Recruiting

Prosthetic Socket

Sponsor:

University of Washington

Code:

NCT05124652

Conditions

Lower Limb Amputation Below Knee (Injury)

Diurnal Residual Limb Fluid Volume Fluctuation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Auto Adjusting Prosthesis

Study Details

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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Diurnal Residual Limb Fluid Volume Fluctuation

Study ID

NCT05124652

Start date

Oct 18, 2021

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Auto Adjusting Prosthesis

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.

Primary outcome measure

  • Socket Comfort Score [ Time Frame: through study completion, an average of 1 year ]
  • Integral Absolute Error of Control System [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Katheryn Allen, CPO

206-390-0228kate@allyn.org

Tessa S Viljamaa

tessasv@uw.edu

Locations

William H. Foege Hall

Recruiting

Seattle, Washington, United States, 98105

Contacts

Katheryn Allyn

206-390-0228kate@allyn.org

More Information

Sponsor

University of Washington

Last update posted

May 7, 2026

Last verified

Mar, 2026

Keywords

  • amputee
  • prosthetic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-07.