Adjusting prosthetic foot stiffness to enhance balance for below-knee amputees
Automatic Activity-Dependent and Phase-Varying Prosthetic Foot Stiffness Modulation to Improve Balance Control in Individuals With Lower-Limb Amputations
This study is testing if changing the stiffness of prosthetic feet can help below-knee amputees improve their balance and reduce the risk of falls while doing everyday activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Seattle Institute for Biomedical and Clinical Research Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06711588 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the optimal stiffness of prosthetic feet that enhances balance control in individuals with below-knee amputations. Participants will wear a novel prosthesis that allows for varying stiffness levels while performing nine different ambulatory activities, such as walking at different speeds and navigating uneven terrain. The study seeks to identify how adjusting the stiffness of the prosthetic foot can improve balance and reduce the risk of falls during daily activities. By tailoring the stiffness to specific tasks, the research hopes to advance prosthetic technology and improve the quality of life for amputees.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with unilateral transtibial amputations who have been using a prosthesis for at least six months.
Not a fit: Patients with additional disorders or injuries affecting their gait, or those using assistive walking devices, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce fall risk and improve mobility for individuals with below-knee amputations.
How similar studies have performed: While there have been studies on prosthetic devices, this approach of actively adjusting stiffness for different activities is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Seattle, Washington
- VA Puget Sound Healthcare System — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Glenn Klute, PhD — US Department of Veterans Affairs
- Study coordinator: Glenn K Klute, PhD
- Email: Glenn.Klute@va.gov
- Phone: 206-277-6792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.