An observational study in Autism and Autism Spectrum Disorder, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Recruiting at 1 site in Italy. Open to participants aged 7 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-22.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Observational
Autism Spectrum Condition (ASC) is a behavioral syndrome characterized by a severe organizational disorder of thinking and major functions that regulate human adaptation. It is to be considered as a functional disorder, or of executive functions, whose dysfunction is expressed in the difficulty of making voluntary movements, sequentially coordinated with each other according to a purpose, and of initiating an action, planning and monitoring it by inhibiting inappropriate responses such as gesture perseveration. Literature studies suggest that, compared to children with typical development (TD) and regardless of cognitive status, children with ASC have pervasive motor dysfunction that results in universal difficulties in several aspects of motor function, including - (1) fine motricity, (2) some aspects of praxis while performing tasks based on imitation of sequences, (3) simultaneous coordination of both sides of the body during rhythmic tasks of the upper limbs, and́ (4) interpersonal coordination and synchrony. The hypothesis of the study is that by comparing these aspects in 2 groups of children with ASC and children with TD using A.I. systems, it will be possible to extract objective markers of motor deficits found in autism, facilitating the validation of measurements acquired with clinical scales. The objective of the study is to investigate the characteristics of manual motor planning and performance difficulties in children with ASC using kinematic measurements. 30 ASC children with medium-high functioning and 30 TD children, aged 7 to 13 years, IQ > 80, in the absence of motor deficits due to another clinical condition, will be recruited. The protocol will take place in a single session during which children will be video-recorded performing simple and complex rhythmic upper limb actions with a social partner. The presence of characteristic fine motor behaviors, practice errors, perseverations, movement variability, and interpersonal synchrony will be observed. The study will involve the use of 3 tasks contained in NEPSY-II: Finger tapping, Visual-motor precision, and Imitation of manual motor sequences. The videos will be recorded simultaneously and the different angles will allow hand kinematics to be extracted and analyzed with A.I. algorithms to measure displacement, velocity, acceleration, frequency and any other kinematic parameters highlighted. Thus, it is expected to identify objective markers of motor deficits found in children with ASC.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's planned enrollment of 60 is below the median of 102 across 267 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 46 studies on the registry; 29 are open to participants now.
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Thirty children with ASD and 30 typically developing (TD) children will participate in the study. The children with ASD will be recruited and tested at the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina. To be included in the study the child needs to have an ASD diagnosis based on the DSM-5 criteria from a licensed clinical child neuropsychiatrist but no established intellectual disability (ID) diagnosis. The TD children will recruit through advertisements in schools located close to the Institute. Informed consent will obtain from all subjects involved in the study.
Exclusion Criteria:
Thirty ASC children with medium-high functioning, aged 7 to 13 years, IQ \> 80, in the absence of motor deficits due to another clinical condition.
Other: Kinematics measures
Thirty TD children, aged 7 to 13 years, IQ \> 80, in the absence of motor deficits due to clinical condition.
Other: Kinematics measures
In a single session each child will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. The study involves the use of three blocks of tasks of the neuropsychological battery (NEPSY-II): Finger Tapping, Visuo-Motor Precision, and Manual Motor Sequences. The order within each block will be randomized.
Reaction time and latency
In a single session the children will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. During the execution of the three blocks of tasks (finger tapping, visuo-motor precision, and manual motor sequences) four GOPRO cameras, mounted on tripods in different angles of the room, record videos simultaneously. The videos will be analyzed through Artificial Intelligence algorithms to determine the movement's reaction time and latency in seconds (s).
Time frame: The recording session needs approximately 20 minutes to complete.
Speed
In a single session the children will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. During the execution of the three blocks of tasks (finger tapping, visuo-motor precision, and manual motor sequences) four GOPRO cameras, mounted on tripods in different angles of the room, record videos simultaneously. The videos will be analyzed through Artificial Intelligence algorithms to determine the movement's speed in millimeter per second (mm/s).
Time frame: The recording session needs approximately 20 minutes to complete.
