Implementation of Therapy Together

NCT06040619 | Recruiting

• 1 other identifier: STU-2023-0553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Hemiplegic Cerebral Palsy

Keywords

constraint induced movement therapy; caregiver coaching

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Canadian Occupational Performance Measure

  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)

  baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

• Measure of Hand and Arm Performance

  baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Other Outcomes (4)

• Pre-training and Post-training Therapist Survey

  Baseline, pre-intervention and within 1 month of post-intervention

• Interviews with therapists and caregivers

  Within 1 month of post intervention

• Weekly Caregiver Log

  weekly for 8 weeks

Study Arms (2)

Therapy Together

EXPERIMENTAL

Participants will complete the 8-week Therapy Together program.

Behavioral: Therapy Together

Usual Care

ACTIVE COMPARATOR

Participants will complete 8 weeks of usual care in early intervention.

Behavioral: Usual Care

Interventions

Therapy Together BEHAVIORAL

8-week caregiver-led pediatric constraint-induced movement therapy program

Therapy Together

Usual Care BEHAVIORAL

8 weeks of usual care received in an early intervention therapy program

Usual Care

Eligibility Criteria

• Age: 3 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• at risk for developing cerebral palsy or have been diagnosed with cerebral palsy
• children ages 3 months to 5 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

You may not qualify if:

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

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead
• American Occupational Therapy Foundation: collaborator

Study Sites (1)

Scottish Rite for Children

Frisco, Texas, 75034, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Angela Shierk, PhD

  Scottish Rite for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Shierk, PhD

CONTACT

(469) 412-7172; angela.shierk@tsrh.org

Heather Roberts, PhD

CONTACT

(214) 794-8117; hroberts3@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Model Details: Pilot randomized control trial comparing treatment group to usual care. The usual care group will have the option to cross over to the treatment group after 8 weeks.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 15, 2023
• Study Start: November 13, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)