Implementation of Therapy Together
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapy Together, Usual Care.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Hemiplegic Cerebral Palsy. Basic parameters: 3 months — 71 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
Overview
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.
Detailed description
A randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 5 yrs 11 mo) with unilateral cerebral palsy (or at risk for developing cerebral palsy) and caregivers comparing Therapy Together to usual care followed by semi-structured interviews with caregivers and therapists will be utilized to examine the implementation and effectiveness of Therapy Together within early intervention.
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).
Interventions
- Behavioral Therapy Together
8-week caregiver-led pediatric constraint-induced movement therapy program - Behavioral Usual Care
8 weeks of usual care received in an early intervention therapy program
Primary outcome measures
- 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]
Secondary outcome measures (3)
- Canadian Occupational Performance Measure [Time frame: baseline, 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) [Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
- Measure of Hand and Arm Performance [Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Scottish Rite for Children — Frisco
Identifiers
NCT: NCT06040619 · STU-2023-0553