Trial Review

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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
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
Secondary ID [1] 288033 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury (stroke and neurosurgery) 3696 0
Condition category
Condition code
Neurological 3861 3861 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3409 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 4764 0
High level Mobility scale (HiMat) is the primary outcome.
Timepoint [1] 4764 0
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.
Secondary outcome [1] 8045 0
Australian Quality of Life (2) AQoL-2
Timepoint [1] 8045 0
3 months follow-up.
Secondary outcome [2] 8160 0
Chedoke McMaster Stroke Assessment -II
6MWT - six minute walk test , 10MWT - 10m walk test
Community Integration questionnaire
Timepoint [2] 8160 0
At the start (baseline) and finish (8 weeks)of the intervention period.

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
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealled Randomisation done by individual "off-site"
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2008
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
1/08/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3873 0
Government body
Name [1] 3873 0
Neurotrauma Research Program
Country [1] 3873 0
Australia
Funding source category [2] 3874 0
Charities/Societies/Foundations
Name [2] 3874 0
Physiotherapy Research Foundation
Country [2] 3874 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Physiotherapy
Curtin University of Technology
GPO Box U1987, Perth, Western Australia 6845
Country
Australia
Secondary sponsor category [1] 3478 0
Hospital
Name [1] 3478 0
Royal Perth Hospital
Address [1] 3478 0
2 Selby Street
Shention Park WA 6008
WA
Country [1] 3478 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5926 0
Royal Perth Hospital HREC
Ethics committee address [1] 5926 0
Ethics committee country [1] 5926 0
Australia
Date submitted for ethics approval [1] 5926 0
Approval date [1] 5926 0
01/10/2009
Ethics approval number [1] 5926 0
Ethics committee name [2] 293943 0
Curtin University HREC
Ethics committee address [2] 293943 0
Ethics committee country [2] 293943 0
Australia
Date submitted for ethics approval [2] 293943 0
01/12/2008
Approval date [2] 293943 0
02/02/2009
Ethics approval number [2] 293943 0
HR 198/2008

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

Contacts
Principal investigator
Name 28937 0
Ms M Kennedy
Address 28937 0
Not known
Country 28937 0
United States of America
Phone 28937 0
+123456789
Fax 28937 0
Email 28937 0
g.allison@curtin.edu.au
Contact person for public queries
Name 12094 0
Garry T Allison
Address 12094 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 12094 0
Australia
Phone 12094 0
+618 9266 2993
Fax 12094 0
Email 12094 0
g.allison"AT".curtin.edu.au
Contact person for scientific queries
Name 3022 0
Dr Garry T Allison
Address 3022 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 3022 0
Australia
Phone 3022 0
08 9266 3626
Fax 3022 0
Email 3022 0
g.allison"AT".curtin.edu.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
No additional documents have been identified.