Footwear and Injury Prevention Study
This study is ongoing, but not recruiting participants.
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00832195
First received: January 28, 2009
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pronation Control |
Device: Motion Controlling Running Shoe Device: Neutral Running Shoe |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Footwear Prevention Study: Investigating the Effects of Running Shoe Pronation Control on the Risk of Injury |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Injury status, as measured at baseline, 6 weeks, and at the end of the 13-week programme [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain levels, as measured at baseline, 6 weeks, and at the end of the 13-week programme [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Adult, runner.
Exclusion Criteria:
- Not currently injured,
- No history of surgery to the lower extremity.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00832195 History of Changes |
| Other Study ID Numbers: | H08-02995 |
| Study First Received: | January 28, 2009 |
| Last Updated: | January 16, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
running injury pronation footwear. |
ClinicalTrials.gov processed this record on May 23, 2013