A Quasi Experimental Study About the Effects Obtained at Manual Function After Applying Anodic Transcranial Direct Current Stimulation in Children With Spastic Hemiparetic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ).
研究概览
简要总结
Spastic Hemiparetic Cerebral Palsy (SHCP) uses to limit the manual function. Using anodic transcranial direct current stimulation, it is possible to activate certain cerebral areas depending on where the electrodes are. This study will use this kind of stimulation on the contralateral primary motor cortex of the affected upper limb and analyze the effects.
详细描述
It has been designed a single-arm prospective longitudinal quasi-experimental pilot clinical study following the SPIRIT 2013 statement. It will value the time that the children spend doing the bimanual activities described by the Children's Hand-Use Experience Questionnaire (CHEQ), it will also value the subjective experience doing those activities; it will analyze the active movement (Fugl-Meyer for upper limb), spasticity (modified Ashworth), manual strength (dynamometry) and the recruitment improvement (surface electromyography) too.
This study will apply the anodic transcranial direct current stimulation over 20 children between 14-18 years old. The protocol that it will follow is the next one: 3 days to value the outcome measures, 4 days (1 session per day of 17 minutes and 30 seconds) to apply the protocol of anodic transcranial direct current stimulation (0,6 mA of intensity). It will use the EPTE V07 Bipolar System by IONCLINICS ®; 3 days to value the outcome measures studying the effects produced at the affected upper limb. Another evaluation will be realized 3 weeks after the last session of anodic transcranial direct current stimulation to know if the effects obtained last at medium-long term.
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
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 14-18 years old.
- •Children with spastic hemiparetic cerebral palsy diagnosis.
- •Children with a cognitive level high enough to understand and to do the activities to value them.
- •Children hemodynamically stable.
- •Children forming part of levels II-IV of the Manual Ability Classification System (MACS).
排除标准
- •Children with defibrillator.
- •Children with pacemaker.
- •Children with cerebral stimulator.
- •Children with intracranial metallic implants.
- •Children with opened cranial after clambering.
- •Children that receive another treatment (pharmacological or physiotherapical) that could interfere or disrupt the results.
- •Another circumstance where the electrotherapy treatment is contraindicated.
结局指标
主要结局
Changes in the timing that children use to complete the 29 items of the Children's Hand-Use Experience Questionnaire (CHEQ).
时间窗: Baseline, after 4 days (after de foruth sessions planned) and 3 weeks later
CHEQ is a questionnaire analyze the time it takes the children (between 6-18 years old) to do 29 functional activities; it also values the subjective experience of the children doing theses activities. It has a punctuation that goes from 1 to 4 (the maximum score is 348). If the score is higher, it means that the children's status is better.
次要结局
- Changes at the spasticity(Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later)
- Changes at the manual strength(Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later)
- Changes at the recruitment of the motor units.(Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later)
- Changes at the active movement(Baseline, after 4 days (after the fourth sessions planned) and 3 weeks later)
研究者
Rocío Martín Valero
Director
University of Malaga