Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000022662
Ethics application status
Not yet submitted
Date submitted
29/10/2013
Date registered
9/01/2014
Date last updated
9/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Yawn induced limb movements in stroke patients with arm weakness
Scientific title
Establishing the neuro-anatomical basis for extrapyramidal yawning movements observed in stroke patients with arm weakness
Secondary ID [1] 283480 0
nil
Universal Trial Number (UTN)
Trial acronym
Yawning Induced Movements in Stroke Study ( YIMSS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke
 290398 0
Yawning Induced Movements in an otherwise paralysed limb 290604 0
Condition category
Condition code
Neurological 290789 290789 0 0
Other neurological disorders
Stroke 290994 290994 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
Observation Study:
1. Observe incidence of YIMS (yawning induced movements in stroke survivors) - subjects will be asked to complete regular surveys noting how frequently they observed autonomous movements associated with yawning.
2. Clinical survey upon admission to tertiary hospital for stroke for up to 6 months following a first stroke
3. Subjects will complete a survey upon admission and at 2 weeks, 1 and 3 and 6 months to determine their individual functional level and incidence of yawning induced movements
4. Subjects will be given a survey kit with the two week and 1,3 and 6 month survey forms, information pack and return prepaid envelopes
5. Investigators provide a reminder phone call prior to each survey to improve adherence
6.As secondary aim, wish to compare neuroanatomical stroke lesions between patients with YIMs against those without YIMs. Identifying these lesions will involve going through Head imaging taken during the diagnosis of stoke and potential fMRI in future studies
Intervention code [1] 288191 0
Not applicable
Comparator / control treatment
N/A - This is an observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290784 0
1. Determine Incidence of Yawning Induced Arm Movements in stroke survivors
Incidence will be determined by participant observation and recollection.
Timepoint [1] 290784 0
At admission and at 2 weeks, 1 month, 3 months and 6 months
Secondary outcome [1] 305284 0
1. Establish (if possible) neuroanatomical correlations between subjects with YIMs compared to subjects without YIMs
This will be assessed through comparison of head imaging done at time of diagnosis and possibly fMRI as a separate study in the future
Timepoint [1] 305284 0
1. Secondary time point for each patient is 6 months

Eligibility
Key inclusion criteria
Age >18
Cerebrovascular Accident (aka Stroke) presenting in 3-13 days
Stroke associated with motor deficit (paralysis) of the upper limbs
Able to give consent/assent
Family member able to give assent on behalf of patient
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe stroke or co-morbidities that make early death more likely
Previous Stroke
Significant movement disorders ( Parkinson’s Disease, Multiple Sclerosis, Motor Neuron Disease)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Predicted sample size of 200-300 subjects

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2014
Actual
Date of last participant enrolment
Anticipated
31/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1634 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 7521 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 288186 0
Self funded/Unfunded
Name [1] 288186 0
Country [1] 288186 0
Australia
Primary sponsor type
Individual
Name
Dr Benjamin Mulo
Address
Sir Charles Gairdner Hospital
Department of Neurology
Hospital Avenue
Nedlands 6009
Western Australia, Australia
Country
Australia
Secondary sponsor category [1] 286911 0
None
Name [1] 286911 0
Address [1] 286911 0
Country [1] 286911 0
Other collaborator category [1] 277673 0
None
Name [1] 277673 0
N/A
Address [1] 277673 0
N/A
Country [1] 277673 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290096 0
SCGH Human Ethics Research Committee
Ethics committee address [1] 290096 0
Ethics committee country [1] 290096 0
Australia
Date submitted for ethics approval [1] 290096 0
01/11/2013
Approval date [1] 290096 0
Ethics approval number [1] 290096 0

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

Contacts
Principal investigator
Name 43950 0
A/Prof David Blacker
Address 43950 0
Department of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country 43950 0
Australia
Phone 43950 0
+61 8 9346 3333
Fax 43950 0
Email 43950 0
[email protected]
Contact person for public queries
Name 43951 0
Benjamin Mulo
Address 43951 0
Department of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country 43951 0
Australia
Phone 43951 0
+61 8 9346 3333
Fax 43951 0
Email 43951 0
[email protected]
Contact person for scientific queries
Name 43952 0
Benjamin Mulo
Address 43952 0
Department of Neurology
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands 6009
Western Australia
Country 43952 0
Australia
Phone 43952 0
+61 8 9346 3333
Fax 43952 0
Email 43952 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.