Implementation of Therapy Together With Early Childhood Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Mini-Assisting Hand Assessment (Mini-AHA)
研究概览
简要总结
The purpose of this project is to conduct a pilot hybrid type two implementation and efficacy study on Therapy Together with Early Childhood Intervention using an explanatory mixed methods approach to evaluate the efficacy and implementation of Therapy Together. Therapy Together is a parent led intensive pediatric constraint induced movement therapy (P-CIMT) program for young children (3 months-2 years 11 months) with unilateral cerebral palsy (UCP). The research team developed the Therapy Together program due to the lack of clinical uptake in use of CIMT with children with UCP, even though there is consistent and robust evidence that demonstrates a positive treatment effect with the intervention. Therapy Together is based on the evidence and active ingredients of P-CIMT with a primary focus on utility and translation of research to clinical practice.
详细描述
The long-term research goal is to implement Therapy Together, a caregiver-led pediatric constraint induced movement therapy program we developed for infants and toddlers with unilateral cerebral palsy, within regular health care models globally. The objective of this proposal is to conduct a pilot study to evaluate the efficacy and implementation of the Therapy Together program within the State of Texas Early Childhood Intervention program by conducting a mixed method, hybrid type two implementation and efficacy study guided by the RE-AIM Framework focusing on reach, effectiveness, adoption, and implementation. The central hypothesis is that Therapy Together can be successfully implemented within the early intervention model resulting in clinically significant improvements in hand function, occupational performance, and development. The rationale for this hypothesis is that Therapy Together is an adapted version of an evidence-based intervention specifically developed for implementation within standard of care practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were children three months to two years and eleven months old who presented with asymmetric hand use with risk of developing cerebral palsy (CP) or have already been diagnosed with CP that present with unilateral upper limb impairment. Inclusion criteria were children who visually attended to objects, showed interest in them, and tried to reach for or grasp objects with their impaired upper extremity were included in the study.
排除标准
- •Exclusion criteria were children with uncontrolled epilepsy, significant visual impairment, severe behavior problems or unable to complete assessment protocol were not included in the study.
研究组 & 干预措施
Therapy Togther
Therapy Together is a parent led intensive pediatric constraint induced movement therapy (P-CIMT) program for young children (3 months-2 years 11 months) with unilateral cerebral palsy (UCP). The research team developed the Therapy Together program due to the lack of clinical uptake in use of CIMT with children with UCP, even though there is consistent and robust evidence that demonstrates a positive treatment effect with the intervention. Therapy Together is based on the evidence and active ingredients of P-CIMT with a primary focus on clinical utility and translation of research to clinical practice
干预措施: Therapy Together (Behavioral)
结局指标
主要结局
Mini-Assisting Hand Assessment (Mini-AHA)
时间窗: pre-intervention and immediate post-intervention
A semi-structured assessment for unilateral CP measuring effectiveness in bimanual hand
Canadian Occupational Performance Measure (COPM)
时间窗: pre-intervention and immediate post-intervention
A semi-structured interview that allows caregivers to evaluate and prioritize their child's current participation in the areas of self-care, leisure, and play
Developmental Assessment of Young Children, Second Edition (DAYC-2)
时间窗: pre-intervention and immediate post-intervention
The DAYC-2 is a normative-based assessment to identify children from birth to 5 years of age to assess a child's ability in areas of cognition, communication, social-emotional development, physical development, and adaptive behavior
Measure of Hand and Arm Performance
时间窗: pre-intervention and immediate post-intervention
The measure of hand and arm performance is an observation-based assessment of upper extremity movements developed by the researchers.
次要结局
未报告次要终点