Application of the Robotic Seal PARO, a Neurological Biofeedback Medical 1 Device, to Elderly Persons with Dementia at Home: An Analysis from Seven Cases

Background: In Japanese society today, many elderly persons with dementia (EPWD) are 20 living at home. This research focused on the family members of EPWD who provide 21 informal care and support. The purpose of this research was (1) to analyse the potential 22 and effectiveness of care provided by the family with the use of the robotic seal PARO, a 23 neurological biofeedback medical device, and (2) to identify and prioritise problems when 24 utilising PARO in the home context. Methods: This study employed a mixed-methods approach involving observational data 27 and interviews. Family members of seven households caring for EPWD were asked to 28 use the seal robot “PARO” as a means to provide care. The family caregivers used PARO 29 at home for more than three times per week, over one to three months. At the initial visit, 30 an individualised purpose of PARO was established. Family members were taught how 31 to operate PARO and how to facilitate PARO use. Research data were collected at initial 32 and subsequent monthly visits, in the form of families’ observational feedback, interviews, 33 and direct assessment of the subjects. Collected data were analysed quantitatively and 34 qualitatively. Results: Five out of the seven elderly persons reacted positively to PARO and achieved 37 their intervention goals. Acceptance of PARO use depended on the positive interaction 38 observed at the initial encounter, which led to continued interest later on. On the other 39 hand, for the subjects where “encouragement was required to trigger interaction” at the 40 initial encounter, their subsequent interest may either increase or decrease. Furthermore, 41 observed activities with PARO use for all families were conversations and physical touch 42 to PARO. Some families facilitated reminiscence and intellectual activities. 43 44 Conclusions: The study indicated that the effect of PARO application at home is possibly 45 influenced by the participants' initial level of interest towards PARO. It is still crucial to 46 perform careful observation and assessment of the benefit of PARO before adapting the 47 treatment strategy. The families need specific advice from relevant healthcare 48 professionals, such as occupational therapists, to maximise the use of PARO. This implies 49 that effective robotic care at home requires professional support. 50 51

Despite the numerous studies, most of these were obtained from healthcare facilities 115 administered by trained HCPs. Furthermore, the only research conducted within one's 116 natural environment did not look into the effects of using PARO solely at home as it was 117 a combination of daytime PARO use in a day-care centre and home [13]. Families of 118 EPWD are already using everyday technology such as alarmed sensors and internets but 119 the everyday use of robots are not as common [18,19]. Thus, it is of benefit to consider 120 PARO use, as the use of robots has the potential to contribute greatly to the extension of 121 community living and become one of the solutions to providing high-quality home care.

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To use a neurological biofeedback medical robot at home, the family must be able to 124 operate it easily and effectively. Adapting the Person-Centred Care (PCC) approach to 125 improve the quality of care is a possible approach for both family members and HCPs as  EPWDs often find it difficult to accurately convey their feelings to others, therefore it is 134 crucial for the caregiver to objectively observe the person to determine the condition when 135 providing care. EPWDs also present with reduced judgement skill to make every-day life 136 decisions, therefore, to ethically provide care by a robot, the viewpoint of the EPWD must 137 be considered. PCC is an approach to dementia care that can be applied in two 138 perspectives: as a way of supporting families and as an education method.

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PARO's functions are described as following: PARO does not speak a language or walk, 160 but it is capable of making an animal-like cry, moves its head and legs, and blinks. With home with a family member, and who, by assessment of a qualified HCP, is expected to 174 benefit from using PARO. Other criteria such as the severity of cognitive deficits were 175 not set.  an assessment tool that objectively evaluates the feeling of burden experienced by 232 caregivers of people with dementia and other conditions requiring assistance [26]. In this 233 research, we used the Japanese version standardised by Arai [29].

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Interview with family caregiver: 236 An inductive analysis method was employed to categorise collected qualitative data.

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First, the PI transcribed the family caregivers' comments recorded in the IC recorder, then 238 selected key sentences or keywords rephrased into short sentences (codes). These codes 239 were synthesised into sub-categories, then into categories. Three experienced HCPs 240 collectively reviewed these codes and categories to clarify any uncertainty. The PI revised 241 short sentences until a unanimous agreement was reached.

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The subjects' profile and the result of standardised assessments are shown in Table 1.

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Out of ten families who volunteered to participate, seven families were included in this  At the beginning of the research, the MMSE score ranged from 4 to 21 points, the N-ADL 279 score from 2 to 46 points, the DBD from 12 to 40 points, and the Zarit care burden score 280 from 14 to 40 points. Throughout the data collection period, none of the subjects was 281 diagnosed with any new medical conditions, nor was their existing medicines changed. The purpose of introducing PARO to the participants included: to increase spontaneous 286 activity (5 cases), to reduce uneasiness/restlessness (4 cases), to feel uplifted (3 cases), to 287 feel soothed (2 cases), and to reduce family's burden of supervision (2 cases). An     The caregivers reported that subjects displayed a positive reaction to PARO (14 labels) 322 in the first month. However, this positive reaction was less noted in subsequent interviews 323 at the second (4 labels) and third (3 labels) months. Improvement in behaviours, which 324 include increased frequency of interaction and diminished agitations, were also reported 325 within the first (4 labels) and second (4 labels) months only. Additionally, the content of 326 reported behaviour considered as an 'improvement' was related to the volume or content  inapplicability of PARO on the second and third months. One caregiver even blamed their 344 self as they said, "It was a shame that I wasn't able to encourage to use PARO very well".

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Caregivers' experiences can be found in table 3. • "Talking PARO is like talking to a child" • "She sat up and reached to pet PARO" 14 Improved behaviour • "She stopped wandering around and stayed seated" • "She became more accepting of care aids' assistance" 4 After 2

Months Positive reaction
• "She appears to love PARO very much" • "She often asks for PARO's whereabouts" 4 Improved behaviour • "She talked more frequently.    It should be noted that this report is a summary of a study of seven cases that were 447 recruited through a public notice, so the participating families had positive attitudes as 448 caregivers, and the result should be interpreted in consideration of it. Accordingly, the 449 benefits observed may not apply to all cases. In the future, it will be necessary to use a 450 larger number of subjects to investigate ways of providing more effective and practical 451 support. Additionally, it will be helpful to explore ways of combining home-based and 452 day-care facility services.