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A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient

5 août 2018 mis à jour par: Lam So Ling, Stefanie, Shatin Hospital
This study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

93

Phase

  • N'est pas applicable

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

45 ans à 85 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age between 45-85
  • Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke
  • Scoring > 6 of 10 of Abbreviated Mental Test
  • Ability of the paretic hand to hold the game controller (minimal control)
  • Able to give informed consent of the study
  • Can understand instructions given by English or Cantonese

Exclusion Criteria:

  • Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment
  • Having cardiac pacemaker
  • Receptive dysphasia
  • Undergoing drug studies or other clinical trials

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: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Bilateral movement-based computer training

All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care.

Subjects in Intervention Group will be assigned an additional 30 minutes bilateral movement-based computer games(Able-X) training program of upper limb.
Autre: Bilateral movement-based computer training
Autre: Video-directed conventional training
All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care.
Autre: Video-directed conventional training

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks
Délai: Change from baseline to 4 weeks
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA-UE scores measure motor impairment of upper extremity. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
Change from baseline to 4 weeks
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks
Délai: Change from baseline to 8 weeks
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA-UE scores measure motor impairment of upper extremity. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
Change from baseline to 8 weeks
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup
Délai: Change from baseline to 12 weeks (4 weeks after training ended)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA-UE scores measure motor impairment of upper extremity. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
Change from baseline to 12 weeks (4 weeks after training ended)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Action Research Arm Test (ARAT) baseline to 4 weeks
Délai: Change from baseline to 4 weeks
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
Change from baseline to 4 weeks
Action Research Arm Test (ARAT) baseline to 8 weeks
Délai: Change from baseline to 8 weeks
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
Change from baseline to 8 weeks
Action Research Arm Test (ARAT) baseline to followup
Délai: Change from baseline to 12 weeks (4 weeks after training ended)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
Change from baseline to 12 weeks (4 weeks after training ended)
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks
Délai: Change from baseline to 4 weeks
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population. SF-36 is the most commonly used generic instrument for measuring quality of life.
Change from baseline to 4 weeks
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks
Délai: Change from baseline to 8 weeks
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population. SF-36 is the most commonly used generic instrument for measuring quality of life.
Change from baseline to 8 weeks
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup
Délai: Change from baseline to 12 weeks (4 weeks after training ended)
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population. SF-36 is the most commonly used generic instrument for measuring quality of life.
Change from baseline to 12 weeks (4 weeks after training ended)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shatin Hospital

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 août 2015

Achèvement primaire (Réel)

1 février 2017

Achèvement de l'étude (Réel)

1 février 2017

Dates d'inscription aux études

Première soumission

6 octobre 2017

Première soumission répondant aux critères de contrôle qualité

5 août 2018

Première publication (Réel)

7 août 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HMRF02133096

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

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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