rTMS Study to Improve Functional Performance for Patients With Stroke
NCT ID: NCT02006875
Last Updated: 2015-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2013-01-31
2015-12-31
Brief Summary
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Detailed Description
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1. Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
2. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
3. Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
4. Study design: controlled trial with stratified randomization
5. Blinding
1. The patients were blinded by the real or sham coil of rTMS
2. The assessors who performed the outcome measurements were blinded to the assignment of treatment.
6. Measurements.
1. 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.
2. 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.
3. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
7. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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real rTMS
Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
rTMS
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.
sham rTMS
the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.
rTMS
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.
Interventions
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rTMS
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* first ever stroke,
* time since stroke: 10-90 days,
* age: 18-80 y/o,
* Functional ambulation classification (FAC): 0-2,
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Yen-Nung Lin
Medical doctor of Department of Physical Medicine & Rehabilitation
Principal Investigators
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Yen-Nung Lin, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Locations
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Shuang Ho Hospital
New Taipei City, , Taiwan
Countries
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References
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Lin YN, Hu CJ, Chi JY, Lin LF, Yen TH, Lin YK, Liou TH. Effects of repetitive transcranial magnetic stimulation of the unaffected hemisphere leg motor area in patients with subacute stroke and substantial leg impairment: A pilot study. J Rehabil Med. 2015 Apr;47(4):305-10. doi: 10.2340/16501977-1943.
Other Identifiers
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102-wf-eva-04
Identifier Type: -
Identifier Source: org_study_id