Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06711588

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

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

20

Participants Needed

1

Research Sites

4 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

Researchers are investigating how different prosthetic foot stiffness levels affect balance control in individuals with below-knee amputations. The study aims to find the best stiffness that improves balance during various daily walking activities, as people with lower limb amputations face higher fall risks due to lost ankle muscle function. This trial focuses on optimizing prosthesis stiffness to enhance stability and reduce falls. Participants will use a special prosthesis fitted with three different prosthetic feet varying in stiffness: their usual prescribed stiffness, one two levels stiffer, and one two levels less stiff. They will perform nine walking tasks including walking at different speeds on level ground, walking up and down slopes, carrying a load, walking on uneven terrain, and walking in circles with the prosthetic limb inside or outside the circle. These tasks occur on treadmills or overground in a randomized order. During visits lasting about 3 hours, participants will be monitored with motion capture to measure their balance by observing body movement patterns. The main measurement is the peak-to-peak range of whole-body angular momentum in the frontal plane during walking. Researchers will analyze which stiffness level best supports balance for each activity. Rest breaks are provided as needed, and participants will continue using their own sockets adjusted as necessary.

CONDITIONS

Brief 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 on average each day
  • At least one year post-amputation
  • Able to walk on a treadmill
Not Eligible

You will not qualify if you...

  • Having any disorder, pain, or injury besides the amputation that affects walking
  • Current skin irritation or injury on the residual limb
  • Using an assistive walking device such as a cane or walker

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 visit (approximately 3 hours)

Participants are fit with three different prosthetic feet of varying stiffness levels to test balance control.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

VA Puget Sound Healthcare System

Seattle, Washington, United States, 98108

Actively Recruiting

Loading map...

Research Team

G

Glenn K Klute, PhD

E

Elise Campbell

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

9

Similar Trials

Clinical Application Observation: Evaluation of Phantom Limb...

Phantom Limb Pain After Amputation

Actively Recruiting

1 location

Clinical Evaluation of the Access Socket Flexible Socket for...

Transtibial Amputation

Actively Recruiting

5 locations

Impact of a Prosthetic Foot With Adjustable Heel Height on P...

Lower Limb Amputation Above Knee

Actively Recruiting

5 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here