NCT05144373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

December 11, 2025

Status Verified

December 1, 2025

Enrollment Period

3.7 years

First QC Date

October 5, 2021

Last Update Submit

December 9, 2025

Conditions

Down Syndrome

Outcome Measures

Primary Outcomes (12)

  • Bayley cognitive scores

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

    10 months for GM and GM+FM groups

  • Bayley cognitive scores

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

    15 months for GM and GM+FM groups

  • Bayley cognitive scores

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

    20 months for all three groups

  • Bayley cognitive scores

    The Bayley Scale of Infant and Toddler Development cognitive composite scores

    25 months for all three groups

  • Bayley language scores

    The Bayley Scale of Infant and Toddler Development language composite scores

    10 months for GM and GM+FM groups

  • Bayley language scores

    The Bayley Scale of Infant and Toddler Development language composite scores

    15 months for GM and GM+FM groups

  • Bayley language scores

    The Bayley Scale of Infant and Toddler Development language composite scores

    20 months for all three groups

  • Bayley language scores

    The Bayley Scale of Infant and Toddler Development language composite scores

    25 months for all three groups

  • Gesture production

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

    10 months for GM and GM+FM groups

  • Gesture production

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

    15 months for GM and GM+FM groups

  • Gesture production

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

    20 months for all three groups

  • Gesture production

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

    25 months for all three groups

Secondary Outcomes (4)

  • Bayley motor scores

    10 months for GM and GM+FM groups

  • Bayley motor scores

    15 months for GM and GM+FM groups

  • Bayley motor scores

    20 months for all three groups

  • Bayley motor scores

    25 months for all three groups

Study Arms (3)

Gross motor intervention

EXPERIMENTAL

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

Gross and fine motor intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants will not receive specific intervention.

Interventions

Gross motor intervention, gross and fine motor interventionBEHAVIORAL

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.

Gross and fine motor interventionGross motor intervention

Eligibility Criteria

Age7 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomechanics lab

Atlanta, Georgia, 30302, United States

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2021

First Posted

December 3, 2021

Study Start

January 1, 2022

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

December 11, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

We will upload the data to the National Institutes of Health INCLUDE data coordination center (DCC). We will share the de-identified data including demographics, diagnosis, and motor, cognitive, and language developmental profile. We will also share the video data including the captured motion data and the footage of parent-child interaction.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
We will deposit the de-identified data and video data into the National Institutes of Health INCLUDE data coordinating center (DCC) as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.

Locations

US(1)