Effects of Lycra Suits in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Change from baseline evaluation of static balance at 6 months
研究概览
简要总结
Lycra garments have recently been used for children with cerebral palsy, with favorable effects on alignment, biomechanics and neuromuscular activity. The aim of the present study is to determine the efficacy of a Lycra suit in improving motor function and static balance in children with cerebral palsy. The children included in this study will be part of a prospective project on children with cerebral palsy, older than 4 years of age, and their families regularly followed at the Child Neurology Unit of the Catholic University of Rome.
详细描述
A total of 10 children with cerebral palsy will be recruited and included in the study. Five of them will be considered as study group and will wear a lycra suit, with shoulder, trunk and pelvis coverage, for more than 4 hours per day for 6 months. The other 5 will be considered as control group, matched for age and sex to the study group, and will not wear the lycra suit. The evaluation of static balance and the gross motor function measure will be used as outcome measure. The children of both groups will be assessed twice, at baseline and 6 months after, each child acting as his/her own control.
The motor function assessments will be performed without the Lycra suit, whereas the static balance assessments were performed with and without the suit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of cerebral palsy based on the predominant type of motor impairment and classified according to the criteria proposed by Himmelmann.
排除标准
- •Presence of major congenital malformations or metabolic or haematological complications.
- •The investigators will also exclude children who had previously worn a lycra garment and who received Botulinum toxin injections or orthopaedic surgery in the year before the study.
结局指标
主要结局
Change from baseline evaluation of static balance at 6 months
时间窗: The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.
The evaluation of static balance will be assessed by a "seated stabilometry exam" performed on a "Prokin PK 254 P" device produced by TecnoBody S.r.l. (Dalmine BG - Italy). This device consists of a static plate (47 centimeters of circumference) equipped internally with four piezoelectric sensors positioned at the extremity of the four cardinals points.
次要结局
- Change from baseline Gross Motor Function Classification System at 6 months(The children were assessed twice, at baseline and 6 months after, each child acting as his/her own control.)
研究者
Domenico Romeo
MD, PhD
Catholic University, Italy