School Readiness Program for Cerebral Palsy

Overseen by Angela Shierk, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Texas Scottish Rite Hospital for Children

Disqualifiers: Uncontrolled epilepsy, Significant visual impairment, Severe behavioral problems, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Smart Start for cerebral palsy?

Research suggests that early intervention for children at risk of cerebral palsy can improve school readiness, which includes cognitive and physical development. Additionally, task-oriented training has been shown to enhance motor function and balance in children with cerebral palsy, indicating that early and targeted interventions can be beneficial. ^{1 2 3 4 5}

Is the School Readiness Program for Cerebral Palsy safe for humans?

The available research does not provide specific safety data for the School Readiness Program or its variants like Smart Start. However, the studies focus on interventions for children with cerebral palsy, suggesting that these programs are generally considered safe for this population. ^{1 6 7 8 9}

How is the Smart Start treatment for cerebral palsy unique?

The Smart Start treatment is unique because it focuses on early intervention to improve school readiness in children with cerebral palsy by harnessing neuroplasticity (the brain's ability to reorganize itself) through a combination of cognitive, socio-emotional, language, and physical development activities, which is different from traditional treatments that may not start as early or be as comprehensive. ^{1 4 10 11 12}

Research Team

Angela Shierk, PhD

Principal Investigator

Scottish Rite for Children

Eligibility Criteria

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.

Inclusion Criteria

I can see and focus on objects.

I can try to grab things with my affected arm.

Shows interest in things or objects.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessment

Participants complete pre-intervention assessments to evaluate baseline school readiness and other relevant measures

2 weeks

2 visits (in-person)

School Readiness Intervention

Participants engage in a 64-hour intensive therapy program focused on school readiness skills across five domains

8 weeks

Weekly sessions (in-person or virtual make-up sessions)

Post-intervention Assessment

Participants complete post-intervention assessments to evaluate the impact of the school readiness program

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for continued school readiness and adaptation to school environment

4 weeks

Treatment Details

Interventions

• Smart Start (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: School Readiness Intervention Program Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Texas Scottish Rite Hospital for Children

Lead Sponsor

Trials

23

Recruited

9,000+

Findings from Research

Early referral for intervention in infants at risk of cerebral palsy (CP) is hypothesized to improve school readiness by age 4-6 years compared to standard care, based on a study involving 425 participants from four randomized trials.

The study also aims to demonstrate that early diagnosis and intervention can lead to cost savings by reducing healthcare utilization, comparing outcomes with a historical control group of 245 children diagnosed later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School readiness of children at high risk of cerebral palsy randomised to early neuroprotection and neurorehabilitation: protocol for a follow-up study of participants from four randomised clinical trials. Boyd, RN., Novak, I., Morgan, C., et al.[2023]

In a study of 48 children with cerebral palsy, those with lower baseline intellectual impairment showed greater improvements in motor function after 3 months of comprehensive rehabilitation.

Starting rehabilitation before 12 months of age significantly enhanced both motor and intellectual functions, highlighting the importance of early intervention for better outcomes in children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of motor and intellectual functions on the effectiveness of comprehensive rehabilitation in young children with cerebral palsy. Zhang, H., Zhang, B., Jia, F., et al.[2015]

In a double-blind study involving 24 children under 18 months with cerebral palsy, those receiving the experimental physical therapy showed significant improvements in motor and social skills compared to the control group over a minimum of six months.

The effectiveness of the therapy appeared to be correlated with the children's age at the start of the study, suggesting that younger children with more severe conditions may require additional treatment approaches for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy as a determinant of change in the cerebral palsied infant. Scherzer, AL., Mike, V., Ilson, J.[2007]

A study of 151 preschool-age children with cerebral palsy (CP) revealed that they scored significantly lower in motor performance, self-care, and social function compared to typically developing peers, with scores ranging from 0.5 to over 4 standard deviations below norms.

Over half of the children with CP showed delayed communication skills, and non-ambulant children had notably lower scores than those who could walk, highlighting the need for targeted interventions to support school readiness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School readiness of children with cerebral palsy. Gehrmann, FE., Coleman, A., Weir, KA., et al.[2014]

Task-oriented training (TOT) significantly improves gross motor function, balance, and daily living activities in children with cerebral palsy, based on a meta-analysis of 16 studies involving 893 participants.

The improvements were measured using various scales, including the Gross Motor Function Measure (GMFM) and the Berg Balance Scale, indicating that TOT is an effective intervention for enhancing motor skills in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. Zai, W., Xu, N., Wu, W., et al.[2022]

Botulinum toxin type A is an effective and generally safe treatment for localized spasticity in children with cerebral palsy, although evidence for functional improvement is mixed.

