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Trial registered on ANZCTR
Registration number
ACTRN12606000173594
Ethics application status
Approved
Date submitted
8/05/2006
Date registered
12/05/2006
Date last updated
12/10/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does an intensive, functionally-based motor training program improve the hand function of people with acquired brain impairment
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Scientific title
Intensive, task-specific, functionally-based motor retraining to improve hand function following acquired brain impairment: a randomised controlled trial
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Secondary ID [1]
290315
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nil known
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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 impairment (stroke, TBI, other ABI)
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Condition category
Condition code
Neurological
1226
1226
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0
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intensive, task-specific, functionally-based upper limb motor retraining.
Experimental:- 4 to 5.25 hours of upper limb motor training (predominately hand) per week for 6 weeks.
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Intervention code [1]
1025
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Rehabilitation
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Comparator / control treatment
Control: 2 hours of upper limb motor trainining (predominately shoulder/elbow based) per week for 6 weeks.
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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Action Research Armtest score
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Assessment method [1]
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Timepoint [1]
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At 6 weeks post treatment
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Primary outcome [2]
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Hand strength
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Assessment method [2]
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Timepoint [2]
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At 6 weeks post treatment
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Secondary outcome [1]
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1.Passive extensibility of wrist and finger flexors.
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Assessment method [1]
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Timepoint [1]
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At 6 weeks post
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Secondary outcome [2]
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2. Wolf Motor Function Test score
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Assessment method [2]
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Timepoint [2]
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At 6 weeks post
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Secondary outcome [3]
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3. Canadian Occupational Performance
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Assessment method [3]
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Timepoint [3]
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At 6 weeks post
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Secondary outcome [4]
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4. Disability of Arm, Schoulder, Hand score
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Assessment method [4]
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Timepoint [4]
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At 6 weeks post
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Eligibility
Key inclusion criteria
1. ABI within past 5 years2. Unable to achieve a score greater than 45 (80%) on the Action Research Armtest3. Cognitively and physically able to participate in an intensive program of repetitive, task-specific motor re-training to improve hand function.
Population: All Adults, admitted to the Rehabilitation Service at The Townsville Hospital will be screened for eligibility.
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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?
No
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Key exclusion criteria
1. Co-existing hand injury or disease other than ABI (e.g. fractures, MS, Rheumatoid Arthritis, peripheral nerve injury)2. Unlikely to be able to complete the 6 week study period (e.g. leaving town, medically unwell/unstable).
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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)
Sequence generated by independent off site person and placed in sequentially numbered, sealed, opaque envelopes. Envelopes held off site, and allocation done via telephone.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated off site using random number function in MS Excell
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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
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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
27/02/2006
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Actual
27/02/2006
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Date of last participant enrolment
Anticipated
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Actual
1/05/2007
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Date of last data collection
Anticipated
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Actual
19/06/2007
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The Townsville Hospital - Douglas
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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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Queensland Health
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Address [1]
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Butterfield St, Herston, Brisbane.
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Queensland Health
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Address
Butterfield St, Herston, Brisbane
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Townsville Health Service District Institutional Ethics Committee
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Ethics committee address [1]
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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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22/02/2006
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Ethics approval number [1]
2687
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01/06
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Ethics committee name [2]
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The Townsville Hospital HREC
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Ethics committee address [2]
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The Townsville Hospital, Douglas, Townsville
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
296118
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06/01/2006
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Approval date [2]
296118
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22/02/2006
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Ethics approval number [2]
296118
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01/2006
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Summary
Brief summary
Many people who acquire a brain impairment (e.g. through stroke or traumatic injury) suffer significant paralysis and loss of function in their arms and hands. This loss of function is extremely disabling and effects many aspects of their daily lives. Therapists frequently provide motor retraining programs to try and help them regain functional use of their limbs. Unfortunately, there is considerable variation in the type and amount of therapy given. Current evidence also suggests that many of these patients do not regain their function despite participating in therapy. This randomised controlled trial will attempt to determine if an intensive daily program of specific functionally based hand exercises is able to improve the hand function of people with acquired brain impairment. It is hoped that its results will help to guide the current and future practice of Occupational and Physiotherapists working in rehabilitation. Final measured outcome assessor of the study is blinded.
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Trial website
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Trial related presentations / publications
Ross, L. Harvey, L. and Lannin, N. (2009) Do people with acquired brain impairment benefit from additional therapy specifically directed at the hand? A randomised controlled trial. Clinical Rehabilitation (23) 492-503 Ross, L. Harvey, L. and Lannin, N (2016) Strategies for increasing the intensity of upper limb task specific practice after acquired brain impairment: A secondary analysis from a randomised controlled trial
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Public notes
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Contacts
Principal investigator
Name
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Mr Leo Ross
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Address
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QEII Jubilee Hospital, Brisbane, Australia
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Country
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Australia
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Phone
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+61 731826148
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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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Leo F Ross
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Address
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Department of Occupational Therapy, QEII Jubilee Hospital. Brisbane, QLD, Australia
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Country
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Australia
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Phone
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+61 731826148
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Fax
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+61 7 47962621
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Email
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[email protected]
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Contact person for scientific queries
Name
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Leo Ross
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Address
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Department of Occupational Therapy, QEII Jubilee Hospital. Brisbane, QLD, Australia
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Country
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Australia
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Phone
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+61 731826148
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Fax
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+61 7 47962621
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Email
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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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