NCT00752934终止4 期
Does Oral Baclofen Improve Care and Comfort in Spastic Children in Nursing Homes?
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- care and comport questionnaires
研究概览
简要总结
Baclofen is a drug that reduces the muscle stiffness. In disabled children that have very stiff muscles, the stiffness and secondary changes in the joints may cause discomfort and pain. In this study we will check if treatment with Baclofen reduces pain in disabled children with stiff muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral palsy nursing homes children ages 1-18 years spastic quadriplegia
排除标准
- •active epilepsy severe truncal hypotonia
研究组 & 干预措施
group a
Experimental
Baclofen followed by Placebo
干预措施: oral baclofen + placebo (Drug)
group b
Experimental
Placebo followed by Baclofen
干预措施: placebo + oral baclofen (Drug)
结局指标
主要结局
care and comport questionnaires
时间窗: 28 weeks
次要结局
未报告次要终点
研究者
Dr. Hilla Ben-Pazi
PI
Shaare Zedek Medical Center
研究点 (1)
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