- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06117319
Immersive Technology and Virtual Reality as a Health Support Tool in a Residence for the Elderly
Development and Validation of Sports Facilities in a Supportive Environment to Improve the Well-being of the Elderly
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 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Édith Martin
- Phone Number: 4187801301
- Email: emartin@topmed.ca
Study Locations
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-
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Quebec, Canada, G1S1C1
- Recruiting
- Edith Martin
-
Contact:
- Edith Martin, Ph.D
- Phone Number: 4187801301
- Email: emartin@topmed.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Independent person living in the sponsor's retirement home
Exclusion Criteria:
- Having a pacemaker
- Being at risk for epilepsy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
5 virtual reality training sessions where feedback will be provided to each individual by the research team
|
Experimental: Collective assistance
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Learning of virtual reality tasks
Time Frame: During each 45 minutes intervention session, up to 6 weeks
|
Total score on 43 different tasks using a 5 point scale for each task(impossible, help, delay, alone, direct scored from 0 to 4 respectively) .
|
During each 45 minutes intervention session, up to 6 weeks
|
Ease
Time Frame: Immediately after each 45 minutes intervention session, up to 6 weeks
|
measurement of the perception of ease using a 5 point scale (higher score means higher ease during the session)
|
Immediately after each 45 minutes intervention session, up to 6 weeks
|
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, up to 6 weeks
|
measurement of the perception of sense of control using a 5 point scale (higher score means higher sens of control during the session)
|
Immediately after each 45 minutes intervention session, up to 6 weeks
|
Satisfaction with supervision
Time Frame: Immediately after each 45 minutes intervention session, up to 6 weeks
|
measurement of the perception of satisfaction using a 5 point scale (higher score means higher satisfaction during the session)
|
Immediately after each 45 minutes intervention session, up to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress Level at the start of the session
Time Frame: Immediately before each 45 minutes intervention session, up to 6 weeks
|
measurement of the participants' stress level using a scale from 1 to 5 (higher score means higher stress during the session)
|
Immediately before each 45 minutes intervention session, up to 6 weeks
|
Desire to play virtual reality games
Time Frame: Immediately before and after each 45 minutes intervention session, up to 6 weeks
|
measurement of the participants' desire to play using an opening question
|
Immediately before and after each 45 minutes intervention session, up to 6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RD-277_VR and elderly
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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