Social robotics to support older people with dementia: a study protocol with Paro seal robot in an Italian Alzheimer's day center.

Introduction: The aging of the population and the high incidence of those over 80 lead to an inevitable increase in chronic degenerative diseases, such as dementia, resulting in increased morbidity and disability. Treatment of people with dementia involves both pharmacological and non-pharmacological interventions. In particular, robot-assisted therapy is a potentially useful treatment for dementia as it has the advantage of improving mood, encouraging social interaction and communication. The overall objective of the study is to evaluate the improvement in patient-perceived quality of life following the use of the Paro robot integrated with usual care in the older people with dementia. Methods and analysis: For this study, 20 patients with dementia are recruited and divided into Experimental Group (EG) and Control Group (CG). Twenty-four session of intervention are conducted, divided into 2 sessions per week, for 12 weeks. The therapy sessions last 20 min. The Experimental Group will receive a social robotic intervention with Paro combined with usual care; the Control Group will receive only the traditional therapy, consisting of cognitive stimulation (reality orientation therapy, cognitive training) and occupational activities (painting workshops, cooking workshops, garden therapy, music therapy, etc.). Paro is a seal-shaped robot designed to have a calming effect and elicit emotional responses in patients in hospitals, nursing homes, and retirement homes. Assessment will be performed at the baseline, at the end of intervention and 3 months after the end of intervention. During these phases, several scales will be administered to the patients, such as Quality of Life-Alzheimer's Disease, Addenbrooke's Cognitive Examination, the Rating Anxiety In Dementia scale and the Cornell Scale for Depression in Dementia, Quebec User Evaluation of Satisfaction, Neuropsychiatric Inventory, the Technology Acceptance Model. Discussions: The final goals of the present study are to evaluate the improvement in patient-perceived quality of life following the use of the Paro robot integrated with usual care in the older people with dementia. Ethics and dissemination: The study was approved by the Ethic Committee of the Istituto Nazionale Ricovero e Cura Anziani, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS INRCA) during the session of 12 April 2022. It was recorded in ClinicalTrials.gov on 23 November 2022 on the number NCT05626205. The study findings will be used for publication in peer-reviewed scientific journals and presentations in scientific meetings.