Auto Control of Volume Management for Limb Loss

Lower Limb Amputation Below Knee (Injury) Clinical Trial

Official title:

Auto Control of Volume Management for Limb Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550118
• Other study ID #: STUDY00001779
• Status: Completed
• Phase: N/A
• Start date: August 7, 2015
• Est. completion date: January 2022

Study information

• Verified date: April 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Unilateral transtibial amputee

• At least 6 months post-amputation

• Wear prosthesis at least 3 hours per day

• Use an elastomeric (i.e. gel) liner

• K3 or higher Medicare Functional Classification Level

• Able to walk continuously with prosthesis for at least 5 minutes at a time, sit, stand, and step up a height of 5.0 cm.

• Residual limb of 9.0 cm or longer

• Experience problems with volume fluctuations that affect their prosthetic socket fit

Exclusion Criteria:

• Participants experiencing skin breakdown on enrollment will be excluded, but can enter after having been free of clinically visually-apparent skin breakdown for two weeks.

Related Conditions & MeSH terms

• Lower Limb Amputation Below Knee (Injury)

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington Bioengineering	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Limb Volume	Limb volume fluctuations will be measured in real-time as socket adjustment strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.	Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.
Primary	Change in Limb Movement	Limb movement within the socket will be measured as socket adjustment strategies are tested. It will be used as an indicator of how well the socket is fitting (loose, tight, etc). The measurement will be made using an inductance sensor that is placed in the socket which measures the displacement of a sensor patch on the prosthetic liner. Specifically, the change in limb movement will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.	Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.
Primary	Number of Participants With Increase in Limb Fluid Volume After Panel Pull	Limb volume fluctuations will be measured in real-time as socket adjustment strategies are tested. This will be accomplished using a portable bioimpedance device with thin sticky electrodes that are placed on the residual limb. Specifically, the change in limb volume will be assessed from a baseline period where no socket adjustments are made to another period within the same test session where socket adjustments are made.	Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.
Primary	Integral of Absolute Error to Maintain Set Point	Clinically acceptable socket volume error as measured by an automatically adjusting prosthetic socket attempting to maintain a set socket volume set point, based on sensed distance (measured in mm).	Over 30 minutes of controlled use of the auto-adjusting socket
Secondary	Adjustable Socket Mode Preference	Participants tested the adjustable prosthesis in their home environment in one of three adjustment configurations: "locked" where panels were kept in position and did not move, similar to their own prosthesis; "manual" where panels were able to be adjusted inward or outward radially, by the participant via a phone app; "automatic" where panels adjusted inward or outward radially as when the participant walked for a sufficiently continuous amount of time. Participants were also able to manual adjust panels as needed in this mode as well.	After 3 weeks of use, where each mode was tested for about 1 week