Digital Weight Bearing Shape Capture Socket Technology (DWB)

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

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 Overview

• Status: Completed
• Conditions: Amputation; Prosthesis User; Residual Limbs
• Intervention / Treatment: Device: Symphonie Aqua Digital System mediated sh

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symphonie Aqua System - Non-Digital (Socket B); A digital weight bearing test socket where shape capturing is done in full weight bearing	Device: Symphonie Aqua Digital System mediated sh; For socket fabrication, the shape capturing is done in full weight bearing.
Active Comparator: Standard of Care (SoC); This is standard of care socket design where sockets are fabricated in non-weight bearing position	Device: Symphonie Aqua Digital System mediated sh; For socket fabrication, the shape capturing is done in full weight bearing.

What is the study measuring?

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. The data is presented as g x m^-2xh^-1. Higher number indicates worse outcome.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser Speckle Imaging (LSI)	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).	6-weeks
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.	6-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.	6-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.	6-weeks

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Sashwati Roy, PhD., Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): July 18, 2023
• Study Completion (Actual): July 18, 2023

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 15478

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes