Efficacy of Repetitive Transcranial Magnetic Stimulation and Virtual Cycling Training on Upper Limb Function in Patients With Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up
研究概览
简要总结
Stroke is the major cause of motor impairment and physical disabilities in the adult population. Spasticity and loss of dexterity are the common problems in stroke. Recently, current interventions, such as cycling training, virtual reality (VR) and repetitive transcranial magnetic stimulation (rTMS), were used for the treatment of upper extremity (UE) dysfunction in patients with stroke. However, few studies investigated the effects of the combinations of different treatment strategies using by integrating brain imaging and motor control studies. This project proposes different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: combined inhibitory/facilitatory rTMS, VR-based cycling training (VCT), and combined rTMS and VCT. We hypothesize that the treatment effect of the combined protocol (optimal rTMS protocol and VCT) is more effective than single treatment due to integration of central and peripheral effects. Different treatment protocols will induce different changes in the brain reorganization and motor control, which further improve motor function, activity, participation, and health related quality of life (HRQOL).
详细描述
This study aims to 1. identify the immediate effects of different treatment protocols in for UE training in these patients through brain image, motor control and clinical measures; 2. to determine the maintaining therapeutic effects; 3. to elucidate the most optimal treatment protocols; 4. to determine the neuro-motor control mechanism underlying clinical improvement; 5. to determine the clinimetric properties of the brain imaging and motor control measure that are responsive and valid for detecting changes after treatment protocol intervention, and 6. to identify clinical predictors influencing the outcome for treatment protocols.
The research will offer valuable motor control biomarkers for outcome prediction and targeting patients who benefit from new protocols. This project is significant for the translational and evidence-based medicine on stroke neurorehabilitation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first stroke
- •chronic stroke (onset > 3 months)
- •unilateral cerebral lesion with hemiparesis or hemiplegia
- •age of 20-80 years
- •no epileptic spikes on the EEG
排除标准
- •brain stem or cerebellum stroke
- •arteriovenous malformation
- •psychiatric disease
- •degenerative disease
- •severe cognitive and communicative impairment or aphasia
- •severe medical disease
- •active medical problems
- •metal implant in the body
- •pregnancy
- •poor cooperation with assessments
结局指标
主要结局
Change from baseline of Muscle strength measurement for stroke after 3 weeks treatment and 3 months follow-up
时间窗: baseline, after 3 weeks of treatment, 3 months
Muscle strength
Change from baseline of mechanical measurement for stroke after 3 weeks treatment and 3 months follow-up
时间窗: baseline, after 3 weeks of treatment, 3 months
Kinematic analysis for upper limb
Change from baseline of Muscle tone measurement for stroke after 3 weeks treatment and 3 months follow-up
时间窗: baseline, after 3 weeks of treatment, 3 months
Muscle tone
Change from baseline of severity for stroke after 3 weeks treatment and 3 months follow-up
时间窗: baseline, after 3 weeks of treatment, 3 months
Brunnstrom stage classification(by severity from stage 1 to stage 6), Modified Ashworth Scale (tension of upper limb from min(0) to max (4)) and National Institute of Health Stroke Scale (severity from min(0) to max(4))
次要结局
- Change from baseline of body composition for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of activity for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of FIM for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of quality of life for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of ABAS for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of MAL for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of TUG for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of WMFT for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)
- Change from baseline of participation for stroke in after 3 weeks treatment and 3 months follow-up(baseline, after 3 weeks of treatment, 3 months)