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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Footwear

Intervention / Treatment
-----------------
* Other: minimalist footwear


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: minimalist footwear<br>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<br>* 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.<br>|
| No Intervention: control<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimalist footwear, shoes, biomechanics, anthropometric parameters, foot, walking