Mollii - Personalized Suit for Treatment of Spasticity, GFMCS3-5
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- modified ashworth scale
研究概览
简要总结
The objective of this study was to examine the effect on spasticity and function of multifocal transcutaneous electrical stimulation incorporated in a 2-piece (Mollii) suit.
详细描述
In this prospective cohort study, the participants (children with predominantly spastic CP, GFMCS 3-5) wore the suit for 1 hour every second day for 24 weeks. The investigators evaluated level of spasticity using the modified Ashworth scale (MAS) and other related measures before initiation, after 4, 12, and 24 weeks. Two motor related smart goals were defined and evaluated by the goal attainment scale (GAS). GMFM-66 and posture and postural ability scale (PPAS) were performed.
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
- 否
入选标准
- •cerebral palsy with spastic disease, GMFCS 3-5.
排除标准
- •other disorders affecting the sensorimotor functions without spasticity,
- •implanted electric medical devices,
- •other severe concomitant diseases such as cancer, cardiovascular, inflammatory, psychiatric disease, medical dysregulated epilepsy or hypertension.
研究组 & 干预措施
intervention
24 weeks of TENS
干预措施: TENS incorporated into the Mollii suit (Device)
结局指标
主要结局
modified ashworth scale
时间窗: 24 weeks
spasticity evaluation from 0 (best) to 4 (worst) in modified ashworth scale
次要结局
- Goal Attainment Scale(24 weeks)
研究者
christian wong
principle investigator
Hvidovre University Hospital