Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Modified Ashworth scale
研究概览
简要总结
Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke onset ≥ 6 months;
- •muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3;
- •minimum age of 30 years old and maximum age of 75 years;
- •absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam
排除标准
- •history of seizure or cerebral aneurism;
- •antispasticity drugs within 6 months before enrollment;
- •previous surgery involving metallic implants;
- •unstable vital signs;
- •other neurological diseases
结局指标
主要结局
Change from Modified Ashworth scale
时间窗: at baseline, 1 month and 2 months
Modified Ashworth scale (MAS) uses a 6-point scale to score the average resistance to passive movement for each joint. In this study, the tonus of the wrist flexor muscles was tested
change from spinal excitability via Hoffmann reflex of the median nerve
时间窗: at baseline, 1 month and 2 months
assess the effects of the intervention (rTMS and physical therapy) on spinal excitability as measured by the change The Hmax/Mmax ratio (calculated by dividing the maximal amplitude of the H wave by that of the M wave in median nerve) before (baseline), after treatment and after follow-up
次要结局
- change from Fugl-Meyer assessment(at baseline, 1 month and 2 months)
- change from cortical excitability via single transcranial magnetic stimulation(per-session: at baseline and one hour (after physical therapy))
研究者
Kátia Monte-Silva
Professor
Universidade Federal de Pernambuco