Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease.
The investigators hypothesis is that the experimental group (EG), which hold gait training with higher cognitive demands (dual-task condition), will make improvements in the parameters measured (functionality of gait and cognitive ability) to a greater extent compared to the control group (CG), which hold gait training without executive tasks (single-task condition).
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.
Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference:
- the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions;
- the control group (CG) will hold an additional 30 minutes of gait training without associated tasks.
It will be a prospective study, single blind, randomized, where 30 patients with PD in stages 1 to 3 on Hoehn & Yahr scale will participate in the study, to be held in Brazil Parkinson Association. Patients will be randomized into an experimental and control group, 15 in each one.
The training will consist of 10 sessions, two times per week for five weeks. The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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São Paulo, Brésil
- Recrutement
- Brazil Parkinson Association
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Contact:
- Grossmann, President
- Numéro de téléphone: 55-11-25788177
- E-mail: parkinson@parkinson.org.br
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Chercheur principal:
- Cynthia B Ferrari, PhD Student
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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:
- Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders;
- In use of dopaminergic medication;
- Disease severity of 1 to 3 according to Hoehn & Yahr scale;
- Absence of other neurological disorders or co-morbidities that may affect gait;
- Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
- Vision and hearing adequate or corrected to normal;
- Ability to walk independently;
- Absence of prolonged off state;
- Age 50 to 85 years.
Exclusion Criteria:
- Biomechanical alterations (other pathologies) that could compromise the completion of training;
- Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
- Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
- Any changes in drug treatment for PD.
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 |
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Expérimental: Gait training executive functions tasks
The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).
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L'entraînement consistera en 10 séances, deux fois par semaine pendant cinq semaines, et consistera en 30 minutes d'exercices globaux qui impliquent des exercices d'étirement, de renforcement musculaire et de mobilité axiale, et 30 minutes supplémentaires d'entraînement à la marche dans une condition de double tâche associée à tâches distrayantes qui nécessitent de gérer les principales fonctions exécutives : volition, conscience de soi, planification, inhibition de la réponse, surveillance de la réponse et attention.
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Comparateur actif: Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
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The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dynamic Gait Index
Délai: 05/2013 (Up to ten months)
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The scale assesses the ability to adapt the gait during motor tasks with different demands.
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05/2013 (Up to ten months)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Montreal Cognitive Assessment
Délai: 05/2013 (Up to ten months)
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This scale was developed in order to detect mild degrees of cognitive impairment.
The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
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05/2013 (Up to ten months)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Maria Elisa P Piemonte, PhD, University of Sao Paulo
- Chercheur principal: Cynthia B Ferrari, PhD Student, University of Sao Paulo
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- USPNEC002
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