- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Paca
-
Hyeres, Paca, Francia, 83418
- Leon Berard hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso-Crossover
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Box and Block test
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quick DASH test
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Valerie Chavineau-Mortelette, MedD, Leon Berard hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 2015-A00381-41.V1.2
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Burned Hands
-
Azienda ULSS 8 BericaReclutamentoTrauma perineale | Tecnica Pratica | Tecnica Hands-of | Protezione Perineale ManualeItalia