical of the limited community ambulator
  1. * Cardiovascular, pulmonary, or neurological disease or disorder or requirement for an assistive device for their unaffected leg (i.e. orthosis, cane)

Contacts and Locations

Study Contact

Alena Grabowski, PhD BA
CONTACT
(720) 435-4270
Alena.Grabowski@va.gov

Principal Investigator

Alena Grabowski, PhD BA
PRINCIPAL_INVESTIGATOR
Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Locations (Sites)

Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Alena Grabowski, PhD BA, PRINCIPAL_INVESTIGATOR, Rocky Mountain Regional VA Medical Center, Aurora, CO

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 Date2022-01-31
Study Completion Date2026-01-30

Study Record Updates

Study Start Date2022-01-31
Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

  • Biomechanics
  • Kinematics
  • Walking
  • Prostheses

Additional Relevant MeSH Terms

  • Transtibial Amputation
  • Transfemoral Amputation