Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

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).

Conditions

Lower Limb Amputation Below Knee

Study Overview

Study Details

Study overview

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).

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

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

Condition
Lower Limb Amputation Below Knee
Intervention / Treatment

-

Contacts and Locations

Seattle

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Unilateral transtibial (below-knee) amputation
  • * Been fit with a prosthesis and used it for at least 6 months
  • * Wear the prosthesis for 4 or more hours on average per day
  • * Be at least one-year post-amputation
  • * Able to walk on a treadmill
  • * Presence of disorder, pain, or injury other than amputation that interferes with gait
  • * Current skin irritation or injury on residual limb
  • * Use of an assistive device for walking (cane, walker, etc.)

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-06