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

22 juli 2022 uppdaterad av: 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)

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients with burned hands

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Case-Crossover
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Box and Block test
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quick DASH test
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Valerie Chavineau-Mortelette, MedD, Leon Berard hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 juni 2016

Primärt slutförande (Faktisk)

3 juli 2016

Avslutad studie (Faktisk)

1 december 2016

Studieregistreringsdatum

Först inskickad

27 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

15 januari 2016

Första postat (Uppskatta)

20 januari 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 juli 2022

Senast verifierad

1 juli 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 2015-A00381-41.V1.2

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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