Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000261617
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Motor recovery following stroke
Scientific title
A novel rehabilitation protocol to enhance motor recovery following stroke
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 348 0
Condition category
Condition code
Stroke 404 404 0 0
Physical Medicine / Rehabilitation 405 405 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One of two types of behavioural therapy, each lasting one month.
Intervention code [1] 265 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 463 0
Arm and hand function at study completion
Timepoint [1] 463 0
At study completion
Secondary outcome [1] 1004 0
Motor cortex excitability and function at study completion.
Timepoint [1] 1004 0

Eligibility
Key inclusion criteria
First-ever monohemispheric stroke at least 6 months prior to enrolment; Upper limb weakness.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to magnetic resonance imaging and/or transcranial magnetic stimulation; Spasticity preventing passive wrist movement; Unable to walk unassisted; Unable to give 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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Customised computer software is used to randomise the participants and minimise differences in age, chronicity and clinical scores between the resulting groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 147 0
New Zealand
State/province [1] 147 0

Funding & Sponsors
Funding source category [1] 454 0
Government body
Name [1] 454 0
Health Research Council of New Zealand
Country [1] 454 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 370 0
None
Name [1] 370 0
Not applicable
Address [1] 370 0
Country [1] 370 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35480 0
Address 35480 0
Country 35480 0
Phone 35480 0
Fax 35480 0
Email 35480 0
Contact person for public queries
Name 9454 0
Dr Cathy Stinear
Address 9454 0
Human Motor Control Laboratory
Department Sport and Exercise Science
University of Auckland
Private Bag 92019
Auckland 1001
Country 9454 0
New Zealand
Phone 9454 0
+64 9 3737599 Ext. 83766
Fax 9454 0
Email 9454 0
[email protected]
Contact person for scientific queries
Name 382 0
Associate Professor Winston Byblow
Address 382 0
Human Motor Control Laboratory
Department Sport and Exercise Science
University of Auckland
Private Bag 92019
Auckland 1001
Country 382 0
New Zealand
Phone 382 0
+64 9 3737599 Ext. 86844
Fax 382 0
Email 382 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.