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Active Not RecruitingNCT07151352

Footwear and Brain Activity in Children

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
37 (actual)
Sponsor
University of Malaga · Academic / Other
Sex
All
Age
6 Years – 7 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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 Each participant will walk 10 meters in three conditions: Barefoot Barefoot-style footwear (3 mm sole, flexible, 0 mm drop, wide toe box) Conventional footwear with heel drop (rigid sole, 12 mm heel / 7 mm forefoot, 5 mm drop, reinforced heel counter, narrow toe box). Brain activity will be recorded using the Emotiv EPOC X wireless EEG system (14 channels) and analyzed using EEGLAB (MATLAB). Relative power in theta (4-7 Hz), alpha (8-12 Hz), beta (13-30 Hz), and gamma (30-45 Hz) frequency bands will be calculated, along with Theta/Alpha and Beta/Alpha ratios. Statistical Analysis A repeated-measures ANOVA and Tukey's post-hoc tests will be applied to compare conditions. Regional analysis, hemispheric asymmetry evaluation, and multivariate analyses (PCA, LDA) will also be performed. Statistical significance will be set at p \< 0.05. Expected Impact This study is expected to improve understanding of how footwear type influences cortical organization during children's gait. Findings may help inform pediatric footwear design and clinical recommendations to support healthy neuromotor development. Ethics and Consent The protocol has been approved by the Ethics Committee of the University of Málaga (CEUMA112104). Written informed consent will be obtained from parents or legal guardians, and verbal assent will be obtained from all child participants.

Conditions

Interventions

TypeNameDescription
OTHERStarting Condition - BarefootParticipants walk barefoot along a 10-meter walkway without wearing shoes or socks.
OTHERBarefoot-Style FootwearParticipants walk along a 10-meter walkway wearing minimalist footwear with a 3 mm flexible sole, 0 mm heel drop, wide toe box, and no rigid heel counter.
OTHERConventional Footwear with Heel DropParticipants walk along a 10-meter walkway wearing structured footwear with a rigid sole (12 mm heel / 7 mm forefoot), 5 mm heel drop, reinforced heel counter, and narrow toe box.

Timeline

Start date
2025-08-01
Primary completion
2025-08-10
Completion
2025-09-10
First posted
2025-09-03
Last updated
2025-09-03

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07151352. Inclusion in this directory is not an endorsement.