rTMS Study to Improve Functional Performance for Patients With Stroke

Protocol:

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.