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Trial registered on ANZCTR
Registration number
ACTRN12608000637347
Ethics application status
Approved
Date submitted
19/09/2008
Date registered
16/12/2008
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
12/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
A multi-modality approach to prevent and treat contracture after traumatic brain injury: a randomised controlled trial
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Scientific title
Does a multi-modality approach combining splinting, tilt table standing and electrical stimulation produce greater increases in passive dorsiflexion range of motion compared to tilt table standing alone in adults with traumatic brain injury: a randomised controlled trial
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Secondary ID [1]
721
0
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:
Contracture after traumatic brain injury
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Condition category
Condition code
Physical Medicine / Rehabilitation
3893
3893
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in the multi-modality group will receive a 6-week programme of 30 minutes of passive standing on a tilt table plus electrical stimulation to the ankle dorsiflexors while on the tilt table, and 12 hours of ankle splinting per day, 5 times per week. Electrical stimulation will be applied using the Neuro Trac Sports stimulation unit at a frequency of 50hz. The amplitude will be set at a level to produce maximum muscle contractions within the participants' tolerance. Electrical stimulation will not be used on participants who have contraindications (ie., rate controlled cardiac pacemaker and broken skin) or are unable to tolerate even the smallest amount of simulation. Commercially available splint (Formit) will be used to splint ankles. The ankles will be splinted in maximum tolerable dorsiflexion. The splints will generally be worn at night however this can be varied to minimise interference with hygiene and therapy. Different splints can be used if there are problems with the Formit and care sill be taken to ensure that they provide adequate stretch.
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Intervention code [1]
3433
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Treatment: Devices
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Intervention code [2]
3434
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Treatment: Other
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Comparator / control treatment
Participants in the control group will be stood on a tilt table for 30 minutes 3 times a week over the 6-week period.
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Control group
Active
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Outcomes
Primary outcome [1]
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Passive ankle dorsiflexion range of motion will be measured with the application of 12Nm of torque.
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Assessment method [1]
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Timepoint [1]
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At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
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Secondary outcome [1]
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Spasticity will be rated using the Tardieu Scale.
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Assessment method [1]
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Timepoint [1]
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At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
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Secondary outcome [2]
8090
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Activity limitations will be assessed in two ways:
i) Using the walking item of the Functional Independence Measures (FIM).
ii) Using the 10-metre walk test. Time taken to walk 10 metres at the fastest speed will be measured and used to calculate walking speed.
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Assessment method [2]
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Timepoint [2]
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At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
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Secondary outcome [3]
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Global perceived effect of treatment will be collected from participants/person responsible for them and treating physiotherapists using two separate questionnaires.
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Assessment method [3]
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Timepoint [3]
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At the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
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Secondary outcome [4]
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General perception of credibility of interventions will be collected from participants/person responsible for them and treating physiotherapists using two separate questionnaires.
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Assessment method [4]
8093
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Timepoint [4]
8093
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At the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up)
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Secondary outcome [5]
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Passive ankle dorsiflexion range of motion will be measured with the application of 3, 5, 7 and 9 Nm of torque.
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Assessment method [5]
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Timepoint [5]
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At baseline, at the end of the 6-week intervention period (ie., post-intervention) and 4 weeks later (ie., follow-up).
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Eligibility
Key inclusion criteria
-Diagnosed with first traumatic brain injury
-Unable to walk 17 metres without physical assistance or 50 metres with supervision, ie., a score of <5 on the walking item of the Functional Independence Measure
-Have passive ankle dorsflexion range of motion <5 and >-15 degrees with the application of 12Nm of torque
-Willing and able to participate in a splinting regimen and tilt table standing
-Do not have unstable medical conditions or recent ankle fractures
-Currently receiving in-patient rehabilitation at the three brain injury units in Sydney
-Unlikely to be discharged in 6 weeks
-Provide consent to participate in the study (the participants or the person responsible for them)
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Minimum age
16
Years
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Maximum age
80
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
-Passive ankle dorsiflexion range of motion >5 degrees
-Severe ankle contracture with passive ankle dorsiflexion range of motion <-15 degrees
-Unstable medical conditions or recent ankle fractures
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Study design
Purpose of the study
Treatment
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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)
Potential participants who fit the eligibility criteria or the persons repsonsible for them will be given the Participant Information Sheets. An investigator will explain the study protocol to them. No pressure to participate will be placed on them under any circumstances. They will be informed that participation in the study is entirely voluntary and they are free to withdraw from the study at any stage without any effect on their current and future treatment. Those who agree to participate will be given the Consent Forms to sign and participate in the study.
