rTMS Study to Improve Functional Performance for Patients With Stroke

Stroke Clinical Trial

Official title: The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

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

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT02006875
• Study type: Interventional
• Source: Taipei Medical University WanFang Hospital
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Completion date: December 2015