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

NCT04971915 | Completed

• 1 other identifier: IGA_FTK_2021_010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Footwear

Keywords

minimalist footwear; shoes; biomechanics; anthropometric parameters; foot; walking

Outcome Measures

Primary Outcomes (20)

• 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

Study Arms (2)

minimalist footwear

EXPERIMENTAL

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

control

NO INTERVENTION

The participants in the control group will be asked to wear their standard footwear as before participating in the study.

Interventions

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.

minimalist footwear

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palacky University: lead

Study Sites (2)

Faculty of Physical Culture, Palacky University Olomouc

Olomouc, 77111, Czechia

Location

Palacky University Olomouc, Faculty of Physical Culture

Olomouc, 77900, Czechia

Location

Study Officials

• Lenka Murinova

  Faculty of Physical Culture, Palacky University Olomouc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 22, 2021
• Study Start: July 5, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)