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

Sponsor

TOPMED (Other)

Overall Status

Recruiting

CT.gov ID

NCT06117319

Collaborator

Conseil de recherches en sciences naturelles et en génie du Canada (Other), SEC Fonds Immobilier Groupe Maurice (Other)

Enrollment

Location

Arms

12.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Well	Other: Individual assistance Virtual reality training sessions Other: Collective assistance Virtual reality training sessions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 groups with different learning modalities (individual feedback compared to collective feedback)2 groups with different learning modalities (individual feedback compared to collective feedback)

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 27, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.	Other: Individual assistance Virtual reality training sessions 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.	Other: Collective assistance Virtual reality training sessions 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.

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.

Other: Individual assistance Virtual reality training sessions

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.

Other: Collective assistance Virtual reality training sessions

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.

Outcome Measures

Primary Outcome Measures

Learning of virtual reality tasks [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) .
Ease [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)
Sense of control: measurement of the participants' sense of control using a scale from 1 to 5 [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)
Satisfaction with supervision [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)

Secondary Outcome Measures

Stress Level at the start of the session [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)
Desire to play virtual reality games [Immediately before and after each 45 minutes intervention session, up to 6 weeks]
measurement of the participants' desire to play using an opening question

Eligibility Criteria

Criteria

Ages Eligible for Study:

64 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Independent person living in the sponsor's retirement home

Exclusion Criteria:

Having a pacemaker
Being at risk for epilepsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edith Martin	Quebec		Canada	G1S1C1

Sponsors and Collaborators

TOPMED
Conseil de recherches en sciences naturelles et en génie du Canada
SEC Fonds Immobilier Groupe Maurice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TOPMED

ClinicalTrials.gov Identifier:

NCT06117319

Other Study ID Numbers:

RD-277_VR and elderly

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by TOPMED

Study Results

No Results Posted as of Nov 7, 2023