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Completed

NCT Number: NCT05144373

Role of Early Motor Experience in Infants With Down Syndrome

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.

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Key information

Age range

7 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomechanics lab

Atlanta, Georgia, 30302, United States

About this study

Down syndrome (DS) is the most common genetic condition and causes significant development delays and weaknesses in the motor, cognitive, and language domains. It is important to study these co-occurring developmental challenges and develop effective intervention strategies for positive learning outcomes in multiple domains simultaneously. It was found that motor development is closely associated with cognitive and language development in typically developing infants and advances in motor development have developmental cascade effects on other domains. However, this interrelation has not been studied in infants with DS. Our prior work has shown that gross motor experience through body-weight-supported treadmill stepping leads to an earlier onset of walking and improves subsequent locomotor ability in infants with DS. However, we do not yet know the extent to which this motor experience advances cognitive and language development in infants with DS. Research also suggests that grasping, a major fine motor skill emerging in infancy, provides the needed scaffolding for subsequent gesture and speech production. However, research on grasping and its potential effects on other domains in infants with DS remains scarce. The objectives of this proposal are to understand: the role of (a) specific gross motor experience and (b) specific fine motor experience on the motor, cognitive and language development of infants with DS. Our central hypothesis is that motor (both gross and fine) experience will help advance cognitive and language development in infants with DS. We will recruit 45 infants with DS from the greater Atlanta area and beyond. There will be three groups: (a) gross motor (GM) group (n=15), entering the study at about 10 months of age; (b) gross motor plus fine motor (GM+FM) group (n=15), entering the study at about 10 months; and (c) control group (n=15), entering the study at about 20 months. Aim 1: Determine the effects of gross motor experience on cognitive and language development in infants with DS, comparing the GM and control groups. Only the GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age (T1) until onset of walking. We hypothesize that the GM group will show higher Bayley scores and better gesture and word production at termination of the GM intervention (T3) and five months thereafter (T4) than the control group. Aim 2: Determine the effects of fine motor experience on cognitive and language development in infants with DS who receive the GM intervention, particularly in gesture and word production, comparing the GM and GM+FM groups. Only the GM+FM group will receive fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. We hypothesize that the GM+FM group will show further improvements in motor, cognitive and language domains, particularly in gesture and word production, than the GM group at termination of the FM intervention (T2) and again at T3 and T4. Our study will gain an in-depth understanding of the cascading effects of motor experience on cognitive and language development and lay the groundwork for future clinical trials in infants with DS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • An appropriate age range of 7-36 months
  • A diagnosis of Down syndrome.

Exclusion criteria

  • The presence of seizure disorders
  • Non-correctable vision, hearing and heart problems
  • Any other severe medical conditions that may prevent the infant from participating in this study

Treatment and study plan

Gross motor intervention, gross and fine motor intervention

Behavioral

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

For gross and fine motor intervention, participants will receive the same treadmill intervention as illustrated above. In addition, participants will receive a fine motor intervention with practice of reaching and grasping using "sticky mittens" from about 10 months of age for five months.

Primary outcomes

  1. Bayley cognitive scores

    Time frame: 10 months for GM and GM+FM groups

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  2. Bayley cognitive scores

    Time frame: 15 months for GM and GM+FM groups

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  3. Bayley cognitive scores

    Time frame: 20 months for all three groups

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  4. Bayley cognitive scores

    Time frame: 25 months for all three groups

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  5. Bayley language scores

    Time frame: 10 months for GM and GM+FM groups

    The Bayley Scale of Infant and Toddler Development language composite scores

  6. Bayley language scores

    Time frame: 15 months for GM and GM+FM groups

    The Bayley Scale of Infant and Toddler Development language composite scores

  7. Bayley language scores

    Time frame: 20 months for all three groups

    The Bayley Scale of Infant and Toddler Development language composite scores

  8. Bayley language scores

    Time frame: 25 months for all three groups

    The Bayley Scale of Infant and Toddler Development language composite scores

  9. Gesture production

    Time frame: 10 months for GM and GM+FM groups

    It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction

  10. Gesture production

    Time frame: 15 months for GM and GM+FM groups

    It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction

  11. Gesture production

    Time frame: 20 months for all three groups

    It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction

  12. Gesture production

    Time frame: 25 months for all three groups

    It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction

Secondary outcomes

  1. Bayley motor scores

    Time frame: 10 months for GM and GM+FM groups

    The Bayley Scale of Infant and Toddler Development motor composite scores

  2. Bayley motor scores

    Time frame: 15 months for GM and GM+FM groups

    The Bayley Scale of Infant and Toddler Development motor composite scores

  3. Bayley motor scores

    Time frame: 20 months for all three groups

    The Bayley Scale of Infant and Toddler Development motor composite scores

  4. Bayley motor scores

    Time frame: 25 months for all three groups

    The Bayley Scale of Infant and Toddler Development motor composite scores

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2021
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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