DWB: Digital Weight Bearing Shape Capture Socket Technology
Study Details
Study Description
Brief Summary
We hope to find out if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability outcomes than traditional sockets. Additionally, we want to see if a well-fitting socket will positively impact the overall health of your residual limb.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 team will look at the differences in comfort and fit between the Symphonie Aqua Digital System and the current standard of care (SOC).
We hope to find out if Symphonie Aqua Digital System, a new method of socket creation, in a weight-bearing environment, may produce more successful fitting and comfortability outcomes than traditional sockets. We want to see if creating a socket while applying full weight on your amputated limb will reveal a more anatomical shape of your residual limb, which will ultimately improve the fit of your prosthetic socket. Additionally, we want to see if a well-fitting socket will positively impact the overall health of your residual limb. This study involves the use of a new commercially available device called Symphonie Aqua Digital System and Symphonie Aqua System (non-digital) aka research socket (Socket B).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard of Care - Non-Weight Bearing (Socket A) 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)
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.
|
| Experimental: Symphonie Aqua System - Non-Digital (Socket B) 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
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 System (Non-Digital)
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.
|
Outcome Measures
Primary Outcome Measures
- Limb Health Measurements using Trans-Epidermal Water Loss (TEWL) Instrument [12-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.
- Limb Health Measurements using Laser Speckle Imaging (LSI) Machine [12-weeks]
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.
Secondary Outcome Measures
- Pressure inside the socket [12-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) [12-weeks]
6-minute walking test; Subject will walk for 6 consecutive minutes and, once the 6 minutes has elapsed, the distance covered will be measured.
- Balance during ambulation (TUG) [12-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.
- Prosthesis Evaluation Questionnaires (Houghton Scale) [12-weeks]
4-item instrument that quantifies functional outcomes; A score of nine or more defined as successful prosthetic rehabilitation.
- Prosthesis Evaluation Questionnaires (Socket Comfort Score) [12-weeks]
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.
- Prosthesis Evaluation Questionnaires (Veterans RAND 36-Item Health Survey) [12-weeks]
Brief, generic, multi-use, healthy survey comprised of 36 items; The instrument is primarily used to measure health-related quality of life, to estimate disease burden and to evaluate disease-specific impact on general and selected populations.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages 18 and above
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Unilateral trans-tibial amputees
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Ambulate at a K3 level or higher
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At least 3 months post-amputation per physician discretion
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Trans-tibial limb length greater than 4.5 inches in length
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Able to follow directions and independently give informed consent
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Must be able to ambulate without assistance
Exclusion Criteria:
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Age < 18 years
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Conditions that prevent wearing a prosthetic socket
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Soc Socket made with weight bearing system
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Cognitive deficits or mental health problems that would limit ability to consent and participate fully in the study protocol
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Women who are pregnant or who plan to become pregnant in the near future
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Weight > 280 lbs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Health Methodist Hospital | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Indiana University
- United States Department of Defense
Investigators
- Principal Investigator: Sashwati Roy, PhD., Indiana University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15478