Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163878




Registration number
NCT00163878
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
4/10/2006

Titles & IDs
Public title
Is Sensory Stimulation Effective in Reducing Time Spent in a Coma or Vegetative State
Scientific title
A Randomised Control Trial to Determine the Effectiveness of Sensory Stimulation Program in Reducing the Length of Time Spent by Severely Brain Injured Patients in a Vegetative State in the Acute Hospital Environment
Secondary ID [1] 0 0
4468
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patients are allocated to a level on the SMART scale every ten days, compariosns are made between the control and experimental groups
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Fucntional status at six months, assessed using the modified Barthel
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* admitted with severe brain injury
* GCS of 9 or less. A GCS score of 9 or less is indicative of a severe brain injury
* medically stable, as documented by medical staff
* age 18 to 65 years
* controlled intracranial pressure no sedation
* no previous brain injury
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* patient declared brain dead
* next of kin withdraws patient from the study
* withdrawal of consent by patient on waking
* raised uncontrolled intracranial pressure, following discussions with treating medical team
* patient enrolled in DECRA or RSI Trials

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
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
The Alfred Hosptial - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne
Recruitment postcode(s) [2] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Victorian Trauma Foundation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A randomised control trial of patients who have a severe brain injury to determine if patients who receive a standardised sensory stimulation program emerge earlier from a vegetative state. The experimental group would receive, in addition to their normal occuaptional therapy, sensory stimulation which would involve the daily application of stimulation to all five senses using the Sensory Modalities Assessment and Rehabilitation Technique (SMART).
Trial website
https://clinicaltrials.gov/study/NCT00163878
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacqui M Morarty, Occupational Therapist
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jacqui M Morarty, Occupational Therapist
Address 0 0
Country 0 0
Phone 0 0
61 (0)3 92763526
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00163878