跳至主要内容
临床试验/NCT00832195
NCT00832195已完成3 期

Footwear Prevention Study: Investigating the Effects of Running Shoe Pronation Control on the Risk of Injury

University of British Columbia1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2009年3月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
103
试验地点
1
主要终点
Injury status, as measured at baseline, 6 weeks, and at the end of the 13-week programme

研究概览

简要总结

The purpose of this study is to assess whether shoes that are more controlling for movement of the foot and ankle, compared to shoes that are less controlling, will reduce the overall number and severity of injuries experienced during a 13-week running programme. Our hypothesis is that runners who wear more controlling footwear during the 13-week programme will experience less injury events.

详细描述

The proposed study will be a non-blinded prospective randomized cohort design.

Subjects will include adult runners of both genders with no history of injury in the 6 months prior to study enrollment. Eligible participants will have no history of surgery or trauma to the lower extremity that might compromise their walking or running gait, and all subjects must be able to comfortably fit into their selected footwear.

Three different foot posture sub-group classifications will be recruited: neutral, mild to moderate, and excessive. The subjects' foot posture will be classified using the Foot Posture Index (Redmond et al. (2006)(1). Twenty four subjects are estimated to be required within each foot posture sub-group; therefore 72 subjects will be our goal for enrollment. Subjects within each foot posture sub-group will be randomized into one of two separate footwear conditions: both the neutral group and the mild to moderate pronator group will be divided to receive either a neutral cushioned running shoe (a.k.a. 'neutral shoe'), or a shoe with mild stability components for controlling overpronation (a.k.a. 'stability shoe'); participants in the excessive pronator sub-group will be randomized to receive either a 'stability shoe' or a shoe will aggressive motion controlling features (a.k.a. 'motion control shoe').

All subjects will undergo an initial baseline test, including an entrance interview for participant eligibility, training history, running injury history and documentation of lower extremity anthropometry (i.e. arch height, knee alignment, standing rearfoot position). Subjects will be randomized during their baseline test to their shoe condition and receive their shoes, training diary and running programme at that time.

Once all subjects have completed their baseline testing, the official running clinic start date will commence on the following Saturday. A running clinic is established so that all subjects will have a chance to meet together, along with knowledgeable run leaders and a study co-investigator (MR), in order to increase group cohesion and provide an opportunity for data monitoring, programme feedback and subject questions. All subjects will begin the running programme at the official running clinic start date. The programme is designed to prepare individuals for a half-marathon (21 kilometre) running event in 13 weeks. Subjects will run on their own time, as indicating in their running programme, for the rest of the week until meeting again the following Saturday. This schedule will be repeated for the entire 13 week duration of the programme.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult, runner.

排除标准

  • Not currently injured,
  • No history of surgery to the lower extremity.

结局指标

主要结局

Injury status, as measured at baseline, 6 weeks, and at the end of the 13-week programme

时间窗: 13 weeks

次要结局

  • Pain levels, as measured at baseline, 6 weeks, and at the end of the 13-week programme(13 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验