Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-05

Study Completion Date

2024-03-30

Brief Summary

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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 traditional intervention in the elderly with dementia.

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Detailed Description

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The primary aim of this study is to evaluate the patient-perceived improvement in terms of quality of life through Quality of Life - Alzheimer's Disease (QoL-AD), following the use of the Paro robot, integrated with traditional intervention carried out within the IRCCS INRCA Alzheimer's Day Center.

The Secondary aims are the evaluation of the improvement in cognitive status of the elderly person with dementia, in terms of orientation, attentional-executive, mnestic and visuospatial functions, detected through the Addenbrooke's Cognitive Examination (ACE-R); the assessment of mood improvement in terms of reduction of anxiety and depression, detected through the Rating Anxiety In Dementia (RAID) scale and the Cornell Scale for Depression in Dementia (CSDD); the assessment of the elderly person's acceptance of the technology through Quebec User Evaluation of Satisfaction (QUEST 2.0), semi-structured interview and analysis of physiological activation during interaction, with the Noldus Face Reader system and direct observation by the operator; the analysis of behavioral symptomatology through Neuropsychiatric Inventory (NPI); the assessment of practitioner's acceptance of technology through Technology Acceptance Model (TAM) and the assessment of job quality through semi-structured interview.

Conditions

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Alzheimer Disease Older Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.

Group Type EXPERIMENTAL

PARO robot

Intervention Type DEVICE

PARO is an advanced interactive robot. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties. PARO has five kinds of sensors: tactile, light, audition, temperature, and posture sensors, with which it can perceive people and its environment. PARO can learn to behave in a way that the user prefers, and to respond to its new name.

Control Group

The Control Group will receive only the traditional therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PARO robot

PARO is an advanced interactive robot. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties. PARO has five kinds of sensors: tactile, light, audition, temperature, and posture sensors, with which it can perceive people and its environment. PARO can learn to behave in a way that the user prefers, and to respond to its new name.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of mild-moderate dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V).
* MMSE between 10 and 24
* Attending the Alzheimer's Day Center since at least 3 months
* Presence of a caregiver

Exclusion Criteria

* Severe sensory disabilities (visual and auditory)
* Comprehension difficulties
* History of syncopal episodes, epilepsy, and dizziness not controlled pharmacologically
* Severe autonomic system dysfunction
* Severe behavioral syndromes not compensated by medication

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No