Healthy VolunteersNCT07735949
Effects of Daily Footwear Use on Lower Extremity Health and Movement in Healthy Adults
An observational study of Healthy Volunteers and Foot Biomechanics, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Footwear is one of the most important external factors influencing lower extremity biomechanics, plantar sensory feedback, and postural control. Although supportive footwear provides cushioning and arch support, prolonged use may reduce intrinsic foot muscle activity and alter natural foot mechanics. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Foot Biomechanics
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults aged 18-35 years will be recruited from the Faculty of Health Sciences at Bahçeşehir University. Participants must have habitually worn either supportive footwear or flat footwear for at least 6 months, with an average daily use of at least 6 hours. Eligible individuals will be assigned to groups according to their habitual footwear type and will undergo assessments of plantar pressure distribution, foot posture, and balance performance.
Who may be able to join
- Adults aged 18 years and older
- Diagnosis of hemophilia A or B
- Scheduled to undergo primary total knee arthroplasty
- Able to understand the study procedures and provide written informed consent
- Willing to participate in the prehabilitation program
Who cannot join
- Presence of neurological disorders affecting balance or gait
- Severe cognitive impairment
- Other musculoskeletal conditions affecting lower extremity function
- Revision total knee arthroplasty
- Any medical condition that would prevent safe participation in the exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Long-Term Daily Supportive and Flat Footwear Use on Foot Posture, Plantar Pressure Distribution and Balance in Healthy Adults: A Cross-Sectional Comparative Study
Footwear is one of the most important external factors influencing lower extremity biomechanics, plantar sensory feedback, and postural control. Although supportive footwear provides cushioning and arch support, prolonged use may reduce intrinsic foot muscle activity and alter natural foot mechanics. Conversely, flat footwear may enhance plantar sensory input and foot muscle activation. However, evidence regarding the long-term biomechanical effects of habitual footwear use in healthy adults remains inconsistent.
This cross-sectional comparative study aims to compare foot posture, plantar pressure distribution, and balance performance between healthy adults who have regularly worn supportive footwear or flat footwear for at least six months. Static plantar pressure distribution will be assessed using the Footwork system, while static and dynamic balance will be evaluated using the Biodex Balance System. The findings are expected to improve understanding of the long-term biomechanical consequences of habitual footwear selection.
Read the detailed description
Footwear is one of the most influential external factors affecting lower extremity biomechanics, plantar sensory feedback, and postural control during daily activities. Modern footwear designs differ considerably in their structural characteristics, including cushioning, arch support, sole stiffness, and heel height. These features may alter foot mechanics, proprioceptive input, and neuromuscular control, potentially leading to long-term adaptations in balance and movement patterns. Supportive footwear is designed to improve comfort and reduce plantar loading through enhanced cushioning and medial arch support. However, prolonged use has been suggested to limit the natural motion of the foot and reduce activation of the intrinsic foot muscles. In contrast, flat footwear provides minimal structural support, allowing greater interaction between the plantar surface and the ground, which may enhance sensory feedback and promote more natural foot function.
Despite increasing interest in footwear biomechanics, evidence regarding the long-term effects of habitual footwear use in healthy individuals remains limited and inconsistent. Most previous studies have focused on the immediate effects of different shoe designs during walking or running, whereas few have investigated the chronic adaptations associated with everyday footwear habits. Furthermore, objective assessments combining plantar pressure analysis and computerized balance evaluation have rarely been used to compare individuals with different long-term footwear preferences.
The aim of this cross-sectional comparative study is to investigate whether habitual use of supportive or flat footwear is associated with differences in foot posture, plantar pressure distribution, and postural stability in healthy adults. Participants aged 18 to 35 years who have consistently worn either supportive or flat footwear for at least six months, for a minimum of six hours per day, will be recruited from the Faculty of Health Sciences at Bahçeşehir University.
Following informed consent, demographic characteristics, anthropometric measurements, and footwear history will be recorded. Static plantar pressure distribution and foot posture characteristics will be assessed using the Footwork Pedobarography System. Static and dynamic balance performance will be evaluated using the Biodex Balance System. Balance measurements will include double-leg and single-leg standing assessments, and objective stability indices will be recorded according to standardized testing protocols.
The primary outcomes will be the Overall Stability Index obtained from the Biodex Balance System and plantar pressure distribution parameters measured using the Footwork Pedobarography System. Secondary outcomes will include anterior-posterior and medial-lateral stability indices, foot contact area, arch-related plantar pressure characteristics, and balance performance during single-leg and double-leg stance.
It is hypothesized that individuals who habitually wear flat footwear will demonstrate different plantar pressure characteristics and balance performance compared with those who regularly wear supportive footwear, reflecting long-term biomechanical adaptations associated with footwear selection.
The findings of this study are expected to improve understanding of the relationship between habitual footwear use and lower extremity biomechanics in healthy adults. The results may contribute to evidence-based recommendations regarding footwear selection and support preventive strategies in physiotherapy, rehabilitation, sports medicine, and footwear design. Additionally, this study may provide a scientific basis for future longitudinal and interventional research investigating the long-term musculoskeletal consequences of everyday footwear habits.
- Conditions
- Healthy Volunteers, Foot Biomechanics
- Keywords
- Footwear, Balance, Plantar Pressure, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Footwear Group | Healthy adults who have habitually worn supportive footwear for at least 6 months, with an average daily use of at least 6 hours. | |
| Flat Footwear Group | Healthy adults who have habitually worn flat footwear for at least 6 months, with an average daily use of at least 6 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Stability Index (OSI)
Overall Stability Index measured using the Biodex Balance System.
Measured: Baseline
Plantar Pressure Distribution
Static plantar pressure distribution assessed using the Footwork Pedobarography System.
Measured: Baseline
Secondary outcomes (4)
Foot Contact Area
Foot contact area will be assessed using the Footwork Pro pressure plate system (Footwork®, AM CUBE, France). Participants will stand barefoot on the pressure platform during the assessment. The system will record the plantar contact area (cm²) of each foot using computerized baropodometric analysis. Higher values indicate a larger plantar contact area during static standing.
Measured: baseline
Arch Index
The Arch Index is a footprint-based measure used to classify foot arch height. It is calculated as the ratio of the midfoot contact area to the total footprint area (excluding the toes). Scores range from 0 to 1, with higher values indicating a flatter foot (lower medial longitudinal arch) and lower values indicating a higher medial longitudinal arch.
Measured: Baseline
Anterior-Posterior Stability Index
Anterior-Posterior Stability Index is a measure of postural stability in the sagittal plane, assessed using the Biodex Balance System. Scores typically range from 0 upward, with lower scores indicating better postural stability (less sway) and higher scores indicating poorer postural stability (greater sway).
Measured: Baseline
Single-leg Balance
Static balance is assessed by measuring the time participants can maintain a one-legged stance. Scores range from 0 to 30 seconds, with higher scores indicating better static balance.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start15 Jul 2026
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Poyraz İşleyen, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735949
- Sponsor's protocol ID
- E-85646034-604.01-130496
- Other IDs
- E-85646034-604.01-130496
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sherafat S, Salavati M, Ebrahimi Takamjani I, Akhbari B, Mohammadirad S, Mazaheri M, Negahban H. Intrasession and intersession reliability of postural control in participants with and without nonspecific low back pain using the Biodex Balance System. J Manipulative Physiol Ther. 2013 Feb;36(2):111-8. doi: 10.1016/j.jmpt.2012.12.005.
PubMed 23499146Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751.
PubMed 30113521Franklin S, Grey MJ, Heneghan N, Bowen L, Li FX. Barefoot vs common footwear: A systematic review of the kinematic, kinetic and muscle activity differences during walking. Gait Posture. 2015 Sep;42(3):230-9. doi: 10.1016/j.gaitpost.2015.05.019. Epub 2015 Jun 3.
PubMed 26220400Cudejko T, Gardiner J, Akpan A, D'Aout K. Minimal footwear improves stability and physical function in middle-aged and older people compared to conventional shoes. Clin Biomech (Bristol). 2020 Jan;71:139-145. doi: 10.1016/j.clinbiomech.2019.11.005. Epub 2019 Nov 11.
PubMed 31739197Chen TL, Sze LK, Davis IS, Cheung RT. Effects of training in minimalist shoes on the intrinsic and extrinsic foot muscle volume. Clin Biomech (Bristol). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10.
PubMed 27195735
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-Term Daily Supportive and Flat Footwear Use on Foot Posture, Plantar Pressure Distribution and Balance in Healthy Adults: A Cross-Sectional Comparative Study
- ClinicalTrials.gov ID
- NCT07735949
- Acronym / sponsor ID
- E-85646034-604.01-130496
- Conditions
- Healthy Volunteers, Foot Biomechanics
- Keywords
- Footwear, Balance, Plantar Pressure, Healthy Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 30 Jul 2026 (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.
Footwear is one of the most important external factors influencing lower extremity biomechanics, plantar sensory feedback, and postural control. Although supportive footwear provides cushioning and arch support, prolonged use may reduce intrinsic foot muscle activity and alter natural foot mechanics. Conversely, flat footwear may enhance plantar sensory input and foot muscle activation. However, evidence regarding the long-term biomechanical effects of habitual footwear use in healthy adults remains inconsistent.
This cross-sectional comparative study aims to compare foot posture, plantar pressure distribution, and balance performance between healthy adults who have regularly worn supportive footwear or flat footwear for at least six months. Static plantar pressure distribution will be assessed using the Footwork system, while static and dynamic balance will be evaluated using the Biodex Balance System. The findings are expected to improve understanding of the long-term biomechanical consequences of habitual footwear selection.
Detailed description
Footwear is one of the most influential external factors affecting lower extremity biomechanics, plantar sensory feedback, and postural control during daily activities. Modern footwear designs differ considerably in their structural characteristics, including cushioning, arch support, sole stiffness, and heel height. These features may alter foot mechanics, proprioceptive input, and neuromuscular control, potentially leading to long-term adaptations in balance and movement patterns. Supportive footwear is designed to improve comfort and reduce plantar loading through enhanced cushioning and medial arch support. However, prolonged use has been suggested to limit the natural motion of the foot and reduce activation of the intrinsic foot muscles. In contrast, flat footwear provides minimal structural support, allowing greater interaction between the plantar surface and the ground, which may enhance sensory feedback and promote more natural foot function.
Despite increasing interest in footwear biomechanics, evidence regarding the long-term effects of habitual footwear use in healthy individuals remains limited and inconsistent. Most previous studies have focused on the immediate effects of different shoe designs during walking or running, whereas few have investigated the chronic adaptations associated with everyday footwear habits. Furthermore, objective assessments combining plantar pressure analysis and computerized balance evaluation have rarely been used to compare individuals with different long-term footwear preferences.
The aim of this cross-sectional comparative study is to investigate whether habitual use of supportive or flat footwear is associated with differences in foot posture, plantar pressure distribution, and postural stability in healthy adults. Participants aged 18 to 35 years who have consistently worn either supportive or flat footwear for at least six months, for a minimum of six hours per day, will be recruited from the Faculty of Health Sciences at Bahçeşehir University.
Following informed consent, demographic characteristics, anthropometric measurements, and footwear history will be recorded. Static plantar pressure distribution and foot posture characteristics will be assessed using the Footwork Pedobarography System. Static and dynamic balance performance will be evaluated using the Biodex Balance System. Balance measurements will include double-leg and single-leg standing assessments, and objective stability indices will be recorded according to standardized testing protocols.
The primary outcomes will be the Overall Stability Index obtained from the Biodex Balance System and plantar pressure distribution parameters measured using the Footwork Pedobarography System. Secondary outcomes will include anterior-posterior and medial-lateral stability indices, foot contact area, arch-related plantar pressure characteristics, and balance performance during single-leg and double-leg stance.
