- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02006875
rTMS Study to Improve Functional Performance for Patients With Stroke
December 10, 2015 updated by: 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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Taipei City, Taiwan
- Shuang Ho Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
Other Names:
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Sham Comparator: 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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Timed Up and Go (TUG)
Time Frame: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: Up to 3 months after interventions completed
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Up to 3 months after interventions completed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yen-Nung Lin, MD, MS, Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 4, 2013
First Submitted That Met QC Criteria
December 4, 2013
First Posted (Estimate)
December 10, 2013
Study Record Updates
Last Update Posted (Estimate)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102-wf-eva-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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