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Footwear and Injury Prevention Study

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ClinicalTrials.gov Identifier: NCT00832195
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Pronation Control Device: Motion Controlling Running Shoe Device: Neutral Running Shoe Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Footwear Prevention Study: Investigating the Effects of Running Shoe Pronation Control on the Risk of Injury
Study Start Date : March 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1
Footwear with motion controlling elements built into construction in order to reduce pronation of the foot and ankle during running.
Device: Motion Controlling Running Shoe
Running shoe with thermoplastic mid-foot shank stiffener, denser durometer foam on medial aspect of mid-sole, reinforced heel counter, wider sole-plate, and lateral foam crash-pad.

Active Comparator: 2
Footwear with standard neutral stabilization elements for the foot and ankle during running.
Device: Neutral Running Shoe
Standard running shoe with single density mid-sole foam.




Primary Outcome Measures :
  1. Injury status, as measured at baseline, 6 weeks, and at the end of the 13-week programme [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Pain levels, as measured at baseline, 6 weeks, and at the end of the 13-week programme [ Time Frame: 13 weeks ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult, runner.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832195


Locations
Canada, British Columbia
Lady Sport
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jack Taunton, MD University of British Columbia
Study Director: Michael Ryan University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00832195     History of Changes
Other Study ID Numbers: H08-02995
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by University of British Columbia:
running
injury
pronation
footwear.