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Recruiting NCT06711588

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance

Trial Parameters

Condition Lower Limb Amputation Below Knee
Sponsor Seattle Institute for Biomedical and Clinical Research
Study Type INTERVENTIONAL
Phase N/A
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-12-19
Completion 2026-03
Interventions
As-prescribed stiffnessTwo categories stiffer than the as-prescribed stiffnessTwo categories less stiff than the as-prescribed stiffness

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).

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.)

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