Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000468224
Ethics application status
Approved
Date submitted
27/05/2009
Date registered
16/06/2009
Date last updated
2/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Priming to enhance rehabilitation after stroke
Scientific title
The effect of adding Active-Passive Bilateral Therapy to standard upper limb rehabilitation following stroke, on Action Research Arm Test score
Secondary ID [1] 281511 0
No secondary ID available
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 4867 0
Condition category
Condition code
Neurological 237219 237219 0 0
Neurodegenerative diseases
Stroke 237282 237282 0 0
Ischaemic
Stroke 237283 237283 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active-Passive Bilateral Therapy. This involves using a simple mechanical device with the arms, for 15 minutes prior to an upper rehabilitation therapy session, 5 times per week for a month. This will be administered by a physiotherapist.
Intervention code [1] 236650 0
Rehabilitation
Comparator / control treatment
Weak cutaneous electrical stimulation of the wrist extensors of the stroke-affected upper limb, for 15 minutes prior to an upper rehabilitation therapy session, 5 times per week for a month. This will be administered by a physiotherapist.
Control group
Placebo

Outcomes
Primary outcome [1] 238033 0
Action Research Arm Test score. This test assesses upper limb function.
Timepoint [1] 238033 0
12 weeks after stroke
Secondary outcome [1] 242188 0
Modified Rivermead Mobility Index. This assesses ambulatory independence.
Timepoint [1] 242188 0
12 weeks after stroke
Secondary outcome [2] 242189 0
National Institutes of Health Stroke Scale. This assesses neurological deficit.
Timepoint [2] 242189 0
12 weeks after stroke
Secondary outcome [3] 242190 0
Modified Rankin Score. This assesses disability in activities of daily living.
Timepoint [3] 242190 0
12 weeks after stroke
Secondary outcome [4] 242191 0
Stroke Impact Scale. This assesses the effect of stroke on quality of life.
Timepoint [4] 242191 0
24 weeks after stroke

Eligibility
Key inclusion criteria
First ever mono-hemispheric stroke
Unilateral upper limb weakness
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Volunteers are not eligible for participation of they have any of the following:
Cardiac pacemaker (contraindication to MRI)
Epilepsy (contraindication to transcranial magnetic stimulation)
A history of previous stroke
Cognitive or communication difficulties that preclude informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
1/08/2009
Actual
24/11/2009
Date of last participant enrolment
Anticipated
Actual
26/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
57
Recruitment outside Australia
Country [1] 1810 0
New Zealand
State/province [1] 1810 0
Auckland

Funding & Sponsors
Funding source category [1] 5033 0
Charities/Societies/Foundations
Name [1] 5033 0
Stroke Foundation
Country [1] 5033 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 4549 0
Hospital
Name [1] 4549 0
Auckland City Hospital
Address [1] 4549 0
Director, Stroke Unit
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1010
Country [1] 4549 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239128 0
Health and Disability Ethics Committee Northern Region X
Ethics committee address [1] 239128 0
Ethics committee country [1] 239128 0
New Zealand
Date submitted for ethics approval [1] 239128 0
03/06/2009
Approval date [1] 239128 0
13/08/2009
Ethics approval number [1] 239128 0

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

Contacts
Principal investigator
Name 29657 0
A/Prof Cathy Stinear
Address 29657 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland
Country 29657 0
New Zealand
Phone 29657 0
+6493737999
Fax 29657 0
Email 29657 0
[email protected]
Contact person for public queries
Name 12904 0
Cathy Stinear
Address 12904 0
Neurology Research Unit
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 12904 0
New Zealand
Phone 12904 0
+64 9 92 33 779
Fax 12904 0
Email 12904 0
[email protected]
Contact person for scientific queries
Name 3832 0
Cathy Stinear
Address 3832 0
Neurology Research Unit
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 3832 0
New Zealand
Phone 3832 0
+64 9 92 33 779
Fax 3832 0
Email 3832 0
[email protected]

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.