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Trial registered on ANZCTR


Registration number
ACTRN12622001358730
Ethics application status
Approved
Date submitted
12/10/2022
Date registered
24/10/2022
Date last updated
16/06/2024
Date data sharing statement initially provided
24/10/2022
Date results information initially provided
24/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of footwear on Landing Error Scoring System outcomes
Scientific title
Effect of footwear on double-leg jump-landing and jump height measures in healthy participants: A randomized cross-over study
Secondary ID [1] 308176 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal injury 327901 0
Sport injury 327902 0
Anterior cruciate ligament injury 327950 0
Condition category
Condition code
Musculoskeletal 324988 324988 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized cross-over study performed in a biomechanics laboratory. Participants will complete the original Landing Error Scoring System testing procedures, jumping horizontally from a 30-cm box to 50% of their body height and jumping vertically as high as possible upon landing. Participants will jump three times in two conditions: (1) barefoot, and
(2) their own habitual athletic footwear. There will be 15 minutes rest between conditions, and 30 seconds rest between trials. Participants will be allowed up to three familiarization trials before formal experimentation. Before each trial, participants will be reminded to jump to 50% of their body height (indicated by the line) with two feet, and jump upwards as high as possible upon landing. Trials will be disregarded when participants do not land at 50% of their body height or do not perform the task in one fluid motion. Unless the task is preformed inappropriately, feedback on performance will not given to avoid influencing outcomes.

Two video cameras will be use to capture the jumps at 120 frames per second. One camera will be placed to the right hand side of participants, and the other in front of participants. Cameras will be placed 3.5 m away from the landing area on 1.3 m high tripods. The videos will be analysed in a video processing software (Kinovea) and the original Landing Error Scoring System template from Padua et al. (2009) used to extract Landing Error Scoring System scores. Briefly, the tool involves 17 items that is scored by an examiner. Movement during the double-leg jump-landing task is scored to identify "landing errors". The overall score ranges from 0 to 17 errors where lower scores reflect fewer landing errors and thus fewer movement patterns linked with noncontact Anterior Cruciate Ligament injuries

The order of conditions will be block randomized prior to study commencement by a third party to ensure an equal number of participants starting in each condition, and allocated sequentially to participants upon study enrolment by a single researcher. Participants will be pre informed of the aims of the study.

Participants will use their own athletic footwear, and will not be tested if their footwear score 70% or more on the Minimalist Index as could potentially mimic barefoot.

Participants will complete an informed consent document, and baseline characteristics will be collected (height, mass, gender, age, and self-administered short-form International Physical Activity Questionnaire). Footwear characteristics will also be recorded using the Minimal Index and a durometer.
Intervention code [1] 324625 0
Treatment: Other
Comparator / control treatment
Participants act as their own controls. Participants performing the task with shoes is considered the control task as it is the most common in research and clinical practice.
Control group
Active

Outcomes
Primary outcome [1] 332790 0
The jump landing biomechanics according to the Landing Error Scoring System Score (mean of three trials) will be assessed. The 17 items in question are:
1 Knee flexion at initial contact (0 to 1 error)
2 Hip flexion at initial contact (0 to 1 error)
3 Trunk flexion at initial contact (0 to 1 error)
4 Ankle plantar flexion at initial contact (0 to 1 error)
5 Knee valgus at initial contact (0 to 1 error)
6 Lateral trunk flexion at initial contact (0 to 1 error)
7 Stance width (wide) at initial contact (0 to 1 error)
8 Stance width (narrow) at initial contact (0 to 1 error)
9 Foot position (toe-in) (0 to 1 error)
10 Foot position (toe-out) (0 to 1 error)
11 Symmetric foot contact at initial contact (0 to 1 error)
12 Knee flexion at maximal knee flexion (0 to 1 error)
13 Hip flexion at maximal knee flexion (0 to 1 error)
14 Trunk flexion at maximal knee flexion (0 to 1 error)
15 Knee valgus displacement (0 to 1 error)
16 Joint displacement (0 to 2 errors)
17 Overall impression (0 to 2 errors)

