Quantified Analysis of Neuronal Recovery Using Myelin Imaging After Robot Assisted Upper Arm Training in Subacute Stroke Patients: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Fugl-Meyer Assessment (FMA)
研究概览
简要总结
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Quantitative assessment method developed for brain plasticity through disability rehabilitation using a brain imaging technique.
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Development of brain imaging technology to improve understanding of brain plasticity during rehabilitation and to improve the efficiency of rehabilitation treatment for people with brain injury. ○ Development of the latest brain function image analysis algorithm and data processing technology
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Development of new technology for imaging brain plasticity in addition to existing functional imaging technology and diffuse imaging technology (Example: Myelinated brain imaging technology, susceptibility imaging (SWI) technology)
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Development of image reconstruction software technology using new image technology
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Multi-image and repeated shot data processing technology, wheat analysis technology development (Example: 3D registration technology, automated segmentation technology)
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Conducted clinical research on clinical quantitative evaluation of brain plasticity due to rehabilitation treatment
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Recruitment of a group of patients for pursuing plasticity through rehabilitation among stroke patients (estimating the number of sample patients by setting a specific patient group and analyzing statistical power)
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Image-based brain change analysis through patient rehabilitation and before and after imaging
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Comparative analysis through securing a control group and activating the control group. Derivation of clinical relevance through comparison with rehabilitation process
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
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 6 months after onset of the stroke
- •have FMA score greater than 7
- •have confirmed that the integrity of the Corticospinal Tract (CST) is preserved in Diffusion Tensor Imaging (DTI) taken using
- •over 20 years of age
- •can understand and participated in study
- •consented to this study in writing or verbally
排除标准
- •quadriplegia
- •past history of stroke
- •past history of Musculoskeletal disease or history of Neurological diseases
- •have a history of injury to the upper limb and upper chest, surgery, or peripheral nerve damage
- •have skin ulcers or skin diseases such as open wounds that have difficulty applying RAT
- •Pregnant woman
- •If it is judged that this clinical participation is not appropriate according to the judgment of medical doctor
结局指标
主要结局
Fugl-Meyer Assessment (FMA)
时间窗: after training(4week)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
次要结局
未报告次要终点