Clinical trial NCT03550118: Auto Control of Volume Management for Limb Loss
Official title: Auto Control of Volume Management for Limb Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury)
Keywords: Prosthetic Socket
Amputee
Adjustable Socket
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Limb Volume
timeFrame: 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.
measure: Change in Limb Movement
timeFrame: 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.
measure: Number of Participants With Increase in Limb Fluid Volume After Panel Pull
timeFrame: 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.
measure: Integral of Absolute Error to Maintain Set Point
timeFrame: Over 30 minutes of controlled use of the auto-adjusting socket
Secondary outcomes:
measure: Adjustable Socket Mode Preference
timeFrame: After 3 weeks of use, where each mode was tested for about 1 week
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Bioengineering
state: Washington
Study officials:
affiliation: University of Washington
name: Joan E Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References: