Footwear Minimalism Study
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|ClinicalTrials.gov Identifier: NCT01334346|
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : March 29, 2013
The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.
The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).
|Condition or disease||Intervention/treatment||Phase|
|Healthy Runners||Other: Nike Pegasus Other: Nike Free 3.0 Other: Vibram Five Fingers Shoe||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation on Footwear Minimalism and Injury Risk in Runners|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
Active Comparator: Neutral Shoe
Conventional, non-minimalist, footwear.
Other: Nike Pegasus
Conventional neutral supportive running footwear. Non minimalist.
|Experimental: Partial minimalist shoe||
Other: Nike Free 3.0
Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.
|Experimental: Full minimalist||
Other: Vibram Five Fingers Shoe
Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.
- Number of Injury Events [ Time Frame: 12 weeks ]Number of run injury events (defined as unable to complete 3 consecutive running workouts due to running related pain). A calculation of injury incidence will be based on this number after dividing by the number of athletic exposures.
- Foot and Ankle Disability Index (FADI) [ Time Frame: Week 12 ]
- Numerical Pain Scale (NPS) for Overall Running Related Pain [ Time Frame: Week 12 ]
- Regional Specific NPS: Shin and Calf Pain [ Time Frame: Week 12 ]
- Regional Specific NPS: Foot and Ankle Pain [ Time Frame: 12 Week ]
- Regional Specific NPS: Knee Pain [ Time Frame: 12 Weeks ]
- Regional Specific NPS: Pelvis and Groin Pain [ Time Frame: 12 Week ]
- Regional Specific NPS: Lower Back Pain [ Time Frame: 12 Week ]
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): NCT01334346
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z3|
|Principal Investigator:||Jack Taunton, MD||University of British Columbia|