Role of Early Motor Experience in Infants With Down Syndrome

Sponsor
Georgia State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05144373
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
45
1
3
32
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gross motor intervention, gross and fine motor intervention
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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. The GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age until walking onset. The GM+FM group will receive both treadmill intervention from 10 months of age until walking onset as well as fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. The control group will not receive an intervention.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. The GM group will receive a home-based, parent-guided practice of treadmill stepping from 10 months of age until walking onset. The GM+FM group will receive both treadmill intervention from 10 months of age until walking onset as well as fine motor experience in practice of grasping using "sticky mittens" from 10 months of age for about five months. The control group will not receive an intervention.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Role of Early Motor Experience in Infants With Down Syndrome
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Gross motor intervention, gross and fine motor intervention
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.

Experimental: Gross and fine motor 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.

Behavioral: Gross motor intervention, gross and fine motor intervention
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.

No Intervention: Control

Participants will not receive specific intervention.

Outcome Measures

Primary Outcome Measures

  1. Bayley cognitive scores [10 months for GM and GM+FM groups]

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  2. Bayley cognitive scores [15 months for GM and GM+FM groups]

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  3. Bayley cognitive scores [20 months for all three groups]

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  4. Bayley cognitive scores [25 months for all three groups]

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

  5. Bayley language scores [10 months for GM and GM+FM groups]

    The Bayley Scale of Infant and Toddler Development language composite scores

  6. Bayley language scores [15 months for GM and GM+FM groups]

    The Bayley Scale of Infant and Toddler Development language composite scores

  7. Bayley language scores [20 months for all three groups]

    The Bayley Scale of Infant and Toddler Development language composite scores

  8. Bayley language scores [25 months for all three groups]

    The Bayley Scale of Infant and Toddler Development language composite scores

  9. Gesture production [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 [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 [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 [25 months for all three groups]

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

Secondary Outcome Measures

  1. Bayley motor scores [10 months for GM and GM+FM groups]

    The Bayley Scale of Infant and Toddler Development motor composite scores

  2. Bayley motor scores [15 months for GM and GM+FM groups]

    The Bayley Scale of Infant and Toddler Development motor composite scores

  3. Bayley motor scores [20 months for all three groups]

    The Bayley Scale of Infant and Toddler Development motor composite scores

  4. Bayley motor scores [25 months for all three groups]

    The Bayley Scale of Infant and Toddler Development motor composite scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Months to 24 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • An appropriate age range of 7-24 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biomechanics lab Atlanta Georgia United States 30302

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jianhua Wu, Associate Professor, Georgia State University
ClinicalTrials.gov Identifier:
NCT05144373
Other Study ID Numbers:
  • H21604
  • 1R21HD105879-01
  • 352307
First Posted:
Dec 3, 2021
Last Update Posted:
Jul 21, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2022