For generalized spasticity, diazepam may be effective for short-term treatment, but there is limited data on its impact on motor function and potential side effects, while tizanidine shows possible effectiveness but also lacks sufficient data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Delgado, MR., Hirtz, D., Aisen, M., et al.[2022]

The study assessed the feasibility and reliability of classifying gross motor function (GMF) in children with cerebral palsy (CP) using medical records, finding that 70% of the evaluated children had sufficient data for classification.

Inter-rater reliability was high, with 75% agreement on GMFCS ratings and 94% agreement on walking ability classifications, indicating that this method can effectively enhance population-based surveillance and provide valuable insights into the functional impact of CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of classifying gross motor function among children with cerebral palsy using population-based record surveillance. Benedict, RE., Patz, J., Maenner, MJ., et al.[2018]

A systematic review of 17 studies found that there are currently no high-level evidence interventions for speech, language, and communication in infants at high risk for or diagnosed with cerebral palsy (CP).

The overall evidence quality was very low, but some promising approaches, like Responsivity and Prelinguistic Milieu Teaching, were identified as beneficial for parent-infant interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech and language interventions for infants aged 0 to 2 years at high risk for cerebral palsy: a systematic review. Chorna, O., Hamm, E., Cummings, C., et al.[2023]

The Small Step Program, tested in a randomized controlled trial with 39 infants at risk for cerebral palsy, showed that it can help the most affected children improve their development in mobility, hand use, and communication, independent of their initial abilities.

By the end of the 35-week intervention, infants in the Small Step group demonstrated sustained developmental gains, as measured by the Peabody Developmental Motor Scales and the Pediatric Evaluation of Disability Inventory, even two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Small Step Program in a Randomized Controlled Trial for Infants under 12 Months Old at Risk of Cerebral Palsy (CP) and Other Neurological Disorders. Holmström, L., Eliasson, AC., Almeida, R., et al.[2020]

The Kindy Moves program is designed to improve school readiness in preschool-aged children with cerebral palsy (CP) by providing motor-based interventions in a play environment, with a focus on functional and goal-directed activities over a 4-week period.

The study will assess the feasibility of this program by measuring goal attainment and other functional outcomes in 40 children aged 2 to 5 years, using various standardized assessments before and after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kindy Moves: a protocol for establishing the feasibility of an activity-based intervention on goal attainment and motor capacity delivered within an interdisciplinary framework for preschool aged children with cerebral palsy. Pool, D., Elliott, C.[2023]

A program designed for severely and profoundly handicapped children with cerebral palsy aged 5 to 9 years emphasizes the importance of a collaborative team approach involving both therapy and teaching professionals.

The study highlights the effectiveness of partnerships between university and clinical personnel in evaluating the program's impact, suggesting that teamwork is crucial for improving outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teamwork in the education of severely and profoundly handicapped cerebral palsy children. Cooksley, E.[2014]

A systematic review identified 48 intelligence assessments for children with cerebral palsy (CP), but only nine had psychometric data specifically for this population, highlighting a gap in reliable testing methods.

There is a need for more research to establish reliable and valid intelligence assessments for children with CP, especially for those with higher motor, communication, or visual impairments, to ensure appropriate evaluation of their intellectual function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intelligence assessments for children with cerebral palsy: a systematic review. Yin Foo, R., Guppy, M., Johnston, LM.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

School readiness of children at high risk of cerebral palsy randomised to early neuroprotection and neurorehabilitation: protocol for a follow-up study of participants from four randomised clinical trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The effects of motor and intellectual functions on the effectiveness of comprehensive rehabilitation in young children with cerebral palsy. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Physical therapy as a determinant of change in the cerebral palsied infant. [2007]

4. England pubmed.ncbi.nlm.nih.gov

School readiness of children with cerebral palsy. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of task-oriented training on gross motor function, balance and activities of daily living in children with cerebral palsy: A systematic review and meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of classifying gross motor function among children with cerebral palsy using population-based record surveillance. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Speech and language interventions for infants aged 0 to 2 years at high risk for cerebral palsy: a systematic review. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of the Small Step Program in a Randomized Controlled Trial for Infants under 12 Months Old at Risk of Cerebral Palsy (CP) and Other Neurological Disorders. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Kindy Moves: a protocol for establishing the feasibility of an activity-based intervention on goal attainment and motor capacity delivered within an interdisciplinary framework for preschool aged children with cerebral palsy. [2023]

11. Australia pubmed.ncbi.nlm.nih.gov

Teamwork in the education of severely and profoundly handicapped cerebral palsy children. [2014]

12. England pubmed.ncbi.nlm.nih.gov

Intelligence assessments for children with cerebral palsy: a systematic review. [2018]