Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000795099
Ethics application status
Not yet submitted
Date submitted
22/09/2010
Date registered
24/09/2010
Date last updated
24/09/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Computer-based cognitive retraining for traumatic brain injuries (TBI) clients with attention deficits
Scientific title
the influence of a computer-based attention retraining on cognitive and functional outcomes for residential clients with traumatic brain injuries (TBI)
Secondary ID [1] 252754 0
N/A
Universal Trial Number (UTN)
U1111-1117-1821
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury (TBI) 258247 0
Condition category
Condition code
Neurological 258418 258418 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 258446 258446 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 258447 258447 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:

'Rehacom' computer-based cognitive retraining software (Hasomed):
This is designed to train attentional, memory and other cognitive functions through visually-based tasks which are graded in difficulty (rather like simple computer games). This involves 16 training sessions (45 minutes each, 2 training sessions per week) facilitated by the principal investigator and co-investigator (both registered Clinical Psychologists in New Zealand) over an 8 week period. The Rehacom software is designed to systematically record and save participanmts scores and progress through the different stages of each training procedure.
Intervention code [1] 257257 0
Rehabilitation
Comparator / control treatment
This will be a pre-intervention assessment (Time A) - intervention - post-intervention assessment design (Time B), with each participant serving as his/her own control. Standardised neuriopsychological tests will be used so that participants performances can be compared to normative reference data (stratified for age). Prior to the intervention (the Rehacom computer-based training), an initial cognitive assessment will be carried out at the point of study entry and a repeat assessment of cognitive functioning will be carried out 3 weeks later to ascertain the stability of cognitive funcitoning for the TBI clients prior to carrying out the computer training intervention.
For the above reasons it has been determined that a control group will not be needed in this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259268 0
1. Difference between mean performance on standardised cognitive tests (as a group) from the pre-intervention stages to early post-intervention stages.

Cognitive tests will be administered, including standardised and well validated, reliable tests of attention and concentration, and psychomotor speed (Digit Symbol Coding Test, Digit Span Test, Symbol Search Test, Test of Everyday Attention), frontal 'executive' functions (Delis-Kaplan Executive Function System), and memory (California Verbal Learning Test and Rey Complex Figure Test).
Timepoint [1] 259268 0
1. At the point of participants agreeing to enter the study, then again at 2-3 weeks later (i.e., one week prior to the intervention), and again at the final timepoint (one week after intervention completion).
Primary outcome [2] 259269 0
2. Stability of cognitive outcome post intervention as indicated by difference between mean performances on cognitive tests (as a group) immediately after the intervention and six months post-intervention.

Cognitive tests will be administered, including standardised and well validated, reliable tests of attention and concentration, and psychomotor speed (Digit Symbol Coding Test, Digit Span Test, Symbol Search Test, Test of Everyday Attention), frontal 'executive' functions (Delis-Kaplan Executive Function System), and memory (California Verbal Learning Test and Rey Complex Figure Test).
Timepoint [2] 259269 0
2. One week post-intervention and six months post-intervention
Secondary outcome [1] 265674 0
1. Differences between means (as a group) within each of the domains of the Quality of Life in Acquired Brain Injury (QOLABI) from pre-intervention to early post-intervention, and from early post-intervention to 6 months post-intervention.
Timepoint [1] 265674 0
1. One week prior to commencing the intervention, again one week post intervention (note, the intervention will take 8 weeks per client), and again six months post-intervention to determine any changes in quality of life.
Secondary outcome [2] 265675 0
2. Differences between means (as a group) for anxiety and depression subscales of the Hospital Anxiety and Depression Scale (HADS) from pre-intervention to early post-intervention, and from early post-intervention to six months post-intervention.
Timepoint [2] 265675 0
2. One week prior to commencing the intervention, again one week post intervention (note, the intervention will take eight weeks per client), and again six months post-intervention to determine the stability of mood.

Eligibility
Key inclusion criteria
TBI of all severity (mild - severe), impairment (demonstrated on cognitive testing) in at least one domain of attention (<1.5 standard deviations (SD) below the mean), time since TBI of at least one year, minimum age of 16 years, male and female, all ethnic and cultural groups.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients on medications which significantly affect arousal/alertness, progressive neurological conditions (eg dementia, Multiple Sclerosis), significant language barrier or severe acquired speech / language disorder, visual / hearing impairments and visual field defects, patients receiving other simultaneous cognitive rehabilitation, premorbid psychiatric disorders, severe upper limb motor or sensory impairments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2932 0
New Zealand
State/province [1] 2932 0
Auckland

Funding & Sponsors
Funding source category [1] 257701 0
Other
Name [1] 257701 0
Abano Rehabilitation, New Zealand
Country [1] 257701 0
New Zealand
Primary sponsor type
Other
Name
Abano Rehabilitation, New Zealand
Address
PO box 9506
Newmarket, Auckland, 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 256920 0
None
Name [1] 256920 0
Address [1] 256920 0
Country [1] 256920 0
Other collaborator category [1] 251527 0
University
Name [1] 251527 0
Auckland University of Technology (AUT)
Address [1] 251527 0
Kathryn McPherson
Health and Rehabilitation Research Institute
AUT, Akoranga Drive Campus
Private Bag 92006, Auckland 1142
Country [1] 251527 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259736 0
Northern X Regional Ethics Committee, Ministry of Health
Ethics committee address [1] 259736 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Road, Penrose 1642
Private Bag 92 522
Wellesley Street, Auckland
Ethics committee country [1] 259736 0
New Zealand
Date submitted for ethics approval [1] 259736 0
09/02/2010
Approval date [1] 259736 0
Ethics approval number [1] 259736 0
NTX/10/02/004

Summary
Brief summary
The aim of the study is to detmine the effect of clinician-facilitated cognitive retraining (using 'Rehacom' computer software) of attention, concentration and speed of information processing on cognitive and emotional outcomes, and quality of life, for clients with traumatic brain injuries (TBI) in the post-acute stage following their injury (i.e., more than 6 months post-injury). Training sessions will be spread over 8 weeks, with 2 sessions per week. Outcome will be determined by performance on standardised cognitive tests of attention, speed of processing, memory and frontal executive functions (ie initiation, flexibility of thinking, ability to inhibit impulsive responses), which will be given before (2 times) and after (2 times) the training programme. We will also be investigating the effects of the computer-based training on participant's mood and quality of life through the use of self-report inventories.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 31679 0
Address 31679 0
Country 31679 0
Phone 31679 0
Fax 31679 0
Email 31679 0
Contact person for public queries
Name 14926 0
Dr. Duncan Frazer
Address 14926 0
Abano Rehabilitation
PO Box 9506
Newmarket, Auckland 1023
New Zealand
Country 14926 0
New Zealand
Phone 14926 0
+64 9 632 1354
Fax 14926 0
+64 9 623 1550
Email 14926 0
[email protected]
Contact person for scientific queries
Name 5854 0
Dr. Duncan Frazer
Address 5854 0
Abano Rehabilitation
PO Box 9506
Newmarket, Auckland 1023
New Zealand
Country 5854 0
New Zealand
Phone 5854 0
+64 9 632 1354
Fax 5854 0
+ 64 9 623 1550
Email 5854 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
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