Developmental DisabilityMOTISENNCT06764810
Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years
An observational study of Developmental Disability and Autism Spectrum Disorder, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial summary
Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability, Autism Spectrum Disorder, Development Coordination Disorder
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2024to 20 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The cohort will include children aged 4 to 11 years with typical or atypical neurodevelopment (ASD, ADHD, or DCD). Participants will be recruited from the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, and Criv in Vic. CDIAP is a free service integrated into the social services network managed by Fundació Sant Tomàs, a non-profit organization in the Osona region. Neuro Xics and Criv are private services for child neurodevelopment. Participants with atypical neurodevelopment (ASD, ADHD, or DCD) will be considered cases, while those with typical neurodevelopment will be controls.
Who may be able to join
- Children aged 4 to 11 years.
- Typical or atypical neurodevelopment, defined as follows:
- ASD: Subclinical symptoms or Level 1 diagnosis.
- ADHD: Predominantly inattentive, hyperactive/impulsive, or combined presentation. For children under 6, typical symptoms of the disorder (e.g., impulsivity, hyperactivity).
- DCD: Diagnosed or meeting the following criteria:
- Motor skills below age expectations.
Show all 9Show fewer
- Significant impact on daily activities or school performance.
- Difficulties not attributable to another condition.
- Parental/legal guardian consent.
Who cannot join
- Moderate to severe intellectual disability (IQ ≤ 51).
- Neurological disorders (e.g., cerebral palsy) or syndromes.
- Severe visual and/or auditory impairments.
- Severe behavioral disorders.
- Severe mental health disorders (e.g., depression, severe anxiety).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University of Vic - Central University of Catalonia
Vic, 08500
About this study
Official title: Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years: A Cross-Sectional Observational Case-Control Study
Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. These disorders impact children's growth and learning, leading to difficulties in key areas such as language, communication, behavior, social interaction, and motor skills. Research in this area is limited, particularly regarding fine and gross motor skills in relation to sensory processing in children with these diagnoses.
Hypothesis and Objectives There is an association between motor skills and sensory processing in children aged 4 to 11 years, depending on whether they have typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.
Read more
Main Objective:
To evaluate the association between motor skills and sensory processing in children aged 4 to 11 years with either typical or atypical neurodevelopment (e.g., ASD, ADHD, and DCD).
Secondary Objectives:
To describe and compare motor skills among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.
To describe and compare sensory processing among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.
Methodology The study is a cross-sectional observational case-control study. Participants are users of the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, or Criv in Vic.
The sample will include 30 children as controls (typical neurodevelopment) and 10 children as cases (atypical neurodevelopment: ASD, ADHD, DCD).
Children will be assessed using the Infant Motor Profile (IMP) to measure motor development and the Short Sensory Profile-2 (SSP-2) to evaluate sensory processing.
Statistical Analysis Quantitative variables will be described using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Statistical tests such as the Student's t-test will be used to compare means between two groups, ANOVA for comparisons among more than two groups, and the Chi-square test to analyze associations between categorical variables.
Expected Results The study is expected to provide essential insights into the differences in motor development between children with typical and atypical neurodevelopment, as well as the relationship between biological and external factors and these differences. These findings could help improve clinical and educational interventions for these children by tailoring them to their specific needs, thereby enhancing their overall well-being and development.
Ethical Considerations The study protocol will be submitted to the Research Ethics Committee (CER) of UVic-UCC, adhering to good clinical practice guidelines in accordance with the Declaration of Helsinki. Participants will be assigned a code to ensure data pseudonymization, with data securely stored on the Microsoft 365 server of UVic-UCC. Participants will have the right to withdraw from the study at any time, and personal data will be deleted once the study is completed.
Researchers will ensure confidentiality as dictated by Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016/679 of April 27, 2016, on data protection, and complementary regulations, as well as Organic Law 1/1982 of May 5 on the right to honor, personal and family privacy, and self-image.
Read the detailed description
Methodology Study Design This study is a cross-sectional observational case-control study designed to generate hypotheses.
The STROBE guidelines will be followed to ensure methodological rigor and transparency in reporting results.
Study Population and Setting The cohort will include children aged 4 to 11 years with typical or atypical neurodevelopment (ASD, ADHD, or DCD).
Participants
Inclusion Criteria:
Children aged 4 to 11 years.
Typical or atypical neurodevelopment, defined as follows:
ASD: Subclinical symptoms or Level 1 diagnosis. ADHD: Predominantly inattentive, hyperactive/impulsive, or combined presentation. For children under 6, typical symptoms of the disorder (e.g., impulsivity, hyperactivity).
