What is the mechanism of action of this treatment?

Educational and developmental interventions for Cerebral Palsy, such as the School Readiness Program, focus on enhancing cognitive and motor skills through structured activities and individualized learning plans. These programs often include physical and occupational therapy to improve motor function, speech therapy to enhance communication skills, and social skills training to aid in social interaction. Pharmacologic treatments like antispasticity medications (e.g., baclofen) and botulinum toxin injections help reduce muscle spasticity, while surgical options like selective dorsal rhizotomy (SDR) aim to improve mobility by cutting nerve fibers that cause spasticity. These treatments are crucial for CP patients as they target the core symptoms, improve functional abilities, and enhance the overall quality of life.

What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy, particularly educational and developmental interventions like physical therapy (PT), occupational therapy (OT), and speech therapy, generally have minimal side effects. These therapies aim to improve motor skills, daily functioning, and communication abilities. However, intensive therapy sessions can sometimes lead to fatigue, muscle soreness, or frustration in children. Pharmacologic treatments, such as muscle relaxants, may cause drowsiness, dizziness, or gastrointestinal issues. Surgical interventions, while potentially beneficial for severe cases, carry risks of infection, bleeding, and prolonged recovery periods. Overall, the side effects of educational and developmental interventions are relatively mild compared to more invasive treatments.

What other types of research exist?

Promising alternatives to the School Readiness Program for children with cerebral palsy include: 1) Early Intervention Services, which provide tailored support and therapies to enhance developmental outcomes; 2) Community-Based Parent Training Programs, such as the 'Getting to Know Cerebral Palsy' program, which empower caregivers with skills and knowledge to support their child's development; and 3) Complementary Therapies like therapeutic horseback riding, which has been shown to improve social functioning and physical abilities in children with cerebral palsy.

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Behavioural Intervention

School Readiness Program for Cerebral Palsy

Q: What prior FDA approvals exist?

FDA-approved treatments for cerebral palsy primarily focus on managing symptoms such as spasticity and movement disorders. These include medications like baclofen, administered intrathecally via a pump, and botulinum toxin injections to reduce muscle stiffness. Surgical options like Selective Dorsal Rhizotomy (SDR) are also used to improve mobility and comfort. While these treatments address physical symptoms, educational and developmental interventions, such as the School Readiness Program, aim to enhance cognitive and social skills, preparing children for school and daily activities.

N/A

Recruiting

Led By Angela Shierk, PhD

Research Sponsored by Texas Scottish Rite Hospital for Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ability to visually attend to objects

attempt to reach for or grasp an item with the impaired upper extremity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention]

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special training program for preschoolers with a specific type of cerebral palsy to help them get ready for school. The program includes regular therapy sessions that focus on improving important skills like moving, self-care, social interaction, learning, and communication. It also provides guidance to parents on how to support their child's development.

Who is the study for?

This trial is for preschool-aged children (3 to 5 years and 11 months old) with unilateral cerebral palsy who show interest in objects, can focus on them visually, and try to reach or grasp with the impaired arm. They must speak English. Children not meeting these criteria are excluded.

What is being tested?

The study tests a 'Smart Start - School Readiness Program' designed for young children with unilateral cerebral palsy. It checks if the program is doable, liked by kids and caregivers, and how it affects school readiness after an intensive training period followed by assessments.

What are the potential side effects?

Since this trial involves an educational program rather than a medical intervention, traditional side effects like those seen with medications are not applicable here. However, there may be other types of discomfort or stress related to participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can see and focus on objects.

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I can try to grab things with my affected arm.

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I speak English.

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I am between 3 and 5 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention (within 2 weeks of start of intervention), and within 2 weeks of post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Canadian Occupational Performance Measure

Secondary study objectives

Assisting Hand Assessment

Developmental Assessment for Young Children, Second Edition (DAYC-2)

School Readiness Checklist

Other study objectives

Bracken Basic Concept Scale, 4th Edition Receptive (BBCS-4:R)

Communication Function Classification System (CFCS)

Demographic information

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: School Readiness Intervention ProgramExperimental Treatment1 Intervention

The School Readiness Program is a 64 hour intensive therapy program focused on school readiness skills for young children with unilateral cerebral palsy (UCP). The program will include 64 hours of intervention supporting the development and goal attainment across 5 school readiness domains: (1) health and physical development, (2) emotional well-being and social competence, (3) approaches to learning, (4) communication skills, and (5) cognitive skills and general knowledge.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Educational and developmental interventions for Cerebral Palsy, such as the School Readiness Program, focus on enhancing cognitive and motor skills through structured activities and individualized learning plans. These programs often include physical and occupational therapy to improve motor function, speech therapy to enhance communication skills, and social skills training to aid in social interaction. Pharmacologic treatments like antispasticity medications (e.g., baclofen) and botulinum toxin injections help reduce muscle spasticity, while surgical options like selective dorsal rhizotomy (SDR) aim to improve mobility by cutting nerve fibers that cause spasticity. These treatments are crucial for CP patients as they target the core symptoms, improve functional abilities, and enhance the overall quality of life.