Trial Outcomes & Findings for Immersive Technology and Virtual Reality as a Health Support Tool in a Residence for the Elderly (NCT NCT06117319)
NCT ID: NCT06117319
Last Updated: 2025-08-27
Results Overview
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).
COMPLETED
NA
34 participants
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)
2025-08-27
Participant Flow
No participant was ever assigned to the collective assistance group.
The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions.
Participant milestones
| Measure |
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
0
|
|
Overall Study
COMPLETED
|
34
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immersive Technology and Virtual Reality as a Health Support Tool in a Residence for the Elderly
Baseline characteristics by cohort
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=93 Participants
|
—
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=93 Participants
|
—
|
24 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
—
|
10 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
—
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=93 Participants
|
—
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=93 Participants
|
—
|
34 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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).
Outcome measures
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Learning of Virtual Reality Tasks
Session 1
|
2.13 score on a scale
Standard Deviation 0.10
|
—
|
|
Learning of Virtual Reality Tasks
Session 2
|
2.17 score on a scale
Standard Deviation 0.08
|
—
|
|
Learning of Virtual Reality Tasks
Session 3
|
2.22 score on a scale
Standard Deviation 0.10
|
—
|
|
Learning of Virtual Reality Tasks
Session 4
|
2.22 score on a scale
Standard Deviation 0.15
|
—
|
|
Learning of Virtual Reality Tasks
Session 5
|
2.28 score on a scale
Standard Deviation 0.10
|
—
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Ease
Session 1(day 1)
|
4.06 units on a scale
Standard Deviation 1.01
|
—
|
|
Ease
Session 2(day 8)
|
3.53 units on a scale
Standard Deviation 1.16
|
—
|
|
Ease
Session 3(day 15)
|
4.11 units on a scale
Standard Deviation 1.03
|
—
|
|
Ease
Session 4(day 22)
|
3.58 units on a scale
Standard Deviation 1.18
|
—
|
|
Ease
Session 5(day 29)
|
4.00 units on a scale
Standard Deviation 1.19
|
—
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
Session 1(day 1)
|
3.85 units on a scale
Standard Deviation 0.82
|
—
|
|
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
Session 2(day 8)
|
3.53 units on a scale
Standard Deviation 0.92
|
—
|
|
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
Session 3(day 15)
|
3.57 units on a scale
Standard Deviation 0.96
|
—
|
|
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
Session 4(day 22)
|
3.19 units on a scale
Standard Deviation 1.14
|
—
|
|
Sense of Control: Measurement of the Participants' Sense of Control Using a Scale From 1 to 5
Session 5(day 29)
|
3.79 units on a scale
Standard Deviation 1.07
|
—
|
PRIMARY outcome
Timeframe: 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)Population: 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.
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.
Outcome measures
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Satisfaction With Supervision
Session 1(day 1)
|
4.76 score on a scale
Standard Deviation 0.61
|
—
|
|
Satisfaction With Supervision
Session 2(day 8)
|
4.41 score on a scale
Standard Deviation 0.95
|
—
|
|
Satisfaction With Supervision
Session 3(day 15)
|
4.68 score on a scale
Standard Deviation 0.26
|
—
|
|
Satisfaction With Supervision
Session 4(day 22)
|
4.35 score on a scale
Standard Deviation 0.95
|
—
|
|
Satisfaction With Supervision
Session 5(day 29)
|
4.93 score on a scale
Standard Deviation 0.37
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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.
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
Outcome measures
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Stress Level at the Start of the Session
Session 1(day 1)
|
4.38 score on a scale
Standard Deviation 0.85
|
—
|
|
Stress Level at the Start of the Session
Session 2(day 8)
|
4.78 score on a scale
Standard Deviation 0.55
|
—
|
|
Stress Level at the Start of the Session
Session 3(day 15)
|
4.89 score on a scale
Standard Deviation 0.42
|
—
|
|
Stress Level at the Start of the Session
Session 4(day 22)
|
4.77 score on a scale
Standard Deviation 0.50
|
—
|
|
Stress Level at the Start of the Session
Session 5(day 29)
|
4.76 score on a scale
Standard Deviation 0.44
|
—
|
SECONDARY outcome
Timeframe: 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)Population: 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. 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.
number of participants mentionning the desire to play virtual reality games
Outcome measures
| Measure |
Individual Assistance
n=34 Participants
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.
Individual assistance Virtual reality training sessions: 5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Collective Assistance
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.
|
|---|---|---|
|
Desire to Play Virtual Reality Games
Session 5(Day 29)
|
9 Participants
|
—
|
|
Desire to Play Virtual Reality Games
Session 1(Day 1)
|
4 Participants
|
—
|
|
Desire to Play Virtual Reality Games
Session 2(Day 8)
|
3 Participants
|
—
|
|
Desire to Play Virtual Reality Games
Session 3(Day 15)
|
2 Participants
|
—
|
|
Desire to Play Virtual Reality Games
Session 4(Day 22)
|
4 Participants
|
—
|
Adverse Events
Individual Assistance
Collective Assistance
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60