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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06144775
Other study ID # CNR-IRIB-PRO-2023-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2022
Est. completion date March 31, 2025

Study information

Verified date November 2023
Source Istituto per la Ricerca e l'Innovazione Biomedica
Contact Ileana Scarcella
Phone +393408322948
Email ileana.scarcella@irib.cnr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 31, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 13 Years
Eligibility Inclusion Criteria: - Diagnosis of Autism - QI = 80. Exclusion Criteria: - Motor deficits due to another clinical condition

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina

Sponsors (2)

Lead Sponsor Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (7)

Backstrom A, Johansson AM, Rudolfsson T, Ronnqvist L, von Hofsten C, Rosander K, Domellof E. Motor planning and movement execution during goal-directed sequential manual movements in 6-year-old children with autism spectrum disorder: A kinematic analysis. Res Dev Disabil. 2021 Aug;115:104014. doi: 10.1016/j.ridd.2021.104014. Epub 2021 Jun 24. — View Citation

Foster NC, Bennett SJ, Causer J, Elliott D, Bird G, Hayes SJ. Getting Off to a Shaky Start: Specificity in Planning and Feedforward Control During Sensorimotor Learning in Autism Spectrum Disorder. Autism Res. 2020 Mar;13(3):423-435. doi: 10.1002/aur.2214. Epub 2019 Oct 29. — View Citation

Glazebrook CM, Elliott D, Lyons J. A kinematic analysis of how young adults with and without autism plan and control goal-directed movements. Motor Control. 2006 Jul;10(3):244-64. doi: 10.1123/mcj.10.3.244. — View Citation

Grace N, Johnson BP, Rinehart NJ, Enticott PG. Are Motor Control and Regulation Problems Part of the ASD Motor Profile? A Handwriting Study. Dev Neuropsychol. 2018;43(7):581-594. doi: 10.1080/87565641.2018.1504948. Epub 2018 Aug 20. — View Citation

Kaur M, M Srinivasan S, N Bhat A. Comparing motor performance, praxis, coordination, and interpersonal synchrony between children with and without Autism Spectrum Disorder (ASD). Res Dev Disabil. 2018 Jan;72:79-95. doi: 10.1016/j.ridd.2017.10.025. Epub 2017 Nov 6. — View Citation

Vivanti G, Trembath D, Dissanayake C. Mechanisms of imitation impairment in autism spectrum disorder. J Abnorm Child Psychol. 2014 Nov;42(8):1395-405. doi: 10.1007/s10802-014-9874-9. — View Citation

Zampella CJ, Wang LAL, Haley M, Hutchinson AG, de Marchena A. Motor Skill Differences in Autism Spectrum Disorder: a Clinically Focused Review. Curr Psychiatry Rep. 2021 Aug 13;23(10):64. doi: 10.1007/s11920-021-01280-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
The recording session needs approximately 20 minutes to complete.
Primary 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).
The recording session needs approximately 20 minutes to complete.
Primary 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.
The recording session needs approximately 20 minutes to complete.
Primary 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.
The recording session needs approximately 20 minutes to complete.
Primary 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).
The recording session needs approximately 20 minutes to complete.
Primary 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).
The recording session needs approximately 20 minutes to complete.
Secondary 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. The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 25-40 minutes to complete.
Secondary 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 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.
The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 20-40 minutes. The checklist needs approximately 10 minutes.
Secondary 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.
The evaluation session will be scheduled before of kinematics measurements. Questionnaires take 10 minutes to administer.
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