DCD: Diagnosed or meeting the following criteria:
Motor skills below age expectations. Significant impact on daily activities or school performance. Difficulties not attributable to another condition. Parental/legal guardian consent.
Exclusion Criteria:
Moderate to severe intellectual disability (IQ ≤ 51). Neurological disorders (e.g., cerebral palsy) or syndromes. Severe visual and/or auditory impairments. Severe behavioral disorders. Severe mental health disorders (e.g., depression, severe anxiety). Participant Recruitment Recruitment will occur between September and October 2024.
Atypical neurodevelopment cases will be recruited from CDIAP Tris Tras, Neuro Xics, and Criv, with service coordinators pre-informed and trained in study procedures and eligibility criteria. Coordinators will review criteria among their clients, provide study details to parents/legal guardians, and share an information sheet and video link explaining the project.
Typical neurodevelopment controls will be recruited from the local community around the research team. Recruitment will follow the same procedure as for atypical cases.
Parents/legal guardians will have 2-5 days to review the study details and sign an informed consent form via Microsoft 365 Forms, ensuring secure data collection.
Sample Size Due to the exploratory nature of this undergraduate project and resource constraints, a formal sample size calculation was not performed. The target is 15 controls (typical neurodevelopment) and 15 cases (5 each for ASD, ADHD, and DCD). This sample size is expected to provide a basis for exploring group-specific dynamics and patterns for future studies.
Variables and Data Collection Independent Variables
Parental Demographics: Age, education level, origin, number of children. Child Demographics: Age, gestational age, birth weight, family type, development type (typical/atypical with diagnosis).
Dependent Variables
Primary Variable:
Motor skills, assessed using the Movement Assessment Battery for Children-Second Edition (MABC-2). This standardized tool evaluates manual dexterity, coordination, and balance through age-adjusted scores. Evaluations will be video-recorded for consistency and scored by trained researchers.
Secondary Variable:
Sensory processing, assessed using the Short Sensory Profile-2 (SSP-2), a caregiver-reported questionnaire evaluating sensory patterns across various domains.
Statistical Analysis Descriptive statistics will summarize quantitative variables using means/standard deviations and medians/interquartile ranges. Categorical variables will be reported as frequencies and percentages. Baseline comparisons will use Student's t-tests or ANOVA for quantitative variables and Chi-square tests for categorical data.
Multivariate analyses will use mixed-effects linear models to evaluate primary outcomes, controlling for significant covariates. Statistical significance is set at p < 0.05.
Ethical Considerations The protocol was approved by the UVic-UCC Research Ethics Committee. The study complies with the Declaration of Helsinki and data protection laws (GDPR and Spanish Organic Law 3/2018).
Parents/legal guardians will receive information sheets and sign informed consent forms. Participation is voluntary, and participants can withdraw at any time without consequences. Video recordings will be securely stored and used solely for study purposes, with images anonymized and deleted after evaluation.
- Conditions
- Developmental Disability, Autism Spectrum Disorder, Development Coordination Disorder, Attention Deficit Disorder With Hyperactivity, Typical Development
- Keywords
- motor skills disorders, physical therapy modalities, pediatrics, child development
- Medical subject headings
- Developmental Disabilities, Autism Spectrum Disorder, Motor Skills Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Typical development | Children aged 4 to 11 years will be recruited from the local community, including schools and social networks connected to the research team. Recruitment will follow the same protocol as for the atypical cohort, including the use of an information sheet and video link to explain the study's aims, methodology, and voluntary participation. Inclusion Criteria: Children aged 4 to 11 years with no history or diagnosis of developmental, neurological, or sensory disorders. Reported by parents as meeting typical developmental milestones. Exclusion Criteria: Children with reported or observed delays in motor or sensory development. Presence of medical conditions (e.g., chronic illness, vision or hearing impairments) that could affect sensory or motor performance. Data on age, gender, gestational history, birth weight, family type (e.g., nuclear, single-parent), and parents' educational levels will be collected to characterize the cohort. | |
| Atypical development | Children aged 4 to 11 years with atypical neurodevelopment (ASD, ADHD, DCD) will be recruited from CDIAP Tris Tras, Neuro Xics, and Criv in Vic. Parents will receive an information sheet and video explaining the study objectives, methods, and participation requirements. Inclusion Criteria: Diagnosed or reported atypical neurodevelopment: ASD: Subclinical symptoms or Level 1 diagnosis. ADHD: Predominantly inattentive, hyperactive/impulsive, or combined presentation; children under six exhibiting typical ADHD behaviors. DCD: Diagnosed or meeting criteria for motor skills below age expectations, impacting daily life or school performance, and not explained by another condition. Aged 4 to 11 years. Parent/legal guardian consent. Exclusion Criteria: Moderate to severe intellectual disability (IQ ≤ 51) neurological disorders, severe behavioral/mental health issues, or sensory impairments affecting motor/sensory assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Motor Skills
Conducted using the Movement Assessment Battery for Children-Second Edition (MABC-2). This is an internationally recognized standard assessment tool widely used to evaluate motor skills in children aged 4 to 16 years. Consists of three main subtests: Manual Dexterity: evaluates the precision of manual movements and hand-eye coordination through activities such as dragging and releasing objects, drawing straight lines, and working with puzzle pieces.
