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

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ClinicalTrials.gov Identifier: NCT05626205
Recruitment Status : Recruiting
First Posted : November 23, 2022
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Istituto Nazionale di Ricovero e Cura per Anziani

Tracking Information
First Submitted Date  ICMJE November 15, 2022
First Posted Date  ICMJE November 23, 2022
Last Update Posted Date March 5, 2024
Actual Study Start Date  ICMJE November 5, 2022
Estimated Primary Completion Date March 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2022)		 changes in quality of life [ Time Frame: baseline, 12 and 24 weeks later ]
This outcome will be assesed by the Quality of life in Alzheimer's Disease (QoL-AD) test. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2022)
  • changes in cognitive status [ Time Frame: baseline, 12 and 24 weeks later ]
    This outcome will be assessed by the Addenbrooke's Cognitive Examination (ACE-R). It contains5 sub-scores, each one representing one cognitivedomain: attention/orientation (18 points), memory(26 points), fluency (14 points), language (26 points)and visuospatial (16 points). ACE-R maximum score is 100, composed by the addition of the all domains. is scored out of 100, with a higher score denoting better cognitive function.
  • changes in mood [ Time Frame: baseline, 12 and 24 weeks later ]
    This outcome will be assessed by the Rating Anxiety In Dementia (RAID). Rating should be based on symptoms and signs occurring during two weeks prior to the interview. No score should be given if symptoms result from physical disability or illness. Total score is the sum of items 1 to 18. A score of 11 or more suggests significant clinical anxiety.
  • changes in signs and symptoms of major depression [ Time Frame: baseline, 12 and 24 weeks later ]
    This outcome will be assessed by the Cornell Scale for Depression in Dementia (CSDD). Information is elicited through two semi-structured interviews: an interview of an informant and an interview of the patient. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.
  • changes in acceptance of the technology [ Time Frame: baseline, 12 and 24 weeks later ]
    This outcome will be assessed by the technology through Quebec User Evaluation of Satisfaction (QUEST 2.0). The QUEST 2.0 evaluates the patient's satisfaction with various assistive technologies.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia
Official Title  ICMJE PARO: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Alzheimer Disease
  • Older Adults
Intervention  ICMJE Device: 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.
Study Arms  ICMJE
  • Experimental: Experimental Group
    The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.
    Intervention: Device: PARO robot
  • No Intervention: Control Group
    The Control Group will receive only the traditional therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2022)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2024
Estimated Primary Completion Date March 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anna Rita Bonfigli 00390718003719 a.bonfigli@inrca.it
Contact: Elvira Maranesi, Eng 00390718004767 e.maranesi@inrca.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05626205
Other Study ID Numbers  ICMJE INRCA_006_2022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Istituto Nazionale di Ricovero e Cura per Anziani
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Istituto Nazionale di Ricovero e Cura per Anziani
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roberta Bevilacqua IRCCS INRCA
PRS Account Istituto Nazionale di Ricovero e Cura per Anziani
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP