Footwear and Brain Activity in Children (FooTBAC)

August 28, 2025 updated by: Gabriel Gijon-Nogueron, University of Malaga

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Malaga
      • Málaga, Malaga, Spain, 29071
        • University of Malaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Starting Condition - Barefoot
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.
Participants walk barefoot along a 10-meter walkway without wearing shoes or socks.
Other Names:
  • No Shoes
Participants 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.
Other Names:
  • Minimalist shoes
Participants 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.
Other Names:
  • Structured shoes
Experimental: Starting Condition - Barefoot-Style Footwear
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.
Participants walk barefoot along a 10-meter walkway without wearing shoes or socks.
Other Names:
  • No Shoes
Participants 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.
Other Names:
  • Minimalist shoes
Participants 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.
Other Names:
  • Structured shoes
Active Comparator: Starting Condition - Conventional Drop Footwear
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.
Participants walk barefoot along a 10-meter walkway without wearing shoes or socks.
Other Names:
  • No Shoes
Participants 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.
Other Names:
  • Minimalist shoes
Participants 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.
Other Names:
  • Structured shoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative spectral power ratios (Theta/Alpha, Beta/Alpha) during walking in children
Time Frame: 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.
Day 1 (single data collection session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

August 10, 2025

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

August 15, 2025

First Submitted That Met QC Criteria

August 28, 2025

First Posted (Estimated)

September 3, 2025

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • UCCSSMalaga

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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