Immersive Technology and Virtual Reality as a Health Support Tool in a Residence for the Elderly

November 1, 2023 updated by: TOPMED

Development and Validation of Sports Facilities in a Supportive Environment to Improve the Well-being of the Elderly

The purpose of this clinical trial is to learn more about the potential for using virtual reality in older adults living in residences for elderly to maintain health (physical activity, cognitive activity, social behaviors). The main questions it aims to answer are:

  • To what extent can virtual reality be a tool to support health in older adults?
  • What are the support needs of older adults in learning to use this immersive technology?

Participants are invited to complete 5 training sessions on the use of a virtual reality headset. At the beginning and end of each session, participants will complete a questionnaire on their perception of their experience. During the sessions, the participants are asked to test games that mobilize the upper limbs. Two learning modalities are set up in two separate groups. These modalities aim to test two different support formulas in order to compare the support needs of the elderly in the use and integration of virtual reality to support the activities and health of this population.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Quebec, Canada, G1S1C1
        • Recruiting
        • Edith Martin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Independent person living in the sponsor's retirement home

Exclusion Criteria:

  • Having a pacemaker
  • Being at risk for epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual assistance

5 sessions with individual assistance

The Virtual Reality (VR) activity will take the form of five (5) training sessions.

  • Session 1: Basics of VR.
  • Session 2: 1-multiplayer game mode.
  • Session 3: Playing with a library. Browsing a library
  • Session 4: 2-individual game mode.
  • Session 5: Game practice.

For each session, in small groups of 3 people, it will be proposed to test games requiring only movements of the upper limbs of low to moderate intensity. Sitting will be mandatory for the tests in order to avoid falls.

5 virtual reality training sessions where feedback will be provided to each individual by the research team
Experimental: Collective assistance

4 sessions with collective assistance and 1 session with individual assistance (session 5)

The Virtual Reality (VR) activity will take the form of five (5) training sessions.

  • Session 1: Basics of VR.
  • Session 2: 1-multiplayer game mode.
  • Session 3: Playing with a library. Browsing a library
  • Session 4: 2-individual game mode.
  • Session 5: Game practice.

For each session, in small groups of 3 people, it will be proposed to test games requiring only movements of the upper limbs of low to moderate intensity. Sitting will be mandatory for the tests in order to avoid falls.

4 virtual reality training sessions where feedback will be provided to the whole group by the research team and 1 session where feedback will be individual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Learning of virtual reality tasks
Time Frame: During each 45 minutes intervention session, up to 6 weeks
Total score on 43 different tasks using a 5 point scale for each task(impossible, help, delay, alone, direct scored from 0 to 4 respectively) .
During each 45 minutes intervention session, up to 6 weeks
Ease
Time Frame: Immediately after each 45 minutes intervention session, up to 6 weeks
measurement of the perception of ease using a 5 point scale (higher score means higher ease during the session)
Immediately after each 45 minutes intervention session, up to 6 weeks
Sense of control: measurement of the participants' sense of control using a scale from 1 to 5
Time Frame: Immediately after each 45 minutes intervention session, up to 6 weeks
measurement of the perception of sense of control using a 5 point scale (higher score means higher sens of control during the session)
Immediately after each 45 minutes intervention session, up to 6 weeks
Satisfaction with supervision
Time Frame: Immediately after each 45 minutes intervention session, up to 6 weeks
measurement of the perception of satisfaction using a 5 point scale (higher score means higher satisfaction during the session)
Immediately after each 45 minutes intervention session, up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress Level at the start of the session
Time Frame: Immediately before each 45 minutes intervention session, up to 6 weeks
measurement of the participants' stress level using a scale from 1 to 5 (higher score means higher stress during the session)
Immediately before each 45 minutes intervention session, up to 6 weeks
Desire to play virtual reality games
Time Frame: Immediately before and after each 45 minutes intervention session, up to 6 weeks
measurement of the participants' desire to play using an opening question
Immediately before and after each 45 minutes intervention session, up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • RD-277_VR and elderly

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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