Footwear and Brain Activity in Children (FooTBAC)

University of Malaga

Status: Active, not recruiting

Conditions: Foot; Children; Footwear

Treatments: Other: Starting Condition - Barefoot; Other: Conventional Footwear with Heel Drop; Other: Barefoot-Style Footwear

Study type: Interventional

Funder types: Other

Identifiers

NCT07151352

UCCSSMalaga

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 6 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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37 participants in 3 patient groups

Starting Condition - Barefoot

Sham Comparator group

Description:

Participants will first complete the walking task barefoot along a 10-meter walkway. They will then perform the same task in barefoot-style (minimalist) footwear and in conventional footwear with heel drop. The order of the second and third conditions will be randomized. EEG will be recorded during all walking trials, with rest periods between conditions.

Treatment:

Other: Barefoot-Style Footwear

Other: Conventional Footwear with Heel Drop

Other: Starting Condition - Barefoot

Starting Condition - Barefoot-Style Footwear

Experimental group

Description:

Participants will first complete the walking task in barefoot-style (minimalist) footwear with a 3 mm flexible sole, 0 mm heel drop, wide toe box, and no rigid heel counter. They will then perform the task barefoot and in conventional footwear with heel drop. The order of the second and third conditions will be randomized. EEG will be recorded during all walking trials, with rest periods between conditions.

Treatment:

Other: Barefoot-Style Footwear

Other: Conventional Footwear with Heel Drop

Other: Starting Condition - Barefoot

Starting Condition - Conventional Drop Footwear

Active Comparator group

Description:

Participants will first complete the walking task in conventional structured footwear with a rigid sole (12 mm heel / 7 mm forefoot), 5 mm heel drop, reinforced heel counter, and narrow toe box. They will then perform the task barefoot and in barefoot-style footwear. The order of the second and third conditions will be randomized. EEG will be recorded during all walking trials, with rest periods between conditions.

Treatment:

Other: Barefoot-Style Footwear

Other: Conventional Footwear with Heel Drop

Other: Starting Condition - Barefoot