Implementation of Therapy Together

Not Applicable

Recruiting

Brief Summary: 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: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Participants will complete 8 weeks of usual care in early intervention.
Therapy Together	Therapy Together	Participants will complete the 8-week Therapy Together program.

Primary Outcome Measures

Name	Time	Method
Hand Assessment for Infants	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention	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)
Mini-Assisting Hand Assessment	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention	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)
Assisting Hand Assessment	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention	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)

Secondary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention	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)
Developmental Assessment for Young Children, Second Edition (DAYC-2)	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention	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)
Measure of Hand and Arm Performance	baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention	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