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The Effect of Minimalist Footwear on the Anthropometric and Biomechanical Parameters of the Lower Limb and Foot

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ClinicalTrials.gov Identifier: NCT04971915
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Zdenek Svoboda, Palacky University

Brief Summary:
The study aims to determine whether 3months of wearing minimalist footwear causes changes in anthropometric parameters of the foot and the biomechanical parameters of the foot and lower limb.

Condition or disease Intervention/treatment Phase
Footwear Other: minimalist footwear Not Applicable

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 minimalist footwear on the foot and lower limb's anthropometric and biomechanical parameters during long-term wearing.

The study is designed as a parallel interventional study. The sample size consists of 20 healthy individuals, which will be divided into two groups, 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 3months intervention of wearing minimalist footwear, during which the participants will record their movement behavior by electronic diary.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : July 5, 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: minimalist footwear
The participants in the experimental group will receive one pair of minimalist footwear and will be asked to use them for the interventional period.
Other: minimalist footwear
The intervention consists of wearing the minimalist footwear in recommended progression during the interventional period (3months). The using progression will start at around one hour a day in the first week, then will be increased to fully use (if possible) over the final period according to the participant´s tolerance rate to the footwear wearing. The consultation about the subjective effect of footwear will take place after the first month of wearing. Also, there will be the opportunity to consult any issue connected with footwear or their wearing through the duration of research.

No Intervention: control
The participants in the control group will be asked to wear their standard footwear as before participating in the study.



Primary Outcome Measures :
  1. 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 3 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).

  2. 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 3 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).

  3. 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 3 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).

  4. 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 3 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).

  5. Change in walking velocity [ Time Frame: at baseline and at the end of 3 months intervention ]
    Walking velocity will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).

  6. Change in walking cadence [ Time Frame: at baseline and at the end of 3 months intervention ]
    Walking cadence will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).

  7. Change in step length during walking [ Time Frame: at baseline and at the end of 3 months intervention ]
    Step length will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).

  8. Change in duration of stance phase of the gait cycle [ Time Frame: at baseline and at the end of 3 months intervention ]
    Duration of stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).

  9. Change in maximum value of the vertical component of ground reaction force during walking [ Time Frame: at baseline and at the end of 3 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).

  10. Change in minimum value of the vertical component of ground reaction force during walking [ Time Frame: at baseline and at the end of 3 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).

  11. Change in impulse of the vertical component of ground reaction force during walking [ Time Frame: at baseline and at the end of 3 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).

  12. Change in lower limbs joints moments during walking [ Time Frame: at baseline and at the end of 3 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).

  13. Change in peak plantar pressure at anatomical regions of the foot sole during walking [ Time Frame: at baseline and at the end of 3 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).

  14. Change in contact time at anatomical regions of the foot sole during walking [ Time Frame: at baseline and at the end of 3 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).

  15. Change in contact area at anatomical regions of the foot sole during walking. [ Time Frame: at baseline and at the end of 3 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).

  16. Change in pressure-time integral at anatomical regions of the foot sole during walking [ Time Frame: at baseline and at the end of 3 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).

  17. Change in maximum force at anatomical regions of the foot sole during walking [ Time Frame: at baseline and at the end of 3 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).


Secondary Outcome Measures :
  1. Change in foot length [ Time Frame: at baseline and at the end of 3 months intervention ]
    Foot length will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).

  2. Change in foot width [ Time Frame: at baseline and at the end of 3 months intervention ]
    Foot width will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).

  3. Change in tactile-foot perception [ Time Frame: at baseline and at the end of 3 months intervention ]
    Tactile-foot perception will be measured by Baseline Tactile Monofilaments (Fabrication Enterprises, White Plains, NY, USA).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy individuals
  • Individuals with neutral foot posture according to the Foot Posture Index (Redmond, Crane, & Menz, 2008)
  • Individuals without previous experience of wearing minimalist footwear

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971915


Contacts
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Contact: Lenka Murinova +421904616818 lenka.murinova01@upol.cz
Contact: Tomas Klein tomas.klein@upol.cz

Locations
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Czechia
Faculty of Physical Culture, Palacky University Olomouc Recruiting
Olomouc, Czechia, 77111
Contact: Zdenek Svoboda, Ph.D.    +420585636414    zdenek.svoboda@upol.cz   
Contact: Miroslav Janura, Prof.    +420585636400    miroslav.janura@upol.cz   
Palacky University Olomouc, Faculty of Physical Culture Recruiting
Olomouc, Czechia, 77900
Contact: Miroslav Janura       miroslav.janura@upol.cz   
Sponsors and Collaborators
Palacky University
Investigators
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Study Director: Lenka Murinova Faculty of Physical Culture, Palacky University Olomouc
Publications:
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Responsible Party: Zdenek Svoboda, Assistent Professor, Palacky University
ClinicalTrials.gov Identifier: NCT04971915    
Other Study ID Numbers: IGA_FTK_2021_010
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zdenek Svoboda, Palacky University:
minimalist footwear
shoes
biomechanics
anthropometric parameters
foot
walking