Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06711588

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2026-05-13

20

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

Sponsors

S

Seattle Institute for Biomedical and Clinical Research

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral transtibial (below-knee) amputation
  • Using a prosthesis for at least 6 months
  • Wearing the prosthesis for 4 or more hours per day on average
  • At least one year has passed since amputation
  • Able to walk on a treadmill
Not Eligible

You will not qualify if you...

  • Any disorder, pain, or injury besides amputation that affects walking
  • Current skin irritation or injury on the residual limb
  • Use of assistive walking devices like a cane or walker

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

VA Puget Sound Healthcare System

Seattle, Washington, United States, 98108

Actively Recruiting

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Research Team

G

Glenn K Klute, PhD

CONTACT

E

Elise Campbell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

9

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Automatic Prosthetic Foot Stiffness Modulation to Improve Balance | DecenTrialz