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.

Study Overview

• Status: Recruiting
• Conditions: Down Syndrome
• Intervention / Treatment: Behavioral: Gross motor intervention, gross and fine motor intervention

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 Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jerry Wu, Ph.D.; Phone Number: 4044138476; Email: jwu11@gsu.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30302
      • Recruiting
      • Biomechanics lab
      • Contact: Jerry Wu; Phone Number: 404-413-8476; Email: jwu11@gsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 months to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley motor scores	The Bayley Scale of Infant and Toddler Development motor composite scores	10 months for GM and GM+FM groups
Bayley motor scores	The Bayley Scale of Infant and Toddler Development motor composite scores	15 months for GM and GM+FM groups
Bayley motor scores	The Bayley Scale of Infant and Toddler Development motor composite scores	20 months for all three groups
Bayley motor scores	The Bayley Scale of Infant and Toddler Development motor composite scores	25 months for all three groups

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: H21604; 1R21HD105879-01 (U.S. NIH Grant/Contract); 352307 (Other Identifier: National Institutes of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No