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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 1 year to 14 years
• All sexes
• Healthy volunteers accepted
• Child

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Intellectual Disability

Being tested

Clinical evaluation, Neuropsychological evaluation, Neurophysiological evaluation, Genetic evaluation

Medical subject headings

Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Intellectual Disability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Clinical evaluationDiagnostic test

  Clinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale, Children Behavior Check List, Conners' Scale

• Neuropsychological evaluationDiagnostic test

  The participants' motor skills are measured using the Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007), the Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007), and the kinematic analysis of a reach-to-drop task (Forti et al., 2011; Crippa et al., 2015).Sensorimotor domain will be also further investigated with NEPSY-II (Korkman et al., 2007) (Fingertip Tapping, Imitating Hand Positions, Manual Motor Sequences, and Visuomotor Precision).

• Neurophysiological evaluationDiagnostic test

  Magnetic Resonance Imaging (structural MRI and DTI)

• Genetic evaluationDiagnostic test

  Either blood or saliva will be obtained for participants for DNA collection. DNA will be extracted in the Molecular Biology Laboratory at the Scientific Institute IRCCS Medea. Captured 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). The analysis will be focused on non-synonymous variants enrichment in Gene Ontology and Human Phenotype.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Movement Assessment Battery for Children 2 (MABC2)

   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.

   Measured: immediately after the intervention

2. Developmental Coordination Disorder Questionnaire (DCDQ)

   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.

   Measured: immediately after the intervention

3. kinematic analysis of a reach-to-drop task

   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.

   Measured: immediately after the intervention

4. Magnetic Resonance (MRI)

   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)

   Measured: immediately after the intervention

5. Diffusion Tensor Imaging (DTI)

   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

   Measured: immediately after the intervention

6. Exome sequencing

   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).

   Measured: immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted24 Feb 2021
2. Study start2 Jan 2018
3. Primary completion31 Dec 2023
4. Study completion31 Dec 2023

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
• More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.