NCT06144775

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2 years

First QC Date

November 7, 2023

Last Update Submit

November 17, 2023

Conditions

Keywords

autism spectrum conditionmotor planningkinematic analysischildren

Outcome Measures

Primary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)

    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 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 evaluation session will be scheduled before of kinematics measurements. Questionnaires take 10 minutes to administer.

Study Arms (2)

Children with autism spectrum condition

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

Children with typical development

Thirty TD children, aged 7 to 13 years, IQ \> 80, in the absence of motor deficits due to clinical condition.

Other: Kinematics measures

Interventions

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.

Children with autism spectrum conditionChildren with typical development

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • Diagnosis of Autism
  • QI ≥ 80.

You may not qualify if:

  • Motor deficits due to another clinical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

RECRUITING

Related 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.

    PMID: 34174471BACKGROUND
  • 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.

    PMID: 31661192BACKGROUND
  • 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.

    PMID: 17106133BACKGROUND
  • 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.

    PMID: 29121516BACKGROUND
  • 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.

    PMID: 30124332BACKGROUND
  • 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.

    PMID: 24736983BACKGROUND
  • 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.

    PMID: 34387753BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Flavia Marino

    Istituto per la Ricerca e l'Innovazione Biomedica

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Unit

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 22, 2023

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

March 31, 2025

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations