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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of PARO (Therapeutic Robots) on quality of life (in people living with dementia in residential care
Scientific title
The effect of PARO (Therapeutic Robots) on social engagement, communication, and quality of life (QOL) in people living with dementia in residential care
Secondary ID [1] 259765 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia 261341 0
Condition category
Condition code
Mental Health 259495 259495 0 0
Other mental health disorders
Neurological 286971 286971 0 0

Study type
Description of intervention(s) / exposure
To compare the effects of PARO (a therapeutic, pet-type robot with the appearance of a baby harp seal) and participation in a reading group on social engagement, communication and QOL in people living with moderate to severe dementia in a residential care setting. Participants will be engaged in a structured group activity involving either PARO or a reading activity for 45 minutes, three times a week, for 5 weeks. This will be followed by 3 weeks of no activity (wash-out period), after which participants will ‘cross-over’ treatment groups and experience 5 weeks of the opposite activity (also three times a week for 45 minutes each time).
Intervention code [1] 264191 0
Intervention code [2] 285056 0
Treatment: Devices
Intervention code [3] 285057 0
Treatment: Other
Comparator / control treatment
Reading will include three, 40-minute group reading sessions per week for 5 weeks. A reading group represents ‘usual care’ for diversional therapy. A facilitator reads to and interacts with questions addressed to the group. After completion of the first treatment arm of the study, post-test measures will be collected and participants will receive no research-structured activity for three weeks (wash-out). Following the wash-out period, participants will then ‘cross-over’ and complete the second treatment arm, followed by a second round of post-testing.
Control group

Primary outcome [1] 262299 0
Social engagement (including communication) and emotional state using Observation Measure of Engagement (OME) and the Observed Emotion Rating Scale (OERS).
Timepoint [1] 262299 0
During each session
Primary outcome [2] 262301 0
Anxiety using Rating Anxiety in Dementia Scale (RAID) and Geriatric Depression Scale (GDS).
Timepoint [2] 262301 0
Baseline and post-test
Secondary outcome [1] 273496 0
Quality of Life using Quality of Life in Alzheimers' Disease Scale (QoL-AD)
Timepoint [1] 273496 0
Baseline and post-test
Secondary outcome [2] 273497 0
Apathy using Apathy Evaluation Scale (AES)
Timepoint [2] 273497 0
Baseline and post-test

Key inclusion criteria
Aged 65 years or older; have a diagnosis of mid to late stage dementia, or meet the criteria for probable mid to late stage dementia of the Alzheimer’s type as per the DSM-IV; be identified by family or staff as socially isolated, depressed, or having low quality of life; be able to sit upright comfortably in chair / wheelchair so that they can see the PARO activity; be able to move both hands.
Minimum age
65 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Blind or severely deaf

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation - under the guidance of a biostatistician, a research assistant not associated with data collection will conduct the randomization process using a computer-generated program to determine the different ordering of treatments for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264637 0
Government body
Name [1] 264637 0
Dementia Collaborative Research Centres (DCRC) - Carers and Consumers (CC) - Department of Health and Ageing (DOHA)
Address [1] 264637 0
Queensland University of Technology,
Dementia Collaborative Research Centre - Carers and Consumers
Kelvin Grove Road
Brisbane, QLD 4059
Country [1] 264637 0
Primary sponsor type
Griffith University
170 Kessels Road
Nathan, Brisbane,
QLD 4111
Secondary sponsor category [1] 284272 0
Name [1] 284272 0
Address [1] 284272 0
Country [1] 284272 0
Other collaborator category [1] 251866 0
Name [1] 251866 0
Glenda Cook
Address [1] 251866 0
Northumbria University
Ellison Place
Newcastle upon Tyne
Country [1] 251866 0
United Kingdom
Other collaborator category [2] 251867 0
Name [2] 251867 0
Barbara Klein
Address [2] 251867 0
Fachochschule Frankfurt am Main,
Nibelungenplatz 1
60318 Frankfurt am Main
Gebaude 2, Raum 109a
Country [2] 251867 0

Ethics approval
Ethics application status
Ethics committee name [1] 266638 0
Griffith University Ethics Committee
Ethics committee address [1] 266638 0
170 Kessels Road
Nathan, Brisbane, QLD 4111
Ethics committee country [1] 266638 0
Date submitted for ethics approval [1] 266638 0
Approval date [1] 266638 0
Ethics approval number [1] 266638 0

Brief summary
To compare the effects of PARO and participation in a reading group on social engagement, communication and quality of life (QOL) in people living with moderate to severe dementia in a residential care setting. Furthermore, to examine the associations between changes in social engagement, communication and QOL resulting from PARO and changes in participants’ emotional state
Trial website
Trial related presentations / publications
Moyle W, Cooke M, Beattie E, Jones C, Klein B, Cook G, Gray C. 2013. Exploring the effect of companion robots on emotional expression in older adults with dementia: a pilot randomized controlled trial. J Gerontol Nurs 39: 46-53.
Public notes

Principal investigator
Name 32330 0
Prof Wendy Moyle
Address 32330 0
Griffith University, Nathan campus, 170 Kessels Road Nathan, Brisbane, QLD, Australia 4111.
Country 32330 0
Phone 32330 0
+61 (0) 7 3735 5526
Fax 32330 0
Email 32330 0
Contact person for public queries
Name 15577 0
Prof Professor Wendy Moyle
Address 15577 0
170 Kessels Road
Nathan, Brisbane, QLD 4111
Country 15577 0
Phone 15577 0
+61 (0) 7 3735 5526
Fax 15577 0
Email 15577 0
Contact person for scientific queries
Name 6505 0
Prof Professor Wendy Moyle
Address 6505 0
170 Kessels Road
Nathan, Brisbane, QLD 4111
Country 6505 0
Phone 6505 0
+61 (0) 7 3735 5526
Fax 6505 0
Email 6505 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary