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Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

NCT06711588 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-13

No results posted yet for this study

Summary

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

Interventions

DEVICE

As-prescribed stiffness

A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).

DEVICE

Two categories stiffer than the as-prescribed stiffness

A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories stiffer than the as-prescribed stiffness.

DEVICE

Two categories less stiff than the as-prescribed stiffness

A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories less stiff than the as-prescribed stiffness.

Sponsors & Collaborators

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

    collaborator NIH

  • Seattle Institute for Biomedical and Clinical Research

    lead OTHER

Principal Investigators

  • Glenn Klute, PhD · US Department of Veterans Affairs

  • Richard Neptune, PhD · The University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-07-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06711588 on ClinicalTrials.gov