Footwear Minimalism Study
|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|
|Primary Completion Date :||July 2012|
|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 ]
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|