Implementation of Therapy Together

Официальное название

Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое Therapy Together
  8-week caregiver-led pediatric constraint-induced movement therapy program
• Поведенческое Usual Care
  8 weeks of usual care received in an early intervention therapy program

Первичные конечные точки

• Mini-Assisting Hand Assessment [Срок оценки: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
• Assisting Hand Assessment [Срок оценки: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
• Hand Assessment for Infants [Срок оценки: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]

Вторичные конечные точки (3)

• Canadian Occupational Performance Measure [Срок оценки: 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) [Срок оценки: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
• Measure of Hand and Arm Performance [Срок оценки: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• uncontrolled epilepsy
• significant visual impairment
• severe behavioral problems
• inability to complete the assessment protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Scottish Rite for Children — Frisco

Идентификаторы

NCT: NCT06040619 · STU-2023-0553

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