The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG)
研究概览
简要总结
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.
详细描述
Protocol:
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Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
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Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
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Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
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Study design: controlled trial with stratified randomization
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Blinding
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The patients were blinded by the real or sham coil of rTMS
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The assessors who performed the outcome measurements were blinded to the assignment of treatment.
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Measurements.
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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.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unilateral hemiplegia caused by the stroke,
- •first ever stroke,
- •time since stroke: 10-90 days,
- •age: 18-80 y/o,
- •Functional ambulation classification (FAC): 0-2,
排除标准
- •contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
- •cranial metal implants
- •intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
- •able to complete Timed Up and Go (TUG) test within 2 minutes
- •unable to walk normally before the stroke
- •those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
研究组 & 干预措施
real rTMS
Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
干预措施: rTMS (Device)
sham rTMS
the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.
干预措施: rTMS (Device)
结局指标
主要结局
Timed Up and Go (TUG)
时间窗: Up to 3 months after interventions completed
次要结局
- the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)(up to 3 months after the intervention completed)
- The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)(up to 3 months after the interventions completed)
- Barthel Index (BI)(Up to 3 months after interventions completed)
- Postural control was assessed by Postural Assessment Scale for Stroke (PASS)(up to 3 months after the intervention completed)
- modified Rankin Scale (MRS)(Up to 3 months after interventions completed)
研究者
Yen-Nung Lin
Medical doctor of Department of Physical Medicine & Rehabilitation
Taipei Medical University WanFang Hospital