NCT05124652

An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2021-10-18
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2021-11-18
• Last updated: 2022-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study