Footwear Prevention Study: Investigating the Effects of Running Shoe Pronation Control on the Risk of Injury
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Injury status, as measured at baseline, 6 weeks, and at the end of the 13-week programme
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adult, runner.
Exclusion Criteria
- •Not currently injured,
- •No history of surgery to the lower extremity.
Arms & Interventions
1
Footwear with motion controlling elements built into construction in order to reduce pronation of the foot and ankle during running.
Intervention: Motion Controlling Running Shoe (Device)
2
Footwear with standard neutral stabilization elements for the foot and ankle during running.
Intervention: Neutral Running Shoe (Device)
Outcomes
Primary Outcomes
Injury status, as measured at baseline, 6 weeks, and at the end of the 13-week programme
Time Frame: 13 weeks
Secondary Outcomes
- Pain levels, as measured at baseline, 6 weeks, and at the end of the 13-week programme(13 weeks)