Digital Weight Bearing Shape Capture Socket Technology

Amputation Clinical Trial

— DWB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05749952
• Other study ID #: 15478
• Status: Completed
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: July 18, 2023

Study information

• Verified date: September 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Prosthesis User
• Residual Limbs

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Houghton Scale	4-item instrument that quantifies functional outcomes; A score of nine or more defined as successful prosthetic rehabilitation.	12-weeks
Secondary	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
Secondary	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