Clinical trial NCT05749952: Digital Weight Bearing Shape Capture Socket Technology
Official title: Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Prosthesis User
Residual Limbs
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-03-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Detailed description: This study will compare the use of Symphonie Aqua Digital System, which is a new way to create a socket for prosthetics, to the current method that is generally used to create sockets. The study will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).

The study will determine if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability \& functional outcomes than traditional sockets (non-weight bearing scanning). Additionally, the study will determine if a well-fitting socket will positively impact the overall health of amputee residual limb.

Eligibility criteria: Inclusion Criteria:

* Ages 18 and above
* Unilateral trans-tibial amputees
* Ambulate at a K3 level or higher
* At least 3 months post-amputation per physician discretion
* Trans-tibial limb length greater than 4.5 inches in length
* Able to follow directions and independently give informed consent
* Must be able to ambulate without assistance

Exclusion Criteria:

* Age \< 18 years
* Conditions that prevent wearing a prosthetic socket
* Soc Socket made with weight bearing system
* Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
* Women who are pregnant or who plan to become pregnant in the near future
* Weight \> 280 lbs

Primary outcomes:
measure: Trans-Epidermal Water Loss (TEWL)
timeFrame: 12-weeks
measure: Laser Speckle Imaging (LSI)
timeFrame: 12-weeks
Secondary outcomes:
measure: In-socket pressure
timeFrame: 12-weeks
measure: Mobility (6MWT)
timeFrame: 12-weeks
measure: Balance during ambulation (TUG)
timeFrame: 12-weeks
measure: Houghton Scale
timeFrame: 12-weeks
measure: Socket Comfort Score
timeFrame: 12-weeks
measure: Veterans RAND 36-Item Health Survey
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Sashwati Roy, PhD.
role: PRINCIPAL_INVESTIGATOR
References: