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

Last updated: March 4, 2024
Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

PARO robot

Clinical Study ID

NCT05626205
INRCA_006_2022
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of mild-moderate dementia according to the Diagnostic and Statistical Manualof 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

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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: PARO robot
Phase:
Study Start date:
November 05, 2022
Estimated Completion Date:
March 30, 2024

Study 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.

Connect with a study center

  • IRCCS INRCA Hospital

    Ancona,
    Italy

    Active - Recruiting

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