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Trial registered on ANZCTR
Registration number
ACTRN12616001056482
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
8/08/2016
Date last updated
13/07/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Efficacy of computer versus group memory training for memory rehabilitation post-stroke
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Scientific title
A Comparison of Compensatory and Restorative Approaches to Memory Rehabilitation Post-STroke
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Secondary ID [1]
289588
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
cognition
299351
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memory loss
299402
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Condition category
Condition code
Stroke
299336
299336
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0
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Ischaemic
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Stroke
299342
299342
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomly allocated into one of three conditions; restoration, compensation or a wait list control group. Participants allocated into the restoration condition will be asked to complete six weeks of computer memory training while participants in the compensation condition will be asked to attend a face to face memory group once a week for six weeks. Further details of each respective intervention are provided below.
For the computer memory training (i.e. restoration condition), participants will be required to complete a project specific suite of memory games developed in collaboration with Lumos labs. Training is completed on a computer at home for 30 minutes, five times per week for six weeks. Participants can flexibly decide upon which days and times to train . There are 13 different memory games that form apart of the training, with each session alternating between these games. Researchers will be in regular contact with participants throughout the 6 week training period to address any concerns or technical complications. Frequency of training will be monitored electronically by researchers.
For the group memory sessions (i.e. compensation), participants will be required to attend a face to face memory skills group for 2 hours on a weekday for a six week period. The groups are held in Notting Hill, the Austin Hospital and Monash Health sites and are run by neuropsychologists who have experience in the field of brain injury. Groups provide participants with education surrounding the impact of stroke on memory and cover a number of strategies that aim to minimise the impact of these changes on daily functioning. For instance, the group covers strategies that may be helpful to remember peoples names. Compliance with group training will be monitored using a register of attendance at each session. We will attempt to match participants to the closest group where possible.
Finally all participants will be asked to complete 'pen and paper' memory tasks immediately prior to the rehabilitation, immediately following the rehabilitation and at a six week follow up.
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Intervention code [1]
295192
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Rehabilitation
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Intervention code [2]
295227
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Treatment: Other
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Comparator / control treatment
If allocated to the waitlist control condition, participants will be placed on a waiting list for a 12 week period but will be given the choice about which rehabilitation they would like to complete (i.e. either the group or the computer training).
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Control group
Active
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Outcomes
Primary outcome [1]
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Goal Attainment Scaling will be used to evaluate the extent to which participants percieve thier personalised memory goals were accomplished during the course of the intervention.
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Assessment method [1]
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Timepoint [1]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [1]
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Total score on Royal Prince Alfred Prospective Memory Task (RPA-ProMem)
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Assessment method [1]
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Timepoint [1]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [2]
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Total self reported memory failures on the Everyday Memory Questionnaire-Revised
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Assessment method [2]
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Timepoint [2]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [3]
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Bilateral working memory performance as assessed by aged scaled scores on Digits backwards and Spatial span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV) and Wechsler Memory Scale Fourth Edition (WMS-IV) respectivley
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Assessment method [3]
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Timepoint [3]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [4]
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Visual memory and learning T-scores on the Brief Visuospatial Memory Test Revised (BVMT-R)
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Assessment method [4]
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Timepoint [4]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [5]
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Other reports of patient memory failure assessed on the other version of the Comprehensive Assessment of Prospective Memory (CAPM-other)
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Assessment method [5]
325273
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Timepoint [5]
325273
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [6]
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Quality of life as assessed by the Assessment of Quality of Life (AQoL-8D)
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Assessment method [6]
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Timepoint [6]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [7]
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Anxiety total scores on the Hospital Anxiety and Depression Scale (HADS)
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Assessment method [7]
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Timepoint [7]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [8]
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Self reported prospective memory failures on the Comprehensive Assessment of Prospective Memory (CAPM)
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Assessment method [8]
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Timepoint [8]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Secondary outcome [9]
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Depression total score on the Hospital Anxiety and Depression Scale (HADS)
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Assessment method [9]
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Timepoint [9]
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Baseline prior to the start of an intervention, immediately following the completion of the intervention and six weeks post end of intervention.