Participants will be randomly allocated to one of two groups: splinting plus tilt table standing and electrical stimulation (experimental) and tilt table standing only (control). The allocation sequence is computer generated by a person not involved in recruitment and concealed using consecutively numbered, sealed and opaque envelopes. The envelopes will be kept off-site in a centralised registry and only opened by a person not involved in the study after the participants have completed all initial assessments.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence is computer generated by a person not involved in recruitment.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
15/10/2008
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Actual
1/01/2009
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Date of last participant enrolment
Anticipated
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Actual
20/09/2013
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Date of last data collection
Anticipated
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Actual
30/04/2014
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Sample size
Target
36
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
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2112
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Recruitment postcode(s) [2]
1166
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2145
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Recruitment postcode(s) [3]
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2170
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Rehabilitation and Disability Research Foundation Grant
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Address [1]
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59 Charles Street, Ryde, NSW 2112
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Royal Rehabilitation Centre Sydney
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Address
59 Charles Street, Ryde, NSW 2112
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Brain Injury Unit, Royal Rehabilitation Centre Sydney
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Address [1]
3502
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59 Charles Street, Ryde, NSW 2112
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Country [1]
3502
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Australia
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Other collaborator category [1]
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University
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Name [1]
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Rehabilitation Studies Unit, Northern Clinical School, Faculty of Medicine, University of Sydney, Australia
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Address [1]
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PO Box 6, RYDE NSW 1680
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Hawkesbury Human Research Ethics Committee of Northern Sydney Central Coast Health
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Ethics committee address [1]
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Level 4 Vindin House, Royal North Shore Hospital, St Leonards NSW 2065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
5957
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19/03/2008
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Approval date [1]
5957
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14/07/2008
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Ethics approval number [1]
5957
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Protocol 0804-050M
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Ethics committee name [2]
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Human Research Ethics Committee of the Sydney South West Area Health Service
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Ethics committee address [2]
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Locked Bag 7117
LIVERPOOL BC 1871
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Ethics committee country [2]
5958
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Australia
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Date submitted for ethics approval [2]
5958
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05/08/2008
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Approval date [2]
5958
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Ethics approval number [2]
5958
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Ethics committee name [3]
5959
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Human Research Ethics Committee of the South West Area Health Service
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Ethics committee address [3]
5959
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The Research Office
Room 2020 Clinical Sciences
Westmead Hospital
PO Box 533
Wentworthville
NSW 2145
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Ethics committee country [3]
5959
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Australia
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Date submitted for ethics approval [3]
5959
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30/07/2008
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Approval date [3]
5959
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Ethics approval number [3]
5959
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Summary
Brief summary
The primary objective of the project is to determine the benefit of using multiple physical modalities for treating and preventing contracture in adults with traumatic brain injury. An assessor blinded, multi-centre, randomised controlled study will be conducted. In this study, the ankle is selected as a model to asess if a multi-modality programme (tilt table standing combined with ankle splinting and electrical stimulation) is more effective than usual care (tilt table standing alone). The participants are people with traumatic brain injury admitted to the brain injury rehabilitation units of the Royal Rehabilitation Centre Sydney, Liverpool Hospital and Westmead Hospital.
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Trial website
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Trial related presentations / publications
Publication:
Leung, J, Harvey, LA, Moseley, AM, Whiteside, B, Simpson, M, Stroud, K. Standing, electrical stimulation and splinting is no better than standing alone for ankle contractures in people with brain injury: a randomised controlled trial. Journal of Physiotherapy; 2014: 60:201-208.
Presentations:
(1) Leung, J, Harvey, LA, Moseley, AM, Whiteside, B, Simpson, M, Stroud, K. Physiotherapy for contracture management . New Horizons 2014 Conference, Kolling Institute of Medical Research; 19 Nov 2014
(2) Leung, J, Harvey, LA, Moseley, AM, Whiteside, B, Simpson, M, Stroud, K. Multimodality approach for contracture management after severe traumatic brain injury: a randomised trial.. Australasian Society for the study of brain impairment (ASSBI) conference; 8 to 10 May 2014
(3) Leung, J, Harvey, LA, Moseley, AM, Whiteside, B, Simpson, M, Stroud, K. Clinical management of contracture: To stretch or not to stretch. World Confederation for Physical Therapy congress; 16 Sept 2015
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Public notes
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Contacts
Principal investigator
Name
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Dr Joan Leung
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Address
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Royal Rehabilitation Centre Sydney, 235 Morrison Road, RYDE 2112.
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Country
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Australia
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Phone
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+61 2 98099020
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Joan Leung
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Address
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Brain Injury Unit, Royal Rehabilitation Centre Sydney, 59 Charles Street, RYDE 2112, NSW, Australia
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Country
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Australia
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Phone
12113
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+61 2 9808 9215
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Fax
12113
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+61 2 9809 9027
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Email
12113
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[email protected]
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Contact person for scientific queries
Name
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Dr Joan Leung
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Address
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Brain Injury Unit, Royal Rehabilitation Centre Sydney, 59 Charles Street, RYDE 2112, NSW, Australia
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Country
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Australia
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Phone
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+61 2 9808 9215
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Fax
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+61 2 9809 9027
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Email
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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)?
Undecided
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No/undecided IPD sharing reason/comment
It depends if there is a need or request or it.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
199
Study protocol
83187-(Uploaded-12-11-2018-08-20-14)-Study-related document.doc
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
http://dx.doi.org/10.1016/j.jphys.2014.09.007
Plain language summary
No
Results: The mean between-group differences (95%CI...
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