rTMS Study to Improve Functional Performance for Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): 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 name(s): Magstim Rapid2
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation; postural; balance; mobility; leg; stroke