RECRUITING

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

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 goal of this clinical trial is to identify prosthesis stiffness that optimizes balance control in individuals with below knee amputations. The main question this clinical trial will answer is: • Is there an optimal stiffness that improves balance control for specific ambulatory activities and users? Participants will wear a novel prosthesis assembled with three prosthetic feet with a range of stiffness levels: each individual's clinically-prescribed foot stiffness and ± two stiffness categories. While wearing the study prostheses, participants will perform nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain).

Official Title

Automatic Activity-Dependent and Phase-Varying Prosthetic Foot Stiffness Modulation to Improve Balance Control in Individuals With Lower-Limb Amputations

Quick Facts

Study Start:2024-12-19
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06711588

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 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Unilateral transtibial (below-knee) amputation
  2. * Been fit with a prosthesis and used it for at least 6 months
  3. * Wear the prosthesis for 4 or more hours on average per day
  4. * Be at least one-year post-amputation
  5. * Able to walk on a treadmill
  1. * Presence of disorder, pain, or injury other than amputation that interferes with gait
  2. * Current skin irritation or injury on residual limb
  3. * Use of an assistive device for walking (cane, walker, etc.)

Contacts and Locations

Study Contact

Glenn K Klute, PhD
CONTACT
206-277-6792
Glenn.Klute@va.gov
Elise Campbell
CONTACT
206-277-6792
Elise.Campbell@va.gov

Principal Investigator

Glenn Klute, PhD
PRINCIPAL_INVESTIGATOR
US Department of Veterans Affairs
Richard Neptune, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas at Austin

Study Locations (Sites)

VA Puget Sound Healthcare System
Seattle, Washington, 98108
United States

Collaborators and Investigators

Sponsor: Seattle Institute for Biomedical and Clinical Research

  • Glenn Klute, PhD, PRINCIPAL_INVESTIGATOR, US Department of Veterans Affairs
  • Richard Neptune, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas at Austin

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 Date2024-12-19
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12-19
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • lower limb prosthesis
  • transtibial amputation
  • below knee amputation
  • biomechanics
  • gait

Additional Relevant MeSH Terms

  • Lower Limb Amputation Below Knee