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

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

Sponsors

Lead Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani

Source Istituto Nazionale di Ricovero e Cura per Anziani
Brief Summary

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.

Detailed Description

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.

Overall Status Recruiting
Start Date 2022-10-01
Completion Date 2023-04-29
Primary Completion Date 2023-04-29
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
changes in quality of life baseline, 12 and 24 weeks later
Secondary Outcome
Measure Time Frame
changes in cognitive status baseline, 12 and 24 weeks later
changes in mood baseline, 12 and 24 weeks later
changes in signs and symptoms of major depression baseline, 12 and 24 weeks later
changes in acceptance of the technology baseline, 12 and 24 weeks later
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: PARO robot

Description: 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.

Arm Group Label: Experimental Group

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

65 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Roberta Bevilacqua Principal Investigator IRCCS INRCA
Overall Contact

Last Name: Anna Rita Bonfigli

Phone: 00390718003719

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: IRCCS INRCA Hospital Roberta Bevilacqua
Location Countries

Italy

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Experimental Group

Type: Experimental

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

Label: Control Group

Type: No Intervention

Description: The Control Group will receive only the traditional therapy.

Acronym PARO
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: Single (Outcomes Assessor)

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