Scottish Rite for Children
Frisco, Texas, 75034, United States
Location status: Recruiting
NCT Number: NCT06040619
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.
Interested in participating?
Request Info3 month–71 month
All sexes
Interventional
Not applicable
Frisco, Texas, 75034, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8-week caregiver-led pediatric constraint-induced movement therapy program
8 weeks of usual care received in an early intervention therapy program
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Baseline, pre-intervention and within 1 month of post-intervention
The pre-training and post-training survey includes questions on knowledge, appropriateness, and acceptability of pediatric constraint-induced movement therapy (includes likert scale questions, demographic questions, and open ended qualitative responses)
Time frame: Within 1 month of post intervention
Interviews to explore feasibility, fidelity, cost, appropriateness, and acceptability, qualitative data
Time frame: weekly for 8 weeks
The caregiver log includes feasibility (time), stress, and impact on unilateral and bimanual hand function measured using a likert scale of 1-4
Time frame: weekly for 8 weeks
Weekly therapist logs include feasibility, fidelity, cost of the program, measured using a checklist, and qualitative responses
Contact information is provided by the study sponsor or research team.
Texas Scottish Rite Hospital for Children
Other
Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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