Aging WellNCT06117319

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

A study testing Individual assistance Virtual reality training sessions and Collective assistance Virtual reality training sessions in people with Aging Well, run by TOPMED at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 64 years and olderHealthy volunteers can take part
Conditions the study is for: Aging Well
What is being tested?: Individual assistance Virtual reality training sessions and Collective assistance Virtual reality training sessions
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteCanada
Study dates: 27 Feb 2023to 16 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 64 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Independent person living in the sponsor's retirement home

Who cannot join

Having a pacemaker
Being at risk for epilepsy

Trial locations and contacts

1 site in 1 country.

Canada1 site

Edith Martin
Québec, Quebec, G1S1C1

Other trials in Canada

About this study

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

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 weekly 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.

Conditions: Aging Well
Being tested: Individual assistance Virtual reality training sessions, Collective assistance Virtual reality training sessions
Keywords: Aging well, virtual reality, activity, learning
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Individual assistance Virtual reality training sessionsOther
5 virtual reality training sessions where feedback will be provided to each individual by the research team
Collective assistance Virtual reality training sessionsOther
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. No participant was ever assigned to this intervention.

Study groups in NCT06117319
Study group	Role	What they receive
Individual assistance	Experimental	5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) weekly training sessions. * Session 1(day 1): Basics of VR. * Session 2(day 8): 1-multiplayer game mode. * Session 3(day 15): Playing with a library. Browsing a library * Session 4(day 22): 2-individual game mode. * Session 5(day 29): 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. Receives: Other: Individual assistance Virtual reality training sessions
Collective assistance	Experimental	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(day 1): Basics of VR. * Session 2(day 8): 1-multiplayer game mode. * Session 3(day 15): Playing with a library. Browsing a library * Session 4(day 22): 2-individual game mode. * Session 5(day 29): 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. The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions. No participants were ever assigned to this group. Receives: Other: Collective assistance Virtual reality training sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

Learning of Virtual Reality Tasks
Total score on 43 different tasks using a 5 point scale for each task(impossible(0), completion with external help(1), delay before individual completion and multiple repetitions(2), individual completion with less than 2 repetitions(3), individual completion without repetition(4) scored from 0 to 4 respectively). Scores for each session are averaged (Total score range from 0 to 4). Interpretations should be taken with caution(see Analysis population description).
Measured: During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Ease
Measurement of the perception of ease using a one item 5 point scale (higher score means higher ease during the session).Total score range from 1 to 5.
Measured: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
measurement of the perception of sense of control using a one item 1-5 point scale (higher score means higher sense of control during the session).Total score range from 1 to 5.
Measured: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Satisfaction With Supervision
measurement of the perception of satisfaction using a one item 5 point scale (higher score means higher satisfaction during the session). Total score range from 1 to 5.
Measured: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

Secondary outcomes (2)

Stress Level at the Start of the Session
Measurement of the participants' stress level using a 1-item scale from 1 to 5 (lower score means higher stress), total scale range is 1 to 5
Measured: Immediately before each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Desire to Play Virtual Reality Games
number of participants mentionning the desire to play virtual reality games
Measured: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 202316 Apr 2024

First posted7 Nov 2023
Study start27 Feb 2023
Primary completion16 Apr 2024
Study completion16 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Aging WellStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: 2 groups with different learning modalities (individual feedback compared to collective feedback)
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06117319
Sponsor's protocol ID: RD-277_VR and elderly
Status last verified: Aug 2025
First submitted: 13 Sep 2023
Last updated: 27 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Effectiveness Evaluation for Pathway to Healthy Aging (Path-HA) Care on Health Status of Older Adults
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Effectiveness of a Smartphone Chatbot to Improve Exercise Adherence in Older Adults
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All Aging Well trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Validation of Sports Facilities in a Supportive Environment to Improve the Well-being of the Elderly
ClinicalTrials.gov ID: NCT06117319
Acronym / sponsor ID: RD-277_VR and elderly
Conditions: Aging Well
Keywords: Aging well, virtual reality, activity, learning
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: TOPMEDUniversity, hospital or other
Collaborators: Natural Sciences and Engineering Research Council, Canada, SEC Fonds Immobilier Groupe Maurice
Study start: 27 Feb 2023 (actual)
Primary completion: 16 Apr 2024 (actual)
Study completion: 16 Apr 2024 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 27 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 2 groups with different learning modalities (individual feedback compared to collective feedback)

Arm	Type	Receives
Individual assistance	Experimental	Other: Individual assistance Virtual reality training sessions5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) weekly training sessions. * Session 1(day 1): Basics of VR. * Session 2(day 8): 1-multiplayer game mode. * Session 3(day 15): Playing with a library. Browsing a library * Session 4(day 22): 2-individual game mode. * Session 5(day 29): 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.
Collective assistance	Experimental	Other: Collective assistance Virtual reality training sessions4 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(day 1): Basics of VR. * Session 2(day 8): 1-multiplayer game mode. * Session 3(day 15): Playing with a library. Browsing a library * Session 4(day 22): 2-individual game mode. * Session 5(day 29): 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. The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions. No participants were ever assigned to this group.

