Effect of Magnesium Therapy on Spasticity and Constipation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria
研究概览
简要总结
This study is considered a pilot exploratory study. Intervention, prospective, double-armed, randomized, placebo-control clinical trial.
The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be studied.
详细描述
Spasticity and constipation are major problems hindering improvement in motor development in children with cerebral palsy.
Decreasing spasticity will have a positive effect on motor development and quality of life for the child and his family.
The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on spasticity and constipation in infants and children with cerebral palsy.
Hundred children with spastic cerebral palsy will be randomized to either intervention group n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and constipation in addition to their conventional treatment, or placebo group n=50 will receive conventional treatment and placebo.
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, Investigator)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age below12 years.
- •Presence of spasticity without joint contracture Spasticity is defined as velocity dependent, increased resistance to passive muscle stretch.
- •Acceptance of caregivers to participate in the study and signing the written consent.
- •Constipation will be defined according to Rome lll criteria.presence of at least 2 of the following 2 motions week, history of painful or hard bowel movement, presence of large diameter stools that stools that may obstruct the toilets (Burgers et al., 2012).
排除标准
- •Severe growth retardation (Below the 10th centile for weight and length charts children with cerebral palsy).
- •Gastrostomy tube feeding.
- •Joint contractures.
- •Congenital malformations.
- •Suspected inborn error of metabolism.
- •Suspected inherited neurologic disease.
- •Care giver's refusal to participate in the study.
- •Occurrence of side effects of oral magnesium sulfate.
- •Patients with cardiac, renal, GIT problem or chronic diarrhea.
结局指标
主要结局
Decrease in muscle tone evaluated by Modified Ashworth Index and constipation ROM-lll criteria
时间窗: 1 month
次要结局
- Improvement in H/M ratio in H-reflex by electrophysiologic assessment(1 month)
研究者
Sahar M.A. Hassanein, MD
Professor of Pediatrics , Faculty of Medicine
Ain Shams University