Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

NCT06711588 | Recruiting FDA Device

• 2 other identifiers: 18173271R01HD111514-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Peak-to-peak range of the frontal plane whole-body angular momentum

  Frontal plane whole-body angular momentum is a measure of the extent to which a person will rotate in the frontal plane in the absence of an external force or torque. The peak-to-peak range quantifies how much this metric varies and is used to describe a person's balance.

  During study visit (approximately 3 hours)

Study Arms (9)

Walking on 0% slope at self-selected speed

EXPERIMENTAL

All participants will walk on a treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking overground.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking on 0% slope at 15% slower than self-selected speed

EXPERIMENTAL

All participants will walk on a treadmill, in a straight line, on a 0% slope, at a speed that is 15% slower than their self-selected walking speed determined while walking overground.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking on 0% slope at 15% faster than self-selected speed

EXPERIMENTAL

All participants will walk on a treadmill, in a straight line, on a 0% slope, at a speed that is 15% faster than their self-selected walking speed determined while walking overground.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking up an 8% slope at self-selected speed

EXPERIMENTAL

All participants will walk on a treadmill, in a straight line, up an 8% slope, at their self-selected walking speed determined while walking overground up an 8% slope.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking down an 8% slope at self-selected speed

EXPERIMENTAL

All participants will walk on a treadmill, in a straight line, down an 8% slope, at their self-selected walking speed determined while walking overground up an 8% slope.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic side

EXPERIMENTAL

All participants will walk on a treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking overground, while carrying a 5 kg load in one hand on their prosthetic side.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking on uneven terrain at self-selected speed

EXPERIMENTAL

All participants will walk on an uneven terrain treadmill, in a straight line, on a 0% slope, at their self-selected walking speed determined while walking on the uneven terrain treadmill.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking around a 2-meter diameter circle with the prosthesis on the inside of the circle

EXPERIMENTAL

All participants will walk overground while following the outline of a 2-meter diameter circle, at their self-selected walking speed determined while walking around the circle, with their prosthetic limb on the inside of the circle.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Walking around a 2-meter diameter circle with the prosthesis on the outside of the circle

EXPERIMENTAL

All participants will walk overground while following the outline of a 2-meter diameter circle, at their self-selected walking speed determined while walking around the circle, with their prosthetic limb on the outside of the circle.

Device: As-prescribed stiffness; Device: Two categories stiffer than the as-prescribed stiffness; Device: Two categories less stiff than the as-prescribed stiffness

Interventions

Two categories less stiff than the as-prescribed stiffness DEVICE

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

Walking around a 2-meter diameter circle with the prosthesis on the inside of the circle; Walking around a 2-meter diameter circle with the prosthesis on the outside of the circle; Walking down an 8% slope at self-selected speed; Walking on 0% slope at 15% faster than self-selected speed; Walking on 0% slope at 15% slower than self-selected speed; Walking on 0% slope at self-selected speed; Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic side; Walking on uneven terrain at self-selected speed; Walking up an 8% slope at self-selected speed

As-prescribed stiffness DEVICE

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).

Walking around a 2-meter diameter circle with the prosthesis on the inside of the circle; Walking around a 2-meter diameter circle with the prosthesis on the outside of the circle; Walking down an 8% slope at self-selected speed; Walking on 0% slope at 15% faster than self-selected speed; Walking on 0% slope at 15% slower than self-selected speed; Walking on 0% slope at self-selected speed; Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic side; Walking on uneven terrain at self-selected speed; Walking up an 8% slope at self-selected speed

Two categories stiffer than the as-prescribed stiffness DEVICE

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

Walking around a 2-meter diameter circle with the prosthesis on the inside of the circle; Walking around a 2-meter diameter circle with the prosthesis on the outside of the circle; Walking down an 8% slope at self-selected speed; Walking on 0% slope at 15% faster than self-selected speed; Walking on 0% slope at 15% slower than self-selected speed; Walking on 0% slope at self-selected speed; Walking on 0% slope at self-selected speed while hand carrying a 5 kg load on their prosthetic side; Walking on uneven terrain at self-selected speed; Walking up an 8% slope at self-selected speed

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

VA Puget Sound Healthcare System

Seattle, Washington, 98108, United States

RECRUITING

Study Officials

• Glenn Klute, PhD

  US Department of Veterans Affairs

  PRINCIPAL INVESTIGATOR

• Richard Neptune, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn K Klute, PhD

CONTACT

206-277-6792; Glenn.Klute@va.gov

Elise Campbell

CONTACT

206-277-6792; Elise.Campbell@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 2, 2024
• Study Start: December 19, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Publication-associated datasets will be submitted to DASH at least 4 months prior to publication so that data can be shared on or before the initial publication date. The full study dataset will be submitted to DASH at least 6 months prior to the end of the award period. DASH does not currently have any data deprecation or sunsetting protocols, allowing shared data to be preserved for the foreseeable future.
• Access Criteria: DASH is an NIH controlled-access data repository. The NICHD DASH Data Access Committee reviews all requests to access DASH data from identity-verified requesters to determine whether the proposed use is scientifically and ethically appropriate and does not conflict with constraints or research data use limitations identified by the institutions that submitted the research data. The Recipient's institution and the Recipient must sign and agree to the terms and conditions in the NICHD DASH Data Use Agreement for accessing research data.

Locations

US (1)