Feasibility and Effectiveness of Therapy Together

NCT07225673 | Active Not Recruiting

• 1 other identifier: STU-2019-1211
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Canadian Occupational Performance Measure

  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)

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

• Weekly Caregiver Log

  weekly for 8 weeks

Study Arms (2)

4 hour group

ACTIVE COMPARATOR

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

1 hour group

ACTIVE COMPARATOR

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

Interventions

Therapy Together - 4 hour group BEHAVIORAL

a caregiver partnered constraint induced movement therapy program

4 hour group

Therapy Together - 1 hour group BEHAVIORAL

a caregiver partnered constraint induced movement therapy program

1 hour group

Eligibility Criteria

• Age: 3 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

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

Study Sites (1)

Scottish Rite for Children

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Angela Shierk

  Scottish Rite for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 10, 2025
• Study Start: January 2, 2020
• Primary Completion: July 20, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)