- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02659449
Assessing the Impact of Different Compression of the Hand Versus Free Hand on the Implementation of the Precision Grip (EvICoMaB)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Paca
-
Hyeres, Paca, France, 83418
- Leon Berard hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-Crossover
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Box and Block test
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quick DASH test
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Valerie Chavineau-Mortelette, MedD, Leon Berard hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2015-A00381-41.V1.2
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