AutismNCT06144775
A Kinematic Analysis of Motor Planning and Movement Execution of Children With Autism Spectrum Condition
An observational study of Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Kinematics measures
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Diagnosis of Autism
- QI ≥ 80.
Who cannot join
- Motor deficits due to another clinical condition
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Giovanni Pioggia, +393203390892, giovanni.pioggia@irib.cnr.it
About this study
Official title: Manual Motor Planning Deficits and Performance Differences in Children With Autism Spectrum Condition: a Kinematic Analysis to Extract Objective Markers of Motor Atypia
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.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Kinematics measures
- Keywords
- autism spectrum condition, motor planning, kinematic analysis, children
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinematics measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Kinematics measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: The recording session needs approximately 20 minutes to complete.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: The evaluation session will be scheduled before of kinematics measurements. Questionnaires take 10 minutes to administer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- 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.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144775
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-004
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34174471Foster 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.
PubMed 31661192Glazebrook 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.
PubMed 17106133Kaur 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.
PubMed 29121516Grace 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.
PubMed 30124332Vivanti 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.
PubMed 24736983Zampella 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.
PubMed 34387753
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Motor Planning Deficits and Performance Differences in Children With Autism Spectrum Condition: a Kinematic Analysis to Extract Objective Markers of Motor Atypia
- ClinicalTrials.gov ID
- NCT06144775
- Acronym / sponsor ID
- CNR-IRIB-PRO-2023-004
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism spectrum condition, motor planning, kinematic analysis, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with autism spectrum condition | – | Other: Kinematics measuresThirty ASC children with medium-high functioning, aged 7 to 13 years, IQ > 80, in the absence of motor deficits due to another clinical condition. |
| Children with typical development | – | Other: Kinematics measuresThirty TD children, aged 7 to 13 years, IQ > 80, in the absence of motor deficits due to clinical condition. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of Autism
- QI ≥ 80.
Key exclusion criteria (1 listed)
- Motor deficits due to another clinical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinematics measuresIn 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. | Other | Children with autism spectrum condition, Children with typical development |
Primary outcome
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).
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).
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.
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.
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).
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).
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 34174471Backstrom 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.
- Background: PubMed 31661192Foster 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.
- Background: PubMed 17106133Glazebrook 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.
- Background: PubMed 29121516Kaur 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.
- Background: PubMed 30124332Grace 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.
- Background: PubMed 24736983Vivanti 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.
- Background: PubMed 34387753Zampella 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flavia Marino principal investigator
Istituto per la Ricerca e l'Innovazione Biomedica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ileana Scarcella (+393408322948, ileana.scarcella@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction time and latency (time frame: The recording session needs approximately 20 minutes to complete.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06144775, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.