Light Constraint Induced Therapy Experiment (LICITE)
Effects of a Modified Constraint Induced Therapy Intervention in Stroke Patients: A Multicenter, Randomized Controlled Trial.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Constraint-Induced Movement therapy or CI therapy is a rehabilitation method, that has been shown in controlled studies to produce improvements of upper limb motor function in stroke patients. However, in the original method, 6 hours of daily training are requested, which is often impossible to apply in the majority of rehabilitation unit.
The aim of this trial is to compare the effect of a modified constraint induced therapy (90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation) to the treatment described originally by Taub et al. (360 minutes of motor training with a physical or occupational therapist).
Patients randomly received one of the two treatment and be evaluated pre- post- and 3 months after the intervention ended. The treatment will last two weeks, five days per week. The evaluations will include clinical measure of motor function and functional MRI of the brain. The brain activity will be measure just before and after the intervention with a manual motor task in order to asses brain plasticity.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Paris Cedex 18
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Paris, Paris Cedex 18, France, 75877
- Service de Médecine Physique et de Réadaptation - Hôpital BICHAT
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
INCLUSION CRITERIA:
- Age > 18 years
- First ischemic or hemorrhagic stroke between 2 and 12 months
- at least 10°of active wrist extension and at least 10° of thumb abduction/ extension, and at least 10° of extension in at least 2 additional digits.
- adequate balance while wearing the restraint
EXCLUSION CRITERIA:
- Major cognitive impairment
- Prior stroke
- Excessive fatigability
- Severe aphasia
- MAL score ≥ 2,5
- Specific exclusion criteria for fMRI ancillary study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Thérapie standard
|
360 minutes of motor training with a physical or occupational therapist, 5 days/week/2 weeks
Autres noms:
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Comparateur actif: Modified Therapy
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90 minutes of motor training with a physical or occupational therapist and 270 minutes of self-rehabilitation, 5 days/week/2 weeks.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Motor activity log scale
Délai: 10 days before inclusion, 10 days and 3 months after treatment achievement
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10 days before inclusion, 10 days and 3 months after treatment achievement
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Wolf Motor Function test Stroke impact scale Functional MRI HAD scale
Délai: 10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
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10 days before inclusion, 10 days and 3 months after treatment achievement except for fMRI (no evaluation at 3 month)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Olivier SIMON, MD, PhD, Assistance Publique - Hôpitaux de Paris
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- 1- Constraint induced therapy
- 2- Stroke
- 3- Upper limb
- 4- Rehabilitation
- 5- Motor training
- 1- First time clinical ischemic or hemorrhagic stroke
- 2- At least 10° of active wrist extension
- 3- At least 10° of thumb abduction/ extension
- 4- At least 10° of extension in at least 2 additional digits
- 3- Adequate balance while wearing the restraint.
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P070161
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