Implementation of Therapy Together With Early Childhood Intervention

February 28, 2025 updated by: Texas Scottish Rite Hospital for Children
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Denton, Texas, United States, 76201
        • Texas Woman's Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Therapy Together
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
pre-intervention and immediate post-intervention
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
pre-intervention and immediate post-intervention
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
pre-intervention and immediate post-intervention
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.
pre-intervention and immediate post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Scottish Rite Hospital for Children

Collaborators

Texas Woman's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2022

Primary Completion (Actual)

September 14, 2023

Study Completion (Actual)

September 14, 2023

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2022-258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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