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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04971915
Other study ID # IGA_FTK_2021_010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2021
Est. completion date December 5, 2022

Study information

Verified date December 2022
Source Palacky University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 5, 2022
Est. primary completion date December 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Czechia Faculty of Physical Culture, Palacky University Olomouc Olomouc
Czechia Palacky University Olomouc, Faculty of Physical Culture Olomouc

Sponsors (1)

Lead Sponsor Collaborator
Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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