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Prosthetic Socket

Adjustable Prosthetic Sockets for Leg Amputation

N/A
Waitlist Available
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and 3 weeks post-intervention
Awards & highlights

Study Summary

This trial will test whether or not adjustable sockets improve quality of life for people with limb loss.

Who is the study for?
This trial is for individuals with one leg amputated who use a prosthetic leg and can walk on uneven surfaces. They should be able to communicate well and not have other major health issues like neurological or cardiovascular diseases, severe vision problems, or conditions affecting their walking ability.Check my eligibility
What is being tested?
The study is comparing four types of prosthetic sockets: Laminated Socket, Infinite Socket, Quatro, and CJ Socket. It aims to understand the benefits of adjustable sockets to help clinicians make better decisions for their patients.See study design
What are the potential side effects?
Since this trial involves non-drug interventions (prosthetic sockets), typical drug side effects are not applicable. However, participants may experience discomfort or skin issues at the site where the prosthesis attaches to the body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and 3 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and 3 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Comfort between laminated and adjustable prosthesis using the Socket Fit Comfort Score
Change in Comfort between laminated and adjustable sockets using the Socket Fit Comfort Score
Change in Confidence in different activities between laminated and adjustable sockets using the Activities Specific Balance Confidence Scale (ABC Scale)
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Adjustable SocketsExperimental Treatment3 Interventions
In this condition, participants will be fitted with 3 different adjustable transfemoral sockets by a certified prosthetist. The order in which the sockets are fitted are randomized and the participant will spend approximately 4 weeks in each socket.
Group II: Prescribed Laminated SocketPlacebo Group1 Intervention
In this arm, participants will wear their clinically prescribed laminated socket. This period is approximately 2 weeks.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,378,028 Total Patients Enrolled

Media Library

CJ Socket (Prosthetic Socket) Clinical Trial Eligibility Overview. Trial Name: NCT04038580 — N/A
Amputation Research Study Groups: Prescribed Laminated Socket, Adjustable Sockets
Amputation Clinical Trial 2023: CJ Socket Highlights & Side Effects. Trial Name: NCT04038580 — N/A
CJ Socket (Prosthetic Socket) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038580 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently eligible to join this medical experiment?

"Precisely. Clinicaltrials.gov attests that this clinical research is actively recruiting, commencing on August 15th 2019 and most recently edited on October 24th 2022. 30 participants must be enrolled across two sites for the study to commence."

Answered by AI

Is enrollment for this clinical trial still available?

"As per clinicaltrials.gov, this study is presently in search of participants. It was first initiated on the 15th August 2019 and underwent its latest update on 24th October 2022."

Answered by AI

Who else is applying?

What state do they live in?
South Dakota
How old are they?
18 - 65
What site did they apply to?
Rosalind Franklin University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Comparative Assessment of Transfemoral Prosthetic Sockets
Deanna H Gates 2019. "A Comparative Assessment of Transfemoral Prosthetic Sockets". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038580.
~0 spots leftby May 2024
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