The overall LESS score ranges from 0 to 17 errors where lower scores reflect fewer landing errors. The overall score cannot be greater than 17 as items 7 and 8 and items 9 and 10 cannot be marked as "errors" simultaneously.
Timepoint [1] 332790 0
The outcomes will be collected continuously in a single assessment session comprised of 6 jump trials (3 treatment [barefoot], 3 control [footwear]). The videos will be rated by a single assessor within 4 weeks of the data collection.
Primary outcome [2] 332791 0
Landing Error Scoring System Risk Category (scores of 5 or more defines high injury risk) based on the mean of the three trials.
Timepoint [2] 332791 0
The outcomes will be collected continuously in a single assessment session comprised of 6 jump trials (3 treatment [barefoot], 3 control [footwear]). The videos will be rated by a single assessor within 4 weeks of the data collection.
Primary outcome [3] 332792 0
The occurrence of specific Landing Error Scoring System Specific Errors will be compared between conditions. Notably, the occurrence of errors in the following 17 items will be compared:
1 Knee flexion at initial contact (0 to 1 error)
2 Hip flexion at initial contact (0 to 1 error)
3 Trunk flexion at initial contact (0 to 1 error)
4 Ankle plantar flexion at initial contact (0 to 1 error)
5 Knee valgus at initial contact (0 to 1 error)
6 Lateral trunk flexion at initial contact (0 to 1 error)
7 Stance width (wide) at initial contact (0 to 1 error)
8 Stance width (narrow) at initial contact (0 to 1 error)
9 Foot position (toe-in) (0 to 1 error)
10 Foot position (toe-out) (0 to 1 error)
11 Symmetric foot contact at initial contact (0 to 1 error)
12 Knee flexion at maximal knee flexion (0 to 1 error)
13 Hip flexion at maximal knee flexion (0 to 1 error)
14 Trunk flexion at maximal knee flexion (0 to 1 error)
15 Knee valgus displacement (0 to 1 error)
16 Joint displacement (0 to 2 errors)
17 Overall impression (0 to 2 errors)

An error will be considered present when present in two of the three trials for Items 1-15. For Items 16-17, an error will be considered present when the ‘average’ rating is present in two of three trials or when the ‘poor/stiff’ rating is present in one of three trials
Timepoint [3] 332792 0
The outcomes will be collected continuously in a single assessment session comprised of 6 jump trials (3 treatment [barefoot], 3 control [footwear]). The videos will be rated by a single assessor within 4 weeks of the data collection.
Secondary outcome [1] 414715 0
The time from take-off from the ground to the final landing will be extracted from the sagittal plane videos to compute jump heights from flight times using validated equations (Linthorne, 2001). The mean jump height from the three trials in each condition will be used for analysis,
Timepoint [1] 414715 0
The outcomes will be collected continuously in a single assessment session comprised of 6 jump trials (3 treatment [barefoot], 3 control [footwear]). The videos will be rated by a single assessor within 4 weeks of the data collection.

Eligibility
Key inclusion criteria
Free of injury, illness, or conditions that may affect movements or landing mechanics. Free of lower extremity, back, or pelvis injury in the last three months. Footwear scores lower than 70% on Minimalist Index.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The order of conditions was block randomized prior to study commencement by a third party to ensure an equal number of participants starting in each condition, and allocated sequentially to participants upon study enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The order of conditions was block randomized prior to study commencement by a third party to ensure an equal number of participants starting in each condition, and allocated sequentially to participants upon study enrolment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations were performed a priori using G*Power 3.1.9.7 applying a standard two-tailed hypothesis, 90% power (ß = 0.10), 5% significance level (a = 0.05), one error LESS difference in paired means defining a clinically-meaningful change, and 2.47 standard deviation of the difference in paired means based on previous work.

