Examination of the Acute Effect of Mollii Suit in Children With Cerebral Palsy: A Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- NMC Tests with Seansamove Sensbalance
研究概览
简要总结
The aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.
详细描述
Cerebral Palsy (CP) is the most common developmental disorder in childhood. Individuals' independence in daily living activities and participation in education, games, social and community activities are restricted. Technology applications in the field of rehabilitation are gaining momentum. EXOPULSE Mollii Suit method, one of the newest rehabilitation technology products, is a non-invasive neuromodulation approach with a garment that covers the whole body and electrodes placed inside. Designed to improve motor function by reducing spasticity and pain, the method is based on the principle of reciprocal inhibition, which occurs by stimulating the antagonist of a spastic muscle at low frequencies and intensities. Therefore, the aim of our study is to examine the acute effect of Mollii Suit application on balance and muscle tone problems in children with spastic cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The statistician in the study and the physiotherapist performing the evaluation will be blinded.
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
- •volunteering to participate in the study
- •Having a diagnosis of spastic CP
- •1 or 2 on the Gross Motor Classification System (GMFCS)
- •Between the ages of 4-18.
排除标准
- •Having GMFCS 3,4,5
- •Botulinum Toxin A performed before 3 months or surgical intervention before 6 months
- •Having an invasive medical pump (baclofen, insulin, etc.)
研究组 & 干预措施
Molli Suit Apply Group (Device On)
Evaluations will be made before the children are dressed in the Mollii Suit, and the evaluations will be repeated after the children are dressed and practiced for 60 minutes.
干预措施: Molli Suit Apply (Other)
Control Group
Children will be evaluated and the evaluations will be repeated 60 minutes later.
Mollii Suit Placebo Group (Device Off)
Evaluations will be made before the children are dressed in the Mollii Suit, and the evaluations will be repeated after the children are dressed and applied for 60 minutes with the device in off mode.
干预措施: Molli Suit Apply (Other)
结局指标
主要结局
NMC Tests with Seansamove Sensbalance
时间窗: 5 minutes
NMC Tests means Neuro Muscular Control tests, and it consists of a number of fully adjustable balance tests. The software calculates up to what point the person is able to perform within the outlines of the exercise, and it will give a score per test. The tests and their duration can be adjusted. Individually applicable and very handy. Once it is adjusted, the same test can be repeated by just pushing a button. Time and results are easy to compare with previous tests.
Gross Motor Function Classification System (GMFCS)
时间窗: 1 Minute
Gross Motor Function Classification System (GMFCS) developed by R. Palisano will be used in the classification of motor function.
Modifiye Modified Ashworth Scale (MAS)
时间窗: 5 Minutes
The modified Ashworth scale (MAS), has been applied in clinical practice and research as a measure of spasticity. The modified Ashworth scale purpose is to grade muscle spasticity.
Modified Tardiue Scale (MTS)
时间窗: 5 minutes
The MTS assesses the muscle's response to stretch at given velocities.
次要结局
未报告次要终点
研究者
Kübra Uğurlu
research assistant
Kırıkkale University