An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

Lower Limb Amputation Below Knee (Injury) Clinical Trial

Official title:

An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124652
• Other study ID #: STUDY00009418
• Secondary ID: 1R01HD103815-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: June 2027

Study information

• Verified date: September 2022
• Source: University of Washington
• Contact: Katheryn Allen, CPO
• Phone: 206-390-0228
• Email: kate[@]allyn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 or older (Prosthetists and Prosthesis Users)

• must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)

• had a trans-tibial amputation at least 12 months prior (prosthesis users only)

• regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)

• self-report experiencing limb volume fluctuation in the past (prosthesis users only)

• have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)

• walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)

• capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)

Exclusion Criteria:

• Are not certified prosthetists (prosthetists only)

• neuropathy (prosthesis users only)

• reduced skin sensation (prosthesis users only)

• regular use of an assisted device (prosthesis users only)

• sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)

Related Conditions & MeSH terms

• Diurnal Residual Limb Fluid Volume Fluctuation
• Lower Limb Amputation Below Knee (Injury)

Intervention

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.

Locations

Country	Name	City	State
United States	William H. Foege Hall	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Socket Comfort Score	Participants in Aim 2 and Aim 3 will test various configurations of the auto adjustment algorithm. Socket comfort score will be asked at various time points during testing, and overall changes in this metric will be calculated from the start and end of session.	through study completion, an average of 1 year
Primary	Integral Absolute Error of Control System	Calculated error will be measured through each test session, both in and out of lab.	through study completion, an average of 1 year
Secondary	Thermal Recovery Time (TRT)	An infrared (IR) camera will measure residual limb thermal recovery time at the beginning and end of testing--following at least 5 minutes of walking.	through study completion, an average of 1 year
Secondary	Percent change in Limb Fluid Volume	Participant's limb fluid volume will be measured during the structured in-lab protocol (Aim 2), and changes will be compared against an initial reference point of activity during which no interventions will take place.	through study completion, an average of 1 year