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Completed

NCT Number: NCT04971915

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

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.

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Key information

Conditions

Footwear

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Culture, Palacky University Olomouc, Olomouc, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals
  • Individuals without previous experience in wearing minimalist footwear

Exclusion criteria

  • 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

Treatment and study plan

minimalist footwear

Other

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.

Primary outcomes

  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 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).

  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 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).

  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 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).

  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 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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).

  18. 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).

  19. 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).

  20. 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).

Sponsors and collaborators

Lead sponsor

Palacky University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2021
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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