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
Seattle Institute for Biomedical and Clinical Research
20 participants
Dec 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria3
- 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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Interventions
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).
A novel prosthesis that includes a low-profile prosthetic foot whose stiffness category is two categories stiffer 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06711588