rTMS Study to Improve Functional Performance for Patients With Stroke
10 décembre 2015 mis à jour par: Yen-Nung Lin, Taipei Medical University WanFang Hospital
The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea.
Previous studies seemed to support its effects on facilitating motor recovery after stroke.
This study focuses on the motor recovery of lower extremities.
Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients.
Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Protocol:
- Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
- Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
- Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
- Study design: controlled trial with stratified randomization
Blinding
- The patients were blinded by the real or sham coil of rTMS
- The assessors who performed the outcome measurements were blinded to the assignment of treatment.
Measurements.
- Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention.
Clinical assessments.
- Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS)
- The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
- The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
- Timed Up and Go (TUG) test was used to assess the gross mobility.
- Barthel Index (BI) for the ADL independence
- modified Rankin Scale (MRS) for disability classification were also collected.
- These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
- Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Type d'étude
Interventionnel
Inscription (Réel)
60
Phase
- Phase 3
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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New Taipei City, Taïwan
- Shuang Ho Hospital
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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
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- unilateral hemiplegia caused by the stroke,
- first ever stroke,
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- Functional ambulation classification (FAC): 0-2,
Exclusion Criteria:
- contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
- cranial metal implants
- intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
- able to complete Timed Up and Go (TUG) test within 2 minutes
- unable to walk normally before the stroke
- those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
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 factorielle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: real rTMS
Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
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Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays.
Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.
Autres noms:
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Comparateur factice: sham rTMS
the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.
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Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays.
Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Timed Up and Go (TUG)
Délai: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Délai: up to 3 months after the intervention completed
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up to 3 months after the intervention completed
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The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
Délai: up to 3 months after the interventions completed
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up to 3 months after the interventions completed
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Barthel Index (BI)
Délai: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
Délai: up to 3 months after the intervention completed
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PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance.
This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke.
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up to 3 months after the intervention completed
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modified Rankin Scale (MRS)
Délai: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Yen-Nung Lin, MD, MS, Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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
1 janvier 2013
Achèvement primaire (Réel)
1 décembre 2015
Achèvement de l'étude (Réel)
1 décembre 2015
Dates d'inscription aux études
Première soumission
4 décembre 2013
Première soumission répondant aux critères de contrôle qualité
4 décembre 2013
Première publication (Estimation)
10 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
11 décembre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 décembre 2015
Dernière vérification
1 décembre 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 102-wf-eva-04
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