Clinical trial NCT06040619: Implementation of Therapy Together
Official title: Implementation of Therapy Together With the State of Texas Early Childhood Intervention Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Hemiplegic Cerebral Palsy
Keywords: constraint induced movement therapy
caregiver coaching
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2023-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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).

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.

Primary outcomes:
measure: Mini-Assisting Hand Assessment
timeFrame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
measure: Assisting Hand Assessment
timeFrame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
measure: Hand Assessment for Infants
timeFrame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Secondary outcomes:
measure: Canadian Occupational Performance Measure
timeFrame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
measure: Developmental Assessment for Young Children, Second Edition (DAYC-2)
timeFrame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
measure: Measure of Hand and Arm Performance
timeFrame: baseline, pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention
Other outcomes:
measure: Pre-training and Post-training Therapist Survey
timeFrame: Baseline, pre-intervention and within 1 month of post-intervention
measure: Interviews with therapists and caregivers
timeFrame: Within 1 month of post intervention
measure: Weekly Caregiver Log
timeFrame: weekly for 8 weeks
measure: Weekly Therapist Log
timeFrame: weekly for 8 weeks
Locations:
city: Frisco
country: United States
facility: Scottish Rite for Children
state: Texas
Study officials:
affiliation: Scottish Rite for Children
name: Angela Shierk, PhD
role: PRINCIPAL_INVESTIGATOR
References: