rTMS Study to Improve Functional Performance for Patients With Stroke

Completed

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • RTMS Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: real rTMS
    Description: Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
    ARM 2: Kind: Experimental
    Label: sham rTMS
    Description: the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Postural control was assessed by Postural Assessment Scale for Stroke (PASS) up to 3 months after the intervention completed No
Secondary the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) up to 3 months after the intervention completed No
Secondary The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) up to 3 months after the interventions completed No
Secondary Barthel Index (BI) Up to 3 months after interventions completed No
Secondary Timed Up and Go (TUG) Up to 3 months after interventions completed No
Secondary modified Rankin Scale (MRS) Up to 3 months after interventions completed No
Secondary Corticomotor excitability assessments measured by TMS before and immediatly after the 15-day interventions No

Sponsors