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NOT YET RECRUITING
NCT07791433
NA

Automatic Prosthetic Foot Stiffness Modulation to Improve Balance in the Real World

Sponsor: Seattle Institute for Biomedical and Clinical Research

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine if automatic stiffness modulation improves balance control in ambulatory individuals with below-knee amputations in real-world conditions. The main question this clinical trial will answer is: • Can a user-specific automatic stiffness prosthesis improve balance control compared to user's fixed stiffness prosthesis that was clinically prescribed? Participants will perform free-ranging ambulatory activities outside the laboratory that include nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent/descent, while carrying a load, and while walking on uneven terrain) while wearing, in random order, 1) a fixed stiffness prosthesis that was clinically prescribed and 2) an automatic stiffness prosthesis that uses an open source ankle configured to implement a user- and activity-specific automatic stiffness modulation control scheme intended to improve balance control.

Official title: Automatic Activity-Dependent and Phase-Varying Prosthetic Foot Stiffness Modulation to Improve Balance Control in Individuals With Lower-Limb Amputations in the Real World

Key Details

Gender

All

Age Range

18 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-11

Completion Date

2028-11

Last Updated

2026-08-28

Healthy Volunteers

No

Interventions

DEVICE

Fixed stiffness prosthesis

The participant's clinically prescribed prosthesis whose stiffness category is determined by the person's body weight and activity level (standard clinical practice).

DEVICE

Automatic stiffness prosthesis

A novel prosthesis whose user-specific and activity-specific stiffness profile is automatically modulated based on their ambulatory activity.

Locations (1)

VA Puget Sound Healthcare System

Seattle, Washington, United States