An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05124652
Status
Recruiting
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Conditions

  • Diurnal Residual Limb Fluid Volume Fluctuation
  • Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Auto Adjusting Prosthesis — 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

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.

Key Dates

Start date
Oct 18, 2021
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • No Intervention: Focus Group Testing
    Focus group testing of key-fob device to control adjusting socket system
  • Experimental: In-Lab, Crossover Study
    Testing of auto-adjusting algorithm in-lab. Participants will carry out a structured protocol wearing the socket in all modes. Order will be randomly assigned.
  • Experimental: Out-of-Lab Crossover Study
    Evaluate socket performance in user free-living environments. Participants will use the prosthesis in all modes by end of study, order will be randomly assigned.

Primary Outcome Measure

Socket Comfort Score [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
William H. Foege HallSeattleWashington98105
Katheryn Allyn
[email protected]
206-390-0228

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William H. Foege Hall· Seattle, WA

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