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Footwear Minimalism Study

An Investigation on Footwear Minimalism and Injury Risk in Runners

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01334346
Enrollment
91
Registered
2011-04-13
Start date
2011-08-31
Completion date
2012-07-31
Last updated
2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Runners

Keywords

Running, Footwear, Injury incidence, injury risk, pain

Brief summary

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).

Interventions

OTHERNike Pegasus

Conventional neutral supportive running footwear. Non minimalist.

OTHERNike Free 3.0

Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.

OTHERVibram Five Fingers Shoe

Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.

Sponsors

Nike
CollaboratorINDUSTRY
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Minimum of 5 years experience running * Have been running on a regular basis (minimum once per week) over the past 6 months * Able to run for 60 minutes continuously * Can tolerate 20-40km per week in training * Neutral foot posture according to the Foot Posture Index.

Exclusion criteria

* Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months * History of surgery to their plantar fascia or Achilles tendon * Have already been running in a minimalist shoe * Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity * Are currently taking analgesic medication.

Design outcomes

Primary

MeasureTime frameDescription
Number of Injury Events12 weeksNumber 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.

Secondary

MeasureTime frame
Numerical Pain Scale (NPS) for Overall Running Related PainWeek 12
Regional Specific NPS: Shin and Calf PainWeek 12
Regional Specific NPS: Foot and Ankle Pain12 Week
Foot and Ankle Disability Index (FADI)Week 12
Regional Specific NPS: Pelvis and Groin Pain12 Week
Regional Specific NPS: Lower Back Pain12 Week
Regional Specific NPS: Knee Pain12 Weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026