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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00222339
Registration number
NCT00222339
Ethics application status
Date submitted
13/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Titles & IDs
Public title
Task-Related Training of Arm Use After Stroke
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Scientific title
Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial
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Secondary ID [1]
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H2001/01313
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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:
Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Grip and pinch strength measured using dynamometers.
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [1]
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Dexterity measured using the NK Dexterity Board
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Sensation using a validated assessment of tactile spatial resolution.
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Assessment method [3]
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Timepoint [3]
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Eligibility
Key inclusion criteria
* within 6 weeks of first stroke
* unilateral stroke
* impaired arm function
* able to cope with intensive training program
* medically stable
* able to understand instructions
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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
* uncontrolled systemic disease
* significant musculotendinous or bony restrictions of the affected upper limb
* any serious chronic disease independently causing significant disability of the affected limb
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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)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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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
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Melbourne
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Recruitment postcode(s) [1]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Melbourne
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training can result in substantial improvement in function. The hypothesis is that task-specific training of the affected upper limb to subjects in the early period following stroke will result in significantly better functional outcome than standard intervention.
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Trial website
https://clinicaltrials.gov/study/NCT00222339
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Trial related presentations / publications
Miller K, Galea M, Kilbreath S, Phillips B (2002) Early intensive task-specific sensory and motor training of the upper limb following acute stroke: a pilot study. In Battistin L, Dam M, Tonin P(eds) Neurological Rehabilitation. Bologna:Mondizzi Editore.
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Public notes
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Contacts
Principal investigator
Name
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Mary P Galea, PhD
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
Type
Citations or Other Details
Journal
Miller K, Galea M, Kilbreath S, Phillips B (2002) ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00222339
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