FootFooTBACNCT07151352
Footwear and Brain Activity in Children
A study testing Starting Condition - Barefoot, Barefoot-Style Footwear and Conventional Footwear with Heel Drop in people with Foot and Footwear, run by University of Malaga at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 7 yearsHealthy volunteers can take part
- What is being tested?
- Starting Condition - Barefoot, Barefoot-Style Footwear and Conventional Footwear with Heel Drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Starting Condition - Barefoot, Barefoot-Style Footwear, Conventional Footwear with Heel Drop
- Keywords
- Children, footwear, Gait, electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting Condition - BarefootOther
Also called No Shoes
Participants walk barefoot along a 10-meter walkway without wearing shoes or socks.
Barefoot-Style FootwearOther
Also called Minimalist 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.
Conventional Footwear with Heel DropOther
Also called Structured 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Starting Condition - Barefoot; Other: Barefoot-Style Footwear; Other: Conventional Footwear with Heel Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (single data collection session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Aug 2025
- Primary completion10 Aug 2025
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Gijon-Nogueron, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151352
- Sponsor's protocol ID
- UCCSSMalaga
- Acronym
- FooTBAC
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Footwear and Brain Activity in Children: Insights From EEG During Walking
- ClinicalTrials.gov ID
- NCT07151352
- Acronym / sponsor ID
- FooTBAC / UCCSSMalaga
- Keywords
- Children, footwear, Gait, electroencephalography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Starting Condition - Barefoot | Sham comparator | Other: Starting Condition - Barefoot, Other: Barefoot-Style Footwear, Other: Conventional Footwear with Heel DropParticipants 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. |
| Starting Condition - Barefoot-Style Footwear | Experimental | Other: Starting Condition - Barefoot, Other: Barefoot-Style Footwear, Other: Conventional Footwear with Heel DropParticipants 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. |
| Starting Condition - Conventional Drop Footwear | Active comparator | Other: Starting Condition - Barefoot, Other: Barefoot-Style Footwear, Other: Conventional Footwear with Heel DropParticipants 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. |
Who may qualify
- Ages
- 6 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starting Condition - BarefootAlso: No ShoesParticipants walk barefoot along a 10-meter walkway without wearing shoes or socks. | Other | Starting Condition - Barefoot, Starting Condition - Barefoot-Style Footwear, Starting Condition - Conventional Drop Footwear |
| Barefoot-Style FootwearAlso: Minimalist shoesParticipants 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 | Starting Condition - Barefoot, Starting Condition - Barefoot-Style Footwear, Starting Condition - Conventional Drop Footwear |
| Conventional Footwear with Heel DropAlso: Structured shoesParticipants 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 | Starting Condition - Barefoot, Starting Condition - Barefoot-Style Footwear, Starting Condition - Conventional Drop Footwear |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starting Condition - Barefoot, Barefoot-Style Footwear and Conventional Footwear with Heel Drop in people with Foot and Footwear, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative spectral power ratios (Theta/Alpha, Beta/Alpha) during walking in children (time frame: Day 1 (single data collection session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.