- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02006875
rTMS Study to Improve Functional Performance for Patients With Stroke
10. desember 2015 oppdatert av: 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.
Studieoversikt
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
60
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Taipei City, Taiwan
- Shuang Ho Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Sham-komparator: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Timed Up and Go (TUG)
Tidsramme: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Yen-Nung Lin, MD, MS, Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2013
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
4. desember 2013
Først innsendt som oppfylte QC-kriteriene
4. desember 2013
Først lagt ut (Anslag)
10. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 102-wf-eva-04
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