Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

Completed · Not applicable

Conditions studied: Lower Limb Amputation Below Knee

In brief

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).

Key facts

Study ID

NCT06711588

Run by

Seattle Institute for Biomedical and Clinical Research

People needed

21

Starts

2024-12-19

Expected to finish

2026-07-24

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.)

Where it is running

• VA Puget Sound Healthcare System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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