Implementation of Therapy Together

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

The goal of this pilot 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Hemiplegic Cerebral Palsy
• Intervention / Treatment: Behavioral: Therapy Together; Behavioral: Usual Care

Detailed Description

A pilot randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 2 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 early intervention therapist. The early intervention 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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Shierk, PhD; Phone Number: 1045 (469) 412-7172; Email: angela.shierk@tsrh.org
• Study Contact Backup: Name: Heather Roberts, PhD; Phone Number: (214) 794-8117; Email: hroberts3@twu.edu

Study Locations

• United States
  • Texas
    • Frisco, Texas, United States, 75034
      • Recruiting
      • Scottish Rite for Children
      • Contact: Angela Shierk, PhD; Phone Number: 469-412-7172; Email: angela.shierk@tsrh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
• children ages 3 months to 2 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy Together; Participants will complete the 8-week Therapy Together program.	Behavioral: Therapy Together; 8-week caregiver-led pediatric constraint-induced movement therapy program
Active Comparator: Usual Care; Participants will complete 8 weeks of usual care in early intervention.	Behavioral: Usual Care; 8 weeks of usual care received in an early intervention therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Assisting Hand Assessment	The Mini-Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assesses bimanual hand function for children with cerebral palsy aged 8-18 months (measured in logits/units)	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Assisting Hand Assessment	The Assisting Hand Assessment is an observation-based, criterion-referenced assessment that assess bimanual hand function for children with cerebral palsy, aged 18 months-12 years (measured in logits/units)	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Hand Assessment for Infants	The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units)	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Occupational Performance Measure	The Canadian Occupational Performance Measure is an interview-based assessment of self-perception of performance of everyday living activities (measured on a scale from 1-10)	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)	The Developmental Assessment for Young Children is an interview and observation based norm-referenced developmental assessment (raw scores 0 or 1, converted to standard scores)	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Measure of Hand and Arm Performance	The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-training and Post-training Therapist Survey	The pre-training and post-training survey includes questions on knowledge, appropriateness, and acceptability of pediatric constraint-induced movement therapy (includes likert scale questions, demographic questions, and open ended qualitative responses)	Baseline, pre-intervention and within 1 month of post-intervention
Interviews with therapists and caregivers	Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data	Within 1 month of post intervention
Weekly Caregiver Log	The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4	weekly for 8 weeks
Weekly Therapist Log	Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses	weekly for 8 weeks

Collaborators and Investigators

• Sponsor: Texas Scottish Rite Hospital for Children
• Collaborators: American Occupational Therapy Foundation
• Investigators: Principal Investigator: Angela Shierk, PhD, Scottish Rite for Children

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: constraint induced movement therapy; caregiver coaching
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STU-2023-0553

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