Digital Weight Bearing Shape Capture Socket Technology

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.

• Symphonie Aqua Digital System mediated sh (Device): For socket fabrication, the shape capturing is done in full weight bearing.

Primary outcomes

• Trans-Epidermal Water Loss (TEWL) [6 weeks]: Differences between two systems and effects on Trans-Epidermal Water Loss (TEWL) will be measured by placing a non-invasive probe on the surface of the skin. Each measurement takes approximately 7-30 seconds each. The data is presented as g x m\^-2xh\^-1. Higher number indicates worse outcome.

Secondary outcomes

• Laser Speckle Imaging (LSI) [6-weeks]: Differences between two systems and effects on blood flow will be measured using Laser Speckle Imaging (LSI) which is a non-invasive machine that uses light to capture the blood flow of participants residual limb. The blood flow (perfusion) data is expressed as perfusion units (PU) where PU is a relative, dimensionless measure of tissue blood flow or microvascular perfusion. Higher value indicates better perfusion (increase in blood flow).
• In-socket Pressure [6-weeks]: Measurements of socket pressure will be evaluated using in-socket sensors, which are positioned into the socket and function to detect the amount of residual load (pressure) that is placed on the limb.
• Mobility (6MWT) [6-weeks]: 6-minute walking test (6MWT); Subject will walk for 6 consecutive minutes and, once the 6 minutes has elapsed, the distance covered will be measured.
• Balance During Ambulation (TUG) [6-weeks]: Timed up and go test; In the timed up-and-go outcome, the patient rises from a seated position, walks three meters at a self-selected speed, turns around, and returns to the chair where they reseat themselves.

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Trans-Epidermal Water Loss (TEWL) (Primary), Mean, g x m^-2xh^-1: Socket A - Standard of Care Socket 22.9 +/- 9.46; Socket B - Symphonie Aqua Digital System 14.7 +/- 5.11
• Laser Speckle Imaging (LSI) (Secondary), Mean, PU: Socket A - Standard of Care Socket 4.8 +/- 3.4; Socket B - Symphonie Aqua Digital System 4.1 +/- 2.8
• In-socket Pressure (Secondary), Mean, kPa: Socket A - Standard of Care Socket 1.93 +/- 1.36; Socket B - Symphonie Aqua Digital System 0.91 +/- 0.79
• Mobility (6MWT) (Secondary), Mean, meters: Socket A - Standard of Care Socket 376 +/- 57; Socket B - Symphonie Aqua Digital System 364 +/- 47
• Balance During Ambulation (TUG) (Secondary), Mean, Seconds: Socket A - Standard of Care Socket 9.3 +/- 2.3; Socket B - Symphonie Aqua Digital System 9.6 +/- 2.0

Adverse events

Time frame: 12-weeks

• Study Protocol and Statistical Analysis Plan (PDF, 2022-09-06)
• Informed Consent Form (PDF, 2022-09-06)

• Sashwati Roy, PhD., Principal investigator, Indiana University