Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Hand Assessment for Infants
研究概览
简要总结
The goal of this clinical trial is to learn about the implementation of Therapy Together, a pediatric constraint-induced movement therapy program in young children with unilateral cerebral palsy. The main question[s] it aims to answer are:
- Is the Therapy Together program effective in improving hand function and occupational performance compared to usual care?
- Is it feasible to implement the Therapy Together program within the standard care, early intervention framework?
Participants will participate in an 8-week pediatric constraint-induced movement therapy program. Researchers will compare the group completing the Therapy Together Program to a group that is receiving usual care to see if there is a difference in the change in hand function, occupational performance, and development.
详细描述
A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.
Therapy Together Program:
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 sessions with their therapist. The therapist is trained to educate the caregiver on the Therapy Together program, demonstrate how to engage the child in therapeutic activities, and observe the caregiver implement the program during each weekly session. 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
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
- •children ages 3 months to 5 years 11 months
- •present with asymmetric hand use
- •present with a unilateral upper limb impairment
- •able to visually attend to objects
- •demonstrate an interest in objects
- •attempt to reach for or grasp objects with the impaired upper extremity
排除标准
- •uncontrolled epilepsy
- •significant visual impairment
- •severe behavioral problems
- •inability to complete the assessment protocol.
结局指标
主要结局
Hand Assessment for Infants
时间窗: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)
Mini-Assisting Hand Assessment
时间窗: baseline, 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: baseline, 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(baseline, 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)(baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention)
- Measure of Hand and Arm Performance(baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention)
研究者
Angela Shierk
Clinical Scientist
Texas Scottish Rite Hospital for Children