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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Enrolling

Conditions

Alzheimer Disease
Older Adults

Treatments

Device: PARO robot

Study type

Interventional

Funder types

Other

Identifiers

NCT05626205
INRCA_006_2022

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Experimental Group
Experimental group
Description:
The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.
Treatment:
Device: PARO robot
Control Group
No Intervention group
Description:
The Control Group will receive only the traditional therapy.

Trial contacts and locations

1

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Central trial contact

Anna Rita Bonfigli; Elvira Maranesi, Eng

Data sourced from clinicaltrials.gov

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