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Trial registered on ANZCTR
Registration number
ACTRN12618001739202
Ethics application status
Approved
Date submitted
28/09/2018
Date registered
23/10/2018
Date last updated
22/03/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Use half-cut wood training method for rehabilitation of Chinese patients with knee instability
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Scientific title
The effectiveness of half-cut wood training method on rehabilitation of Chinese patients with knee instability
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Secondary ID [1]
296202
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Nil
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Universal Trial Number (UTN)
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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:
knee instability
309841
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Condition category
Condition code
Physical Medicine / Rehabilitation
308630
308630
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0
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Other physical medicine / rehabilitation
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Musculoskeletal
308631
308631
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Previous studies have shown that if a series of overlapping segments were connected via pin joints, these interlocking joints would create a system that would allow the movement of one joint to affect the movement of another joint within the kinetic chain. This leads to knees and ankles operating in unity. In order to stabilize knees, ankle mobility should therefore be improved. Our study therefore developed Half-wood Training method to reflect these principles. In this method, endways quincuncial piles were cut into half and placed transversely, in order to decrease the risk and the degree of difficulty, allowing for comfortable and convenient barefooted practice for patients with knee instability.
There are four phases of the intervention consisting of four phases with 40 lessons in total and the intervention will take both supervised individual level training plus self-directed exercise and qualified physicians will deliver the intervention program. Each lesson takes 45 minutes: (1). Phase 1: 10 lessons in Education and posture training. This include basic understanding of the function of joints, characteristics of normal and abnormal postures and movements and joint related exercise. This phase will last for 5 days, with 90 minutes supervised training, and 60 minutes self-directed exercise per day. The self-directed exercise is to review and repeat the exercise actions during the supervised training session (2). 10 lessons in Phase 2. This phase will focus on multiple joints' training and respiratory training. The purpose of the exercise is to facilitate coordination of action and respiration by exercise starting from one joint exercise to multiple joint based exercise. This will take 5 days with 90 minutes supervised exercise and 1 hours 30 minutes self-directed exercise time per day. The self-directed exercise is to review and repeat the exercise actions during the supervised training session (3). 10 lessons in Phase 3. This phase will focus on abnormal knee joint and spine training. This phase exercise is to correct abnormal posture and shape of the spine. This willl take 5 days with 90 minutes supervised exercise and 1hours 30 minutes self-directed exercise time per day.The self-directed exercise is to review and repeat the exercise actions during the supervised training session (4). 10 lessons in phase 4. This phase will focus on application in daily life. This will include rolling and balance training to enhance physical flexibility. This phase will take 6 days with 90 minutes supervised exercise and 1hours 30 minutes self-directed exercise time per day using. The self-directed exercise is to review and repeat the exercise actions during the supervised training session
Undertaking a supervised series of exercises on the Half-cut woods barefooted improves ankle flexion, and simultaneously strengthens the ankle and back of the calf muscles, quadriceps strength, knee and ankle range of motion, lower extremity muscle flexibility.
Half-cut Wood Training is designed for this study at Tonwo Clinic in China. Half-cut Wood Training materials consist of logs that are cut into halves and placed transversely across the floor (length=40cm-50cm, width=15cm-25cm, height=10cm-20cm).
An intervention guideline is designed for this study. The intervention will consist of 3 hours exercise session per day (which is equivalent 2 lessons per day) over 3 months period of time depending on individual's improvement level. The intervention is individual level based.
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Intervention code [1]
312530
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Rehabilitation
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Comparator / control treatment
The control group consisted of people with symptoms of knee instability aged from 18 years and above. They are selected from the patients who are in the waiting list. They do usual activity and do not participate in any intervention program, but they will participate in the intervention when the intervention group participants have completed the program. The duration of the wait list will be 3 months.
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Control group
Active
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Outcomes
Primary outcome [1]
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Functional measures: Knee functioning will be assessed by a question (How well does knee work now?) from 0 (Cannot do any movement) to 10 (Can do any movement)
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Assessment method [1]
307588
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Timepoint [1]
307588
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Patients receive 40 lessons over 2-3 months and exit the program based on the degree of improvement. They will be assessed at baseline and post intervention time after they have completed intervention after 2-3 months intervention time.
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Primary outcome [2]
307589
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Symptom Severity was assessed firstly by doctors, then patients themselves through self-report about their severity of knee instability from 1 (Not at all) to 5 (Extremely severe).
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Assessment method [2]
307589
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Timepoint [2]
307589
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Baseline in time 1, then time 2 for post intervention assessment
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Primary outcome [3]
307590
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The clinician reported effect of Half-cut Wood Training will be assessed by the treating doctor about the improvement of patient knee instability from 0 to 100%.
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Assessment method [3]
307590
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Timepoint [3]
307590
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Data will be collected at baseline and post intervention time.
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Secondary outcome [1]
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Self-esteem Scale: The self-esteem scale 27 includes ten items on a 4 point Likert scale to assess self-esteem.
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Assessment method [1]
352375
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Timepoint [1]
352375
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Data will be collected at baseline and post intervention time.
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Secondary outcome [2]
353046
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Self-efficacy: An adapted version of the Self-efficacy questionnaire, 28 consisting of 10 items using a five-point Likert Scale from 1 = Strongly disagree to 5 = Totally agree was used to measure self-efficacy. The overall reliability of the scale is acceptable (Cronbach's alpha= 0.83).
