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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in maximum value of the vertical component of ground reaction force during walking
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals
- •Individuals without previous experience in wearing minimalist footwear
排除标准
- •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
结局指标
主要结局
Change in maximum value of the vertical component of ground reaction force during walking
时间窗: at baseline and at the end of 6 months intervention
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).
Change in duration of stance phase of the gait cycle
时间窗: at baseline and at the end of 6 months intervention
Duration of stance phase of the gait cycle will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in impulse of the vertical component of ground reaction force during walking
时间窗: at baseline and at the end of 6 months intervention
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).
Change in lower limbs joints moments during walking
时间窗: at baseline and at the end of 6 months intervention
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).
Change in peak plantar pressure at anatomical regions of the foot sole during walking
时间窗: at baseline and at the end of 6 months intervention
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).
Change in contact time at anatomical regions of the foot sole during walking
时间窗: at baseline and at the end of 6 months intervention
Contact time at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
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
时间窗: at baseline and at the end of 6 months intervention
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).
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
时间窗: at baseline and at the end of 6 months intervention
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).
Change in walking velocity
时间窗: at baseline and at the end of 6 months intervention
Walking velocity will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in walking cadence
时间窗: at baseline and at the end of 6 months intervention
Walking cadence will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
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
时间窗: at baseline and at the end of 6 months intervention
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).
Change in step length during walking
时间窗: at baseline and at the end of 6 months intervention
Step length will be measured by the Vicon Vantage V5 (Vicon Motion System, London, Great Britain).
Change in foot width
时间窗: at baseline and at the end of 6 months intervention
Foot width will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).
Change in tactile-foot perception
时间窗: at baseline and at the end of 6 months intervention
Tactile-foot perception will be measured by Baseline Tactile Monofilaments (Fabrication Enterprises, White Plains, NY, USA).
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
时间窗: at baseline and at the end of 6 months intervention
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).
Change in minimum value of the vertical component of ground reaction force during walking
时间窗: at baseline and at the end of 6 months intervention
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).
Change in contact area at anatomical regions of the foot sole during walking.
时间窗: at baseline and at the end of 6 months intervention
Contact area at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in maximum force at anatomical regions of the foot sole during walking
时间窗: at baseline and at the end of 6 months intervention
Maximum force at anatomical regions of the foot sole during walking will be measured by pressure plate 2M footscan® (RSscan International NV, Paal, Belgium).
Change in pressure-time integral at anatomical regions of the foot sole during walking
时间窗: at baseline and at the end of 6 months intervention
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).
Change in foot length
时间窗: at baseline and at the end of 6 months intervention
Foot length will be measured by RSS 3D Scanner (RSScan International NV, Paal, Belgium).
次要结局
未报告次要终点
研究者
Zdenek Svoboda
Assistent Professor
Palacky University