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| Name | Class |
|---|---|
| Natural Sciences and Engineering Research Council, Canada | OTHER |
| SEC Fonds Immobilier Groupe Maurice | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual assistance | Experimental | 5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) weekly training sessions.
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. |
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| 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.
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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individual assistance Virtual reality training sessions | Other | 5 virtual reality training sessions where feedback will be provided to each individual by the research team |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edith Martin | Québec | Quebec | G1S1C1 | Canada |
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The collective assistance group was abandonned because tests revealed issues with ability of participants to help each other during VR sessions.
No participant was ever assigned to the collective assistance group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Assistance | 5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) training sessions.
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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Assistance | 5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) training sessions.
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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
Adverse event data was collected for the duration of the protocol wich took 29 days.
No participants were ever assigned to the collective assistance group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Individual Assistance | 5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) training sessions.
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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edith Martin | Topmed | 418 683-2104 | 1302 | emartin@topmed.ca |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2025 | Jun 25, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2025 | Jun 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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2 groups with different learning modalities (individual feedback compared to collective feedback)
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| Collective assistance Virtual reality training sessions | Other | 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. |
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| Desire to Play Virtual Reality Games |
number of participants mentionning the 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ID |
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| Title |
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| Description |
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| OG000 | Individual Assistance | 5 sessions with individual assistance The Virtual Reality (VR) activity will take the form of five (5) training sessions.
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 |
| OG001 | 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. |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
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| Secondary | Desire to Play Virtual Reality Games | number of participants mentionning the desire to play virtual reality games | 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. | Posted | Count of Participants | Participants | 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) |
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| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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