Digital Weight Bearing Shape Capture Socket Technology

Not Applicable

Completed

• Conditions: Prosthesis User; Amputation; Residual Limbs

• Registration Number: NCT05749952
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-02-19
• Study First Posted: 2023-03-01
• Study Start: 2023-03-06
• Primary Completion: 2023-07-18
• Study Completion: 2023-07-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Laser Speckle Imaging (LSI)	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.
Trans-Epidermal Water Loss (TEWL)	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.

Secondary Outcome Measures

Name	Time	Method
In-socket pressure	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 (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)	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.
Houghton Scale	12-weeks	4-item instrument that quantifies functional outcomes; A score of nine or more defined as successful prosthetic rehabilitation.
Veterans RAND 36-Item Health Survey	12-weeks	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.
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. The scale ranges from 0 to 10 with 0 being the most uncomfortable socket fit and 10 being the most comfortable socket fit.

Trial Locations

Locations (1)

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States