Who may qualify

Ages: 64 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Independent person living in the sponsor's retirement home

Key exclusion criteria (2 listed)

Having a pacemaker
Being at risk for epilepsy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Individual assistance Virtual reality training sessions5 virtual reality training sessions where feedback will be provided to each individual by the research team	Other	Individual assistance
Collective assistance Virtual reality training sessions4 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. No participant was ever assigned to this intervention.	Other	Collective assistance

Primary outcome

Learning of Virtual Reality Tasks
Time frame: During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Total score on 43 different tasks using a 5 point scale for each task(impossible(0), completion with external help(1), delay before individual completion and multiple repetitions(2), individual completion with less than 2 repetitions(3), individual completion without repetition(4) scored from 0 to 4 respectively). Scores for each session are averaged (Total score range from 0 to 4). Interpretations should be taken with caution(see Analysis population description).
Ease
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Measurement of the perception of ease using a one item 5 point scale (higher score means higher ease during the session).Total score range from 1 to 5.
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 on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
measurement of the perception of sense of control using a one item 1-5 point scale (higher score means higher sense of control during the session).Total score range from 1 to 5.
Satisfaction With Supervision
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
measurement of the perception of satisfaction using a one item 5 point scale (higher score means higher satisfaction during the session). Total score range from 1 to 5.

2 secondary outcomes

Stress Level at the Start of the Session
Time frame: Immediately before each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)
Desire to Play Virtual Reality Games
Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)

Results and safety

Results posted to the registry on 27 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Individual Assistance	34	34
Collective Assistance	0	0

Primary outcome: Learning of Virtual Reality Tasks

Time frame: During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29). Mean (Standard Deviation). Unit: score on a scale

Measure	Individual Assistance n = 34	Collective Assistance n = 0
Session 1	2.13 (0.10)	–
Session 2	2.17 (0.08)	–
Session 3	2.22 (0.10)	–
Session 4	2.22 (0.15)	–
Session 5	2.28 (0.10)	–

Population analysed: The evaluators were also tasked to provide assistance to the participants, if needed, during sessions. However, the amount of assistance needed by the participants was much higher than anticipated and hindered data collection. Each task and each participant were missing data. Some participants were missing data for up to 80% of all tasks for a session. As an example, for a particular task, only 7 participants provided data in session 1, whereas in session 3, 26 participants provided data.

Primary outcome: Ease

Time frame: Immediately after each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29). Mean (Standard Deviation). Unit: units on a scale

Measure	Individual Assistance n = 34	Collective Assistance n = 0
Session 1(day 1)	4.06 (1.01)	–
Session 2(day 8)	3.53 (1.16)	–
Session 3(day 15)	4.11 (1.03)	–
Session 4(day 22)	3.58 (1.18)	–
Session 5(day 29)	4.00 (1.19)	–

Population analysed: Number of participants analyzed for each session varies based on the number of participants present that day. Since group session were scheduled, absent participants couldn't complete the session later.

Primary outcome: Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5

Measure	Individual Assistance n = 34	Collective Assistance n = 0
Session 1(day 1)	3.85 (0.82)	–
Session 2(day 8)	3.53 (0.92)	–
Session 3(day 15)	3.57 (0.96)	–
Session 4(day 22)	3.19 (1.14)	–
Session 5(day 29)	3.79 (1.07)	–

Primary outcome: Satisfaction With Supervision

Measure	Individual Assistance n = 34	Collective Assistance n = 0
Session 1(day 1)	4.76 (0.61)	–
Session 2(day 8)	4.41 (0.95)	–
Session 3(day 15)	4.68 (0.26)	–
Session 4(day 22)	4.35 (0.95)	–
Session 5(day 29)	4.93 (0.37)	–

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the duration of the protocol wich took 29 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Individual Assistance	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Collective Assistance	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The collective assistance group was abandoned because tests revealed issues with the ability of participants to help each other during VR sessions. No participants were ever assigned to this group. Primary outcome 1 has a 80% missing data ratio for some tasks, futhermore missing data was present in all participants. Interpretations should be taken with caution.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Individual assistance Virtual reality training sessions and Collective assistance Virtual reality training sessions in people with Aging Well, run by TOPMED at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Learning of Virtual Reality Tasks (time frame: During each 45 minutes intervention session on Session 1(Day 1), Session 2(Day 8), Session 3(Day 15), Session 4(Day 22), Session 5(Day 29)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06117319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.