Footwear and Injury Prevention Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00832195
First received: January 28, 2009
Last updated: February 17, 2014
Last verified: February 2014
  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 ]

Enrollment: 103
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 17, 2014
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 15, 2014