Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-11-13
2026-08-31
Brief Summary
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* 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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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Therapy Together
Participants will complete the 8-week Therapy Together program.
Therapy Together
8-week caregiver-led pediatric constraint-induced movement therapy program
Usual Care
Participants will complete 8 weeks of usual care in early intervention.
Usual Care
8 weeks of usual care received in an early intervention therapy program
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* significant visual impairment
* severe behavioral problems
* inability to complete the assessment protocol.
3 Months
71 Months
ALL
No
Sponsors
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American Occupational Therapy Foundation
OTHER
Texas Scottish Rite Hospital for Children
OTHER
Responsible Party
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Angela Shierk
Clinical Scientist
Principal Investigators
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Angela Shierk, PhD
Role: PRINCIPAL_INVESTIGATOR
Scottish Rite for Children
Locations
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Scottish Rite for Children
Frisco, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU-2023-0553
Identifier Type: -
Identifier Source: org_study_id
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