Feasibility and Effectiveness of Therapy Together

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Therapy Together - 4 hour group; Behavioral: Therapy Together - 1 hour group

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Frisco, Texas, United States, 75034
      • Scottish Rite for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 4 hour group; The 4-hour group completed 32 hours in clinic and 24 hours at home (30 minutes per day) to complete the Therapy Together program.	Behavioral: Therapy Together - 4 hour group; a caregiver partnered constraint induced movement therapy program
Active Comparator: 1 hour group; The 1-hour group completed 8 hours of in-clinic therapy and 48 hours of home-based activities (1 hour per day) to complete the Therapy Together program.	Behavioral: Therapy Together - 1 hour group; a caregiver partnered constraint induced movement therapy program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)	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)	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)	pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Collaborators and Investigators

• Sponsor: Texas Scottish Rite Hospital for Children
• Investigators: Principal Investigator: Angela Shierk, Scottish Rite for Children

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): July 20, 2024
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 4, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 4, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: STU-2019-1211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No