RecruitingNot ApplicableNCT06711588

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

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

Sponsor

Seattle Institute for Biomedical and Clinical Research

Enrollment

20 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee

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).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called As-prescribed stiffness, a medical device called Two categories less stiff than the as-prescribed stiffness, and others for people with lower limb amputation below knee. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAs-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).

DEVICETwo 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.

DEVICETwo 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.