NCT06040619

Implementation of Therapy Together

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Texas Scottish Rite Hospital for Children · Academic / Other
• Sex: All
• Age: 3 Months – 71 Months
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Interventions

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

Timeline

• Start date: 2023-11-13
• Primary completion: 2026-05-01
• Completion: 2026-08-01
• First posted: 2023-09-15
• Last updated: 2025-09-11

Locations

1 site across 1 country: United States