Motor Impairments in Children With Autism Spectrum Disorder: a Multimodal Approach

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Intellectual Disability
• Interventions: Diagnostic Test: Clinical evaluation; Diagnostic Test: Neuropsychological evaluation; Diagnostic Test: Neurophysiological evaluation; Diagnostic Test: Genetic evaluation

• Registration Number: NCT04769011
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

The general goal of the present proposal, Progetto MOSAICO, is the identification of a multimodal panel of neuropsychological, kinematic, neurophysiological, and genetic markers associated with motor abnormalities present in ASD.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2021-02-11
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-24
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• having a clinical diagnosis of neurodevelopmental disorders (either ASD, ADHD, or intellectual disability) according to DSM-5 criteria;
• children with typical development are also recruited from the general population by local pediatricians or from kindergartens/schools sited near our institute

Exclusion Criteria

• using any stimulant or non-stimulant medication affecting the central nervous system
• having an identified genetic disorder
• having vision or hearing problems
• suffering from chronic or acute medical illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical, neuropsychological, neurophysiological, and genetic evaluations	Clinical evaluation	Clinical, neuropsychological, neurophysiological, and genetic evaluations
Clinical, neuropsychological, neurophysiological, and genetic evaluations	Neuropsychological evaluation	Clinical, neuropsychological, neurophysiological, and genetic evaluations
Clinical, neuropsychological, neurophysiological, and genetic evaluations	Neurophysiological evaluation	Clinical, neuropsychological, neurophysiological, and genetic evaluations
Clinical, neuropsychological, neurophysiological, and genetic evaluations	Genetic evaluation	Clinical, neuropsychological, neurophysiological, and genetic evaluations

Primary Outcome Measures

Name	Time	Method
Exome sequencing	immediately after the intervention	Exome libraries will be sequenced using the Illumina NextSeq 500 in 100 bp paired end reads. Postsequencing reads will be aligned using BWA Enrichment application on BaseSpace. VCF file will be then marked using wANNOVAR (Wang Genomics Lab).
Developmental Coordination Disorder Questionnaire (DCDQ)	immediately after the intervention	The DCDQ (Wilson et al., 2007) is a parent questionnaire originally developed for estimating gross and fine motor skill difficulties in children. The questionnaire consists of 15 items investigating different subdomains of motor abilities, such as ball skills, complex motor coordination, fine and general motor skills. For each item, parents rate the children's degree of motor coordination on a 5-point scale comparing it to same-age peers.
kinematic analysis of a reach-to-drop task	immediately after the intervention	3D kinematic data of a reach-to-drop movement are collected by a motion-capture system (The SMART D from BTS Bioengineering® - Garbagnate Milanese, Italy). The reach-to-drop task consists in reaching and grasping a ball placed over a support and dropping it in a hole (Fig. 1; Forti et al., 2011; Crippa et al., 2015). The task is simple enough to warrant compliance by all children across groups. Each participant is asked to complete at least five trials of the task with their dominant hand. Kinematic data are recorded by eight infrared-motion analysis cameras at 60 Hz with a spatial accuracy of 0.2 mm.
Magnetic Resonance (MRI)	immediately after the intervention	Magnetic Resonance (MRI) of the Brain - MRI signal allowing tridimensional multiplanar reconstruction of the brain's structures. Anatomical images obtained with high definition T1 weighted sequences of radio frequencies - the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
Movement Assessment Battery for Children 2 (MABC2)	immediately after the intervention	The MABC2 (Henderson et al., 2007) is one of the most commonly used tests for the identification of motor difficulties in children aged 3-16 years. The MABC2 includes eight subtests grouped into three areas related to different components of motor domain: manual dexterity, ball skills (such as aiming and catching), and static and dynamic balance.
Diffusion Tensor Imaging (DTI)	immediately after the intervention	Diffusion Tensor Imaging (DTI) measures of the brain microstructure and connectivity - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel

Trial Locations

Locations (1)

IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy