Clinical trial NCT05124652: An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation
Official title: An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury)
Diurnal Residual Limb Fluid Volume Fluctuation
Keywords: amputee
prosthetic
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All aims will be conducted as randomized control trials and test various developments to the auto adjusting system, with each previous aim informing the next.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Socket Comfort Score
timeFrame: through study completion, an average of 1 year
measure: Integral Absolute Error of Control System
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Thermal Recovery Time (TRT)
timeFrame: through study completion, an average of 1 year
measure: Percent change in Limb Fluid Volume
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: William H. Foege Hall
state: Washington
Study officials:
affiliation: University of Washington
name: Joan E Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
References: