Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001285145p
Ethics application status
Submitted, not yet approved
Date submitted
1/08/2019
Date registered
18/09/2019
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How accurate and reliable are wearable inertial measurement units (IMUs) in assessing athletic change-of-direction and landing movements
Scientific title
Validity and reliability of wearable inertial measurement units (IMUs) in quantifying athletic movements change-of-direction and landing movements
Secondary ID [1] 298908 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Injury 313885 0
Knee Injury 313886 0
Condition category
Condition code
Injuries and Accidents 312300 312300 0 0
Other injuries and accidents
Musculoskeletal 312301 312301 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All participants will perform 3 athletic tasks - a) unanticipated 45 degrees change-of-direction manoeuvre, b) single-leg drop jump landing and c) bilateral drop landing. Their movements will be simultaneously assessed using a wearable inertial measurement unit (IMU) system (exposure), and a marker-based optical tracking system (comparator).

The exposure group - where movement will be assessed using wearable IMUs - will be performed using devices with in-built accelerometers, magnetometers, and gyroscopes mounted on an elastic band to be snugly worn across the trunk (like a waist strap) and/or bodypart (like a thigh strap).

The assessment will last a total of 90mins:
Part 1 (15-30mins) - Participant brief, fitting wearable IMU system, and instrumenting retro-reflective markers on their body
Part 2 (10-15mins x 3) - For performing each of the three tasks
Part 3 (10-15mins) - Debrief participant and removal of instrumentation

The entire process will be administered by an Australian Health Practitioner Regulation Agency registered Physiotherapist.
Intervention code [1] 315182 0
Not applicable
Comparator / control treatment
The comparator - motion capture using a marker-based optical tracking system - will utilize 16 infra-red cameras that capture the movement of retro-reflective markers attached to bony landmarks on the participant's skin. There will be 51 head-to-toe marker locations. Movement analysis will be performed using 'Cortex Software' (Motion Anaysis Corporation, California, USA).

Validity of wearable IMUs to 3-Dimensional Biomechanical Motion Capture will be assessed through statistical analyses like Band-Altman plots and Pearson correlations.

Reliability will be assessed through inter- and intra-rater class correlation coefficient calculations.
Control group
Active

Outcomes
Primary outcome [1] 320935 0
Composite Trunk biomechanics - trunk angles and moments on all 3 sagittal planes will be measured on initial contact and at peak values.

Their movements will be simultaneously assessed using a wearable inertial measurement unit (IMU) system, and a marker-based optical tracking system. The wearable IMUs are devices with in-built accelerometers, magnetometers, and gyroscopes mounted on an elastic band to be snugly worn across the trunk (like a waist strap) and/or bodypart (like a thigh strap). The marker-based optical tracking system will utilize 16 infra-red cameras that capture the movement of retro-reflective markers attached to bony landmarks on the participant's skin. There will be 51 head-to-toe marker locations. Movement analysis will be performed using 'Cortex Software' (Motion Anaysis Corporation, California, USA).
Timepoint [1] 320935 0
Baseline
Primary outcome [2] 321233 0
Composite Hip biomechanics - hip joint angles and moments on all 3 sagittal planes will be measured on initial contact and at peak values

Their movements will be simultaneously assessed using a wearable inertial measurement unit (IMU) system, and a marker-based optical tracking system. The wearable IMUs are devices with in-built accelerometers, magnetometers, and gyroscopes mounted on an elastic band to be snugly worn across the trunk (like a waist strap) and/or bodypart (like a thigh strap). The marker-based optical tracking system will utilize 16 infra-red cameras that capture the movement of retro-reflective markers attached to bony landmarks on the participant's skin. There will be 51 head-to-toe marker locations. Movement analysis will be performed using 'Cortex Software' (Motion Anaysis Corporation, California, USA).
Timepoint [2] 321233 0
Baseline
Primary outcome [3] 321234 0
Composite Knee biomechanics - knee angles and moments on all 3 sagittal planes will be measured on initial contact and at peak values

Their movements will be simultaneously assessed using a wearable inertial measurement unit (IMU) system, and a marker-based optical tracking system. The wearable IMUs are devices with in-built accelerometers, magnetometers, and gyroscopes mounted on an elastic band to be snugly worn across the trunk (like a waist strap) and/or bodypart (like a thigh strap). The marker-based optical tracking system will utilize 16 infra-red cameras that capture the movement of retro-reflective markers attached to bony landmarks on the participant's skin. There will be 51 head-to-toe marker locations. Movement analysis will be performed using 'Cortex Software' (Motion Anaysis Corporation, California, USA).
Timepoint [3] 321234 0
Baseline
Secondary outcome [1] 373408 0
Validity

