rTMS Study to Improve Functional Performance for Patients With Stroke
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- unilateral hemiplegia caused by the stroke,
- ...
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- unilateral hemiplegia caused by the stroke,
- first ever stroke,
- Functional ambulation classification (FAC): 0-2,
Exclusion Criteria
- those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
- able to complete Timed Up and Go (TUG) test within 2 minutes
- cranial metal implants
- ...
- those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
- able to complete Timed Up and Go (TUG) test within 2 minutes
- cranial metal implants
- unable to walk normally before the stroke
- contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
- intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
Summary
- Conditions
- Stroke
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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....
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.
Inclusion Criteria
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- unilateral hemiplegia caused by the stroke,
- ...
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- unilateral hemiplegia caused by the stroke,
- first ever stroke,
- Functional ambulation classification (FAC): 0-2,
Exclusion Criteria
- those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
- able to complete Timed Up and Go (TUG) test within 2 minutes
- cranial metal implants
- ...
- those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
- able to complete Timed Up and Go (TUG) test within 2 minutes
- cranial metal implants
- unable to walk normally before the stroke
- contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
- intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
Tracking Information
- NCT #
- NCT02006875
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yen-Nung Lin, MD, MS Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
- Yen-Nung Lin, MD, MS Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
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