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Role of Early Motor Experience in Infants With Down Syndrome

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gross motor intervention, gross and fine motor intervention
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Down Syndrome

Eligibility Criteria

7 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Biomechanics labRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Gross motor intervention

Gross and fine motor intervention

Control

Arm Description

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

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.

Participants will not receive specific intervention.

Outcomes

Primary Outcome Measures

Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley cognitive scores
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Bayley language scores
The Bayley Scale of Infant and Toddler Development language composite scores
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Gesture production
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction

Secondary Outcome Measures

Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores
Bayley motor scores
The Bayley Scale of Infant and Toddler Development motor composite scores

Full Information

First Posted
October 5, 2021
Last Updated
September 6, 2023
Sponsor
Georgia State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05144373
Brief Title
Role of Early Motor Experience in Infants With Down Syndrome
Official Title
Role of Early Motor Experience in Infants With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gross motor intervention
Arm Type
Experimental
Arm Description
Participants will receive a home-based, parent-administered body-weight supported treadmill intervention from about 10 months of age until walking onset.
Arm Title
Gross and fine motor intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will not receive specific intervention.
Intervention Type
Behavioral
Intervention Name(s)
Gross motor intervention, gross and fine motor intervention
Intervention Description
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 Outcome Measure Information:
Title
Bayley cognitive scores
Description
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Time Frame
10 months for GM and GM+FM groups
Title
Bayley cognitive scores
Description
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Time Frame
15 months for GM and GM+FM groups
Title
Bayley cognitive scores
Description
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Time Frame
20 months for all three groups
Title
Bayley cognitive scores
Description
The Bayley Scale of Infant and Toddler Development cognitive composite scores
Time Frame
25 months for all three groups
Title
Bayley language scores
Description
The Bayley Scale of Infant and Toddler Development language composite scores
Time Frame
10 months for GM and GM+FM groups
Title
Bayley language scores
Description
The Bayley Scale of Infant and Toddler Development language composite scores
Time Frame
15 months for GM and GM+FM groups
Title
Bayley language scores
Description
The Bayley Scale of Infant and Toddler Development language composite scores
Time Frame
20 months for all three groups
Title
Bayley language scores
Description
The Bayley Scale of Infant and Toddler Development language composite scores
Time Frame
25 months for all three groups
Title
Gesture production
Description
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Time Frame
10 months for GM and GM+FM groups
Title
Gesture production
Description
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Time Frame
15 months for GM and GM+FM groups
Title
Gesture production
Description
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Time Frame
20 months for all three groups
Title
Gesture production
Description
It measures the type, frequency, and quality of gestures that the infant produces during infant-parent interaction
Time Frame
25 months for all three groups
Secondary Outcome Measure Information:
Title
Bayley motor scores
Description
The Bayley Scale of Infant and Toddler Development motor composite scores
Time Frame
10 months for GM and GM+FM groups
Title
Bayley motor scores
Description
The Bayley Scale of Infant and Toddler Development motor composite scores
Time Frame
15 months for GM and GM+FM groups
Title
Bayley motor scores
Description
The Bayley Scale of Infant and Toddler Development motor composite scores
Time Frame
20 months for all three groups
Title
Bayley motor scores
Description
The Bayley Scale of Infant and Toddler Development motor composite scores
Time Frame
25 months for all three groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Wu, Ph.D.
Phone
4044138476
Email
jwu11@gsu.edu
Facility Information:
Facility Name
Biomechanics lab
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerry Wu
Phone
404-413-8476
Email
jwu11@gsu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Role of Early Motor Experience in Infants With Down Syndrome

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