Validity of wearable inertial measurement unit (IMU) system (exposure) compared to marker-based optical tracking system (comparator) will be assessed through statistical analyses like Band-Altman plots and Pearson correlations.
Timepoint [1] 373408 0
Baseline
Secondary outcome [2] 374738 0
Reliability

Reliability of wearable inertial measurement unit (IMU) system will be assessed through inter- and intra-rater class correlation coefficient calculations.
Timepoint [2] 374738 0
Baseline

Eligibility
Key inclusion criteria
Male and female; 13-45 years old; good physical capacity according to the Physical Activity Readiness Questionnaire (PAR-Q) (i.e. answered “NO” to all questions)
Minimum age
13 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: existing self-reported musculoskeletal disorder(s) or history of musculoskeletal conditions that required medical intervention for a period of more than 4 weeks during the past 12 months; previously diagnosed with a systemic, vestibular, balance, and/or cardiac disorder; suffered from medical condition 2 weeks before testing

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303456 0
University
Name [1] 303456 0
The University of Sydney
Country [1] 303456 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 303509 0
None
Name [1] 303509 0
None
Address [1] 303509 0
None
Country [1] 303509 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303986 0
The University of Sydney, Human Ethics Research Committee 3
Ethics committee address [1] 303986 0
The University of Sydney
Camperdown NSW 2006
Ethics committee country [1] 303986 0
Australia
Date submitted for ethics approval [1] 303986 0
23/07/2019
Approval date [1] 303986 0
Ethics approval number [1] 303986 0

Summary
Brief summary
Accurate quantification and analysis of jumping and landing technique is one method to improve sport performance. The current gold-standard method for quantifying movement is three-dimensional biomechanical analysis in a motion analysis laboratory. However, due to financial, time, and logistical constraints, this method is frequently inaccessible to the wider sporting population. Wearable inertial measurement units (IMU) – consisting of micro-sensors– have been used as a cost-effective, accessible option that can provide real-time feedback of performance. To further promote wearable IMU use, it is important to evaluate the validity and reliability compared to the previously established method of motion analysis – three-dimensional biomechanical analysis.

Study hypothesis: that wearable IMUs are a valid and reliable alternative to quantifying jumping and landing movements compared to three-dimensional biomechanical analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95466 0
Prof Evangelos Pappas
Address 95466 0
The University of Sydney (Cumberland Campus)
Office O151
Lidcombe, NSW 2141, AUSTRALIA
Country 95466 0
Australia
Phone 95466 0
+61 2 93519188
Fax 95466 0
Email 95466 0
[email protected]
Contact person for public queries
Name 95467 0
Prof Evangelos Pappas
Address 95467 0
The University of Sydney (Cumberland Campus)
Office O151
Lidcombe, NSW 2141, AUSTRALIA
Country 95467 0
Australia
Phone 95467 0
+61 2 93519188
Fax 95467 0
Email 95467 0
[email protected]
Contact person for scientific queries
Name 95468 0
Prof Evangelos Pappas
Address 95468 0
The University of Sydney (Cumberland Campus)
Office O151
Lidcombe, NSW 2141, AUSTRALIA
Country 95468 0
Australia
Phone 95468 0
+61 2 93519188
Fax 95468 0
Email 95468 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?
Individual participant data underlying published results only
When will data be available (start and end dates)?
6 months following publication of main results; no end-date
Available to whom?
Only researchers who provide a methodologically sound proposal and at the discretion of Primary Sponsor
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Contacting Principal Investigato, Professor Evangelos Pappas

E [email protected]
T + (61) 2 93519188
A O151 – Cumberland Campus, The University of Sydney (Cumberland Campus), Lidcombe NSW 2141 AUSTRALIA


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
SourceTitleYear of PublicationDOI
EmbaseEvaluating the validity and reliability of inertial measurement units for determining knee and trunk kinematics during athletic landing and cutting movements.2021https://dx.doi.org/10.1016/j.jelekin.2021.102589
N.B. These documents automatically identified may not have been verified by the study sponsor.