NCT05626205

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

November 15, 2022

Last Update Submit

March 4, 2024

Conditions

Alzheimer DiseaseOlder Adults

Keywords

technology-based interventionAlzheimer DiseaseDementiaOlder Adults

Outcome Measures

Primary Outcomes (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.

    baseline, 12 and 24 weeks later

Secondary Outcomes (4)

  • changes in cognitive status

    baseline, 12 and 24 weeks later

  • changes in mood

    baseline, 12 and 24 weeks later

  • changes in signs and symptoms of major depression

    baseline, 12 and 24 weeks later

  • changes in acceptance of the technology

    baseline, 12 and 24 weeks later

Study Arms (2)

Experimental Group

EXPERIMENTAL

The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.

Device: PARO robot

Control Group

NO INTERVENTION

The Control Group will receive only the traditional therapy.

Interventions

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.

Experimental Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS INRCA Hospital

Ancona, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37415712DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Roberta Bevilacqua

    IRCCS INRCA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

00390718003719a.bonfigli@inrca.it

Elvira Maranesi, Eng

CONTACT

00390718004767e.maranesi@inrca.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 23, 2022

Study Start

November 5, 2022

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Locations

IT(1)