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Eligibility
Key inclusion criteria
*diagnosis of stroke occurring at least three months prior to the intervention start date
*Sufficient English language and cognition to ensure successful and valid completion of outcome measures and rehabilitation
*Access to a computer and the internet and computer proficiency necessary to navigate through an online platform of training
*Subjective (self or other) memory complaints
*Ability to attend weekly memory groups held at Notting Hill, the Austin hospital or Monash Health sites
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
*History of other neurological conditions such as epilepsy and traumatic brain injury
*Diagnosis of dementia or mild cognitive impairment
*Diagnosis of transient ischemic attack (TIA) rather than stroke
*History of psychiatric or medical issues impacting upon cognition
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation was concealed in opaque sealed envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomization will be used to create the random order for allocation of participants. Block sequences will be generated through computer software and sealed by a person independent to the research project
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
Nil other features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A 3(restorative, compensation, waitlist) x 3(baseline, post intervention, follow up) mixed model ANOVA will be conducted.
G*power calculations (version 3.1), with an expected small-medium effect size (conservative estimate based upon recent meta analytic findings), suggest that a sample size of 69 would achieve 80% power, at an alpha level of .05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/04/2015
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Date of last participant enrolment
Anticipated
31/12/2016
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Actual
1/02/2017
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Date of last data collection
Anticipated
1/02/2017
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Actual
15/03/2017
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Sample size
Target
69
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Accrual to date
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Final
65
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
6068
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Kingston Centre - Cheltenham
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Recruitment postcode(s) [1]
13516
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3800 - Monash University
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Recruitment postcode(s) [2]
13517
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3152 - Knox City Centre
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Recruitment postcode(s) [3]
13518
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3168 - Clayton
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Recruitment postcode(s) [4]
13519
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3153 - Bayswater
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Recruitment postcode(s) [5]
13520
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3192 - Cheltenham
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Recruitment postcode(s) [6]
13521
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3199 - Frankston
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Recruitment postcode(s) [7]
13522
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3191 - Sandringham
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Recruitment postcode(s) [8]
13523
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3150 - Brandon Park
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Recruitment postcode(s) [9]
13524
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3150 - Wheelers Hill
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Recruitment postcode(s) [10]
13525
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3150 - Glen Waverley
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Recruitment postcode(s) [11]
13526
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3152 - Studfield
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Recruitment postcode(s) [12]
13527
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3154 - The Basin
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Recruitment postcode(s) [13]
13528
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3151 - Burwood East
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Recruitment postcode(s) [14]
13529
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3156 - Ferntree Gully
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Recruitment postcode(s) [15]
13530
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3158 - Upwey
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Recruitment postcode(s) [16]
13531
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3159 - Menzies Creek
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Recruitment postcode(s) [17]
13532
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3162 - Caulfield
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Recruitment postcode(s) [18]
13533
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3163 - Glen Huntly
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Recruitment postcode(s) [19]
13534
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3166 - Oakleigh
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Recruitment postcode(s) [20]
13535
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3167 - Oakleigh South
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Recruitment postcode(s) [21]
13536
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3101 - Kew
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Recruitment postcode(s) [22]
13537
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3103 - Balwyn
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Recruitment postcode(s) [23]
13538
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3105 - Bulleen
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Recruitment postcode(s) [24]
13539
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3108 - Doncaster
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Recruitment postcode(s) [25]
13540
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3109 - Tunstall Square Po
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Recruitment postcode(s) [26]
13541
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3102 - Kew East
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Recruitment postcode(s) [27]
13542
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3121 - Burnley
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Recruitment postcode(s) [28]
13543
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3121 - Richmond
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Recruitment postcode(s) [29]
13544
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3122 - Hawthorn
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Recruitment postcode(s) [30]
13545
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3124 - Camberwell
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Recruitment postcode(s) [31]
13546
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3128 - Box Hill
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Recruitment postcode(s) [32]
13547
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3126 - Canterbury
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Recruitment postcode(s) [33]
13548
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3125 - Burwood
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Funding & Sponsors
Funding source category [1]
293978
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University
