- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06144775
A Kinematic Analysis of Motor Planning and Movement Execution of Children With Autism Spectrum Condition
Manual Motor Planning Deficits and Performance Differences in Children With Autism Spectrum Condition: a Kinematic Analysis to Extract Objective Markers of Motor Atypia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giovanni Pioggia
- Phone Number: +393203390892
- Email: giovanni.pioggia@irib.cnr.it
Study Contact Backup
- Name: Ileana Scarcella
- Phone Number: +393408322948
- Email: ileana.scarcella@irib.cnr.it
Study Locations
-
-
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Messina, Italy, 98164
- Recruiting
- Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
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Contact:
- Flavia Marino
- Phone Number: +393395798263
- Email: flavia.marino@irib.cnr.it
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Contact:
- Giovanni Pioggia
- Phone Number: +393203390892
- Email: giovanni.pioggia@irib.cnr.it
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Principal Investigator:
- Flavia Marino
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Sub-Investigator:
- Giovanni Pioggia
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Sub-Investigator:
- Paola Chilà
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Sub-Investigator:
- Roberta Minutoli
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Sub-Investigator:
- Noemi Vetrano
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Sub-Investigator:
- Chiara Failla
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Sub-Investigator:
- Germana Doria
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Sub-Investigator:
- Ileana Scarcella
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Sub-Investigator:
- Serena Previti
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Sub-Investigator:
- Antonio Cerasa
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Sub-Investigator:
- Gennaro Tartarisco
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Sub-Investigator:
- Roberta Bruschetta
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Sub-Investigator:
- Simona Campisi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of Autism
- QI ≥ 80.
Exclusion Criteria:
- Motor deficits due to another clinical condition
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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 typical development
Thirty TD children, aged 7 to 13 years, IQ > 80, in the absence of motor deficits due to clinical condition.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction time and latency
Time Frame: The recording session needs approximately 20 minutes to complete.
|
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
Time Frame: The recording session needs approximately 20 minutes to complete.
|
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
Time Frame: The recording session needs approximately 20 minutes to complete.
|
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
Time Frame: The recording session needs approximately 20 minutes to complete.
|
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
Time Frame: The recording session needs approximately 20 minutes to complete.
|
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
Time Frame: The recording session needs approximately 20 minutes to complete.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wechsler Abbreviated Scale of Intelligence - Second Edition (WASI-II)
Time Frame: The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 25-40 minutes to complete.
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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.
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The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 25-40 minutes to complete.
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Movement Assessment Battery for Children - Second Edition (MABC-2)
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.
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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:
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The evaluation session will be scheduled before of kinematics measurements. The test needs approximately 20-40 minutes. The checklist needs approximately 10 minutes.
|
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Behavioral Rating Inventory of Executive Function (BRIEF)
Time Frame: The evaluation session will be scheduled before of kinematics measurements. Questionnaires take 10 minutes to administer.
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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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CNR-IRIB-PRO-2023-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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