An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

University of Washington

Status: Enrolling

Conditions: Diurnal Residual Limb Fluid Volume Fluctuation; Lower Limb Amputation Below Knee (Injury)

Treatments: Device: Auto Adjusting Prosthesis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05124652

STUDY00009418

1R01HD103815-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Focus Group Testing

No Intervention group

Description:

Focus group testing of key-fob device to control adjusting socket system

In-Lab, Crossover Study

Experimental group

Description:

Testing of auto-adjusting algorithm in-lab. Participants will carry out a structured protocol wearing the socket in all modes. Order will be randomly assigned.

Treatment:

Device: Auto Adjusting Prosthesis

Out-of-Lab Crossover Study

Experimental group

Description:

Evaluate socket performance in user free-living environments. Participants will use the prosthesis in all modes by end of study, order will be randomly assigned.

Treatment:

Device: Auto Adjusting Prosthesis