Pilot Study on the Development of Cortical Reorganization Models for Motor Areas and Inter-hemispheric Equilibrium in the Post-stroke Early Recovery Phase Evaluated by Functional Near-infrared Spectroscopy (fNIRS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
研究概览
简要总结
The main objective is to develop models for the cortical reorganization of motor areas and inter-hemispheric equilibrium in the early phase of post stroke recovery evaluated by the fNIRS technique from day 0 to day 60 (day 0 being the day of inclusion in the study) and to correlate the latter with the early phases of motor recovery over the same period, as measured by the test Fugl-Meyer.
详细描述
The secondary objectives of this study are:
A. To evaluate changes in functional outcomes (Box and Blocks Test and NineHolePeg Test from Day 0 to Day 60.
B- To evaluate changes in autonomy (Barthel Index) from Day 0 to Day 60.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient has had a first ischemic or haemorrhagic supra-tentorial stroke within the 2 to 4 weeks preceding inclusion
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient presents with a severe cognitive disorder
- •The patient has severe aphasia with a Boston Diagnostic Aphasia Examination (BDAE) scale score strictly less than 2
- •The patient has heminegligence with a bells test > 6 on the left.
- •The patient presents with limited amplitude in the paretic upper limb (shoulder abduction <60°, elbow flexion > 30° or dorsal wrist flexion <20°).
- •Imbalanced/uncontrolled epilepsy
结局指标
主要结局
Near-infrared spectroscopy signal analysis: the average amplitude of cortical activation
时间窗: Day 60
Voluntary force: the target error which measures the difference between the average of the force developed by the arm and target strength
时间窗: Day 60
Voluntary force refers to the force applied during motricity tasks.
Near-infrared spectroscopy signal analysis: the time required to reach the peak
时间窗: Day 60
Voluntary force: average
时间窗: Day 60
Voluntary force refers to the force applied during motricity tasks. "Average" refers to the sum of measures weighted by the number of measures.
Voluntary force: coefficient of variation
时间窗: Day 60
Voluntary force refers to the force applied during motricity tasks.
Near-infrared spectroscopy signal analysis: the amplitude peak
时间窗: Day 60
Near-infrared spectroscopy signal analysis: the laterality index
时间窗: Day 60
Fugl-Meyer motricity score
时间窗: Day 60
The Fugl-Meyer motricity score includes evaluations of tone, strength and motor skills.
次要结局
- The Nine Hole Peg Test: The score is the total time to complete the task.(Day 60)
- The Box and Block test: The score is the number of blocks transferred in one minute.(Day 60)
- The Barthell test for autonomy(Day 60)