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Completed

NCT Number: NCT06853717

Implementation of Therapy Together With Early Childhood Intervention

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.

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Key information

Conditions

Unilateral Cerebral Palsy

Age range

3 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Woman's Univeristy

Denton, Texas, 76201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Therapy Together

Behavioral

CIMT consists of retraining the preferred hand by covering the hand with a soft mitt to promote the use of the assisting hand. With consistent practice, a toddler or infant builds the fine and gross motor skills of their assisting hand and bilateral coordination skills.

Other names: Constraint Induced Movement Therapy

Primary outcomes

  1. Mini-Assisting Hand Assessment (Mini-AHA)

    Time frame: pre-intervention and immediate post-intervention

    A semi-structured assessment for unilateral CP measuring effectiveness in bimanual hand

  2. Canadian Occupational Performance Measure (COPM)

    Time frame: 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

  3. Developmental Assessment of Young Children, Second Edition (DAYC-2)

    Time frame: 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

  4. Measure of Hand and Arm Performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Collaborators

  • Texas Woman's University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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