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Trial registered on ANZCTR


Registration number
ACTRN12617000266369
Ethics application status
Approved
Date submitted
19/02/2017
Date registered
21/02/2017
Date last updated
22/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of wearable motion sensors combined with the Microsoft Kinect to measure shoulder range of motion in healthy individuals.
Scientific title
Reliability and validity of using wearable inertial sensors integrated with the Microsoft Kinect (BioCap System) to measure shoulder range of motion in healthy individuals
Secondary ID [1] 291192 0
Nil
Universal Trial Number (UTN)
U1111-1193-1220
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy individuals with no shoulder pathology 302091 0
Condition category
Condition code
Musculoskeletal 301719 301719 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The purpose of this study is to investigate whether using inertial sensors integrated with the Microsoft Kinect v2 (BioCap system) is a reliable and valid method to measure shoulder range-of motion, velocity and acceleration forces in healthy adults. The BioCap system enables motion tracking and movement analysis of the shoulder in real-time.

Data collection will be conducted by a physiotherapist with 10 years of clinical experience and a 6th year medical student.

Participants wearing wrist bands mounted with inertial sensors will stand in front of a camera sensor (Kinect sensor) connected to a LCD television displaying a full-body, real-time kinematic model describing a segmental representation of the human skeleton. Participants will perform two bilateral active shoulder movements (1) forward flexion and (2) abduction for five repetitions to a verbally standardised protocol. Participants will then touch standardised fixed points along a vertical line of rope in shoulder forward flexion and abduction.

For intra-rater and inter-rater reliability analysis, the same participants will be assessed by the same rater, on two different days, with an interval period of 7 days. To assess inter-rater reliability, measurements will be taken twice by on each occasion.

To assess validity, shoulder range of motion will be also be measured using goniometry. The goniometric measurements will be taken 5 minutes after BioCap system measurements. Participants will be required to remove their shirt and stand with feet shoulder-width apart. The participant will be instructed to move their shoulder (thumb pointing upwards) to the end of active shoulder forward flexion and abduction range of motion. The flexion angle will be formed by aligning the goniometer with the lateral epicondyle of the humerus, the middle of the glenoid fossa, a vertical line in the coronal plane. The abduction angle will be formed by aligning the middle of the glenoid fossa, and a vertical line in the coronal plane.
Intervention code [1] 297195 0
Diagnosis / Prognosis
Comparator / control treatment
Goniometry is the traditional approach to measure joint angle range of motion in physiotherapy. To establish validity, the BioCap system measurements will be compared with goniometric measurements for active and fixed-point shoulder forward flexion and abduction.
Control group
Active

Outcomes
Primary outcome [1] 301113 0
Active shoulder range of motion - forward flexion and abduction (degrees) assessed using inertial sensors integrated with the Microsoft Kinect (BioCap system).
Timepoint [1] 301113 0
Baseline, 7 days post-baseline
Primary outcome [2] 301114 0
Fixed shoulder range of motion - forward flexion and abduction (degrees) assessed using inertial sensors integrated with the Microsoft Kinect (BioCap system).

Timepoint [2] 301114 0
Baseline, 7 days post-baseline
Primary outcome [3] 301115 0
Active shoulder range of motion - forward flexion and abduction (degrees) assessed using goniometry.
Timepoint [3] 301115 0
Baseline, 7 days post-baseline
Secondary outcome [1] 331761 0
Shoulder angular velocity - radian per second (rad/s) assessed using inertial sensors integrated with Kinect (BioCap system).
Timepoint [1] 331761 0
Baseline, 7 days post-baseline
Secondary outcome [2] 331762 0
Shoulder linear acceleration – radian per second squared (rad/s2) assessed using inertial sensors integrated with the Kinect (BioCap System)
Timepoint [2] 331762 0
Baseline, 7 days post-baseline

Eligibility
Key inclusion criteria
Aged 18 years and over

Willingness to give written informed consent and willingness to participate to and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Rotator cuff pathology, calcific tendinitis, rotator cuff tear of any size, subacromial impingement, subscapularis tendon tears

Recent or previous fractures of the shoulder complex

Previous shoulder surgery.

