The increase in life expectancy in recent decades has been associated with inevitable aging
of the population and a rise in the prevalence of dementia. The World Health Organization
(WHO) defines dementia as an acquired condition involving multiple cognitive disabilities
that are sufficient to interfere with the daily life of the patients and their environment,
with important associated personal suffering and economic costs. Despite advances in recent
years, the diagnosis and course of dementia remains a challenge for professionals, and there
continue to be important social and healthcare shortcomings regarding prevention, treatment
and care.
Due to the deficiencies of the existing drugs, non-pharmacological therapies (NPT) are
particularly relevant in the management of dementia. A NPT is any non-chemical, theoretically
supported, focused and replicable intervention that is potentially able to produce a relevant
benefit. Among these NPT, mention must be made of robot therapy, which involves the use of
robots that simulate animals and are equipped with artificial intelligence and multiple
sensors that allow them to behave and interact with users as if they were a real animal.
Therapy robots are regarded as an alternative to animal-assisted therapy, avoiding
complications arising from the presence of animals while affording similar effects. The
Personal Assistant Robot (PARO) robot seal was developed with this purpose in mind. It is the
most widely used robot in the field of dementia, and also the most widely studied robot.
Designed in Japan by Professor T. Shibata, PARO is an interactive robot with five types of
sensors (light, touch, posture, temperature and sound), and it has demonstrated the ability
to provide social and emotional stimulation.
In people living with dementia, robot therapy has been shown to offer psychological benefits
(improved relaxation and motivation), physiological benefits (improved vital signs) and
social benefits (stimulation of communication). In addition, the most recent studies have
shown robot therapy to exert positive effects upon cognitive function, agitation, anxiety,
depression, other neuropsychiatric symptoms and quality of life. However, other reviews have
not recorded sufficient evidence of the positive effects of robot therapy upon cognition,
neuropsychiatric symptoms or quality of life. Further quality studies are therefore needed on
the effect of robot therapy in people living with dementia.
In this regard, the proposed study is aimed at evaluating the effectiveness and
cost-effectiveness of group robot therapy intervention with the PARO robot in terms of
quality of life and neuropsychiatric symptoms in people living with dementia in residential
centers. In addition, the acceptability of the intervention on the part of the users
participating in the study will be evaluated. For this purpose, a multicenter study will be
carried out in the form of a randomized clinical trial in which the selected participants
will be randomized to an intervention group (PARO Therapy Robot) or a control group (standard
care).
Hypothesis:
After the intervention, participants in the experimental group will improve their
quality of life scores compared with the control group receiving standard care, where
scores will be maintained or will get worse.
Participants in the experimental group will have fewer neuropsychiatric alterations than
participants in the control group.
Participants in the experimental group will reduce their depression scores versus
participants in the control group.
Participants in the experimental group will experience less agitation than participants
in the control group.
Participants in the experimental group will experience less apathy than participants in
the control group.
The PARO robot will be well accepted by the individuals living with dementia.
PARO Therapy Robot will be efficient in comparison with standard care. Objectives
The primary study objective is:
• To compare the effectiveness of the PARO Therapy Robot and standard care in improving the
quality of life of people with dementia living in residential centers.
The secondary objectives are:
To compare the effectiveness of the PARO Therapy Robot and standard care in reducing
neuropsychiatric disorders in people with dementia. Specifically, efficacy will be
compared in terms of:
To evaluate the acceptability of the PARO robot on the part of the patients.
To perform a cost-effectiveness and cost-utility analysis, comparing the direct costs of
the PARO Therapy Robot and standard care with the results afforded by the two
alternatives.