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

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.

Study Overview

• Status: Completed
• Conditions: Footwear
• Intervention / Treatment: Other: minimalist footwear

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 77111
    • Faculty of Physical Culture, Palacky University Olomouc
  • Olomouc, Czechia, 77900
    • Palacky University Olomouc, Faculty of Physical Culture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	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).	at baseline and at the end of 6 months intervention

Collaborators and Investigators

• Sponsor: Palacky University
• Investigators: Study Director: Lenka Murinova, Faculty of Physical Culture, Palacky University Olomouc

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): December 5, 2022

Study Registration Dates

• First Submitted: July 5, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: walking; biomechanics; foot; shoes; anthropometric parameters; minimalist footwear
• Other Study ID Numbers: IGA_FTK_2021_010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No