Clinical trial NCT04971915: The Effect of Minimalist Footwear on the Anthropometric and Biomechanical Parameters of the Lower Limb and Foot
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Footwear
Keywords: minimalist footwear
shoes
biomechanics
anthropometric parameters
foot
walking
Lead sponsor: Palacky University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: 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
timeFrame: at baseline and at the end of 6 months intervention
measure: 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
timeFrame: at baseline and at the end of 6 months intervention
measure: 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
timeFrame: at baseline and at the end of 6 months intervention
measure: 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
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in walking velocity
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in walking cadence
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in step length during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in duration of stance phase of the gait cycle
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in maximum value of the vertical component of ground reaction force during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in minimum value of the vertical component of ground reaction force during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in impulse of the vertical component of ground reaction force during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in lower limbs joints moments during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in peak plantar pressure at anatomical regions of the foot sole during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in contact time at anatomical regions of the foot sole during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in contact area at anatomical regions of the foot sole during walking.
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in pressure-time integral at anatomical regions of the foot sole during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in maximum force at anatomical regions of the foot sole during walking
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in foot length
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in foot width
timeFrame: at baseline and at the end of 6 months intervention
measure: Change in tactile-foot perception
timeFrame: at baseline and at the end of 6 months intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Faculty of Physical Culture, Palacky University Olomouc
city: Olomouc
country: Czechia
facility: Palacky University Olomouc, Faculty of Physical Culture
Study officials:
affiliation: Faculty of Physical Culture, Palacky University Olomouc
name: Lenka Murinova
role: STUDY_DIRECTOR
References: