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NCT Number: NCT06040619

Implementation of Therapy Together

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.

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Key information

Age range

3 month–71 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scottish Rite for Children

Frisco, Texas, 75034, United States

Location status: Recruiting

Location contact

Angela Shierk, PhD

CONTACT

[email protected]

469-412-7172

About this study

A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 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 therapist. The 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).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Therapy Together

Behavioral

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

Usual Care

Behavioral

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

Primary outcomes

  1. Mini-Assisting Hand Assessment

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

    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)

  2. Assisting Hand Assessment

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

    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)

  3. Hand Assessment for Infants

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

    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)

Secondary outcomes

  1. Canadian Occupational Performance Measure

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

    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)

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

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

    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)

  3. Measure of Hand and Arm Performance

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

    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

Other outcomes

  1. Pre-training and Post-training Therapist Survey

    Time frame: Baseline, pre-intervention and within 1 month of post-intervention

    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)

  2. Interviews with therapists and caregivers

    Time frame: Within 1 month of post intervention

    Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data

  3. Weekly Caregiver Log

    Time frame: weekly for 8 weeks

    The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4

  4. Weekly Therapist Log

    Time frame: weekly for 8 weeks

    Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Shierk, PhD

CONTACT

[email protected]

(469) 412-7172 ext. 1045

Heather Roberts, PhD

CONTACT

[email protected]

(214) 794-8117

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Sep 11, 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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