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

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07791433
Lead Sponsor Seattle Institute for Biomedical and Clinical Research
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)		 Lower Limb Amputation Below Knee
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov