FootwearNCT04971915
The Effect of Minimalist Footwear on the Anthropometric and Biomechanical Parameters of the Lower Limb and Foot
A study testing minimalist footwear in people with Footwear, run by Palacky University at 2 sites in Czechia.
Trial summary
The study aims to determine whether 6months of wearing minimalist footwear causes changes in anthropometric parameters of the foot and the biomechanical parameters of the foot and lower limb. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Footwear
- What is being tested?
- minimalist footwear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCzechia
- Study dates
- 5 Jul 2021to 5 Dec 2022
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Individuals without previous experience in wearing minimalist footwear
Who cannot join
- Significant deformities of the feet and toes
- Pain of the musculoskeletal system
- Injury, congenital or gained defect of the musculoskeletal or neural system in past
- Undergo operation of lower limbs in past or during research
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Faculty of Physical Culture, Palacky University Olomouc
Olomouc, 77111
Palacky University Olomouc, Faculty of Physical Culture
Olomouc, 77900
About this study
Official title: The Effect of Minimalist Footwear on the Anthropometric and Biomechanical Parameters of the Lower Limb and Foot During Long-Term Wearing: A Randomized Clinical Trial
The study aims to determine whether 6months of wearing minimalist footwear causes changes in anthropometric parameters of the foot and the biomechanical parameters of the foot and lower limb.
Read the detailed description
The minimalist footwear represents an alternative style of footwear wearing, which could allow the foot to move more naturally compared to the footwear wearing in conventional footwear. That footwear is characterized by no cushioning, wide toe box, zero foot drop, thin sole (1,5 - 8 mm), low weight, and high flexibility of footwear. This study aims to determine the effect of 6months of wearing minimalist footwear on the foot and lower limb's anthropometric and biomechanical parameters.
The study is designed as a parallel interventional study. The sample size consists of 50 healthy individuals divided into experimental and control groups by randomization. All participants undergo the initial examination and baseline and final measurement focused on the foot anthropometry and kinetics and kinematics of the foot and lower limb during walking. Besides, the experimental group undergoes a 6months intervention of wearing minimalist footwear, during which the participants will record their movement behavior by electronic diary.
- Conditions
- Footwear
- Being tested
- minimalist footwear
- Keywords
- minimalist footwear, shoes, biomechanics, anthropometric parameters, foot, walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimalist footwearOther
The intervention consists of wearing the minimalist footwear in recommended progression during the interventional period (6months). The intial load starts at 2,500 steps a day and will be gradually increased up according to the participant´s tolerance rate to the footwear wearing to fully use over the final period. Participants are instructed to report all issues and difficulties possibly connected to the intervention. There will be the opportunity to consult any issue connected with footwear or their wearing through the duration of the research.
| Study group | Role | What they receive |
|---|---|---|
| minimalist footwear | Experimental | The participants in the experimental group will receive one pair of minimalist footwear and will be asked to use them for the interventional period. Receives: Other: minimalist footwear |
| control | No intervention | The participants in the control group will be asked to wear their standard footwear as before participating in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in maximal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Maximal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in minimal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Minimal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in angular velocity of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Angular velocity of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in walking velocity
Walking velocity will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in walking cadence
Walking cadence will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in step length during walking
Step length will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in duration of stance phase of the gait cycle
Duration of stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in maximum value of the vertical component of ground reaction force during walking
Maximum value of the vertical component of ground reaction force will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in minimum value of the vertical component of ground reaction force during walking
Minimum value of the vertical component of ground reaction force will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in impulse of the vertical component of ground reaction force during walking
Impulse of the vertical component of ground reaction force will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in lower limbs joints moments during walking
Lower limbs joints moments will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Measured: at baseline and at the end of 6 months intervention
Change in peak plantar pressure at anatomical regions of the foot sole during walking
Peak plantar pressure at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in contact time at anatomical regions of the foot sole during walking
Contact time at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in contact area at anatomical regions of the foot sole during walking.
Contact area at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in pressure-time integral at anatomical regions of the foot sole during walking
Pressure-time integral at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in maximum force at anatomical regions of the foot sole during walking
Maximum force at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in foot length
Foot length will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in foot width
Foot width will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).
Measured: at baseline and at the end of 6 months intervention
Change in tactile-foot perception
Tactile-foot perception will be measured by Baseline Tactile Monofilaments (Fabrication Enterprises, White Plains, NY, USA).
Measured: at baseline and at the end of 6 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start5 Jul 2021
- Primary completion5 Dec 2022
- Study completion5 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FootwearStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Svoboda, Palacky University
- Investigators
- Lenka Murinova, Study director, Faculty of Physical Culture, Palacky University Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971915
- Sponsor's protocol ID
- IGA_FTK_2021_010
- Status last verified
- Dec 2022
- First submitted
- 5 Jul 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Minimalist Footwear on the Anthropometric and Biomechanical Parameters of the Lower Limb and Foot During Long-Term Wearing: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04971915
- Acronym / sponsor ID
- IGA_FTK_2021_010
- Conditions
- Footwear
- Keywords
- minimalist footwear, shoes, biomechanics, anthropometric parameters, foot, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 5 Dec 2022 (actual)
- First posted
- 22 Jul 2021 (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.
The study aims to determine whether 6months of wearing minimalist footwear causes changes in anthropometric parameters of the foot and the biomechanical parameters of the foot and lower limb.
Detailed description
The minimalist footwear represents an alternative style of footwear wearing, which could allow the foot to move more naturally compared to the footwear wearing in conventional footwear. That footwear is characterized by no cushioning, wide toe box, zero foot drop, thin sole (1,5 - 8 mm), low weight, and high flexibility of footwear. This study aims to determine the effect of 6months of wearing minimalist footwear on the foot and lower limb's anthropometric and biomechanical parameters.
The study is designed as a parallel interventional study. The sample size consists of 50 healthy individuals divided into experimental and control groups by randomization. All participants undergo the initial examination and baseline and final measurement focused on the foot anthropometry and kinetics and kinematics of the foot and lower limb during walking. Besides, the experimental group undergoes a 6months intervention of wearing minimalist footwear, during which the participants will record their movement behavior by electronic diary.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimalist footwear | Experimental | Other: minimalist footwearThe participants in the experimental group will receive one pair of minimalist footwear and will be asked to use them for the interventional period. |
| control | No intervention | –The participants in the control group will be asked to wear their standard footwear as before participating in the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Individuals without previous experience in wearing minimalist footwear
Key exclusion criteria (4 listed)
- Significant deformities of the feet and toes
- Pain of the musculoskeletal system
- Injury, congenital or gained defect of the musculoskeletal or neural system in past
- Undergo operation of lower limbs in past or during research
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 |
|---|---|---|
| minimalist footwearThe intervention consists of wearing the minimalist footwear in recommended progression during the interventional period (6months). The intial load starts at 2,500 steps a day and will be gradually increased up according to the participant´s tolerance rate to the footwear wearing to fully use over the final period. Participants are instructed to report all issues and difficulties possibly connected to the intervention. There will be the opportunity to consult any issue connected with footwear or their wearing through the duration of the research. | Other | minimalist footwear |
Primary outcome
Change in range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Time frame: at baseline and at the end of 6 months intervention
Range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in maximal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Time frame: at baseline and at the end of 6 months intervention
Maximal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in minimal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Time frame: at baseline and at the end of 6 months intervention
Minimal value of range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in angular velocity of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle
Time frame: at baseline and at the end of 6 months intervention
Angular velocity of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in walking velocity
Time frame: at baseline and at the end of 6 months intervention
Walking velocity will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in walking cadence
Time frame: at baseline and at the end of 6 months intervention
Walking cadence will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in step length during walking
Time frame: at baseline and at the end of 6 months intervention
Step length will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in duration of stance phase of the gait cycle
Time frame: at baseline and at the end of 6 months intervention
Duration of stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in maximum value of the vertical component of ground reaction force during walking
Time frame: at baseline and at the end of 6 months intervention
Maximum value of the vertical component of ground reaction force will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in minimum value of the vertical component of ground reaction force during walking
Time frame: at baseline and at the end of 6 months intervention
Minimum value of the vertical component of ground reaction force will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in impulse of the vertical component of ground reaction force during walking
Time frame: at baseline and at the end of 6 months intervention
Impulse of the vertical component of ground reaction force will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in lower limbs joints moments during walking
Time frame: at baseline and at the end of 6 months intervention
Lower limbs joints moments will be measured by two force plates Kistler (Kistler, Winterhur, Switzerland) synchronized with Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in peak plantar pressure at anatomical regions of the foot sole during walking
Time frame: at baseline and at the end of 6 months intervention
Peak plantar pressure at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in contact time at anatomical regions of the foot sole during walking
Time frame: at baseline and at the end of 6 months intervention
Contact time at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in contact area at anatomical regions of the foot sole during walking.
Time frame: at baseline and at the end of 6 months intervention
Contact area at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in pressure-time integral at anatomical regions of the foot sole during walking
Time frame: at baseline and at the end of 6 months intervention
Pressure-time integral at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in maximum force at anatomical regions of the foot sole during walking
Time frame: at baseline and at the end of 6 months intervention
Maximum force at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in foot length
Time frame: at baseline and at the end of 6 months intervention
Foot length will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).
Change in foot width
Time frame: at baseline and at the end of 6 months intervention
Foot width will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).
Change in tactile-foot perception
Time frame: at baseline and at the end of 6 months intervention
Tactile-foot perception will be measured by Baseline Tactile Monofilaments (Fabrication Enterprises, White Plains, NY, USA).
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 16 Dec 2022.
- 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.
Lenka Murinova study director
Faculty of Physical Culture, Palacky University Olomouc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimalist footwear in people with Footwear, run by Palacky University at 2 sites in Czechia.
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 2 inclusion and 4 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
Change in range of motion of pelvis, joints of lower limb and foot in coronal, transversal and frontal plane during stance phase of the gait cycle (time frame: at baseline and at the end of 6 months intervention). The study lists 20 primary outcomes in all. 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 16 Dec 2022.