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临床试验/NCT07151352
NCT07151352进行中(未招募)不适用

Footwear and Brain Activity in Children: Insights From EEG During Walking

University of Malaga2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
37
试验地点
2
主要终点
Relative spectral power ratios (Theta/Alpha, Beta/Alpha) during walking in children

研究概览

简要总结

Childhood is a critical period for neuromotor development, during which footwear may influence both gait biomechanics and the integration of sensory and motor control processes. This study will aim to analyze brain activity in children aged 6-7 years while walking under three conditions: barefoot, in barefoot-style (minimalist) shoes, and in conventional shoes with heel drop.

A quasi-experimental, repeated-measures study will be conducted, in which each participant will complete a 10-meter walking task under the three conditions, in randomized order. Brain activity will be recorded using a 14-channel wireless electroencephalography (EEG) system (Emotiv EPOC X), and relative spectral power (theta, alpha, beta, gamma) as well as Theta/Alpha and Beta/Alpha ratios will be calculated.

Statistical analysis will include global and regional comparisons (frontal, temporal, parieto-occipital), assessment of hemispheric asymmetry, and multivariate analysis. The study is expected to provide novel information on how footwear type may modulate cortical organization during children's gait, with potential implications for pediatric footwear design and clinical recommendations.

详细描述

Background and Rationale Between the ages of 5 and 8 years, basic movement patterns are consolidated and brain plasticity reaches one of its highest levels. Footwear, as an external factor, may modify both gait mechanics and the quality of sensory input reaching the central nervous system. Previous studies suggest that barefoot walking or minimalist footwear may enhance intrinsic foot muscle activation and proprioception; however, limited evidence exists on how these conditions affect cortical activity in children. Electroencephalography (EEG) offers a non-invasive and real-time method to record brain activity during motor tasks, making it a suitable tool for investigating this phenomenon.

Primary Objective The primary objective will be to analyze cortical activity using EEG in children aged 6-7 years while walking under three conditions: barefoot, in barefoot-style footwear, and in conventional footwear with heel drop.

Study Design A quasi-experimental, repeated-measures, within-subject design will be used. Each participant will be assessed under all three experimental conditions, with the order randomized to minimize learning or fatigue effects.

Participants The study will include 37 healthy children aged 6 to 7 years, with no neurological or musculoskeletal disorders, normal motor development, and no habitual use of barefoot-style footwear in the past six months.

Procedure

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This study will be conducted as an open-label trial with no masking. Due to the visible nature of the footwear conditions (barefoot, barefoot-style, and conventional shoes with heel drop), neither participants nor investigators can be blinded to the assigned condition during each walking trial. Data analysts will receive de-identified EEG datasets labeled only by condition codes to minimize potential bias during statistical analysis.

入排标准

年龄范围
6 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-7 years.
  • Typical motor and neurological development according to school or medical reports.
  • Ability to understand and follow simple instructions.
  • No regular use of barefoot-style footwear in the past six months.
  • Written informed consent provided by a parent or legal guardian.
  • Verbal assent provided by the child in an age-appropriate manner.

排除标准

  • Diagnosed neurodevelopmental disorders (e.g., ADHD, autism spectrum disorder, motor dysfunction).
  • Orthopedic or neuromuscular conditions affecting gait (e.g., equinus foot, cerebral palsy).
  • Lower-limb surgery within the previous 6 months.
  • Use of medication affecting alertness, muscle tone, or motor control.
  • Scalp lesions or intolerance to EEG headset use.
  • Any condition that, in the investigator's judgment, could interfere with study participation or data integrity.

结局指标

主要结局

Relative spectral power ratios (Theta/Alpha, Beta/Alpha) during walking in children

时间窗: Day 1 (single data collection session)

EEG-based measurement of relative spectral power in theta (4-7 Hz), alpha (8-12 Hz), and beta (13-30 Hz) frequency bands, and calculation of Theta/Alpha and Beta/Alpha ratios across three footwear conditions (barefoot, barefoot-style, conventional with heel drop). EEG will be recorded using a 14-channel Emotiv EPOC X system during a 10-meter walking task. Analyses will compare regional and global cortical activity patterns between conditions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriel Gijon-Nogueron

Professor

University of Malaga

研究点 (2)

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