Body Coordination: assesses general body coordination and movement planning through activities such as jumping along a line, bouncing a ball, and walking heel-to-toe.
Balance: evaluates the child's ability to maintain balance in various situations, such as walking on a narrow surface, jumping rope, and standing on one foot for a specified time.
Standardized scores are provided based on the child's age. Higher score means a better motor skills. Score will be translate to percentile.
Measured: from enrollment to 1 month
Secondary outcomes (1)
Sensory processing
Sensory processing will be assessed using the Short Sensory Profile-2 (SSP-2), a tool designed to evaluate sensory patterns in children aged 3 to 14 years.
The SSP-2 consists of 38 items that assess various sensory domains (tone modulation, oral sensory response, visuomotor coordination, auditory discrimination, visual perception, and sensory reactivity). Each item is presented as a statement, and parents or guardians rate the frequency with which the child exhibits each behavior on a 5-point scale ranging from "never" to "always." Completing the questionnaire will take approximately 15 minutes. During this time, an experienced occupational therapist will be available to address any.
Higher raw scores indicate more frequent behaviors related to sensory processing, and lower raw scores represent less frequent behaviors. The raw scores will be converted into standardized values.
Measured: From recruitment to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Dec 2024
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirari Ochandorena Acha, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764810
- Sponsor's protocol ID
- MOTISEN01
- Other IDs
- 006_2024
- Acronym
- MOTISEN
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared publicly to ensure the confidentiality and privacy of the participants, as outlined in ethical guidelines and legal regulations, including the General Data Protection Regulation (GDPR) and Spanish Organic Law 3/2018 on Data Protection and Guarantee of Digital Rights. Sharing IPD could pose risks of re-identification, especially in a small sample size with specific demographic and clinical characteristics. Additionally, this study involves sensitive data related to children and their developmental profiles, requiring strict adherence to data protection standards. Any access to data will be limited to authorized researchers and regulatory bodies as specified in the informed consent, ensuring data use solely for the intended purposes of this study. Aggregate or anonymized results may be shared in publications or presentations to advance knowledge while maintaining participant anonymity.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years: A Cross-Sectional Observational Case-Control Study
- ClinicalTrials.gov ID
- NCT06764810
- Acronym / sponsor ID
- MOTISEN / MOTISEN01
- Conditions
- Developmental Disability, Autism Spectrum Disorder, Development Coordination Disorder, Attention Deficit Disorder With Hyperactivity, Typical Development
- Keywords
- motor skills disorders, physical therapy modalities, pediatrics, child development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 8 Jan 2025 (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.
Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. These disorders impact children's growth and learning, leading to difficulties in key areas such as language, communication, behavior, social interaction, and motor skills. Research in this area is limited, particularly regarding fine and gross motor skills in relation to sensory processing in children with these diagnoses.
Hypothesis and Objectives There is an association between motor skills and sensory processing in children aged 4 to 11 years, depending on whether they have typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.
Main Objective:
To evaluate the association between motor skills and sensory processing in children aged 4 to 11 years with either typical or atypical neurodevelopment (e.g., ASD, ADHD, and DCD).
Secondary Objectives:
To describe and compare motor skills among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.
To describe and compare sensory processing among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.
Methodology The study is a cross-sectional observational case-control study. Participants are users of the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, or Criv in Vic.
The sample will include 30 children as controls (typical neurodevelopment) and 10 children as cases (atypical neurodevelopment: ASD, ADHD, DCD).
Children will be assessed using the Infant Motor Profile (IMP) to measure motor development and the Short Sensory Profile-2 (SSP-2) to evaluate sensory processing.
Statistical Analysis Quantitative variables will be described using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Statistical tests such as the Student's t-test will be used to compare means between two groups, ANOVA for comparisons among more than two groups, and the Chi-square test to analyze associations between categorical variables.
