An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Limb Amputation Below Knee (Injury)
- Sponsor
- University of Washington
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Integral Absolute Error of Control System
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.
Investigators
Joan Sanders
Professor: Engineering
University of Washington
Eligibility Criteria
Inclusion Criteria
- •18 or older (Prosthetists and Prosthesis Users)
- •must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
- •had a trans-tibial amputation at least 12 months prior (prosthesis users only)
- •regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)
- •self-report experiencing limb volume fluctuation in the past (prosthesis users only)
- •have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)
- •walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)
- •capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)
Exclusion Criteria
- •Are not certified prosthetists (prosthetists only)
- •neuropathy (prosthesis users only)
- •reduced skin sensation (prosthesis users only)
- •regular use of an assisted device (prosthesis users only)
- •sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)
Outcomes
Primary Outcomes
Integral Absolute Error of Control System
Time Frame: through study completion, an average of 1 year
Calculated error will be measured through each test session, both in and out of lab.
Socket Comfort Score
Time Frame: through study completion, an average of 1 year
Participants in Aim 2 and Aim 3 will test various configurations of the auto adjustment algorithm. Socket comfort score will be asked at various time points during testing, and overall changes in this metric will be calculated from the start and end of session.
Secondary Outcomes
- Percent change in Limb Fluid Volume(through study completion, an average of 1 year)
- Thermal Recovery Time (TRT)(through study completion, an average of 1 year)