It is hypothesized that individuals who habitually wear flat footwear will demonstrate different plantar pressure characteristics and balance performance compared with those who regularly wear supportive footwear, reflecting long-term biomechanical adaptations associated with footwear selection.
The findings of this study are expected to improve understanding of the relationship between habitual footwear use and lower extremity biomechanics in healthy adults. The results may contribute to evidence-based recommendations regarding footwear selection and support preventive strategies in physiotherapy, rehabilitation, sports medicine, and footwear design. Additionally, this study may provide a scientific basis for future longitudinal and interventional research investigating the long-term musculoskeletal consequences of everyday footwear habits.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Footwear Group | – | –Healthy adults who have habitually worn supportive footwear for at least 6 months, with an average daily use of at least 6 hours. |
| Flat Footwear Group | – | –Healthy adults who have habitually worn flat footwear for at least 6 months, with an average daily use of at least 6 hours. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults aged 18-35 years will be recruited from the Faculty of Health Sciences at Bahçeşehir University. Participants must have habitually worn either supportive footwear or flat footwear for at least 6 months, with an average daily use of at least 6 hours. Eligible individuals will be assigned to groups according to their habitual footwear type and will undergo assessments of plantar pressure distribution, foot posture, and balance performance.
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Diagnosis of hemophilia A or B
- Scheduled to undergo primary total knee arthroplasty
- Able to understand the study procedures and provide written informed consent
- Willing to participate in the prehabilitation program
Key exclusion criteria (5 listed)
- Presence of neurological disorders affecting balance or gait
- Severe cognitive impairment
- Other musculoskeletal conditions affecting lower extremity function
- Revision total knee arthroplasty
- Any medical condition that would prevent safe participation in the exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Stability Index (OSI)
Time frame: Baseline
Overall Stability Index measured using the Biodex Balance System.
Plantar Pressure Distribution
Time frame: Baseline
Static plantar pressure distribution assessed using the Footwork Pedobarography System.
4 secondary outcomes
Foot Contact Area
Time frame: baseline
Arch Index
Time frame: Baseline
Anterior-Posterior Stability Index
Time frame: Baseline
Single-leg Balance
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 23499146Sherafat S, Salavati M, Ebrahimi Takamjani I, Akhbari B, Mohammadirad S, Mazaheri M, Negahban H. Intrasession and intersession reliability of postural control in participants with and without nonspecific low back pain using the Biodex Balance System. J Manipulative Physiol Ther. 2013 Feb;36(2):111-8. doi: 10.1016/j.jmpt.2012.12.005.
- Background: PubMed 30113521Ridge ST, Olsen MT, Bruening DA, Jurgensmeier K, Griffin D, Davis IS, Johnson AW. Walking in Minimalist Shoes Is Effective for Strengthening Foot Muscles. Med Sci Sports Exerc. 2019 Jan;51(1):104-113. doi: 10.1249/MSS.0000000000001751.
- Background: PubMed 26220400Franklin S, Grey MJ, Heneghan N, Bowen L, Li FX. Barefoot vs common footwear: A systematic review of the kinematic, kinetic and muscle activity differences during walking. Gait Posture. 2015 Sep;42(3):230-9. doi: 10.1016/j.gaitpost.2015.05.019. Epub 2015 Jun 3.
- Background: PubMed 31739197Cudejko T, Gardiner J, Akpan A, D'Aout K. Minimal footwear improves stability and physical function in middle-aged and older people compared to conventional shoes. Clin Biomech (Bristol). 2020 Jan;71:139-145. doi: 10.1016/j.clinbiomech.2019.11.005. Epub 2019 Nov 11.
- Background: PubMed 27195735Chen TL, Sze LK, Davis IS, Cheung RT. Effects of training in minimalist shoes on the intrinsic and extrinsic foot muscle volume. Clin Biomech (Bristol). 2016 Jul;36:8-13. doi: 10.1016/j.clinbiomech.2016.05.010. Epub 2016 May 10.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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?
An observational study of Healthy Volunteers and Foot Biomechanics, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 2026. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Overall Stability Index (OSI) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07735949, which also lists 5 linked publications.
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 30 Sep 2026.