Expected Results The study is expected to provide essential insights into the differences in motor development between children with typical and atypical neurodevelopment, as well as the relationship between biological and external factors and these differences. These findings could help improve clinical and educational interventions for these children by tailoring them to their specific needs, thereby enhancing their overall well-being and development.
Ethical Considerations The study protocol will be submitted to the Research Ethics Committee (CER) of UVic-UCC, adhering to good clinical practice guidelines in accordance with the Declaration of Helsinki. Participants will be assigned a code to ensure data pseudonymization, with data securely stored on the Microsoft 365 server of UVic-UCC. Participants will have the right to withdraw from the study at any time, and personal data will be deleted once the study is completed.
Researchers will ensure confidentiality as dictated by Organic Law 3/2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016/679 of April 27, 2016, on data protection, and complementary regulations, as well as Organic Law 1/1982 of May 5 on the right to honor, personal and family privacy, and self-image.
Detailed description
Methodology Study Design This study is a cross-sectional observational case-control study designed to generate hypotheses.
The STROBE guidelines will be followed to ensure methodological rigor and transparency in reporting results.
Study Population and Setting The cohort will include children aged 4 to 11 years with typical or atypical neurodevelopment (ASD, ADHD, or DCD).
Participants
Inclusion Criteria:
Children aged 4 to 11 years.
Typical or atypical neurodevelopment, defined as follows:
ASD: Subclinical symptoms or Level 1 diagnosis. ADHD: Predominantly inattentive, hyperactive/impulsive, or combined presentation. For children under 6, typical symptoms of the disorder (e.g., impulsivity, hyperactivity).
DCD: Diagnosed or meeting the following criteria:
Motor skills below age expectations. Significant impact on daily activities or school performance. Difficulties not attributable to another condition. Parental/legal guardian consent.
Exclusion Criteria:
Moderate to severe intellectual disability (IQ ≤ 51). Neurological disorders (e.g., cerebral palsy) or syndromes. Severe visual and/or auditory impairments. Severe behavioral disorders. Severe mental health disorders (e.g., depression, severe anxiety). Participant Recruitment Recruitment will occur between September and October 2024.
Atypical neurodevelopment cases will be recruited from CDIAP Tris Tras, Neuro Xics, and Criv, with service coordinators pre-informed and trained in study procedures and eligibility criteria. Coordinators will review criteria among their clients, provide study details to parents/legal guardians, and share an information sheet and video link explaining the project.
Typical neurodevelopment controls will be recruited from the local community around the research team. Recruitment will follow the same procedure as for atypical cases.
Parents/legal guardians will have 2-5 days to review the study details and sign an informed consent form via Microsoft 365 Forms, ensuring secure data collection.
Sample Size Due to the exploratory nature of this undergraduate project and resource constraints, a formal sample size calculation was not performed. The target is 15 controls (typical neurodevelopment) and 15 cases (5 each for ASD, ADHD, and DCD). This sample size is expected to provide a basis for exploring group-specific dynamics and patterns for future studies.
Variables and Data Collection Independent Variables
Parental Demographics: Age, education level, origin, number of children. Child Demographics: Age, gestational age, birth weight, family type, development type (typical/atypical with diagnosis).
Dependent Variables
Primary Variable:
Motor skills, assessed using the Movement Assessment Battery for Children-Second Edition (MABC-2). This standardized tool evaluates manual dexterity, coordination, and balance through age-adjusted scores. Evaluations will be video-recorded for consistency and scored by trained researchers.
Secondary Variable:
Sensory processing, assessed using the Short Sensory Profile-2 (SSP-2), a caregiver-reported questionnaire evaluating sensory patterns across various domains.
Statistical Analysis Descriptive statistics will summarize quantitative variables using means/standard deviations and medians/interquartile ranges. Categorical variables will be reported as frequencies and percentages. Baseline comparisons will use Student's t-tests or ANOVA for quantitative variables and Chi-square tests for categorical data.
Multivariate analyses will use mixed-effects linear models to evaluate primary outcomes, controlling for significant covariates. Statistical significance is set at p < 0.05.
Ethical Considerations The protocol was approved by the UVic-UCC Research Ethics Committee. The study complies with the Declaration of Helsinki and data protection laws (GDPR and Spanish Organic Law 3/2018).
