Effectiveness and Cost-Effectiveness of Robot Therapy With the Paro Robot in People Living With Dementia

Summary

The purpose of this study is to evaluate the effectiveness and cost-effectiveness of group robot therapy with the PARO therapy robot in terms of quality of life and neuropsychiatric symptoms in people living with dementia in residential centers. In addition, the acceptability of the robot on the part of the users participating in the study will be evaluated.

The evaluation will be carried out through a multicenter pragmatic clinical trial randomized to an intervention group (PARO therapy robot) or a control group (treatment as usual). Participants in the intervention group will complete three sessions per week with the PARO therapy robot during 12 weeks. Participants in the control group will maintain their standard care. In addition, a follow-up evaluation will be made three months after the end of the intervention to assess the duration of the possible effects.

Conditions

• Dementia
• Neurocognitive Disorders
• Mild Cognitive Impairment

Interventions

BEHAVIORAL

PARO Therapy Robot

Participants allocated to the PARO Therapy Robot group will receive three group robot therapy sessions per week for 12 weeks, in addition to continuing their standard care. Robot therapy session will last 20 minutes. The sessions will be partially guided, intending to allow participants to interact with the robot seal freely for as long as possible, but redirecting the activity if necessary. The sessions will be conducted in group format, in groups of 4 users, with participants sitting in a circle around a table. The professional conducting the sessions will be a therapist with experience in NPT for people living with dementia, and who has attended the training session on the study intervention protocol. The sessions will be structured as follows: 1. Welcome and presentation. 2. Main activity with PARO. 3. PARO cleaning. 4. End of session. A total of 13 different sessions are proposed, to be conducted in a cyclical manner (each session 3 times, except sessions 1 and 2).

Sponsors & Collaborators

• Asturhealth SL

  collaborator UNKNOWN

• Servicio de Evaluación y Planificación del Servicio Canario de la Salud (SESCS)

  collaborator UNKNOWN

• Instituto de Mayores y Servicios Sociales (IMSERSO)

  lead OTHER_GOV

Principal Investigators

• Enrique Perez, Phd · Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

• Teresa Rodriguez, MSc · Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

• Mireia Tofiño, MSc · Centro de Referencia Estatal de atención a personas con enfermedad de Alzheimer y otras demencias - Imserso

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-10

Primary Completion

2023-10-06

Completion

2023-10-06

Countries

• Spain

Study Locations