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- Klinische proef NCT02006875
rTMS Study to Improve Functional Performance for Patients With Stroke
10 december 2015 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
60
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New Taipei City, Taiwan
- Shuang Ho Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
Andere namen:
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Sham-vergelijker: 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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Timed Up and Go (TUG)
Tijdsspanne: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Yen-Nung Lin, MD, MS, Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2013
Primaire voltooiing (Werkelijk)
1 december 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
4 december 2013
Eerst ingediend dat voldeed aan de QC-criteria
4 december 2013
Eerst geplaatst (Schatting)
10 december 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
11 december 2015
Laatste update ingediend die voldeed aan QC-criteria
10 december 2015
Laatst geverifieerd
1 december 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 102-wf-eva-04
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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