Parents/legal guardians will receive information sheets and sign informed consent forms. Participation is voluntary, and participants can withdraw at any time without consequences. Video recordings will be securely stored and used solely for study purposes, with images anonymized and deleted after evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typical development | – | –Children aged 4 to 11 years will be recruited from the local community, including schools and social networks connected to the research team. Recruitment will follow the same protocol as for the atypical cohort, including the use of an information sheet and video link to explain the study's aims, methodology, and voluntary participation. Inclusion Criteria: Children aged 4 to 11 years with no history or diagnosis of developmental, neurological, or sensory disorders. Reported by parents as meeting typical developmental milestones. Exclusion Criteria: Children with reported or observed delays in motor or sensory development. Presence of medical conditions (e.g., chronic illness, vision or hearing impairments) that could affect sensory or motor performance. Data on age, gender, gestational history, birth weight, family type (e.g., nuclear, single-parent), and parents' educational levels will be collected to characterize the cohort. |
| Atypical development | – | –Children aged 4 to 11 years with atypical neurodevelopment (ASD, ADHD, DCD) will be recruited from CDIAP Tris Tras, Neuro Xics, and Criv in Vic. Parents will receive an information sheet and video explaining the study objectives, methods, and participation requirements. Inclusion Criteria: Diagnosed or reported atypical neurodevelopment: ASD: Subclinical symptoms or Level 1 diagnosis. ADHD: Predominantly inattentive, hyperactive/impulsive, or combined presentation; children under six exhibiting typical ADHD behaviors. DCD: Diagnosed or meeting criteria for motor skills below age expectations, impacting daily life or school performance, and not explained by another condition. Aged 4 to 11 years. Parent/legal guardian consent. Exclusion Criteria: Moderate to severe intellectual disability (IQ ≤ 51) neurological disorders, severe behavioral/mental health issues, or sensory impairments affecting motor/sensory assessments. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The cohort will include children aged 4 to 11 years with typical or atypical neurodevelopment (ASD, ADHD, or DCD). Participants will be recruited from the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, and Criv in Vic. CDIAP is a free service integrated into the social services network managed by Fundació Sant Tomàs, a non-profit organization in the Osona region. Neuro Xics and Criv are private services for child neurodevelopment. Participants with atypical neurodevelopment (ASD, ADHD, or DCD) will be considered cases, while those with typical neurodevelopment will be controls.
Key inclusion criteria (9 listed)
- Children aged 4 to 11 years.
- Typical or atypical neurodevelopment, defined as follows:
- ASD: Subclinical symptoms or Level 1 diagnosis.
- ADHD: Predominantly inattentive, hyperactive/impulsive, or combined presentation. For children under 6, typical symptoms of the disorder (e.g., impulsivity, hyperactivity).
- DCD: Diagnosed or meeting the following criteria:
Key exclusion criteria (5 listed)
- Moderate to severe intellectual disability (IQ ≤ 51).
- Neurological disorders (e.g., cerebral palsy) or syndromes.
- Severe visual and/or auditory impairments.
- Severe behavioral disorders.
- Severe mental health disorders (e.g., depression, severe anxiety).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of Motor Skills
Time frame: from enrollment to 1 month
Conducted using the Movement Assessment Battery for Children-Second Edition (MABC-2). This is an internationally recognized standard assessment tool widely used to evaluate motor skills in children aged 4 to 16 years. Consists of three main subtests: Manual Dexterity: evaluates the precision of manual movements and hand-eye coordination through activities such as dragging and releasing objects, drawing straight lines, and working with puzzle pieces. Body Coordination: assesses general body coordination and movement planning through activities such as jumping along a line, bouncing a ball, and walking heel-to-toe. Balance: evaluates the child's ability to maintain balance in various situations, such as walking on a narrow surface, jumping rope, and standing on one foot for a specified time. Standardized scores are provided based on the child's age. Higher score means a better motor skills. Score will be translate to percentile.
1 secondary outcome
Sensory processing
Time frame: From recruitment to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared publicly to ensure the confidentiality and privacy of the participants, as outlined in ethical guidelines and legal regulations, including the General Data Protection Regulation (GDPR) and Spanish Organic Law 3/2018 on Data Protection and Guarantee of Digital Rights. Sharing IPD could pose risks of re-identification, especially in a small sample size with specific demographic and clinical characteristics. Additionally, this study involves sensitive data related to children and their developmental profiles, requiring strict adherence to data protection standards. Any access to data will be limited to authorized researchers and regulatory bodies as specified in the informed consent, ensuring data use solely for the intended purposes of this study. Aggregate or anonymized results may be shared in publications or presentations to advance knowledge while maintaining participant anonymity.
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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.
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 Developmental Disability and Autism Spectrum Disorder, run by University of Vic - Central University of Catalonia at 1 site in Spain.
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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mirari Ochandorena-Acha, PhD (+34659408555, mirari.ochandorena@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Motor Skills (time frame: from enrollment to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.