Early Motor Experience for Down Syndrome

Overseen By Jerry Wu, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Disqualifiers: Seizure disorders, Vision, Hearing, Heart, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

45 Participants Needed

Trial Summary

What is the purpose of this trial?

Infants with Down syndrome show significant delays and weaknesses in motor, cognitive, and language development compared to typically developing infants. This project aims to examine the developmental cascade effects of specific gross and fine motor experience on motor, cognitive and language development in infants with Down syndrome. We propose that both gross and fine motor experience will facilitate cognitive and language development in infants with Down syndrome, and particularly, fine motor experience will help advance gesture and early words production.

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

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

What data supports the effectiveness of the treatment for early motor experience in children with Down syndrome?

Research shows that early physical therapy can help improve motor development in children with Down syndrome, especially when started before the age of one. Additionally, physical therapy has been found to benefit people with intellectual disabilities by improving their gross motor skills. ^{1 2 3 4 5}

Is early motor experience therapy safe for humans?

The research does not provide specific safety data for early motor experience therapy, but physical therapy interventions for improving motor skills are generally considered safe for people with intellectual disabilities and children with neurodevelopmental disorders. ^{2 4 5 6 7}

How does the Early Motor Experience treatment for Down Syndrome differ from other treatments?

The Early Motor Experience treatment for Down Syndrome is unique because it focuses on both gross and fine motor skills through physical therapy, starting at a very young age, which can help improve motor development and potentially lead to earlier independent walking. This approach is different from other treatments as it emphasizes early intervention and task-specific training, such as treadmill interventions, to address motor delays. ^{2 3 8 9 10}

Eligibility Criteria

This trial is for infants aged 7-24 months who have been diagnosed with Down syndrome. It's not suitable for those with seizure disorders, uncorrectable vision or hearing issues, heart problems, or any severe medical conditions that would limit their participation.

Inclusion Criteria

You have Down syndrome.

My child is between 7 and 24 months old.

Exclusion Criteria

I have a seizure disorder.

I have vision, hearing, or heart issues that cannot be fixed.

My infant has no severe medical conditions that would prevent participation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gross Motor Intervention

Participants receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset

Approximately 5 months

Home-based intervention

Gross and Fine Motor Intervention

Participants receive additional fine motor intervention using 'sticky mittens' from about 10 months of age for five months

5 months

Home-based intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 months

Treatment Details

Interventions

• Gross and fine motor intervention
• Gross motor intervention

Trial Overview The study is testing the impact of specific motor experiences on development in infants with Down syndrome. It will explore how gross motor (like crawling) and fine motor (like grasping) interventions can influence cognitive and language skills.

Participant Groups

Group I: Gross motor intervention Experimental Treatment 1 Intervention

Participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset.

Group II: Gross and fine motor intervention Experimental Treatment 1 Intervention

Besides the body-weight supported treadmill intervention as illustrated above, participants will receive additional fine motor intervention using "sticky mittens" from about 10 months of age for five months.

Group III: Control Active Control 1 Intervention

Participants will not receive specific intervention.

Gross and fine motor intervention is already approved in United States, European Union for the following indications:

Approved in United States as Physical Therapy for:

• Motor Development Delay
• Cognitive Development Delay
• Language Development Delay

Approved in European Union as Motor Intervention for:

• Down Syndrome
• Motor Skill Development
• Cognitive and Language Development

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A scoping review of 413 papers identified only 33 studies that reported both motor and language data in children with Down syndrome, highlighting a gap in research that connects these two important developmental areas.

Only 9% of the studies used a longitudinal design to explore the predictive links between motor and language skills, suggesting that more comprehensive analyses are needed to understand how improvements in one area may positively influence the other in children with Down syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor-language links in children with Down syndrome: a scoping review to revisit the literature with a developmental cascades lens. Karimi, A., Nelson, EL.[2023]

This study collected longitudinal data on gross motor skills from 509 children with Down syndrome, providing a definitive schedule for when these children typically achieve milestones like sitting, crawling, and walking.

The findings allow healthcare professionals to assess a child's gross motor development relative to peers with Down syndrome, enabling early identification of delays and timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A schedule of gross motor development for children with Down syndrome. Winders, P., Wolter-Warmerdam, K., Hickey, F.[2020]

Children with Down syndrome (DS) who received physical therapy (PT) showed significantly better gross and fine motor development compared to those who did not receive PT, based on a study of 58 children aged 6 to 42 months.

Starting PT before the age of one led to even greater improvements in motor skills, suggesting that early intervention is crucial for enhancing movement development in children with DS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of early physical therapy on motor development in children with Down syndrome. Arslan, FN., Dogan, DG., Canaloglu, SK., et al.[2022]

Physical therapy interventions can lead to significant improvements in gross motor skills (GMSs) for individuals with intellectual disabilities, particularly through specific training methods like body-weight-supported gait training and adapted judo training.

