Symphonie Aqua System - Non-Digital (Socket B) for Amputation

Indiana University Health Methodist Hospital, Indianapolis, IN
Amputation+2 More ConditionsSymphonie Aqua System (Non-Digital) - Device
All Sexes
What conditions do you have?

Study Summary

This trial tests a new method of socket creation to see if it can improve fit and comfort for amputees, and if that can help improve their overall health.

Eligible Conditions
  • Amputation
  • Prosthetic Limbs
  • Prosthesis User

Treatment Effectiveness

Study Objectives

4 Primary · 10 Secondary · Reporting Duration: 12-weeks

Balance during ambulation (TUG)
Houghton Scale
In-socket pressure
Laser Speckle Imaging (LSI)
Limb Health Measurements using Laser Speckle Imaging (LSI) Machine
Limb Health Measurements using Trans-Epidermal Water Loss (TEWL) Instrument
Mobility (6MWT)
Pressure inside the socket
Prosthesis Evaluation Questionnaires (Houghton Scale)
Prosthesis Evaluation Questionnaires (Socket Comfort Score)
Prosthesis Evaluation Questionnaires (Veterans RAND 36-Item Health Survey)
Socket Comfort Score
Trans-Epidermal Water Loss (TEWL)
Veterans RAND 36-Item Health Survey

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Standard of Care - Non-Weight Bearing (Socket A)
1 of 2
Symphonie Aqua System - Non-Digital (Socket B)
1 of 2

Active Control

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Symphonie Aqua System - Non-Digital (Socket B) · No Placebo Group · N/A

Symphonie Aqua System - Non-Digital (Socket B)Experimental Group · 2 Interventions: Symphonie Aqua System (Non-Digital), Symphonie Aqua Digital System · Intervention Types: Device, Device
Standard of Care - Non-Weight Bearing (Socket A)
ActiveComparator Group · 1 Intervention: Symphonie Aqua System (Non-Digital) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-weeks

Who is running the clinical trial?

Indiana UniversityLead Sponsor
910 Previous Clinical Trials
775,989 Total Patients Enrolled
United States Department of DefenseFED
801 Previous Clinical Trials
215,027 Total Patients Enrolled
Sashwati Roy, PhD.Principal InvestigatorIndiana University
1 Previous Clinical Trials
24 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your lower leg (below the knee) is longer than 4.5 inches.
You have lost one leg below the knee.
You can walk independently at a moderate to high level of ability.

Frequently Asked Questions

Is the research still recruiting participants?

"As per, this medical trial is not currently recruiting patients. Initially posted on March 6th 2023 and last updated in February of the same year, no further participants are needed for now; however, 71 other trials remain open to potential volunteers at present." - Anonymous Online Contributor

Unverified Answer

What are the key goals of this experiment?

"The main aim of this 12-week analysis is to gauge Limb Health by assessing Trans-Epidermal Water Loss (TEWL) with an Instrument. Secondary objectives encompass Mobility, Balance while ambulating, and Prosthesis Evaluation Questionnaires - the Houghton Scale in particular - using a 4-item scoring system with nine or more indicating successful prosthetic rehabilitation. A 6-minute walking test will be employed as part of tracking patient Mobility. Additionally, for monitoring balance during movement, participants must complete a Timed up and go task which requires them to rise from their seat, cover three meters at their own pace then return" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.