Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients
14 mars 2019 mis à jour par: Yonsei University
Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial
This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients.
- Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy
- Subjects : total 99 patients with stroke whose upper limb functions are impaired
- Intervention : 4 weeks of therapy (5 days per week)
- Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis
- Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
108
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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Seoul, Corée, République de, 03722
- Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
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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
20 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Upper FMA 7-38
- Hemiplegic patients within 6months after stroke onset
- male or female, 20 years older
Exclusion Criteria:
- Patients with cognitive impairment who are unable to comply with protocol-required procedure
- Quadriplegic or double hemiplegic patients
- Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
- Patients with lower motor neuron disease
- Patients who cannot perform rTMS
- Pregnant woman
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: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Robot and rTMS
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
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The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain. The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Autres noms:
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Expérimental: Robot
Robot-Assisted upper arm training group(intervention group2)
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The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively.
This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software.
The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks.
And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Autres noms:
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Comparateur actif: Conventional
Conventional training group(control group)
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The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS.
And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fugl-Meyer Assessment (FMA)
Délai: 1 minute before the first intervention
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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.
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1 minute before the first intervention
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Fugl-Meyer Assessment (FMA)
Délai: 2 weeks after the first intervention
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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.
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2 weeks after the first intervention
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Fugl-Meyer Assessment (FMA)
Délai: 4 weeks after the first intervention
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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.
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4 weeks after the first intervention
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Fugl-Meyer Assessment (FMA)
Délai: 4 weeks after the final intervention
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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.
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4 weeks after the final intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Wolf motor function test
Délai: 1 minute before the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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1 minute before the first intervention
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Wolf motor function test
Délai: 2 weeks after the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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2 weeks after the first intervention
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Wolf motor function test
Délai: 4 weeks after the first intervention
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The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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4 weeks after the first intervention
|
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Wolf motor function test
Délai: 4 weeks after the final intervention
|
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
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4 weeks after the final intervention
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Manual Function test
Délai: 1 minute before the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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1 minute before the first intervention
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Manual Function test
Délai: 2 weeks after the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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2 weeks after the first intervention
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Manual Function test
Délai: 4 weeks after the first intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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4 weeks after the first intervention
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Manual Function test
Délai: 4 weeks after the final intervention
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The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
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4 weeks after the final intervention
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Kinematic data of computerized 3D motion analysis
Délai: 1 minute before the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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1 minute before the first intervention
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Kinematic data of computerized 3D motion analysis
Délai: 2 weeks after the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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2 weeks after the first intervention
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Kinematic data of computerized 3D motion analysis
Délai: 4 weeks after the first intervention
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D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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4 weeks after the first intervention
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Kinematic data of computerized 3D motion analysis
Délai: 4 weeks after the final intervention
|
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
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4 weeks after the final intervention
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Collaborateurs et enquêteurs
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Parrainer
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)
18 juin 2015
Achèvement primaire (Réel)
26 juin 2018
Achèvement de l'étude (Réel)
26 juin 2018
Dates d'inscription aux études
Première soumission
30 janvier 2017
Première soumission répondant aux critères de contrôle qualité
1 février 2017
Première publication (Estimation)
3 février 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 mars 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 mars 2019
Dernière vérification
1 mars 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1-2014-0083
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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