Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000052639
Ethics application status
Approved
Date submitted
2/01/2014
Date registered
17/01/2014
Date last updated
2/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and safety of early mobilisation in patients following non-traumatic acute subarachnoid haemorrhage or subdural haemorrhage.
Scientific title
The feasibility and safety of early mobilisation in patients following non-traumatic acute subarachnoid haemorrhage or subdural haemorrhage.
Secondary ID [1] 283829 0
nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute subarachnoid haemorrhage 290806 0
acute subdural haemorrhage 290807 0
Condition category
Condition code
Neurological 291175 291175 0 0
Other neurological disorders
Stroke 291276 291276 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Medical, nursing and allied health interventions will not change from those routinely provided. If a patient satisfies certain screening criteria, the physiotherapist will assess the patient as per usual practice, including the patient’s ability to follow commands and trunk/limb strength, and decide on the appropriate type of mobility intervention. The type of mobility intervention will be progressed over time, as per the patient’s condition and tolerance, from progressively upright positions in bed, bed exercises, sitting on the edge of the bed, sitting balance, functional exercises in sitting, standing, standing balance exercises, marching on the spot, sitting out of bed and walking. These mobilisation activities may involve the use of equipment (e.g. lifting machines, appropriate seating). Mobility interventions will commence once the patient is deemed medically stable and will continue for the duration of their in-patient stay.
Intervention code [1] 288515 0
Not applicable
Comparator / control treatment
No control/comparator treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291161 0
Feasibility of mobilisation.
The feasibility of early mobilisation will be documented by recording the following parameters:
* Number of physiotherapy sessions where the criteria to participate in mobilisation are met.
* Number of physiotherapy sessions where the criteria to participate in mobilisation are not met (and reasons why).
* Type of mobilisation undertaken.
* Days from admission to mobility milestones (e.g. sit out of bed, stand, walk).
* Ward location on each occasion of mobilisation (e.g. Intensive Care Unit, High Dependency Unit or neurosurgical ward).
* Ventilatory status (i.e. mechanically ventilated or not).
Timepoint [1] 291161 0
Duration of acute hospital stay.
Primary outcome [2] 291162 0
Safety of mobilisation.
The safety of mobilisation will be documented by recording the following parameters:
* Deterioration in conscious state and/or
* Increase in intracranial pressure or vasospasm requiring active treatment and/or
* Excessive increase or decrease in blood pressure or heart rate accompanied by signs of cardiovascular stress and/or
* Increasing ectopic beats, arrhythmia or signs and symptoms of myocardial ischaemia and/or
* 4% or greater decrease in percutaneous oxygen saturation, respiratory pattern unacceptable, signs of respiratory distress and/or
* Patient appears distressed and/or
* Inadvertent removal of attachment(s) and/or
* Fall.
Any intervention(s) required in the management of these adverse events will also be recorded.
Timepoint [2] 291162 0
Duration of acute hospital stay.
Secondary outcome [1] 306161 0
nil.
Timepoint [1] 306161 0
not applicable.

Eligibility
Key inclusion criteria
* Admitted under the care of the Royal Adelaide Hospital Neurosurgery Department with a diagnosis of non-traumatic acute subarachnoid haemorrhage or subdural haemorrhage (confirmed by computed tomography scan).
* Aged at least 18 years.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Not previously mobile.
* Not for active treatment.
* Other conditions/injuries contraindicating mobilisation.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be collected in paper format, transposed onto an Excel spreadsheet and imported into SPSS for analyses. Analyses will be predominantly descriptive in nature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2014
Actual
1/03/2014
Date of last participant enrolment
Anticipated
31/07/2014
Actual
4/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1883 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7661 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 288487 0
Self funded/Unfunded
Name [1] 288487 0
Kathy Stiller
Country [1] 288487 0
Australia
Primary sponsor type
Individual
Name
Kathy Stiller
Address
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 287189 0
Individual
Name [1] 287189 0
Kristie Stucas
Address [1] 287189 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 287189 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290349 0
Royal Adelaide Hospital
Ethics committee address [1] 290349 0
Level 3, Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 290349 0
Australia
Date submitted for ethics approval [1] 290349 0
Approval date [1] 290349 0
24/12/2013
Ethics approval number [1] 290349 0

Summary
Brief summary
This study involves a prospective, single-group, observational design. No aspect of usual clinical care (i.e. medical, nursing, physiotherapy or other allied health) will be altered. Instead, the study involves documenting the feasibility and safety of our usual practice with respect to early progressive mobilisation of patients with non-traumatic acute subarachnoid haemorrhage or subdural haemorrhage.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45246 0
Ms Kristie Stucas
Address 45246 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 45246 0
Australia
Phone 45246 0
61 8 82225334
Fax 45246 0
61 8 82224279
Email 45246 0
[email protected]
Contact person for public queries
Name 45247 0
Ms Kristie Stucas
Address 45247 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 45247 0
Australia
Phone 45247 0
61 8 82225334
Fax 45247 0
61 8 82224279
Email 45247 0
[email protected]
Contact person for scientific queries
Name 45248 0
Ms Kristie Stucas
Address 45248 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 45248 0
Australia
Phone 45248 0
61 8 822253334
Fax 45248 0
61 8 82224279
Email 45248 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.