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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.
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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
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Secondary ID [1]
291192
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Nil
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Universal Trial Number (UTN)
U1111-1193-1220
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy individuals with no shoulder pathology
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Condition category
Condition code
Musculoskeletal
301719
301719
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0
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Normal musculoskeletal and cartilage development and function
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
297195
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Diagnosis / Prognosis
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Active shoulder range of motion - forward flexion and abduction (degrees) assessed using inertial sensors integrated with the Microsoft Kinect (BioCap system).
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Assessment method [1]
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Timepoint [1]
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Baseline, 7 days post-baseline
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Primary outcome [2]
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Fixed shoulder range of motion - forward flexion and abduction (degrees) assessed using inertial sensors integrated with the Microsoft Kinect (BioCap system).
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Assessment method [2]
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Timepoint [2]
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Baseline, 7 days post-baseline
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Primary outcome [3]
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Active shoulder range of motion - forward flexion and abduction (degrees) assessed using goniometry.
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Assessment method [3]
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Timepoint [3]
301115
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Baseline, 7 days post-baseline
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Secondary outcome [1]
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Shoulder angular velocity - radian per second (rad/s) assessed using inertial sensors integrated with Kinect (BioCap system).
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Assessment method [1]
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Timepoint [1]
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Baseline, 7 days post-baseline
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Secondary outcome [2]
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Shoulder linear acceleration – radian per second squared (rad/s2) assessed using inertial sensors integrated with the Kinect (BioCap System)
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Assessment method [2]
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Timepoint [2]
331762
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Baseline, 7 days post-baseline
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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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).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/02/2017
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Actual
24/02/2017
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Date of last participant enrolment
Anticipated
3/12/2018
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Actual
4/10/2017
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Date of last data collection
Anticipated
12/12/2018
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Actual
4/10/2017
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
7498
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Prince of Wales Hospital - Randwick
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Recruitment postcode(s) [1]
15323
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2031 - Randwick
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Prince of Wales Hospital Foundation
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Address [1]
295637
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Barker Street
Randwick
NSW 2931
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Country [1]
295637
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Australian Government Research Training Program Scholarship
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Address [2]
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Department of Education and Training
GPO Box 9880
Canberra ACT 2601
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Country [2]
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Australia
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Primary sponsor type
Individual
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Name
Prof Bill Walsh
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Address
The Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Peter Beshara
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Address [1]
294477
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The Prince of Wales Hospital
Barker Street
Randwick
NSW 2031
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Country [1]
294477
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296955
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South Eastern Sydney Local Health District Human Research Ethics Committee
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Ethics committee address [1]
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Room G71 East Wing Edmund Blacket Building Prince of Wales Hospital RANDWICK NSW 2031
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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24/01/2017
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Approval date [1]
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14/02/2017
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Ethics approval number [1]
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LNR/17/POWH/17
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Summary
Brief summary
Shoulder range-of-motion measurement (ROM) in clinical settings is an integral component of physical examination to diagnose, evaluate treatment and quantify possible changes in people with shoulder pain. Compared to any other joint in the body, the shoulder has no fixed axis and produces the greatest ROM in the body. Hence, the reliability of measuring shoulder motion presents a challenge to clinicians. Advances in miniature devices and technology have led researchers to utilise wearable inertial sensors to capture human movement. Inertial sensors consisting of accelerometers, gyroscopes and magnetometers have the capability to measure joint angles, angular velocity and dynamic acceleration forces. The Microsoft Kinect (v2) is a low cost, portable, motion-sensing device capable of tracking up to six bodies within its field of view. The device features a depth sensor which provides full-body 3D motion capture capabilities. Up to 25 joint positions are extracted in three dimensions for each tracked body. The BioCap system (Sydney, Australia) combines two wireless inertial sensors worn on the wrists with an optical sensor (Kinect v2) to estimate human motion. Data is processed and merged to produce a full-body skeleton model of the subject. Measurements based on wearable sensors may potentially represent a well-balanced compromise between the practicality of questionnaires and the measurement precision and reliability of laboratory-based movement analysis (Pandyan et al 2002). It may in clinical practice help physicians in decision-making and clarify patients post-treatment expectations. However, before such technology can be used routinely, reliability and validity needs to be established to compare its performance to a gold standard. Thus, the purpose of this research is to determine the reliability and validity of a system that integrates inertial sensors with Kinect v2 to measure human shoulder joint angles. It is hypothesised that the BioCap system will be a highly reliable and valid tool to measure shoulder range-of-motion and kinematics in clinical practice.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Prof Bill Walsh
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Address
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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
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Country
72530
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Australia
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Phone
72530
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61-2-93822663
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Fax
72530
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Email
72530
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[email protected]
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Contact person for public queries
Name
72531
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Prof Bill Walsh
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Address
72531
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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
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Country
72531
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Australia
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Phone
72531
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61-2-93822663
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Fax
72531
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Email
72531
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[email protected]
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Contact person for scientific queries
Name
72532
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Peter Beshara
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Address
72532
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The Prince of Wales Hospital
Physiotherapy Department
Barker Street
Randwick
NSW 2031
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Country
72532
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Australia
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Phone
72532
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61-2-93822850
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Fax
72532
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Email
72532
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[email protected]
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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
No additional documents have been identified.
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