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Trial registered on ANZCTR
Registration number
ACTRN12608000478314
Ethics application status
Approved
Date submitted
15/09/2008
Date registered
29/09/2008
Date last updated
30/11/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
A Randomised Controlled Trial of a running program for Hospital Neurological Outpatients
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Scientific title
The impact of dynamic training (running program) on high level functional mobility in individuals with acquired brain injury - A randomised controlled trial in Neurologcial outpatients clinic
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Secondary ID [1]
288033
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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:
Acquired Brain Injury (stroke and neurosurgery)
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Condition category
Condition code
Neurological
3861
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a randomised controlled trial of a high level mobility exercise program run by physiotherapists for 8 weeks with one session per week for approximately 2 hrs. The focus is on dynamic movements. It is sometimes called a running program although some participants can not run.
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Intervention code [1]
3409
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Rehabilitation
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Comparator / control treatment
Standard Neurological Physiotherapy Outpatient rehabilitation. - 1-2 sessions of 1 - 2 hrs per week for 8 weeks following randomisation. The focus is the facilitate normal control and function of the affected trunk and limbs.
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Control group
Active
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Outcomes
Primary outcome [1]
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High level Mobility scale (HiMat) is the primary outcome.
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Assessment method [1]
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Timepoint [1]
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All participants will be assessed prior to baseline to be able to stratify the population on mobility performance and also basic balance and safety. So this is the baseline stratification period the week before entry into the study. Then post intervention will be performed at 8 weeks.
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Secondary outcome [1]
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Australian Quality of Life (2) AQoL-2
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Assessment method [1]
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Timepoint [1]
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3 months follow-up.
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Secondary outcome [2]
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Chedoke McMaster Stroke Assessment -II
6MWT - six minute walk test , 10MWT - 10m walk test
Community Integration questionnaire
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Assessment method [2]
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Timepoint [2]
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At the start (baseline) and finish (8 weeks)of the intervention period.
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Eligibility
Key inclusion criteria
Acquired brain Injury admitted to Royal Perth Hosiptal neurologcial outpatients
Berg Balance scale - Screening will be conducted by a Senior Neurological Physiotherapist
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Minimum age
16
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?
No
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Key exclusion criteria
The senior physiotherapist in the outpatient clincial will assess all candidates for safety to participate. If they have poor balance or cognitive function they will not be considered for inclusion.
Physical concomitant problems impacting on mobility (i.e. amputation, crainiectomy etc) are also exclsion criteria.
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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)
Concealled Randomisation done by individual "off-site"
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified (Functional mobility and balance performance), Concealled block randomisation with computer generated permutations.
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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
1/10/2008
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Actual
1/04/2009
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Date of last participant enrolment
Anticipated
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Actual
1/08/2010
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
48
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Neurotrauma Research Program
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Address [1]
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Western Australian Institute for Medical Research (WAIMR)
B Block, QEII Medical Centre
2 Verdun Street, Nedlands WA 6009
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Country [1]
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Australia
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Funding source category [2]
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Charities/Societies/Foundations
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Name [2]
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Physiotherapy Research Foundation
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Address [2]
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Australian Physiotherapy Association
Level 1, 1175 Toorak Road, Camberwell Vic 3124
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Country [2]
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
School of Physiotherapy
Curtin University of Technology
GPO Box U1987, Perth, Western Australia 6845
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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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Royal Perth Hospital
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Address [1]
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2 Selby Street
Shention Park WA 6008
WA
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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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Royal Perth Hospital HREC
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Ethics committee address [1]
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GPO Box X2213
Perth, Western Australia, 6001
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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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Approval date [1]
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01/10/2009
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Ethics approval number [1]
5926
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Ethics committee name [2]
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Curtin University HREC
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Ethics committee address [2]
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Curtin University
GPO Box U 1987
Perth WA 6845
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
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01/12/2008
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Approval date [2]
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02/02/2009
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Ethics approval number [2]
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HR 198/2008
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Summary
Brief summary
This is a clincial trial running within Shenton Park Rehabilitation Hospital. Recruitment is from the outpatient rehabilitation list.
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Trial website
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Trial related presentations / publications
n/a
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Public notes
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Contacts
Principal investigator
Name
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Ms M Kennedy
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Address
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Not known
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Country
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United States of America
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Phone
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+123456789
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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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Prof Garry T Allison
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Address
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School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
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Country
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Australia
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Phone
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+618 9266 2993
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Fax
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Email
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g.allison"AT".curtin.edu.au
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Contact person for scientific queries
Name
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Prof Dr Garry T Allison
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Address
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School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
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Country
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Australia
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Phone
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08 9266 3626
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Fax
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Email
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g.allison"AT".curtin.edu.au
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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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