Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000516684
Ethics application status
Approved
Date submitted
26/04/2023
Date registered
19/05/2023
Date last updated
1/06/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Gait analysis and shoe recommendation for recreational runners
Scientific title
Effects of shoe recommendation based on gait analysis on comfort, performance, and injury in recreational runners
Secondary ID [1] 309498 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot biomechanics 329771 0
Condition category
Condition code
Musculoskeletal 326674 326674 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TIDieR checklist:
How does shoe recommendation based on gait analysis influence subjective measures of comfort, performance, and injury prevention?

Runners will participate in a gait analysis reflecting common in-store practices. The gait analysis will take approximately 10 minutes at the beginning of the intervention and will include shoe wear pattern assessment, foot measurement with a Brannock device, standing, walking, and running over a pressure sensor mat, and single leg squats.

They will then be randomly assigned in a repeated measures study design two identical shoe constructions, albeit masked by color and deceived into believing that they are using different shoes. Runners will be randomly assigned shoe order (control and experimental) and receive informational descriptions as part of the intervention (basic/recommended shoe). Runners will be convinced that one shoe is a basic shoe that can be used in distance running, while the other shoe from the lab will be matched to their individual running style based on their gait analysis.

Surveys after each running bout will be collected using Qualtrics offline surveys on an iPad to rate their experience. Runners will use their own shoes as a washout period after each experimental condition within the single session (5 mins running, 5 minutes rest). Runners will also complete a final ranking survey comparing each of the shoes.

Basic shoe: This shoe model is quite basic. It is a generic shoe that doesn’t necessarily match your foot shape or running style. Basically, it CAN be used for distance running, but it is not specifically suited to you.

Recommended shoe: Based on all the tests we did and the 6 pairs of shoes we have in the lab, this pair is the best option for you to maximize your comfort. Since this shoe matches your foot shape and running style, it will be extra comfortable when you run. We know from research that when a shoe is super comfortable and matches your body and running style, it usually leads to better performance and lower injury risk.


The primary researcher will conduct all participant interventions and has a background in sports science research.

Participants will interact face to face for a single session after being recruited via clubs, stores, and word of mouth.

The intervention will occur at the University of Waikato Adam's center for sport performance in the university lab.

Participants will run 4 bouts after a brief warm up, 5 minutes each bout. They will only experience the intervention (gait analysis) once in their single session visit prior to running in shoe conditions. The total session length is approximately 1 hour.



Intervention code [1] 325927 0
Behaviour
Comparator / control treatment
Runners will use two shoes in a randomized order, as well as randomization of how each shoe is labeled during a session. Runners will use their own shoes, a 'neutral' shoe, and 'gait analysis matched' shoes during the single session.

The order of Own shoes has been prescribed as the first bout for treadmill familiarization and the third bout for intra session reliability and washout before the final condition.
Control group
Placebo

Outcomes
Primary outcome [1] 334550 0
Subjective comfort between running shoes measured using 100 mm visual analogue scale (VAS).
Timepoint [1] 334550 0
The primary outcomes will be assessed at four timepoints in a repeated-measures design during a single session:

Own shoes at baseline
Experimental condition 1
Reliability Own shoes
Experimental condition 2.
Secondary outcome [1] 421102 0
Cushioning the heel of the shoe will be measured using 100 mm VA
Timepoint [1] 421102 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [2] 421103 0
Cushioning the forefoot region of the shoe will be measured using 100 mm VAS
Timepoint [2] 421103 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [3] 421104 0
Perceived flexibility of the shoe will be measured using 100 mm VAS
Timepoint [3] 421104 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [4] 421105 0
Perceived stability of the shoe will be measured using 100 mm VAS
Timepoint [4] 421105 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [5] 421106 0
Perceived feeling of the shoe will be measured using 100 mm VAS
Timepoint [5] 421106 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [6] 421107 0
Perceived difficulty while running in the shoe will be measured using 100 mm VAS
Timepoint [6] 421107 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [7] 421108 0
Perceived influence of the shoe on performance will be measured using 100 mm VAS
Timepoint [7] 421108 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [8] 421109 0
Perceived risk of injury wearing the shoe will be measured using 100 mm VAS
Timepoint [8] 421109 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [9] 421110 0
Perceived match to personal running style will be measured using 100 mm VAS
Timepoint [9] 421110 0
The assessment will occur at four timepoints within a single session:

