Footwear and Brain Activity in Children

NCT07151352 | Active Not Recruiting DMC

• 1 other identifier: UCCSSMalaga
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Foot; Footwear; Children

Keywords

Children; footwear; Gait; electroencephalography

Outcome Measures

Primary Outcomes (1)

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

  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)

Study Arms (3)

Starting Condition - Barefoot

SHAM COMPARATOR

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.

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

Starting Condition - Barefoot-Style Footwear

EXPERIMENTAL

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.

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

Starting Condition - Conventional Drop Footwear

ACTIVE COMPARATOR

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.

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

Interventions

Starting Condition - Barefoot OTHER

Participants walk barefoot along a 10-meter walkway without wearing shoes or socks.

Also known as: No Shoes

Starting Condition - Barefoot; Starting Condition - Barefoot-Style Footwear; Starting Condition - Conventional Drop Footwear

Barefoot-Style Footwear OTHER

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.

Also known as: Minimalist shoes

Starting Condition - Barefoot; Starting Condition - Barefoot-Style Footwear; Starting Condition - Conventional Drop Footwear

Conventional Footwear with Heel Drop OTHER

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.

Also known as: Structured shoes

Starting Condition - Barefoot; Starting Condition - Barefoot-Style Footwear; Starting Condition - Conventional Drop Footwear

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

University of Malaga

Málaga, Malaga, 29071, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a within-subject, randomized crossover study in which each participant will complete a walking task under three different footwear conditions: barefoot, barefoot-style (minimalist) shoes, and conventional shoes with heel drop. The order of the conditions will be randomized for each participant to minimize order effects and fatigue. All participants will serve as their own controls, allowing direct comparison of cortical activity across conditions. Each walking trial will be performed on the same 10-meter walkway, with rest periods between conditions to reduce carryover effects.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 3, 2025
• Study Start: August 1, 2025
• Primary Completion: August 10, 2025
• Study Completion: September 10, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)