NCT03550118

Auto Control of Volume Management for Limb Loss

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this research is to create a prosthetic 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.

Detailed description

People with lower limb 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 health problems including skin breakdown and injury to deeper tissues. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The objective of this research is to develop and test an automatically-adjusting prosthetic socket system for prosthesis users. The system integrates with a range of adjustable socket technologies, including those that are commercially available. The system allows small size adjustments for both tightening and loosening the socket. In early aims of the study, the prosthesis will be adjusted manually, but can be controlled remotely, eliminating the need to remove the prosthesis or bend down to make adjustments. The system will later be enhanced to automatically change the fit of an adjustable socket at the appropriate times, without distracting the user. We hypothesize that this system will help to maintain consistent limb fluid volume while the prosthesis user is wearing the socket and that socket fit will be improved. The system functions by continuously collecting measurements from sensors within the socket and uses small motors to control adjustable panels in the socket wall.

Conditions

• Lower Limb Amputation Below Knee (Injury)

Interventions

Type	Name	Description
DEVICE	Adjustable socket	The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.

Timeline

• Start date: 2015-08-07
• Primary completion: 2021-09-01
• Completion: 2022-01-01
• First posted: 2018-06-08
• Last updated: 2023-05-03
• Results posted: 2023-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study