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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of running shoe design on comfort and injury rates in recreational runners
Scientific title
A randomised controlled trial to compare comfort and injury rates in recreational runners with normal foot type wearing motion control running shoes versus barefoot running shoes versus their own running shoes.
Secondary ID [1] 282564 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
running injuries 289233 0
running shoe comfort 289234 0
Condition category
Condition code
Musculoskeletal 289566 289566 0 0
Other muscular and skeletal disorders

Study type
Description of intervention(s) / exposure
Arm1: Participants will receive a pair of dual density running shoes. The ASICS (Registered Trademark) GEL-1100 (Trademark) series shoe provided is a motion control shoe that provides cushioning and stability.
Arm2: Participants will receive a pair of barefoot running shoes. The Vibram FiveFingers (Registered Trademark) Sprint model provided has a polyamide fabric upper and performance rubber sole.

Participants being issued with a new pair of footwear will be given a two week adjustment period to adapt to the new footwear prior to beginning the study. Participants will be asked to wear the shoes for some or all of their weekly running sessions if they are comfortable doing so.

Study duration is 6 months and participants will complete surveys at baseline, 1 month, 3 months and 6 months.

Adherence will be monitored via the surveys. Questions include how many times per week the footwear was used, percentage of training completed in the footwear, and details of training (type, distance, surface)
Intervention code [1] 287227 0
Comparator / control treatment
No treatment: Participants will continue to use their own running shoes
Control group

Primary outcome [1] 289660 0
Running injuries survey specifically written for this study that includes details on footwear worn, type and distance of training, practitioner and self diagnosed injuries.
Timepoint [1] 289660 0
baseline and 1,3 and 6 months after intervention commencement
Secondary outcome [1] 302968 0
Running shoe comfort survey specifically written for this study with questions concerning shoe comfort measured using a 100mm Visual Analogue Scale (VAS)
Timepoint [1] 302968 0
baseline and 1, 3 and 6 months after intervention commencement

Key inclusion criteria
i. Aged greater than or equal to 18 years;
ii. Recreational runners male or female with Foot Posture Index indicating a normal foot type (this category includes neutral to slightly flat);
iii. Must run regularly (2 sessions or more per week).
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
i. The current use of foot orthoses;
ii. Any systemic disease affecting the musculoskeletal system;
iii. A history of major lower back and leg injury and/or surgery;
iv. A current acute injury that prevents running.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Regular recreational runners will be recruited by advertisement. Interested participants will be questioned regarding the inclusion and exclusion criteria during the initial telephone contact and then screened for foot type and other exclusion criteria at the initial appointment. Subjects will be randomised into one of two intervention groups or a control group . Randomisation will be stratified using history of running injury, gender and mileage to ensure similar groups from baseline. Allocation concealment will be used to prevent selection bias. Allocation will be by contacting the holder of the allocation schedule who was “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be via a software randomisation function
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Fifty participants will be allocated to each group. We based the a priori sample size calculations on a minimal important difference of 10.2mm on a 100mm visual analogue scale for comfort (Mills et al., 2010). Assuming a standard deviation of 20 mm, a power of 0.80, and an a level of 0.05, we require 37 participants in each group. We increased the sample size by approximately 20%, in each group, to allow for loss to follow up. This has been rounded up to 50.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 287339 0
Name [1] 287339 0
The University of Newcastle, Australia
Address [1] 287339 0
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country [1] 287339 0
Primary sponsor type
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Secondary sponsor category [1] 286089 0
Name [1] 286089 0
Address [1] 286089 0
Country [1] 286089 0

Ethics approval
Ethics application status
Ethics committee name [1] 289317 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 289317 0
The Chancellery
The University of Newcastle
Callaghan Campus
University Drive
Callaghan NSW 2308
Ethics committee country [1] 289317 0
Date submitted for ethics approval [1] 289317 0
Approval date [1] 289317 0
Ethics approval number [1] 289317 0

Brief summary
Information on comfort levels and incidence of running related pain or injury with each type of footwear will provide valuable evidence on the effect of footwear design, specifically motion control footwear versus barefoot running shoes on injury rates and runner comfort.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 40294 0
Dr Vivienne Chuter
Address 40294 0
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 40294 0
Phone 40294 0
+ 61 2 43 494 424
Fax 40294 0
Email 40294 0
Contact person for public queries
Name 40295 0
Dr Vivienne Chuter
Address 40295 0
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 40295 0
Phone 40295 0
+ 61 2 43 494 424
Fax 40295 0
Email 40295 0
Contact person for scientific queries
Name 40296 0
Dr Vivienne Chuter
Address 40296 0
The University of Newcastle
School of Health Sciences
PO Box 127
Ourimbah, NSW 2258
Country 40296 0
Phone 40296 0
+ 61 2 43 494 424
Fax 40296 0
Email 40296 0

No information has been provided regarding IPD availability
Summary results
No Results