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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how early motor experiences can aid infants with Down syndrome in improving motor skills, cognitive abilities, and language development. Participants will receive either a gross motor intervention, such as using a treadmill with body-weight support, or both gross and fine motor interventions, including "sticky mittens" to enhance hand movements. The goal is to determine if these activities assist in early word and gesture development. Infants diagnosed with Down syndrome, who do not have severe medical conditions like seizure disorders or significant vision, hearing, or heart problems, may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to understanding developmental interventions for infants with Down syndrome.

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 prior data suggests that these motor interventions are safe for infants with Down syndrome?

Research has shown that activities to improve large movements (like walking) and small movements (like gripping) are generally safe and well-received by children with Down syndrome. One case study examined a young child who received intensive physical therapy to enhance large movements and found no negative effects. Other studies have shown that children participating in similar therapies improved their movement skills, indicating these activities are both helpful and safe.

Improving small movements, such as grip strength, is important for everyday tasks in children with Down syndrome. Although specific reports of negative effects from these activities are lacking, research supports their effectiveness and safety in enhancing movement skills.

Overall, evidence for the safety of both large and small movement activities is encouraging, with studies showing positive results and no major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for Down syndrome because they offer a hands-on, developmental approach that isn't typically part of standard care, which often focuses more on general physical therapy. The gross motor intervention uses a body-weight supported treadmill to help infants build early walking skills in a home setting, which is unique because it empowers parents to be actively involved in their child's motor development. The combined gross and fine motor intervention takes this a step further by introducing "sticky mittens," which aim to enhance fine motor skills alongside gross motor development. This dual approach could potentially accelerate overall motor milestones in children with Down syndrome, offering a more comprehensive developmental boost than existing treatments.

What evidence suggests that this trial's treatments could be effective for Down syndrome?

Research has shown that starting physical therapy early can significantly help children with Down syndrome improve their movement skills. In this trial, participants in the "Gross motor intervention" arm will receive a home-based, parent-administered body-weight supported treadmill intervention. Those in the "Gross and fine motor intervention" arm will receive the same treadmill intervention, along with additional fine motor activities using "sticky mittens." Studies have found that early therapy enhances motor development, aiding in walking and overall movement. Adding activities like using "sticky mittens" can also improve coordination and muscle strength. These activities may support better thinking and language skills, as movement skills are crucial for these areas. Overall, these treatments offer hope for improving movement skills in children with Down syndrome. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9039636/

Effects of early physical therapy on motor development in ... Our results revealed that PT especially when started early childhood under had a positive effect on the development of gross and fine motor in children with DS.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35582517/

Effects of early physical therapy on motor development in ... Our results revealed that PT especially when started early childhood under had a positive effect on the development of gross and fine motor in children with DS.

3. nature.com nature.com/articles/s41598-022-16332-x

Therapeutic exercise to improve motor function among ... This study suggests that aerobic exercise therapy has a potentially effective role to promote the gait and motor development of children with DS aged 0 to 3 ...

4. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.1113/EP092739

Improving coordination, proprioception, balance and motor ... Table 7 presents the outcomes of the repeated measures ANOVA, facilitating a comparison of gross motor skills, fine motor skills, upper limb ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/03004430500105233

Children with Down syndrome improved in motor ... These findings suggest that the addition of massage therapy to an early intervention program may enhance motor functioning and increase muscle tone for children ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6199818/

Contribution of Physical and Motor Characteristics to ... This study demonstrated fine motor skills and grip strength to be predictors of functional performance in children and adolescents with DS.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8898616/

Gross motor dysfunction and balance impairments in children ... Overall, the children and adolescents with Down syndrome showed delays and dysfunction in performing various activities such as sitting, pulling to stand, ...

8. research.aota.org research.aota.org/ajot/article/74/2/7402180060p1/6681/Interventions-Within-the-Scope-of-Occupational

Interventions Within the Scope of Occupational Therapy ... An RCT found significant improvements in gross motor skills for children with Down syndrome or CP who received parent-administered qigong ...

9. mdpi.com mdpi.com/2673-7272/5/1/14

Occupational and Physical Therapy Interventions for ... Impact of early intervention on motor outcomes for children with Down syndrome < 8 years. Search: MEDLINE, Cochrane, EBSCO, CINAHL and PsychINFO, 1987 to ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT04603352

Impact of an Orthotic Garment on Gross Motor Skills for ... Effects of intensity of treadmill training on developmental outcomes and stepping in infants with Down syndrome: a randomized trial. Phys Ther. 2008 Jan;88 ...