Implementation of Therapy Together

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040619
• Other study ID #: STU-2023-0553
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: Texas Scottish Rite Hospital for Children
• Contact: Angela Shierk, PhD
• Phone: (469) 412-7172
• Email: angela.shierk[@]tsrh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 35 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
United States	Scottish Rite for Children	Frisco	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Scottish Rite Hospital for Children	American Occupational Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Interviews with therapists and caregivers	Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data	Within 1 month of post intervention
Other	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
Other	Weekly Therapist Log	Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses	weekly for 8 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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