Quantity of motion
In a single session the children will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. During the execution of the three blocks of tasks (finger tapping, visuo-motor precision, and manual motor sequences) four GOPRO cameras, mounted on tripods in different angles of the room, record videos simultaneously. The videos will be analyzed through Artificial Intelligence algorithms to determine the quantity of motion.
Time frame: The recording session needs approximately 20 minutes to complete.
Frequency
In a single session the children will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. During the execution of the three blocks of tasks (finger tapping, visuo-motor precision, and manual motor sequences) four GOPRO cameras, mounted on tripods in different angles of the room, record videos simultaneously. The videos will be analyzed through Artificial Intelligence algorithms to determine the frequency in Hertz (Hz) of the movements.
Time frame: The recording session needs approximately 20 minutes to complete.
Acceleration
In a single session the children will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. During the execution of the three blocks of tasks (finger tapping, visuo-motor precision, and manual motor sequences) four GOPRO cameras, mounted on tripods in different angles of the room, record videos simultaneously. The videos will be analyzed through Artificial Intelligence algorithms to determine the movement's acceleration in millimeter per square second (mm/s2).
Time frame: The recording session needs approximately 20 minutes to complete.
Angular speed
In a single session the children will be video-recorded while performing simple and complex rhythmic actions of the upper limbs with a social partner. The presence of characteristic motor behaviors, practice errors, perseverations, and movement variability will be observed. During the execution of the three blocks of tasks (finger tapping, visuo-motor precision, and manual motor sequences) four GOPRO cameras, mounted on tripods in different angles of the room, record videos simultaneously. The videos will be analyzed through Artificial Intelligence algorithms to determine the movement's angular speed in radians per second (rad/s).
Time frame: The recording session needs approximately 20 minutes to complete.
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
The WASI-II is a general intelligence, or IQ test designed to assess specific and overall cognitive capabilities in clinical, educational, and research settings and is individually administered to children, adolescents and adults (ages 6-89). It is a battery of four subtests: Vocabulary (31-item), Block Design (13-item), Similarities (24-item) and Matrix Reasoning (30-item). In addition to assessing general, or Full Scale (range T Scores min 80 - max 320), intelligence, the WASI-II is also designed to provide estimates of Verbal (range T Scores min 40 - max 160) and Performance (range T Scores min 40 - max 160) intelligence consistent with other Wechsler tests. For each scale higher score corresponds to better performance.
Time frame: The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 25-40 minutes to complete.
Movement Assessment Battery for Children - Second Edition (MABC-2)
The MABC-2 identifies and describes impairments in motor performance of children and adolescents 3 through 16 years of age. The MABC-2 consists of 2 components: * 24 tests divided into 8 tasks for 3 age groups (3-6; 7-10; 11-16), for 3 areas (Manual dexterity, Aiming and grasping, Balance). There is a total score (TS) and separate scores for the 3 areas. Age-and percentile-adjusted standardized scores are provided for each section of the test and for the TS: TS\>67 or a percentile \>15th indicates performance in the normal range; 57 \<TS\> 67 or 6th \<percentile \>15th defines an "at risk" category with the need for close monitoring; TS ≤56 or percentile ≤5th indicates the presence of a significant motor problem. The test allows to draw a qualitative description of the ways in which the child performs each task; * An observation checklist consisting of 43 items divided into 3 sections to be completed by an adult who has the opportunity to observe the child in his daily motor activities.
Time frame: The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 20-40 minutes. The checklist needs approximately 10 minutes.
Behavioral Rating Inventory of Executive Function (BRIEF)
The BRIEF-2 is a set of questionnaires for parents and teachers designed to evaluate executive function. The BRIEF-2 now uses 10 clinical scales: Inhibit; Self-Monitor; Shift; Emotional Control; Initiate; Task Completion; Working Memory; Plan/Organize; Task-Monitor; Organization of Materials. T scores (min 31 - max \>99) and percentile score (min 3 - max \>99) are provided for three broad indexes (Behavior Regulation, Emotion Regulation, and Cognitive Regulation) and for the Total Score. Higher score corresponds to better performance.
Time frame: The evaluation session will be scheduled before of kinematics measurements. Questionnaires take 10 minutes to administer.
Plan to share: No
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