Recruiting

Therapy Together

Sponsor:

Texas Scottish Rite Hospital for Children

Code:

NCT06040619

Conditions

Cerebral Palsy

Hemiplegic Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

Interventions

Therapy Together

Usual Care

Study Details

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

Study ID

NCT06040619

Start date

Nov 13, 2023

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Therapy Together

Participants will complete the 8-week Therapy Together program.

active comparator: Usual Care

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

Interventions

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

Primary outcome measure

  • Mini-Assisting Hand Assessment [ Time Frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention ]
  • Assisting Hand Assessment [ Time Frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention ]
  • Hand Assessment for Infants [ Time Frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention ]

Central Contacts and Locations

Central contacts

Angela Shierk, PhD

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

Heather Roberts, PhD

(214) 794-8117hroberts3@twu.edu

Locations

Scottish Rite for Children

Recruiting

Frisco, Texas, United States, 75034

Contacts

Angela Shierk, PhD

469-412-7172angela.shierk@tsrh.org

More Information

Sponsor

Texas Scottish Rite Hospital for Children

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • constraint induced movement therapy
  • caregiver coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Scottish Rite Hospital for Children on 2025-09-11.