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Behavioural Intervention

School Readiness Intervention Program for Cerebral Palsy

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

Study Summary

This trial aims to determine if a school readiness program is feasible and beneficial for preschool-aged children with unilateral cerebral palsy. The study will assess if the program can be successfully implemented and if the children and

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Canadian Occupational Performance Measure

Secondary outcome measures

Assisting Hand Assessment

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

School Readiness Checklist

Other outcome measures

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

Communication Function Classification System (CFCS)

Demographic information

+6 more

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

Find a Location

Who is running the clinical trial?

Texas Scottish Rite Hospital for ChildrenLead Sponsor

18 Previous Clinical Trials

8,818 Total Patients Enrolled

3 Trials studying Cerebral Palsy

100 Patients Enrolled for Cerebral Palsy

Angela Shierk, PhDPrincipal InvestigatorScottish Rite for Children

2 Previous Clinical Trials

80 Total Patients Enrolled

2 Trials studying Cerebral Palsy

80 Patients Enrolled for Cerebral Palsy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently eligible to participate in this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, this ongoing trial is actively seeking eligible participants. It was initially posted on December 12th, 2023 and underwent its most recent revision on January 15th, 2024."

Answered by AI

Does the inclusion criteria for this medical study encompass individuals who are 60 years of age or older?

"This study is accepting participants who are older than 36 months and younger than 71 months of age."

Answered by AI

What is the current number of participants being recruited for this clinical study?

"Indeed, as stated on clinicaltrials.gov, this study is currently actively recruiting participants. The initial posting date of the trial was December 12th, 2023 and it was last updated on January 15th, 2024. To complete the trial successfully, researchers are seeking a total of 20 eligible individuals at one designated location."

Answered by AI

What are the specific criteria for individuals who can participate in this medical study?

"This clinical trial aims to enroll 20 participants within the age range of 36 months and 71 months, all diagnosed with cerebral palsy. In addition, potential patients must exhibit an interest in objects, be English-speaking individuals aged between 3 years and 5 years and 11 months old, have unilateral cerebral palsy, possess visual attentiveness towards objects, as well as make attempts to reach for or grasp items using their impaired upper extremity."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

School Readiness in Preschool-Aged Children With Cerebral Palsy

2023. "School Readiness in Preschool-Aged Children With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06083220.

All > Cerebral Palsy