Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip (EvICoMaB)

July 22, 2022 updated by: Hôpital Léon Bérard

Assessing the Impact of Different Compression of the Hand (Made to Measure Gloves / Compression Bandaging) Versus Free Hand on the Implementation of the Precision Grip

The purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board / Jamar's test)

Study Overview

Detailed Description

Patients with burned hands will realise prehension test to explore dexterity of hand when they wear compressive's treatments and with free hands.

Each patient will realise each test with all conditions (free hands/ made to measure gloves/ compressive bandaging).

Running order of test and condition is randomly defined. Each patient realized this tests under the care and devices used at usual care. Realisation of this tests are not influenced by the study. Patient realised this tests during reeducation.

Study Type

Observational

Enrollment (Actual)

3

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

    • Paca
      • Hyeres, Paca, France, 83418
        • Leon Berard hospital

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

Sampling Method

Non-Probability Sample

Study Population

Patients with burned hands

Description

Inclusion Criteria :

  • Patient admitted from Leon Bérard Hospital
  • Burn hand with 2nd or 3nd degree depp
  • Dominant hand if bilateral's burning
  • Patients requiring compression of the hand
  • Patient receiving final compression gloves since seven days ± two days weekend
  • Patient affiliated to a social security

Exclusion Criteria :

  • No burning of the hand
  • contraindication for the use of compression
  • Incompatible articular balance with achievement tests
  • Patients already included in a second study
  • Minor patient or pregnant woman
  • Presence of cognitive disorder, preventing the achievement of tests
  • Guardianship or individual under the protection of a conservator
  • Patients not receiving social security

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

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Box and Block test
Time Frame: mesure will be realised three time : 48h - 96h -144 hours after inclusion

A rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, wooden cubes are placed in one compartment or the other. The individual move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds.

The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.

The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive.

Measure will be realised at end of test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves.

The measure will be realised every two days during one week (duration of study after inclusion of patient) after hand's evaluation by the investigator.

mesure will be realised three time : 48h - 96h -144 hours after inclusion
Purdue Pegboard test
Time Frame: mesure will be realised three time: 48h - 96h -144 hours after inclusion

The Purdue Pegboard Test is a rectangular board with 2 sets of 25 holes running vertically and 4 concave cups at the top. Small metal pegs are placed in the cup on the side being tested, with subjects asked to remove the pegs and place them vertically in the holes as rapidly as possible. The number of pegs placed in 30 seconds is scored.

The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive.

Measure will be realised at end of test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves.

the measure will be realised every two days during one week (duration of study) after hand's evaluation by the investigator

mesure will be realised three time: 48h - 96h -144 hours after inclusion
Jamar's Test
Time Frame: mesure will be realised three time :48h - 96h -144 hours after inclusion

A Hand Dynamometer is used for testing hand grip strength. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive.

Measure will be realised at the hand of the test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves.

the measure will be realised every two days during one week (duration of study) after hand's evaluation by the investigator

mesure will be realised three time :48h - 96h -144 hours after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick DASH test
Time Frame: 24 hours after inclusion

This questionnaire asks about your symptoms as well as your ability to perform certain activities.

Quick DASH test is realised 1st day after inclusion of patient on EvICoMaB clinical study and one day before realisation of hand's tests (second day of study) . The measure is obtained at end of questionaire

24 hours after inclusion

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Valerie Chavineau-Mortelette, MedD, Leon Berard hospital

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)

June 23, 2016

Primary Completion (Actual)

July 3, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2015-A00381-41.V1.2

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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