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Active, Not Recruiting

NCT Number: NCT07225673

Feasibility and Effectiveness of Therapy Together

this study proposes to compare the feasibility and effectiveness of 2 methods of delivery of Therapy Together, a caregiver and child intensive upper limb therapy program for children with CP and children at risk for developing CP ages 3 months - 4 years 11 months.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

3 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scottish Rite for Children

Frisco, Texas, 75034, United States

About this study

One group will complete 32 hours onsite (4 hour weekly sessions) and 30 minutes of therapeutic activity at home, and the second group will complete 8 hours onsite and 1 hour of therapeutic activity at home. Both groups will aim to complete 56 hours of the intervention.

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 coaching sessions. 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

  • present with asymmetric hand
  • at risk for developing CP or children that have been diagnosed with CP
  • must be able to visually attend to objects
  • demonstrate an interest in objects
  • attempt to reach for or grasp them 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 - 4 hour group

Behavioral

a caregiver partnered constraint induced movement therapy program

Therapy Together - 1 hour group

Behavioral

a caregiver partnered constraint induced movement therapy program

Primary outcomes

  1. Mini-Assisting Hand Assessment

    Time frame: 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: 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)

Secondary outcomes

  1. Canadian Occupational Performance Measure

    Time frame: 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: 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. 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

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Registry information

Official study title

Feasibility and Effectiveness of Therapy Together: An Intensive Upper Limb Therapy Program for Young Children With Cerebral Palsy and Their Caregivers

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Nov 10, 2025
Registry last updated
Nov 10, 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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