Own shoes at baseline
Experimental condition 1
Own shoes reliability
Experimental condition 2
Secondary outcome [10] 421114 0
Runners will select the most comfortable shoe used during the experiment from their own shoes, neutral, and gait matched shoes by ranking each shoe in order of question related preference.
Timepoint [10] 421114 0
Single measurement will occur as final survey in session.
Secondary outcome [11] 421115 0
Runners will select the least injurious shoe used during the experiment from their own shoes, neutral, and gait matched shoes by ranking each shoe in order of question related preference.
Timepoint [11] 421115 0
This will occur at the final survey in session.
Secondary outcome [12] 421116 0
Runners will select the most performance enhancing shoe used during the experiment from their own shoes, neutral, and gait matched shoes by ranking each shoe in order of question related preference.
Timepoint [12] 421116 0
Final survey of session
Secondary outcome [13] 421117 0
Runners will select the best-matched to running style used during the experiment from their own shoes, neutral, and gait matched shoes by ranking each shoe in order of question related preference.
Timepoint [13] 421117 0
Final survey
Secondary outcome [14] 421118 0
Runners will select their most preferred shoe used during the experiment from their own shoes, neutral, and gait matched shoes by ranking each shoe in order of question related preference.
Timepoint [14] 421118 0
Final survey

Eligibility
Key inclusion criteria
Runners are eligible to participate if they road run at least once weekly for at least one month.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Runners that have been injured within the month prior to enrolment based on the following consensus definition:

Running related (training or competition) musculoskeletal pain in the lower limbs that causes a restriction on or stoppage of running (distance, speed, duration, or training) for at least 7 days or 3 consecutive scheduled training sessions, or that requires the runner to consult a physician or other health professional.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a computer generated sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/05/2023
Date of last participant enrolment
Anticipated
30/06/2023
Actual
18/05/2023
Date of last data collection
Anticipated
30/06/2023
Actual
19/05/2023
Sample size
Target
20
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 25416 0
New Zealand
State/province [1] 25416 0
Bay of Plenty

Funding & Sponsors
Funding source category [1] 313691 0
University
Name [1] 313691 0
University of Waikato Adams Center for High Performance
Country [1] 313691 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
Country
New Zealand
Secondary sponsor category [1] 315677 0
None
Name [1] 315677 0
Address [1] 315677 0
Country [1] 315677 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312857 0
University of Waikato Human Research Ethics Committee
Ethics committee address [1] 312857 0
Ethics committee country [1] 312857 0
New Zealand
Date submitted for ethics approval [1] 312857 0
Approval date [1] 312857 0
10/03/2023
Ethics approval number [1] 312857 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126150 0
Mr Andrew Fife
Address 126150 0
Address: University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
Country 126150 0
New Zealand
Phone 126150 0
+64 07 577 8575
Fax 126150 0
Email 126150 0
[email protected]
Contact person for public queries
Name 126151 0
Andrew Fife
Address 126151 0
Address: University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
Country 126151 0
New Zealand
Phone 126151 0
+64 07 577 8575
Fax 126151 0
Email 126151 0
[email protected]
Contact person for scientific queries
Name 126152 0
Andrew Fife
Address 126152 0
Address: University of Waikato, 52 Miro Street, Mount Maunganui, Tauranga 3116
Country 126152 0
New Zealand
Phone 126152 0
+64 07 577 8575
Fax 126152 0
Email 126152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Purposes related to running shoe selection, any analysis methodology
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.