Feasibility and Effectiveness of Therapy Together: An Intensive Upper Limb Therapy Program for Young Children With Cerebral Palsy and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Mini-Assisting Hand Assessment
研究概览
简要总结
this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months.
详细描述
One group will complete 32 hours onsite (4 hour weekly sessions) and 30 minutes of therapeutic activity at home, and the second group will complete 8 hours onsite and 1 hour of therapeutic activity at home. Both groups will aim to complete 56 hours of the intervention.
The Therapy Together program includes caregiver education and coaching on implementing therapeutic activities that are play-based, age-appropriate, and tailored to meet goals to improve arm/hand function. The child and caregiver complete 8 coaching sessions. The first 7 intervention visits focus on constraint-induced movement therapy (CIMT) and the final intervention visit focuses on bimanual therapy (use of two hands).
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
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •present with asymmetric hand
- •at risk for developing CP or children that have been diagnosed with CP
- •must be able to visually attend to objects
- •demonstrate an interest in objects
- •attempt to reach for or grasp them with the impaired upper extremity
排除标准
- •uncontrolled epilepsy
- •significant visual impairment
- •severe behavioral problems
- •inability to complete the assessment protocol
研究组 & 干预措施
4 hour group
The 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program.
干预措施: Therapy Together - 4 hour group (Behavioral)
1 hour group
The 1-hour group completed 8 hours of in-clinic therapy and 48 hours of home-based activities (1 hour per day) to complete the Therapy Together program.
干预措施: Therapy Together - 1 hour group (Behavioral)
结局指标
主要结局
Mini-Assisting Hand Assessment
时间窗: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)
Assisting Hand Assessment
时间窗: pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)
次要结局
- Canadian Occupational Performance Measure(pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention)
- Developmental Assessment for Young Children, Second Edition (DAYC-2)(pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention)
- Weekly Caregiver Log(weekly for 8 weeks)