- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02600728
Training Based On Declarative Memory Cues Improved Gait In Patients With Parkinson's Disease
Improvement In Gait Performance After Training Based On Declarative Memory Cues In Patients With Parkinson's Disease: A Randomized Clinical Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Deficits in automatic motor control, characteristic of Parkinson's disease (PD), contribute to progressive impairment in gait performance. The use of declarative memory cues in order to promote the engagement of attention and activation of the next movement in gait may minimize the consequences of lack of automatic control.
Objectives: To verify the long-term efficiency of a new strategy based on declarative memory cue to improve the gait performance and independence in daily life activities (DLA) in patients with PD.
Design: Parallel prospective, single blind, randomized clinical trial. Setting: Brazilian Parkinson Association. Participants: Forty-four patients with PD in stages 2-3 of disease evolution according to Hoehn and Yahr Classification Interventions: The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS). The control training (CT) consisted of a similar gait training without DMCS.
Primary outcome measure: Gait performance in terms of speed and stride length. Secondary outcome measure: Independence in DLA according to Section II of the Unified Parkinson's Disease Rating Scale.
Randomization: Participants were randomized into a control group (CG), which performed the CT, and an experimental group (EG), which performed the ET, through blinded drawing of names.
Statistical analysis: The gait performance and ADL independence before, 2 and 60 days after the end of training were compared for CG and EG using Repeated-measures analysis of variance (RM-ANOVA).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
São Paulo, Brésil, 05360-160
- Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
-
-
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 Parkinson's disease according to the UK Brain Bank criteria;
- in stage 2-3 of the disease evolution according to the Hoehn and Yahr;
- treated with levodopa or its synergists;
- capable to ambulate independently indoors without aid;
- referring 5 to 15 years of education;
- good visual and auditory acuity.
Exclusion Criteria:
- presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
- visual and auditory deficiency;
- dementia [assessed by the Mini Mental State Examination (MMSE), cut-off 23];
- depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6]
- participation in other physical therapy training.
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 |
---|---|
Expérimental: experimental group (EG)
The experimental training (ET) consisted of eight gait training sessions, twice a week, using the declarative memory cues strategy (DMCS).
|
The ET consisted of 3 phases being that the first one (Phase 1) was done only in the first session. Phase 1: patients received a short and simple explanation about the deficiency in automatic movement resulting from PD. Following explanation, the patient memorized a sequence of declarative cues. Phase 2: the patient organized a sequence of cues using cards illustrating the subcomponent movements (key movement) involved in taking steps. Phase 3: the patient had to train using declarative cues as a gait performance aid through 8 sets follow the instruction "Walk in your ordinary speed. Use the key movements and going to saying each of them while you make them. The declarative cues had to be evoked verbally by the patients themselves, during gait, triggering the corresponding movement.
Autres noms:
|
Comparateur actif: control group (CG)
The control training (CT) consisted of a similar gait training without DMCS.
|
The CT consisted of 3 phases, being the first one (Phase 1) was done only in the first session of training, and the other two (Phase 2 and 3) were repeated at each of the 8 sessions. Phase 1: Patients received a short and simple explanation about the deficiency in automatic movement resulting from PD. Phase 2: Patients received a general verbal attentional instruction of "pay attention to your steps and try to walk as better as you can", before starting the walk. Phase 3: motor training of gait, where the patient had to perform 8 sets, following the instruction "Walk in your ordinary speed, paying attention to your steps" in the identical trajectories of ET. Additional instructions or cues were not provided. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
gait speed
Délai: up to 3 months
|
The first primary outcome was the gait speed (m/s).
Patients were asked to walk in a straight trajectory of 20 meter following the sole instruction "upon the go signal, walk as fast as possible at the line and stop".
The speed was calculated based on the time to walk 20 meters timed using a digital chronometer.
|
up to 3 months
|
stride length on gait
Délai: up to 3 months
|
The second primary outcome was the stride length (cm) on gait.
Patients were asked to walk in a straight trajectory of 20 meter following the sole instruction "upon the go signal, walk as fast as possible at the line and stop".
The number of steps was measured using a pedometer.
|
up to 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Independence in activities of daily living (ADL)
Délai: up to 3 months
|
The secondary outcome was independence in activities of daily living (ADL), assessed by Section II of the Unified Parkinson Disease Rating Scale (UPDRS-II).
This section includes 12 questions (items 5 to 16) on patient's performance in ADL.
Among these questions, two investigate gait performance (frequent fall due to freezing; inability to walk ), with scores ranging from zero (normal) to 4.
|
up to 3 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Maria Elisa P Piemonte, PhD, Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- USPNEC006
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 .
Essais cliniques sur Maladie de Parkinson
-
ProgenaBiomeRecrutementMaladie de Parkinson | Maladie de Parkinson avec démence | Syndrome de Parkinson-Démence | Maladie de Parkinson 2 | Maladie de Parkinson 3 | Maladie de Parkinson 4États-Unis
-
National Heart, Lung, and Blood Institute (NHLBI)ComplétéMaladie de Parkinson 6, début précoce | Maladie de Parkinson (autosomique récessive, début précoce) 7, humain | Maladie de Parkinson autosomique récessive, début précoce | Maladie de Parkinson, début précoce autosomique récessif, digénique, Pink1/Dj1États-Unis
-
Ahram Canadian UniversityAin Shams UniversityRecrutementMaladie de Parkinson | Parkinson | Maladie de Parkinson et parkinsonismeEgypte
-
Samuel Vilchez, PhDNational Autonomous University of Nicaragua; Wake Forest University; GID BIO... et autres collaborateursComplétéMaladie de Parkinson et parkinsonisme | Maladie de Parkinson idiopathiqueNicaragua
-
King's College LondonGlaxoSmithKlineComplétéMaladie de Parkinson | Maladie de Parkinson idiopathique | Maladie de Parkinson, PARK8Royaume-Uni
-
Ohio State UniversityComplétéLa maladie de Parkinson | Maladie de Parkinson | Maladie de Parkinson idiopathique | Maladie de Parkinson idiopathique | Maladie de Parkinson, idiopathique | Maladie de Parkinson, idiopathiqueÉtats-Unis
-
National Yang Ming UniversityInconnueMaladie de Parkinson à début précoce | Maladie de Parkinson à un stade précoce
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationInconnueContrôles sains | Maladie de Parkinson avec mutation LRRK2 | Maladie de Parkinson sans mutation LRRK2France
-
University of Campania "Luigi Vanvitelli"Neuromed IRCCSInconnueMaladie de Parkinson secondaireItalie
-
Medical College of WisconsinRetiré
Essais cliniques sur Experimental Training
-
Sheba Medical CenterInconnue
-
Istituto Ortopedico RizzoliRecrutementExercer | Gestion de la douleur | Scoliose idiopathique de l'adolescent | Fusion vertébraleItalie
-
Università degli Studi di SassariComplétéSclérose en plaques | Fatigue | FaiblesseItalie
-
Universidad Complutense de MadridComplété
-
Queen's UniversityComplétéLes troubles mentauxCanada
-
Eduardo Fonseca PedreroPsicofundación: Fundación Española para Promoción, Desarrollo Científico... et autres collaborateursRecrutementDépression | Trouble émotionnel | Trouble anxieux | Problème émotionnelEspagne
-
Beirut Arab UniversityComplété
-
Brno University HospitalRecrutement
-
Johns Hopkins UniversityComplétéTrouble de stress post-traumatique | Exercice d'aérobie | Taï chiÉtats-Unis