NCT06117319

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 27, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

September 13, 2023

Results QC Date

April 11, 2025

Last Update Submit

August 7, 2025

Conditions

Keywords

Aging wellvirtual realityactivitylearning

Outcome Measures

Primary Outcomes (4)

  • 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).

    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.

    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.

    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.

    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

    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

    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)

Study Arms (2)

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.

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.

Other: Collective assistance Virtual reality training sessions

Interventions

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

Individual assistance

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.

Collective assistance

Eligibility Criteria

Age64 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Independent person living in the sponsor's retirement home

You may not qualify if:

  • Having a pacemaker
  • Being at risk for epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Martin

Québec, Quebec, G1S1C1, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Limitations and Caveats

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.

Results Point of Contact

Title
Edith Martin
Organization
Topmed

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 2 groups with different learning modalities (individual feedback compared to collective feedback)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2023

First Posted

November 7, 2023

Study Start

February 27, 2023

Primary Completion

April 16, 2024

Study Completion

April 16, 2024

Last Updated

August 27, 2025

Results First Posted

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations