RECRUITING

Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis

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 lower extremity amputation (LEA) have persistent problems with balance, falls, residual limb pain, functional mobility, cognitive attention during gait, and satisfaction with participation in daily activities, despite using prostheses. The purpose of this randomized clinical trial is to advance understanding of how dynamic foot design features may help people with LEA This study will include people with above-knee amputations, or with bilateral amputations, or with below-knee amputations and lower levels of mobility. The main study questions/goals are: 1a) To determine if frontal plane adaptation in a foot prosthesis impacts performance, comfort, activities of daily living, and community mobility in the study populations. To answer this question, we will compare a locked and unlocked version of the novel prosthesis. 1b) To determine how the unlocked investigational foot condition compares to the person's usual foot using the outcomes listed above. 2) To examine the participants' lived experience during community activities. The study will use performance tests, questionnaires, logbooks, and interviews to monitor person-centered outcomes and perceptions of personal functioning during the use of the investigational foot (locked and unlocked) compared to the person's usual foot.

Official Title

The Effectiveness of Frontal Plane Adaptability in a Novel Foot Prosthesis for People With Above-Knee Amputations, Bilateral Amputations, or Limited Mobility

Quick Facts

Study Start:2023-09-01
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06214026

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:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants will be 16-years or older, regardless of gender, race, or ethnicity.
  2. * Potential participants should reside in the community or an independent living environment.
  3. * The upper weight limit is 165.6 kg (365 lbs.).
  4. * Prosthetic foot sizes 22 cm (approximate US Men's shoe size 5) up to 30 cm (13 US Men's).
  5. * Ability to walk more than 400 m on level ground without an increase in pain.
  6. * At least one year post-amputation and using a prosthesis
  7. * People must have the ability to read, write, and comprehend English.
  1. * Participants must not have conditions such as skin wounds that preclude the use of a prosthesis.
  2. * People will be excluded if they have fluctuating conditions that may significantly alter gait mechanics during the \~10-week study. Examples include Parkinson's disease, alcoholism, brain tumor, and hereditary cerebellar ataxias.
  3. * Participants may use a walking aid but should not primarily rely on wheelchair mobility.
  4. * People will be discontinued from the study if they become unable to use a prosthesis. Examples include major surgery and trauma. However, because of the potential for fluctuations in prosthesis use with this population, short-term issues will not disqualify people from continued participation when they resume prosthetic use.

Contacts and Locations

Study Contact

Monica Smersh
CONTACT
206-543-6995
msmersh@u.washington.edu

Principal Investigator

Murray Maitland, PT, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of South Florida
Tampa, Florida, 333620
United States
WillowWood Global
Mount Sterling, Ohio, 43143
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Murray Maitland, PT, 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 Date2023-09-01
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • prosthesis
  • foot prosthesis
  • Above-knee amputation
  • Bilateral lower extremity amputation
  • mobility disability

Additional Relevant MeSH Terms

  • Amputation