Based on these assumptions, 67 participants were required and would be sufficient to detect a small effect size difference (Cohen d = 0.40) between conditions. A sample size of 80 participants was targeted to account for a 20% drop out rate.

Differences in group mean LESS scores and jump heights will be assessed using mean differences, two tailed paired t-tests, and Cohen’s d effect sizes for paired samples using an average variance with 95% confidence intervals.

Differences in the number of participants categorized at high and low risk of injury and occurrence of specific errors between conditions will be assessed using McNemar’s tests and odds ratio with 95% confidence intervals.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
Actual
28/05/2021
Date of last data collection
Anticipated
Actual
28/05/2021
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 25062 0
New Zealand
State/province [1] 25062 0

Funding & Sponsors
Funding source category [1] 312433 0
University
Name [1] 312433 0
University of Waikato
Country [1] 312433 0
New Zealand
Primary sponsor type
Individual
Name
Kim Hebert-Losier
Address
University of Waikato Adams Centre for High Performance
52 Miro Street
Mount Maunganui
3116 Tauranga
Country
New Zealand
Secondary sponsor category [1] 314010 0
None
Name [1] 314010 0
Address [1] 314010 0
Country [1] 314010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311780 0
University of Waikato Human Research Ethics Committee
Ethics committee address [1] 311780 0
University of Waikato
Te Whare Wananga o Waikato
Private Bag 3105
Hamilton 3240
Ethics committee country [1] 311780 0
New Zealand
Date submitted for ethics approval [1] 311780 0
Approval date [1] 311780 0
17/11/2017
Ethics approval number [1] 311780 0
HREC(Health)#2017-41

Summary
Brief summary
Examining individuals in their own footwear in clinics and sports is common, but can affect movement and clinical measures. We aim to compare Landing Error Scoring System (LESS) scores, injury risk categorization, specific LESS errors, and jump heights between habitual athletic footwear and barefoot conditions in healthy individuals. We expect that wearing footwear will involve higher overall LESS scores, lead to a greater number of individuals classified at high risk of injury, and influence specific LESS errors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122338 0
Dr Kim Hebert-Losier
Address 122338 0
University of Waikato Adams Centre for High Performance
52 Miro Street
Mount Maunganui
3116 Tauranga
Country 122338 0
New Zealand
Phone 122338 0
+64 7 837 9476
Fax 122338 0
Email 122338 0
kim.hebert-losier@waikato.ac.nz
Contact person for public queries
Name 122339 0
Dr Kim Hebert-Losier
Address 122339 0
University of Waikato Adams Centre for High Performance
52 Miro Street
Mount Maunganui
3116 Tauranga
Country 122339 0
New Zealand
Phone 122339 0
+64 7 837 9476
Fax 122339 0
Email 122339 0
kim.hebert-losier@waikato.ac.nz
Contact person for scientific queries
Name 122340 0
Dr Kim Hebert-Losier
Address 122340 0
University of Waikato Adams Centre for High Performance
52 Miro Street
Mount Maunganui
3116 Tauranga
Country 122340 0
New Zealand
Phone 122340 0
+64 7 837 9476
Fax 122340 0
Email 122340 0
kim.hebert-losier@waikato.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participants de-identified data used in statistical analysis will be shared. Specifically, data will be made openly available in a public repository that issues datasets with DOIs (e.g., open science framework). Data will include LESS scores for the three trials performed in the two separate conditions, demographic characteristics of participants (age, height, body mass, physical activity)
When will data be available (start and end dates)?
Data will be made available when data analysis and write-up is completed, and available alongside publication submission. There is no end date to data availability.
Available to whom?
Data will be openly available in a public repository.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Through DOI ((e.g., open science framework - to be confirmed and updated in the registry once available). https://doi.org/10.17605/OSF.IO/KHS7V


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.