Evaluation of Multifocal Transcutaneous Electrical Stimulation for Self-treatment Among Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Modified Ashworth Scale
研究概览
简要总结
The main purpose with this study is to investigate the effectiveness of a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for treatment of spasticity in children with cerebral palsy.
详细描述
The effect and use of the garment will be evaluated in single - case studies using ABAB design.
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
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cerebral palsy diagnosis, with spasticity as the main symptom
- •Established GMFCS, levels 1-5
- •MACS level, levels 1-5
- •Included in the CPUP * national quality register
- •Person should be between 4 years and up to 18 years
- •Secured communication to and from person
- •Neing able to convey pain or discomfort.
排除标准
- •No treatment received within next three months before participation with botulinum toxin treatment to reduce spasticity.
- •The patient may not have a shunt or other medical pump that may be affected by the electrical stimulation provided by the garment.
结局指标
主要结局
Modified Ashworth Scale
时间窗: four weeks
Measures of spasticity at 12 Occasions using the Modified Ashworth Scale. Measures include both upper and lower limbs. Scores are rated by:: 0= No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+= Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension The mesures will be perfomed three times each week for four weeks.
次要结局
- Faces pain scale 0-5(four weeks)
- Timed Up and Go (time)(four weeks)
- Two questions of sleeling quality, three answer options provided(four weeks)
- Box and block test (number of blocks moved in one minute)(four weeks)
- Adherence measured by days using the garment during the intervention(four weeks)
- Level of Sitting Scale (score 1-8)(four weeks)