Clinical trial NCT06764810: Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Development of Motor Skills
timeFrame: from enrollment to 1 month
Secondary outcomes:
measure: Sensory processing
timeFrame: From recruitment to 1 month
Other outcomes:
Locations:
city: Vic
country: Spain
facility: University of Vic - Central University of Catalonia
Study officials:
References: