Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia (PARO)
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| ClinicalTrials.gov Identifier: NCT05626205 |
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Recruitment Status :
Recruiting
First Posted : November 23, 2022
Last Update Posted : March 5, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease Older Adults | Device: PARO robot | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Other |
| Official Title: | PARO: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia |
| Actual Study Start Date : | November 5, 2022 |
| Estimated Primary Completion Date : | March 30, 2024 |
| Estimated Study Completion Date : | March 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental Group
The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.
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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. |
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No Intervention: Control Group
The Control Group will receive only the traditional therapy.
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- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05626205
| Contact: Anna Rita Bonfigli | 00390718003719 | a.bonfigli@inrca.it | |
| Contact: Elvira Maranesi, Eng | 00390718004767 | e.maranesi@inrca.it |
| Italy | |
| IRCCS INRCA Hospital | Recruiting |
| Ancona, Italy | |
| Contact: Roberta Bevilacqua | |
| Contact 00390718004767 r.bevilacqua@inrca.it | |
| Principal Investigator: | Roberta Bevilacqua | IRCCS INRCA |
| Responsible Party: | Istituto Nazionale di Ricovero e Cura per Anziani |
| ClinicalTrials.gov Identifier: | NCT05626205 |
| Other Study ID Numbers: |
INRCA_006_2022 |
| First Posted: | November 23, 2022 Key Record Dates |
| Last Update Posted: | March 5, 2024 |
| Last Verified: | March 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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technology-based intervention Alzheimer Disease Dementia Older Adults |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |