Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Assisting Hand Assessment 5.0
研究概览
简要总结
This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.
详细描述
Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.
Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has perinatal brachial plexus injury
- •Participant walking at time of study inception
- •Ability to cooperate with interventions and assessment
- •Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study
排除标准
- •Co-morbid diagnosis not related to perinatal brachial plexus injury
- •Flaccidity of the involved upper extremity or no observable hand function
- •Planned surgery or drug intervention during the study period
- •Allergy or intolerance to constraint intervention materials
结局指标
主要结局
Assisting Hand Assessment 5.0
时间窗: change from baseline at 8 weeks and 16 weeks
Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100.
次要结局
未报告次要终点
研究者
julie werner
Clinical Scientist
Children's Hospital Los Angeles