跳至主要内容
临床试验/NCT04830540
NCT04830540Unknown不适用

Impact of 'Recovery' Footwear on Lower Extremity Comfort and Biomechanics

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Muscle EMG activity

研究概览

简要总结

The goal of this study is to understand the impact of wearing shoes with a compliant, energy absorbing midsole material, outside of athletic training sessions on the mechanics of movement, performance, and perceived joint pain and stiffness. Advances in material science have led to a wider range of cushioning system material properties and mid and outsole geometries in footwear. While there are many marketing claims about the potential health benefits of this new class of footwear these have not yet been investigated in well-designed scientific studies.

It is hypothesized that the intervention shoe as compared to the control will reduce self-reported joint pain and stiffness, improve ankle plantarflexion function and increase intersegmental foot motion during walking.

详细描述

Participants will be asked to make 2 visits, 6 weeks apart, to the Umass Biomechanics Lab in the Totman Building at UMass Amherst for gait analysis and biomechanical performance testing.

At the first study visit, participants will be randomly assigned to one of two groups. Participants assigned to the control group will be asked to continue wearing their typical shoes and to complete every two weeks the footwear and injury log provided. Individuals assigned to the intervention group will be provided with 2 styles of the OOFOS recovery shoes, and will be asked to wear the OOFOS slide, sandal and/or closed toe shoes as their primary footwear outside training and competition for the 6 weeks between study visits. Intervention participants will also be asked to complete a daily shoe wear log and a shoe comfort assessment survey every other week.

At each study visit, subjects will be asked to read and sign an Informed Consent Form, and will also be asked questions about their health, exercise, and injury history. To prepare for the data collection, participants will be asked to change into a pair of shorts and tight shirt that will be provided. Anatomic measurements will then be made with a measuring tape, and ankle flexibility will be assessed by manually moving the participant's ankle into the most flexed and most extended position.

Reflective markers will then be placed on subject's feet/shoes, legs, thighs, hips, shoulders, and arms to record 3-D limb kinematics. To place the markers, we will put little circles of double-sided tape on skin or clothing, with reflective balls on the outer side. The position of the reflective markers will be recorded by high-speed infrared cameras surrounding the data collection space. Subjects will also be instrumented with electromyography (EMG) sensors on the skin over muscles of the leg, to measure the activity of those muscles. Before placing the EMG sensors, a small patch of skin will be shaved to ensure the sensor stays in place and captures the signals needed.

Once markers have been placed, subjects will stand in the data collection space to record a standing calibration trial of the markers. The standing calibration trial will be used to create a computer model on which data analysis will be performed. Subjects will then walk on a long walkway with the cameras surrounding it at a both self-selected and a set speed of 1.4 m/s. This will be repeated several times until at least 5 successful trials have been recorded. A successful trial means that the walking speed varies by no more than 5 % from the previous trial. Subjects will perform the walking trials barefoot and in the OOFOS sandal and closed toe shoes.

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 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • BMI 18 - 35 kg/m
  • Stiff or cleated footwear athlete on a competitive team.

排除标准

  • Current injury that required absence from one or more practices in the last 3 weeks of regular team practice.
  • Orthotic or other shoe insert used outside of athletic training times.

结局指标

主要结局

Muscle EMG activity

时间窗: Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s

Unilateral Surface Electromyography of Medial Gastrocnemius, Lateral Gastrocnemius, Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Peroneus Longus, Soleus, Biceps Femoris, and Semitendinosus, during overground walk.

Calf Muscles Strength

时间窗: 2 - 3 hours on week 6.

Unilateral isometric and isokinetic strength based on maximal contractions performed on a dynamometer.

Gait Mechanics

时间窗: Gait analysis test at week 6 with 5 trials of overground walking at a speed of 1.4 m/s

Gait kinematics during overground walk at preferred speed, and 1.4m/s, evaluated with a motion capture system.

Maximum Vertical Jump

时间窗: 2 - 3 hours on week 6

Height (m) of center of mass above ground measured by markers place on posterior superior iliac spine.

Self-reported shoe comfort

时间窗: Week 6, 5 minutes

Shoe wear and comfort log

Self-reported pain, and injury.

时间窗: Week 6, 5 minutes

Injury and pain log

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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