Digital Weight Bearing Shape Capture Socket Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Digital Weight Bearing Shape Capture Socket Technology to Preserve Limb Health and Improve Rehabilitation Outcomes

Conditions
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Amputation, Prosthesis User, Residual Limbs

Intervention / Treatment
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* Device: Symphonie Aqua Digital System
* Device: Symphonie Aqua System (Non-Digital)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care - Non-Weight Bearing (Socket A)<br>A non-digital weight-bearing socket will be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use. | Device: Symphonie Aqua System (Non-Digital)<br>* A non-digital weight-bearing socket will be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use.<br>|
| Experimental: Symphonie Aqua System - Non-Digital (Socket B)<br>We will digitally capture (via computer) the shape of your limb, which will create a digital file (computer file) of what the internal shape of your socket should be. This file will then be used with a computer software program to optimize the fit of your prosthesis. This image will be used to create a check socket (temporary socket) to confirm a correct anatomical and comfortable socket. Then the check socket (temporary socket) will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use. | Device: Symphonie Aqua Digital System<br>* We will digitally capture (via computer) the shape of your limb, which will create a digital file (computer file) of what the internal shape of your socket should be. This file will then be used with a computer software program to optimize the fit of your prosthesis. This image will be used to create a check socket (temporary socket) to confirm a correct anatomical and comfortable socket. Then the check socket (temporary socket) will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use.<br>Device: Symphonie Aqua System (Non-Digital)<br>* A non-digital weight-bearing socket will be used to create the check socket (temporary socket), which will be used to create a laminated final socket for home use and research outcomes. The check socket is temporarily used; whereas, the final socket is for long-term use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trans-Epidermal Water Loss (TEWL) | 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. | 12-weeks | 
| Laser Speckle Imaging (LSI) | Differences between two systems and effects on vasculature will be measured using Laser Speckle Imaging (LSI) which is a non-invasive machine that uses light to capture the vasculature of participants residual limb. | 12-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-socket pressure | 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. | 12-weeks | 
| Mobility (6MWT) | 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. | 12-weeks | 
| Balance during ambulation (TUG) | 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. | 12-weeks | 
| Houghton Scale | 4-item instrument that quantifies functional outcomes; A score of nine or more defined as successful prosthetic rehabilitation. | 12-weeks | 
| Socket Comfort Score | Single item self-report instrument; This score is a subjective measure of how comfortable the amputee feels in the socket at the time the score is taken. The scale ranges from 0 to 10 with 0 being the most uncomfortable socket fit and 10 being the most comfortable socket fit. | 12-weeks | 
| Veterans RAND 36-Item Health Survey | Brief, generic, multi-use, healthy survey comprised of 36 items; The instrument is primarily used to qualitatively measure health-related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations. | 12-weeks |