Despite some positive outcomes, the overall quality of evidence is low, with only two randomized controlled trials included in the review, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy interventions for gross motor skills in people with an intellectual disability aged 6 years and over: a systematic review. Hocking, J., McNeil, J., Campbell, J.[2018]

A systematic review of 9 trials involving children with Developmental Coordination Disorder (DCD) and Cerebral Palsy (CP) found that only two trials showed any significant effect of physical therapy interventions on gross motor skills, indicating limited effectiveness of current therapies.

While some interventions demonstrated a large beneficial effect in improving gross motor outcomes, the overall evidence quality was rated as very low, highlighting the need for more rigorous and higher-quality studies in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to improve gross motor performance in children with neurodevelopmental disorders: a meta-analysis. Lucas, BR., Elliott, EJ., Coggan, S., et al.[2022]

The Basic Gross Motor Assessment was specifically developed to evaluate minor motor problems in children, addressing the inadequacies of existing measures used for more severely disabled children.

The assessment was normed on a large sample of 1,260 children and validated with an additional 285 subjects, demonstrating its reliability and effectiveness in identifying children who may need further physical therapy evaluation or treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic gross motor assessment. Tool for use with children having minor motor dysfunction. Hughes, JE., Riley, A.[2019]

The Peabody Developmental Gross Motor Scale (PDMS-GM) was found to be a valid evaluative measure for assessing motor development in infants receiving physical therapy, with significant mean score increases observed across various diagnostic groups over a 6-month period involving 124 infants.

However, the PDMS-GM was not sensitive enough to detect individual changes in motor skills for many infants, especially those with cerebral palsy, suggesting it should be used primarily in large clinical trials rather than for evaluating the immediate effects of physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of the Peabody Developmental Gross Motor Scale as an evaluative measure of infants receiving physical therapy. Palisano, RJ., Kolobe, TH., Haley, SM., et al.[2019]

In a study of 79 children with Down syndrome, significant delays in gross motor functions such as standing and walking were observed, with only 10% of children under 3 years achieving these milestones compared to 95% of those aged 3-6 years.

There is a strong correlation between balance and gross motor function, suggesting that both should be addressed together in physical therapy to improve overall motor development in children with Down syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delays in Motor Development in Children with Down Syndrome. Malak, R., Kostiukow, A., Krawczyk-Wasielewska, A., et al.[2018]

In a study of 86 children with Down syndrome, the average age for achieving independent walking was 26 months, indicating a significant delay compared to typical development.

Early physical therapy using the NDT-Bobath approach was effective in reducing the delay in walking onset, suggesting it can positively influence the development of subsequent motor and cognitive skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can early physical therapy positively affect the onset of independent walking in infants with Down syndrome? A retrospective cohort study. Corrado, B., Sommella, N., Ciardi, G., et al.[2022]

Treadmill intervention may help children with Down syndrome achieve independent walking earlier compared to those who do not receive this intervention, based on a systematic review of five studies involving 139 children.

However, the evidence is limited and inconclusive regarding the overall effectiveness of treadmill training on gross motor function and its benefits for children at high risk of neuromotor disabilities, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill interventions with partial body weight support in children under six years of age at risk of neuromotor delay: a report of a Cochrane systematic review and meta-analysis. Valentin-Gudiol, M., Bagur-Calafat, C., Girabent-Farrés, M., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Motor-language links in children with Down syndrome: a scoping review to revisit the literature with a developmental cascades lens. [2023]

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

A schedule of gross motor development for children with Down syndrome. [2020]

3. Turkey pubmed.ncbi.nlm.nih.gov

Effects of early physical therapy on motor development in children with Down syndrome. [2022]

4. Australia pubmed.ncbi.nlm.nih.gov

Physical therapy interventions for gross motor skills in people with an intellectual disability aged 6 years and over: a systematic review. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Interventions to improve gross motor performance in children with neurodevelopmental disorders: a meta-analysis. [2022]

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

Basic gross motor assessment. Tool for use with children having minor motor dysfunction. [2019]

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

Validity of the Peabody Developmental Gross Motor Scale as an evaluative measure of infants receiving physical therapy. [2019]

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

Delays in Motor Development in Children with Down Syndrome. [2018]

9. Italy pubmed.ncbi.nlm.nih.gov

Can early physical therapy positively affect the onset of independent walking in infants with Down syndrome? A retrospective cohort study. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Treadmill interventions with partial body weight support in children under six years of age at risk of neuromotor delay: a report of a Cochrane systematic review and meta-analysis. [2018]