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Robotic Therapy

PARO Therapy for Dementia (PARO Trial)

N/A

Waitlist Available

Led By Pamela Z Cacchione, PhD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2 this tool is assessed at 70 minutes post the baseline

Awards & highlights

PARO Trial Summary

This trial is testing whether a robotic seal can help decrease agitation in people with dementia or delirium.

Who is the study for?

This trial is for hospitalized adults aged 60-110 with Alzheimer's or related dementia, or delirium, who have shown agitation. They must consent to participate and wear an isolation gown. It excludes those in isolation, with excessive secretions, open wounds, or who do not assent.Check my eligibility

What is being tested?

The study tests if a robotic seal (PARO) can calm patients over two days of interaction versus just having someone sit with them. It also evaluates the robot's cleaning protocol. Agitation levels and emotional responses are recorded both visually and numerically.See study design

What are the potential side effects?

There are no direct medical side effects from participating in this trial as it involves non-pharmacological interventions like interacting with a robotic seal or receiving attention from a researcher.

PARO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within one year of the participants engagement with the study the videotapes are reviewed and coded.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within one year of the participants engagement with the study the videotapes are reviewed and coded.

This trial's timeline: 3 weeks for screening, Varies for treatment, and within one year of the participants engagement with the study the videotapes are reviewed and coded. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cohen-Mansfield agitation inventory observational

Pain in Dementia Scale

Social Interaction Tool

Secondary outcome measures

Emotional response to the robot

Length of stay

Number of 1:1 sitter hours

+1 more

PARO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

This group is randomly selected from the Acute care for elders unit and receives a one hour intervention with the PARO robotic seal two days in a row during their hospital stay.

Group II: Attention Control GroupActive Control1 Intervention

This group is randomly selected from the Acute Care for Elders unit and receives a one hour visit from the Researcher or research assistant two days in a row.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,879,986 Total Patients Enrolled

18 Trials studying Dementia

36,750 Patients Enrolled for Dementia

Pamela Z Cacchione, PhDPrincipal InvestigatorUniversity of Pennsylvania

Media Library

PARO Robotic Seal Intervention (Robotic Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05565703 — N/A

Dementia Research Study Groups: Intervention Group, Attention Control Group

Dementia Clinical Trial 2023: PARO Robotic Seal Intervention Highlights & Side Effects. Trial Name: NCT05565703 — N/A

PARO Robotic Seal Intervention (Robotic Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05565703 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications for enrolling in this clinical research endeavor?

"This medical study seeks 102 elderly participants with dementia, ranging from 60 to 110 years of age. Primarily, the candidates must be admitted in an acute Care for Elders unit and diagnosed with Alzheimer's disease or a related disorder. Furthermore, they need to have experienced agitation during their hospital stay, grant permission through informed consent/assent and agree to wear isolation apparel."

Answered by AI

What aims does this investigation seek to accomplish?

"This detailed trial aims to measure the effects of this tool on Pain in Dementia Scale 70 minutes after baseline. Secondary goals include gauging the patient's use of psychoactive medications, number of 1:1 sitter hours and length of stay post-discharge as recorded in their electronic health record."

Answered by AI

Is the experiment currently recruiting participants?

"According to data available on clinicaltrials.gov, it appears that this medical trial is not actively seeking patients at present. The study was initially posted in October of 2018 and last updated approximately 4 months ago; however, there are currently 541 other trials accepting new participants."

Answered by AI

Does the trial permit individuals aged eighteen and older to participate?

"This specific medical study requires participants to be within a certain age bracket of 60-110 years old. There are 36 trials open for those under 18 and 525 options available for adults over 65."

Answered by AI

Recent research and studies

AJN, American Journal of NursingJournal

Delirium Superimposed on Dementia

Fick, Donna Marie, and Lorraine C. Mion. 2008. “Delirium Superimposed on Dementia”. AJN, American Journal of Nursing. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.naj.0000304476.80530.7d.

International Journal of Geriatric PsychiatryJournal

Regier, Natalie G., and Laura N. Gitlin. 2017. “Dementia-related Restlessness: Relationship to Characteristics of Persons with Dementia and Family Caregivers”. International Journal of Geriatric Psychiatry. Wiley. doi:10.1002/gps.4705.

Journal of GerontologyJournal

A Description of Agitation in a Nursing Home

Cohen-mansfield, J., M. S. Marx, and A. S. Rosenthal. 1989. “A Description of Agitation in a Nursing Home”. Journal of Gerontology. Oxford University Press (OUP). doi:10.1093/geronj/44.3.m77.

clinicaltrials.govStudy

The Use of PARO to Decrease Agitation in Persons With Dementia and/or Delirium