What this study is
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.
What's being tested
- Auto Adjusting Prosthesis
Intervention · DEVICE
Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.
Study details
- Official title
- An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation
- Sponsor
- University of Washington
- Conditions
- Lower Limb Amputation Below Knee (Injury) · Diurnal Residual Limb Fluid Volume Fluctuation
- Enrolling
- 100 people
- Starts
- 2021-10-18
- Est. completion
- 2027-06
- Design
- Open-label, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWilliam H. Foege Hall
Seattle, Washington, United States
- Katheryn Allyn · Contact206-390-0228kate@allyn.org
Recruiting
Study team
Sponsor
University of Washington
Study ID STUDY00009418
Principal investigator
Joan E Sanders, PhD
University of Washington
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.