Above-knee Socket Evaluation : Sub-ischial vs Ischial Containment (P20-EMBSUBI)

August 8, 2022 updated by: Proteor Group

AK Socket Evaluation : Sub-ischial vs Ischial Containment. Multi-center Randomised Crossover Study

Socket is key to provide comfort and function to lower limb amputees. A new socket, the sub-ischial socket, will be compared to "traditional" ischial containment sockets, based on comfort self-evaluation, and locomotor capacities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects wearing ischail containment sockets will be proposed to enter the research. They will be provided and fitted with a sub-ischial socket. Randomly, they will use one or the other socket for four weeks, then be tested : finctional test and questionnaires. After this testing session, they will use the other socket, and be re-tested accordingly.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Les Capucins
      • Bruges, France, 33523
        • UGECAM La Tour de Gassies
      • Colomiers, France, 31771
        • Clinique du Cabirol
      • Hyères, France, 83418
        • Hôpital Léon Berard
      • Nancy, France, 54000
        • UGECAM - IRR Nancy
      • Paris, France, 75007
        • Institution Nationale des Invalides
      • Ploemeur, France, 56275
        • Centre Mutualiste de Kerpape
      • Saint-Herblain, France, 44818
        • UGECAM La Tourmaline
      • Vannes, France, 56000
        • CHBA Vannes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • can give informed consent
  • aged 18 or more
  • above-knee amputee, wearing a definitive ischial containment socket
  • stump longer than 16cm
  • wearing a liner, whatever the suspension system
  • able to walk (d4600, d4601, d4602, d4608 accordinf to IFC)
  • unilaterla or bilateral amputee
  • able to done the socket standing
  • whatever the etiology

Exclusion Criteria:

  • protected person
  • pregnant woman or nursing mother
  • subject having comorbidities heavily impacting feeling or socket donning
  • allergic to silicon
  • suffering from big volume variations in a same day
  • infecté stump (may lead to lymphatic problems)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sub-ischial socket
Start using the sub-ischial socket for four weeks and be tested with this socket.
Device: Socket evaluation
The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test
Active Comparator: Ischial containment socket
Start using the ischial containment socket for four weeks and be tested with this socket.
Device: Socket evaluation
The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort evaluation
Time Frame: 1 minute
Socket Comfort Score (SCS)
1 minute

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort evaluation in various situations
Time Frame: 1 minute
Same question for four detailed situations
1 minute
Locomotor capability
Time Frame: 5 minutes
PLUS-M questionnaire and 2-minute walking test
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteor Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

March 8, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 10, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-A03303-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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