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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Anterior Cruciate Ligament Injury

Knee Injury

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Musculoskeletal

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]

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]

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]

Baseline

Primary outcome [2]

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]

Baseline

Primary outcome [3]

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]

Baseline

Secondary outcome [1]

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]

Baseline

Secondary outcome [2]

Reliability Reliability of wearable inertial measurement unit (IMU) system will be assessed through inter- and intra-rater class correlation coefficient calculations.

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Sydney

Address [1]

The University of Sydney Camperdown NSW 2006

Country [1]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney
Camperdown NSW 2006

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

The University of Sydney, Human Ethics Research Committee 3

Ethics committee address [1]

The University of Sydney
Camperdown NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/07/2019

Approval date [1]

Ethics approval number [1]

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

Prof Evangelos Pappas

Address

The University of Sydney (Cumberland Campus) Office O151 Lidcombe, NSW 2141, AUSTRALIA

Country

Australia

Phone

+61 2 93519188

Fax

[email protected]

Contact person for public queries

Name

Evangelos Pappas

Address

The University of Sydney (Cumberland Campus) Office O151 Lidcombe, NSW 2141, AUSTRALIA

Country

Australia

Phone

+61 2 93519188

Fax

[email protected]

Contact person for scientific queries

Name

Evangelos Pappas

Address

The University of Sydney (Cumberland Campus) Office O151 Lidcombe, NSW 2141, AUSTRALIA

Country

Australia

Phone

+61 2 93519188

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal and at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data underlying published results only

What types of analyses could be done with individual participant data?

• Meta-analyses

When can requests for individual participant data be made (start and end dates)?

From:
6 months following publication of main results; no end-date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• 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

Are there extra considerations when requesting access to individual participant data?

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

Source	Title	Year of Publication	DOI
Embase	Evaluating the validity and reliability of inertial measurement units for determining knee and trunk kinematics during athletic landing and cutting movements.	2021	https://dx.doi.org/10.1016/j.jelekin.2021.102589

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically