RECRUITING

An Automatically Adjusting Prosthetic Socket for People With Transtibial 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

People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.

Official Title

An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation

Quick Facts

Study Start:2021-10-18
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05124652

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 or older (Prosthetists and Prosthesis Users)
  2. * must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
  3. * had a trans-tibial amputation at least 12 months prior (prosthesis users only)
  4. * regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)
  5. * self-report experiencing limb volume fluctuation in the past (prosthesis users only)
  6. * have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)
  7. * walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)
  8. * capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)
  1. * Are not certified prosthetists (prosthetists only)
  2. * neuropathy (prosthesis users only)
  3. * reduced skin sensation (prosthesis users only)
  4. * regular use of an assisted device (prosthesis users only)
  5. * sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)

Contacts and Locations

Study Contact

Katheryn Allen, CPO
CONTACT
206-390-0228
kate@allyn.org
Daniel Ballesteros
CONTACT
danielb25@uw.edu

Principal Investigator

Joan E Sanders, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

William H. Foege Hall
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Joan E Sanders, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

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 Date2021-10-18
Study Completion Date2027-06

Study Record Updates

Study Start Date2021-10-18
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • amputee
  • prosthetic

Additional Relevant MeSH Terms

  • Lower Limb Amputation Below Knee (Injury)
  • Diurnal Residual Limb Fluid Volume Fluctuation