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

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ClinicalTrials.gov Identifier: NCT02659449
Recruitment Status : Unknown
Verified January 2016 by Hôpital Léon Bérard.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Hôpital Léon Bérard

Study Description
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Brief Summary:
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)

Condition or disease Intervention/treatment
Burned Hands Device: made to measure compression gloves Device: Compression bandaging Other: Free Hands

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: 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
Study Start Date : January 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017
Groups and Cohorts
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Intervention Details:
  • Device: made to measure compression gloves
    Patients achieve tests with compression glove
    Other Name: gloves of medical Z laboratory
  • Device: Compression bandaging
    Patients achieve tests with compression bandaging
    Other Name: Coheban
  • Other: Free Hands
    Patients achieve tests without device

Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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


  3. 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



Secondary Outcome Measures :
  1. 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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with burned hands
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659449


Contacts
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Contact: Marie-Noelle Bartholomei, PharmD 494381943 ext +33 mn.bartholomei@leonberard.com
Contact: Nathalie Hoarau, Mrs 494380505 ext +33 info@leonberard.com

Locations
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France
Leon Berard hospital Recruiting
Hyeres, Paca, France, 83418
Contact: Marie-Noelle Bartholomei    +3394381943    mn.bartholomei@leonberard.com   
Contact: Nathalie Hoarau    +3394381943    info@leonberard.com   
Sponsors and Collaborators
Hôpital Léon Bérard
Investigators
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Principal Investigator: Valerie Chavineau-Mortelette, MedD Léon Bérard Hospital
More Information
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Responsible Party: Hôpital Léon Bérard
ClinicalTrials.gov Identifier: NCT02659449    
Other Study ID Numbers: 2015-A00381-41.V1.2
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: January 2016
Keywords provided by Hôpital Léon Bérard:
hands