Implementation of Therapy Together

Study Overview
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Brief Summary
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The goal of this pilot 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
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A pilot randomized waitlist control trial with early intervention therapists, infants/toddlers (ages 3 mo - 2 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 early intervention therapist. The early intervention 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).

Official Title
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Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program

Conditions
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Cerebral Palsy, Hemiplegic Cerebral Palsy

Intervention / Treatment
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* Behavioral: Therapy Together
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at risk for developing cerebral palsy or have been diagnosed with cerebral palsy children ages 3 months to 2 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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Pilot randomized control trial comparing treatment group to usual care. The usual care group will have the option to cross over to the treatment group after 8 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy Together<br>Participants will complete the 8-week Therapy Together program. | Behavioral: Therapy Together<br>* 8-week caregiver-led pediatric constraint-induced movement therapy program<br>|
| Active Comparator: Usual Care<br>Participants will complete 8 weeks of usual care in early intervention. | Behavioral: Usual Care<br>* 8 weeks of usual care received in an early intervention therapy program<br>|

What is the study measuring?
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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) | baseline, 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) | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention | 
| Hand Assessment for Infants | The Hand Assessment for Infants is an observation-based, criterion-referenced and norm-referenced assessment of unilateral and bimanual hand function for children with cerebral palsy aged 3 months-12 months (measured in logits/units) | baseline, 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 |
| --- | --- | --- |
| 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) | 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) | 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) | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention | 
| Measure of Hand and Arm Performance | The Measure of Hand and Arm Performance is a criterion-referenced, observational assessment of hand and arm use based on observation, measured on a scale of 1-10 | baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constraint induced movement therapy, caregiver coaching