Automatically adjusting prosthetic socket for below-knee amputees
An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation
This study is testing a new type of prosthetic socket that automatically adjusts to fit better for people with below-knee amputations, making it more comfortable and reducing the risk of pain or skin problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT05124652 on ClinicalTrials.gov |
What this trial studies
This research focuses on developing an innovative prosthetic socket system that automatically adjusts to accommodate daily fluctuations in the volume of a residual limb for individuals with transtibial amputations. The goal is to enhance the fit of the prosthesis, thereby reducing discomfort and preventing complications such as pain and skin breakdown. Participants will include both prosthesis users who experience volume changes and certified prosthetists who treat these patients. The study aims to create a more user-friendly solution that eliminates the need for manual adjustments throughout the day.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have had a transtibial amputation for at least 12 months and regularly experience limb volume fluctuations.
Not a fit: Patients with neuropathy, reduced skin sensation, or those who regularly use an assisted device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the comfort and quality of life for individuals with below-knee amputations by providing a better-fitting prosthesis.
How similar studies have performed: While there have been studies on prosthetic adjustments, this approach of automatic adjustment is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
* 18 years or older * Unilateral or bilateral trans-tibial amputation at least 12 months prior * Have a limb of length 9 cm or greater * Are capable of at least 5 minutes of continuous walking * Are capable of at least 1 hour of intermittent walking * Regularly use a definitive prosthesis with a pin-lock suspension system and no or few pads * Have adequate sensation to verbalize a socket that is too large or too small to be tolerated * Do not regularly use assistive devices (e.g., cane, walker) for ambulation * Do not have open wounds on their residual limb at the time of enrollment
Where this trial is running
Seattle, Washington
- William H. Foege Hall — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Joan E Sanders, PhD — University of Washington
- Study coordinator: Katheryn Allen, CPO
- Email: kate@allyn.org
- Phone: 206-390-0228
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.