Radiologically verified malignancy

Shoulder instability/dislocation/subluxation

Adhesive capsulitis

Symptoms referred from the cervical spine

Clinically verified polyarthritis, rheumatoid arthritis, fibromyalgia

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
50 individuals will be recruited. This sample size was based on comparing data from a previous pilot study of nine healthy volunteers using the BioCap System with data obtained from participants with rotator cuff pathology. This sample size was calculated using the G*Power statistical tool, based on a power calculation of 95% and alpha set on 5%.

Validity:
Statistical comparison between the BioCap System and goniometry will use intra-class coefficients ICC (2,1), Bland-Altman mean differences and 95% limits of agreement (LOAs), Pearson’s correlations (r) and standard of error measurement (SEM). The relative angles of the active range of motion movements between the two measurement methods will be compared using regression analysis and paired t-tests to study significance of association (P < 0.05).

Reliability:
Inter-rater reliability will be evaluated using an intraclass correlation coefficient ICC (2, 1) and two-way random-effects model (observers and subjects are treated as random effects) with a single measure and consistency among measurements for each movement. The ICC (2,1) for each measurement modality will be compared by use of one-way analysis of variance (ANOVA) with a Tukey post hoc test to assess for statistical significance at an alpha= .05 level.

Intra-rater reliability for each observer will be assessed in terms of the ICC (3,1), a two-way fixed effects model (observers are treated as fixed and subjects are treated as random effects) with a single measure and absolute agreement for each movement.

An ICC of = 0.75 is considered as excellent reliability, an ICC of 0.4-0.75 is considered modest reliability, an ICC of < 0.4 is considered as poor reliability.

An ICC will be calculated for each range-of-motion measurement and expressed as ICC with 95% confidence interval. Absolute reliability will be analysed using the coefficients of variation (CV), standard error of measurement (SEM) and Bland-Altman plots (95% LOA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/02/2017
Actual
24/02/2017
Date of last participant enrolment
Anticipated
3/12/2018
Actual
4/10/2017
Date of last data collection
Anticipated
12/12/2018
Actual
4/10/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7498 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 15323 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 295637 0
Charities/Societies/Foundations
Name [1] 295637 0
The Prince of Wales Hospital Foundation
Country [1] 295637 0
Australia
Funding source category [2] 295639 0
Government body
Name [2] 295639 0
Australian Government Research Training Program Scholarship
Country [2] 295639 0
Australia
Primary sponsor type
Individual
Name
Prof Bill Walsh
Address
The Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 294477 0
Individual
Name [1] 294477 0
Peter Beshara
Address [1] 294477 0
The Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
Country [1] 294477 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296955 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 296955 0
Ethics committee country [1] 296955 0
Australia
Date submitted for ethics approval [1] 296955 0
24/01/2017
Approval date [1] 296955 0
14/02/2017
Ethics approval number [1] 296955 0
LNR/17/POWH/17

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

Contacts
Principal investigator
Name 72530 0
Prof Prof Bill Walsh
Address 72530 0
Surgical & Orthopaedic Research Laboratories (SORL)
Prince of Wales Clinical School - The University of New South Wales
Level 1, Clinical Science Bldg
Prince of Wales Hospital
Gate 6, Avoca Street
Randwick, Sydney, NSW, Australia, 2031
Country 72530 0
Australia
Phone 72530 0
61-2-93822663
Fax 72530 0
Email 72530 0
wrwalshau@gmail.com
Contact person for public queries
Name 72531 0
Prof Bill Walsh
Address 72531 0
Surgical & Orthopaedic Research Laboratories (SORL)
Prince of Wales Clinical School - The University of New South Wales
Level 1, Clinical Science Bldg
Prince of Wales Hospital
Gate 6, Avoca Street
Randwick, Sydney, NSW, Australia, 2031
Country 72531 0
Australia
Phone 72531 0
61-2-93822663
Fax 72531 0
Email 72531 0
wrwalshau@gmail.com
Contact person for scientific queries
Name 72532 0
Peter Beshara
Address 72532 0
The Prince of Wales Hospital
Physiotherapy Department
Barker Street
Randwick
NSW 2031
Country 72532 0
Australia
Phone 72532 0
61-2-93822850
Fax 72532 0
Email 72532 0
peter.beshara@health.nsw.gov.au

No information has been provided regarding IPD availability


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
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