- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03103048
Application of Different Techniques of Elastic Bandage
17 mai 2018 mis à jour par: Terigi Augusto Scardovelli, University of Mogi das Cruzes
Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
This study will be featured as a randomized controlled.
As the dependent variable, was considered isometric grip manual force.
As independent variable, the presence or absence of forearm bandage in the fist flexor region of the volunteers.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
This study is directed to the population of students at the University of Mogi das Cruzes (UMC), and will take part of this study forty volunteers, twenty men and twenty women, aged from eighteen and thirty-eight years old.
Will be selected and included volunteers who do not do physical professional activity with upper members, which have no symptom of pain skeletal muscle in the upper members, which have not undergone any type of surgery in the region of the forearm and hand of both members.
Will be excluded the volunteers who have injuries, joint injuries, neuromuscular disorder or those who have knowledge of own vestibular or neurological changes.
Will also be excluded from study volunteers who do not agree to participate after reading and understanding of informed consent in accordance with resolution 466/12 of the National Ethics Committee and Research.
The data acquisition interface will be acquired by an electromyography e a standard of strentgh will maintened in forty Newtons assured by an electronic dynamometer for tests of palmar prehension without and with bandages.
The volunteers will not know what kind of intervention will pass.
After each application before testing, their both forearms will be covered with a protection.
The researcher and the volunteers will not know the tests order.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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São Paulo
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Mogi Das Cruzes, São Paulo, Brésil, 08615120
- Terigi Augusto Scardovelli
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 38 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Who do not do physical professional activity with upper members;
- Who have no symptom of pain skeletal muscle in the upper members;
- Who have not undergone any type of surgery in the region of the forearm and hand of both members;
- Consent form signed by the volunteer.
Exclusion Criteria:
- Having less than 18 years old;
- Having more than 38 years old;
- To present some compromise skeletal muscle in the upper members;
- Who do not want take part in the research;
- Who do not signed consent form as volunteer.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group 1
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages (start); 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage.
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
|
Comparateur placebo: Group 2
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo (start); 3 - With bandage; 4 - With tensioned bandage.
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
|
Comparateur actif: Group 3
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage (start); 4 - With tensioned bandage.
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
|
Comparateur actif: Group 4
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage (start).
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Efforts
Délai: 15 minutes
|
Thru palmar prehension there will be data acquisition interface by an electromyography e a standard of strentgh maintened in 40 Newtons assured by an electronic dynamometer for tests of palmar prehension, with and without elastic adhesive bandages in the region of flexor muscle of fist.
|
15 minutes
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Terigi A Scardovelli, Ph.D., University of Mogi das Cruzes
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
3 avril 2017
Achèvement primaire (Réel)
8 mai 2017
Achèvement de l'étude (Réel)
21 juin 2017
Dates d'inscription aux études
Première soumission
31 mars 2017
Première soumission répondant aux critères de contrôle qualité
31 mars 2017
Première publication (Réel)
6 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 mai 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 mai 2018
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- CAAE 64513617.3.0000.5497
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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