Actively Recruiting
An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation
Led by University of Washington · Updated on 2026-05-07
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on people with transtibial (below-knee) amputations who experience daily changes in the size of their residual limb. These changes can cause discomfort and poor prosthesis fit, leading to problems such as pain and skin breakdown. The study aims to evaluate whether an automatically adjusting prosthetic socket can provide better comfort and fit compared to a manually adjusting socket or a standard care control. Participants will test three different socket types: an automatic-adjusting socket that changes fit using built-in panels controlled automatically or via a key fob, a manual-adjusting socket, and a standard care socket where adjustments are made by adding or removing socks. Each socket will be worn for two weeks, separated by two-week washout periods. The study includes initial assessments, socket fabrication, training on socket use, and check-in visits during each test period. Throughout the study, participants will complete self-report questionnaires about comfort, convenience, fatigue, and experiences with the socket. Residual limb health will be assessed at multiple points. Researchers will also monitor prosthesis wear time, activity levels, and socket fit variability. The total study duration includes repeated testing with each socket type and follow-ups, lasting up to one year for outcome measurements.
CONDITIONS
Brief Title
An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Unilateral or bilateral transtibial amputation at least 12 months prior
- Residual limb length of 9 cm or greater
- Capable of at least 5 minutes of continuous walking
- Capable of at least 1 hour of intermittent walking
- Regular user of a definitive prosthesis with a pin-lock suspension system and few or no pads
- Adequate sensation to report if the socket fit is too large or too small
You will not qualify if you...
- Regular use of assistive devices such as a cane or walker for walking
- Presence of open wounds on the residual limb at the time of enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants undergo demographic data collection, bioimpedance and thermal imaging tests, and scanning of their existing socket. Activity data is collected for 2 weeks while the investigational prosthesis is fabricated.
1 initial visit and monitoring for 2 weeks
Duration - Approximately 14 weeks total, including washout periods
Participants test each of the three socket conditions—automatic-adjusting, manual-adjusting, and standard of care—in a randomized crossover design. For each condition, they receive training, use the socket for 2 weeks, including a check-in visit 3 to 5 days after starting, and complete self-report questionnaires and limb health assessments.
3 treatment periods each with 1 training visit, 1 check-in visit (in-person or remote), and 1 end-of-period visit (in-person)
Duration - 4 weeks total
Participants have 2-week washout periods between testing each socket condition to minimize carryover effects.
No visits during washout periods
Trial Site Locations
Total: 1 location
1
William H. Foege Hall
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
K
Katheryn Allen, CPO
T
Tessa S Viljamaa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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