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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
8-week caregiver-led pediatric constraint-induced movement therapy program
8 weeks of usual care received in an early intervention therapy program
Scottish Rite for Children
Frisco, Texas, United States
RECRUITINGMini-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)
Time frame: 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)
Time frame: 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)
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
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)
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)
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)
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
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
Time frame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.