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Assessment method [2]
353046
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Timepoint [2]
353046
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Data will be collected at baseline and post intervention time.
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Secondary outcome [3]
353047
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Quality of life scale: The SF-12 scale 29, consisting of 12 items, is used to assess quality of life on eight dimensions including physical functioning (PF),role-physical (RP),body pain (BP), general health (GH),vitality (VT),social functioning (SF),role-emotional (RE), and mental health,(MH). The summary score for physical health includes four dimensions of PF, RP, BP, and GH. The summary score for mental health includes four dimensions of VT, SF, RE, and MH. The raw scores were converted to the standard score. The range of the score is 0~100. The higher the score means the healthier and better perception of health. The scale has a reliability level of Chronbach Alpha of 0.78.
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Assessment method [3]
353047
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Timepoint [3]
353047
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Data will be collected at baseline and post intervention time.
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Secondary outcome [4]
353050
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Telehealth assessment on anthropometry and biomedical factor: The HBF-306 is a body-fat analyzer device that uses bioelectrical impedance analysis (BIA) to assesses anthropometric and biomedical indexes of participants including BMI, waist circumference, fat percentage, protein percentage, bone mass, and muscle mass.26 Formulas were used to calculate these indexes, for example, Body fat percentage (%) ={body fat mass (kg) / body weight (kg)}×100, Body fat mass (kg) = Body weight (kg) – Fat-free mass (kg). The HBF-306 connected with an APP via WIFI connection, and measurement results are sent instantly to the APP when body composition factors will be measured.
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Assessment method [4]
353050
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Timepoint [4]
353050
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Data will be collected as baseline, once per week from baseline to post intervention time, and post intervention time.
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Eligibility
Key inclusion criteria
Patients with knee instability and with pains.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Healthy people and patients with arthritis are excluded from the study
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients are randomised to intervention and control group. Third party will participate in the concealment allocation process by generating sequence number and randomised participants into intervention and control group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised program using SPSS is used to randomise people who consent to the study to either intervention or control group
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Nil
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Repeated-measures analysis of variance (ANOVA) or intention to treat method will be employed to compare the two groups over time on these variables.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
24/10/2018
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Date of last participant enrolment
Anticipated
10/03/2020
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Actual
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Date of last data collection
Anticipated
1/11/2019
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Actual
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Sample size
Target
50
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Accrual to date
42
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Final
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Recruitment outside Australia
Country [1]
20876
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China
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State/province [1]
20876
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Guang Zhou, Guang Dong Province
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Funding & Sponsors
Funding source category [1]
300792
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University
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Name [1]
300792
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Griffith University
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Address [1]
300792
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Griffith University, School of Medicine
Parkland Drive, Gold Coast, Queensland, 4222
Australia
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Country [1]
300792
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Australia
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Primary sponsor type
University
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Name
Griffith University
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Address
Griffith University, School of Medicine
Parkland Drive, Gold Coast, Queensland, 4222
Australia
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Country
Australia
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Secondary sponsor category [1]
300344
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None
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Name [1]
300344
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Address [1]
300344
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Country [1]
300344
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301576
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Griffith University Human Ethics Committee
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Ethics committee address [1]
301576
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School of Medicine
Griffith University,
Parkland Drive, Southport, Gold Coast, Q4222, Queensland
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Ethics committee country [1]
301576
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Australia
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Date submitted for ethics approval [1]
301576
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01/12/2015
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Approval date [1]
301576
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30/11/2016
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Ethics approval number [1]
301576
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2015/522
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Summary
Brief summary
Previous studies have shown that if a series of overlapping segments were connected via pin joints, these interlocking joints would create a system that would allow the movement of one joint to affect the movement of another joint within the kinetic chain. This leads to knees and ankles operating in unity. In order to stabilize knees, ankle mobility should therefore be improved. Our study aims to develop Half-wood Training method to reflect and test these principles using natural therapy method in its effectiveness and efficacy in patients with knee instability and spinal cord problems.. In this method, endways quincuncial piles were cut into half and placed transversely, in order to decrease the risk and the degree of difficulty, allowing for comfortable and convenient barefooted practice for patients with knee instability. Randomised controlled trial will be used for the study design and participants will be recruited from a natural therapy clinics. They will be randomised into intervention and control group. It is expected that the half wood training method is efficacious to improve the symptoms of patients with knee instability and spinal cord problems, and improve their quality of life.
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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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A/Prof Jing Sun
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Address
87442
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School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland Q4222
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Country
87442
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Australia
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Phone
87442
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+617 56780924
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Fax
87442
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+61756780303
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Email
87442
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[email protected]
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Contact person for public queries
Name
87443
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A/Prof Jing Sun
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Address
87443
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School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland, Q4222
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Country
87443
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Australia
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Phone
87443
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+617 56780924
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Fax
87443
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+6156780303
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Email
87443
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[email protected]
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Contact person for scientific queries
Name
87444
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A/Prof Jing Sun
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Address
87444
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School of Medicine, Griffith University, Australia
Parkland Drive, Gold Coast, Queensland, Q4222
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Country
87444
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Australia
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Phone
87444
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+617 56780924
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Fax
87444
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+61756780303
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Email
87444
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Based on ethical reason. No individual person's information will be provided, but summary data will be provided.
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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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