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Alzheimer DiseasePARONCT05626205

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

A study testing PARO robot in people with Alzheimer Disease and Older Adults, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Alzheimer Disease, Older Adults
What is being tested?
PARO robot
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
5 Nov 2022to 30 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Anna Rita Bonfigli contact

00390718003719

a.bonfigli@inrca.it

Elvira Maranesi, Eng contact

00390718004767

e.maranesi@inrca.it

Italy1 site, 1 recruiting

  • IRCCS INRCA Hospital

    Ancona

    Roberta Bevilacqua

    00390718004767, r.bevilacqua@inrca.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
PARO robot
Keywords
technology-based intervention, Alzheimer Disease, Dementia, Older Adults
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PARO robotDevice

    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 groups in NCT05626205
Study groupRoleWhat they receive
Experimental GroupExperimentalThe Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.
Receives: Device: PARO robot
Control GroupNo interventionThe Control Group will receive only the traditional therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in quality of life

    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.

    Measured: baseline, 12 and 24 weeks later

Secondary outcomes (4)

  1. changes in cognitive status

    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.

    Measured: baseline, 12 and 24 weeks later

  2. changes in mood

    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.

    Measured: baseline, 12 and 24 weeks later

  3. changes in signs and symptoms of major depression

    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.

    Measured: baseline, 12 and 24 weeks later

  4. changes in acceptance of the technology

    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.

    Measured: baseline, 12 and 24 weeks later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2022
  2. Study start5 Nov 2022
  3. Primary completion30 Mar 2024 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05626205
Sponsor's protocol ID
INRCA_006_2022
Acronym
PARO
Status last verified
Mar 2024
First submitted
15 Nov 2022
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bevilacqua R, Maranesi E, Felici E, Margaritini A, Amabili G, Barbarossa F, Bonfigli AR, Pelliccioni G, Paciaroni L. Social robotics to support older people with dementia: a study protocol with Paro seal robot in an Italian Alzheimer's day center. Front Public Health. 2023 Jun 21;11:1141460. doi: 10.3389/fpubh.2023.1141460. eCollection 2023.

    PubMed 37415712

Questions about this trial

What is this clinical trial studying?

A study testing PARO robot in people with Alzheimer Disease and Older Adults, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Rita Bonfigli (00390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes in quality of life (time frame: baseline, 12 and 24 weeks later). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05626205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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