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

Footwear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971915
• Other study ID #: IGA_FTK_2021_010
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Footwear

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