Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
研究概览
简要总结
Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view.
A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.
详细描述
The aim of this study is to compare the observance and efficiency of the Intensive Visual Simulation 3 (IVS3) therapy as compared to traditional Mirror Therapy (TM) in a population of hemiplegic stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •First ischemic or hemorrhagic stroke for less than one year
- •Not having reoffend
- •Responsible for an initially complete hemiplegia,
- •Upper-limb deficiency with the modified Frenchay Score below 70,
- •Not neurological history other than stroke,
- •Having signed the written consent
- •Affiliated or entitled to a social security scheme
排除标准
- •Patient who have not Magnetic Resonance Images (MRI) of the brain during stroke
- •Having complete lesion of the primary motor cortex
- •With an addiction to alcohol or drugs
- •With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignancy, severe renal or pulmonary impairment
- •History of associated disabling general disease
- •With associated cerebellar syndrome
- •With clinical involvement of the brainstem
- •Pregnancy in progress
- •Patients under the protection of justice.
研究组 & 干预措施
Experimental group
Patient with stroke ischemic or hemorrhagic will be included. They will have visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device and electroencephalography (EEG).
干预措施: Intensive Visual Simulation 3 (IVS3) device (Device)
Experimental group
Patient with stroke ischemic or hemorrhagic will be included. They will have visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device and electroencephalography (EEG).
干预措施: Electroencephalography (EEG) (Device)
Control group
Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG).
干预措施: traditional Mirror Therapy (TM) (Device)
Control group
Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG).
干预措施: Electroencephalography (EEG) (Device)
结局指标
主要结局
Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
时间窗: Day: 0, 18, 32, 60
Measured by Fugl-Meyer motor assessment score at baseline, at 18 days, at 32 days, and at 60 days. Fugl-Meyer score assesses the analytical motor skills of the upper limb with minimum score at 0 (hemiplegia) and maximum score at 66 (normal motor performance).
次要结局
- Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.(Day: 0, 18, 32, 60)
- Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.(Day: 0, 18, 32, 60)
- Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.(Day: 0, 18, 32, 60)
- Analysis of brain activity(Month: 2)