Randomized Clinical Trial of Hand Arm Bimanual Intensive Therapy (HABIT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from baseline in manual dexterity at 12 months
研究概览
简要总结
A randomized control trial of bimanual training in children with hemiplegia. The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators will test the hypothesis that bimanual training (HABIT) will result in improved hand function in children with hemiplegia.
详细描述
A new treatment involving bimanual (Hand-Arm Bimanual Intensive Therapy (HABIT). The protocols have been developed at Columbia University to be child friendly and draws upon our experience since 1997 with constraint-induced movement therapy in children with cerebral palsy. The investigators developed HABIT in 2004 as an alternative to constraint-therapy that avoids use of a restraint. The interventions are performed in a 15 day day-camp setting with several children and at least one therapist per child. The investigators have conducted 24 day camps to date since 2002, and are now collaborating with clinicians worldwide to expand our treatment availability. The aim is to promote the use of and improve the coordination of movement of both hands together. PARTICIPATION IS FREE. Please check out our website for more information: http://www.tc.edu/centers/cit/
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •*willingness to agree to intervention and testing procedures and travel to the University for participation and testing
排除标准
- •health problems not associated with CP
- •uncontrollable seizures
- •visual problems that would interfere with carrying out the intervention or testing
- •botulinum toxin therapy in the upper extremity musculature during the last six months or who wish to receive it within the period of study
研究组 & 干预措施
HABIT
Hand-Arm Bimanual Intensive Therapy (HABIT)
干预措施: HABIT (Behavioral)
Ongoing usual and customary rehabilitation care
Subjects are tested over 6 months while receiving their ongoing usual and customary care schedule of physical and occupational therapy or following constraint-induced movement therapy received as usual and customary care independent of the study, and then are crossed-over to receive HABIT.
结局指标
主要结局
Change from baseline in manual dexterity at 12 months
时间窗: 12 months
Change from baseline in timed performance of standardized manual activities
Change from baseline in quality of bimanual hand use at 12 months
时间窗: 12 months
Changes in quality of how the two hands are used during manual activity as determined from video analysis.
次要结局
- Change from baseline in range of upper extremity motion at 12 months(12 months)
- Change from baseline in upper extremity strength at 12 months(12 months)
- Change from baseline in goal achievement at 12 months(12 months)
研究者
Andrew Gordon
Professor
Columbia University