Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years

NCT06764810 | Recruiting

• 2 other identifiers: MOTISEN01006_2024
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  from enrollment to 1 month

Secondary Outcomes (1)

• Sensory processing

  From recruitment to 1 month

Study Arms (2)

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.

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (1)

University of Vic - Central University of Catalonia

Vic, 08500, Spain

RECRUITING

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MeSH Terms

Conditions

Developmental Disabilities; Autism Spectrum Disorder; Motor Skills Disorders; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders

Central Study Contacts

Mirari Ochandorena-Acha, PhD

CONTACT

+34659408555; mirari.ochandorena@uvic.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: December 1, 2024
• Primary Completion: December 20, 2025
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)