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临床试验/NCT06764810
NCT06764810招募中不适用

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

University of Vic - Central University of Catalonia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Development of Motor Skills

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Development of Motor Skills

时间窗: 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.

次要结局

  • Sensory processing(From recruitment to 1 month)

研究者

发起方
University of Vic - Central University of Catalonia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirari Ochandorena Acha

PhD

University of Vic - Central University of Catalonia

研究点 (1)

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