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| Name | Class |
|---|---|
| Natural Sciences and Engineering Research Council, Canada | OTHER |
| SEC Fonds Immobilier Groupe Maurice | UNKNOWN |
| Fédération Québécoise des Loisirs en Institution | UNKNOWN |
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The objective of this clinical trial is to understand the determinants and opportunities for acceptance of immersive technologies to support physical, cognitive, and social health and the possibilities for "aging well" among the new generation of older adults. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual then multiplayer games | Experimental | Participants of this group will conduct the sessions in the following order : Focus group about individual virtual reality games then Focus group about multiplayer virtual reality games. |
|
| Multiplayer then individual games | Experimental | Participants of this group will conduct the sessions in the following order : Focus group about multiplayer virtual reality games then Focus group about individual virtual reality games. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality games | Device | three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perception of Immersive Technologies Experience | 4 open questions were asked during the focus group about satisfaction with the trials. The answers were assessed through a qualitative data theme analysis. The total number of mentionned items by the intervention group is reported for two themes: appreciated items(things that the participants liked during the games), less appreciated items (things that the participants didn't like during the games). | Immediately after each intervention (Week 1, Week 2) |
| Integration of Virtual Reality | 3 open questions were asked during the focus group about intergration of virtual reality(VR) in the daily lives of the participants. The answers were assessed through a qualitative data theme analysis. The total number of mentionned items by the intervention group is reported for two themes: obstacles(factors that make the integration of VR harder in the participant's life), facilitating factors(factors that make the integration of VR easier in the participant's life), . | Immediately after each intervention (Week 1, Week 2) |
| Acceptability of Immersive Technologies | 1 open question was asked during the focus group about intention to use virtual reality(VR) in the daily lives of the participants. The answers were assessed through a qualitative data theme analysis. The total number of mentionned items by the intervention group is reported for one theme: use case of VR items(ways of using VR in the participants daily lives). | Immediately after each intervention (Week 1, Week 2) |
| Change From Baseline in Interest in Immersive Activities | Change from baseline in total score for 13 questions with 3 point scale (low, medium, high respectively scored 1,2,3). Minimum=13(low interest); Maximum=39(High interest); | Baseline and immediately after each intervention (Week 1, Week 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TOPMED | Québec | Quebec | G1S1C1 | Canada |
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7 participants were randomized.
7 candidates were screened for eligibility between April 14, 2023 and May 23, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Individual Then Multiplayer Games | Participants of this group will conduct the sessions in the following order : Focus group about individual virtual reality games then Focus group about multiplayer virtual reality games. Virtual reality games: three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested. |
| FG001 | Multiplayer Then Individual Games | Participants of this group will conduct the sessions in the following order : Focus group about multiplayer virtual reality games then Focus group about individual virtual reality games. Virtual reality games: three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individual Then Multiplayer Games | Participants of this group will conduct the sessions in the following order : Focus group about individual virtual reality games then Focus group about multiplayer virtual reality games. Virtual reality games: three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Perception of Immersive Technologies Experience | 4 open questions were asked during the focus group about satisfaction with the trials. The answers were assessed through a qualitative data theme analysis. The total number of mentionned items by the intervention group is reported for two themes: appreciated items(things that the participants liked during the games), less appreciated items (things that the participants didn't like during the games). | All participants who received the intervention. | Posted | Number | Number of mentionned items | Immediately after each intervention (Week 1, Week 2) |
|
Adverse event data was collected during protocol, which lasted up to 4 weeks, only adverse events which happened during sessions were collected.
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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 Games | Focus group about individual virtual reality games Virtual reality games: three individual games (physical, cognitive and relaxation) |
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| 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 |
| D012919 | Social Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Fédération de l'Age D'Or du Québec |
| UNKNOWN |
All participants will test both multiplayer and individual games. Order of testing is reversed in between arms.
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| BG001 |
| Multiplayer Then Individual Games |
Participants of this group will conduct the sessions in the following order : Focus group about multiplayer virtual reality games then Focus group about individual virtual reality games. Virtual reality games: three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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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| Interest in immersive activities | Total score for 13 questions with 3 point scale (low, medium, high respectively scored 1,2,3). Minimum=13(low interest); Maximum=39(High interest); | Mean | Standard Deviation | units on a scale |
|
| OG001 | Multiplayer Then Individual Games | Participants of this group will conduct the sessions in the following order : Focus group about multiplayer virtual reality games then Focus group about individual virtual reality games. Virtual reality games: three individual games (physical, cognitive and relaxation) and two multiplayer games will be tested. |
|
|
| Primary | Integration of Virtual Reality | 3 open questions were asked during the focus group about intergration of virtual reality(VR) in the daily lives of the participants. The answers were assessed through a qualitative data theme analysis. The total number of mentionned items by the intervention group is reported for two themes: obstacles(factors that make the integration of VR harder in the participant's life), facilitating factors(factors that make the integration of VR easier in the participant's life), . | All participants who received the intervention. | Posted | Number | Total number of mentionned items | Immediately after each intervention (Week 1, Week 2) |
|
|
|
| Primary | Acceptability of Immersive Technologies | 1 open question was asked during the focus group about intention to use virtual reality(VR) in the daily lives of the participants. The answers were assessed through a qualitative data theme analysis. The total number of mentionned items by the intervention group is reported for one theme: use case of VR items(ways of using VR in the participants daily lives). | All participants who received the intervention. | Posted | Number | Number of mentionned items | Immediately after each intervention (Week 1, Week 2) |
|
|
|
| Primary | Change From Baseline in Interest in Immersive Activities | Change from baseline in total score for 13 questions with 3 point scale (low, medium, high respectively scored 1,2,3). Minimum=13(low interest); Maximum=39(High interest); | All participants who received the intervention. | Posted | Mean | Standard Deviation | score on a scale | Baseline and immediately after each intervention (Week 1, Week 2) |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Multiplayer Games | Focus group about multiplayer virtual reality games Virtual reality games: two multiplayer games were tested. | 0 | 7 | 0 | 7 | 0 | 7 |
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| Obstacles, week 2 |
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| Facilitating factors, week 2 |
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