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Name [1]
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Monash Unviersity
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Address [1]
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School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton, VIC 3800
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Country [1]
293978
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton 3800 VIC
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Country
Australia
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Secondary sponsor category [1]
292793
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None
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Name [1]
292793
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Nil
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Address [1]
292793
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Nil
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Country [1]
292793
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Other collaborator category [1]
279055
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Hospital
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Name [1]
279055
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Monash Health
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Address [1]
279055
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246 Clayton Rd, Clayton VIC 3168
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Country [1]
279055
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295393
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Monash Health
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Ethics committee address [1]
295393
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246 Clayton Rd, Clayton VIC 3168
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Ethics committee country [1]
295393
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Australia
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Date submitted for ethics approval [1]
295393
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22/01/2015
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Approval date [1]
295393
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10/03/2015
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Ethics approval number [1]
295393
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15037A
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Ethics committee name [2]
295394
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Monash University Human Research Ethics Committee (MUHREC)
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Ethics committee address [2]
295394
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Monash University Room 111, Chancellery Building E 24 Sports Walk, Clayton Campus, Wellington Rd, Clayton VIC 3800, Australia
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Ethics committee country [2]
295394
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Australia
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Date submitted for ethics approval [2]
295394
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10/03/2015
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Approval date [2]
295394
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23/03/2015
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Ethics approval number [2]
295394
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CF15/916 - 2015000408
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Summary
Brief summary
Approximately half of all survivors of stroke experience memory impairment, which can significantly impact functional independence and quality of life. Two different approaches have typically been implemented in an effort to rehabilitate memory: restoration (computer based training) and compensation (group based training). Overall, there is no clear consensus as to whether either computer-based training or compensatory approaches to memory rehabilitation are effective or efficient for stroke patients. As a result, many survivors of stroke are purchasing costly computer training programs with unknown effectiveness. At Monash University, we are currently running a randomised controlled trial to explore the efficacy and cost efficiency of different approaches to memory rehabilitation post stroke. Eligible participants will be randomised into a waitlist control,memory group or computer training group and will receive free memory rehabilitation over a six week period. In doing so we aim to explore the most cost-efficient and effective way in which memory can be rehabilitated post stroke, thereby addressing a clear gap in service provision.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
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/AnzctrAttachments/371011-HREC & SSA Approval Letter (1).pdf
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Attachments [2]
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/AnzctrAttachments/371011-MUHREC approval.pdf
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Attachments [3]
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/AnzctrAttachments/371011-study advert for participants (1).pdf
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Attachments [4]
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/AnzctrAttachments/371011-study summary.pdf
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Contacts
Principal investigator
Name
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Dr Rene Stolwyk
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Address
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School of Psychological Sciences, 18 Innovation Walk, Monash Unviersity, Clayton 3800 VIC
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Country
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Australia
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Phone
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+61 434 194 230
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Toni Withiel
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Address
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School of Psychological Sciences, 18 Innovation Walk, Monash Unviersity, Clayton 3800 VIC
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Country
67103
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Australia
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Phone
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+61 411 729 045
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Fax
67103
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Email
67103
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[email protected]
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Contact person for scientific queries
Name
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Toni Withiel
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Address
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School of Psychological Sciences, 18 Innovation Walk, Monash Unviersity, Clayton 3800 VIC
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Country
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Australia
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Phone
67104
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+61 411 729 045
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Fax
67104
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Email
67104
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Research Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry
2024
https://doi.org/10.1016/j.jphys.2024.02.015
N.B. These documents automatically identified may not have been verified by the study sponsor.
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