Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-30 @ 4:47 PM
Study NCT ID:
NCT04717895
Status:
UNKNOWN
Last Update Posted:
2023-01-17
First Post:
2020-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological and Postural Effects of Exposure to Both Types of Virtual Environments
Sponsor:
Gérond'if
Organization:
Study Overview
Official Title:
Psychological and Postural Effects of Exposure to Both Types of Virtual Environments
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREUV
Brief Summary:
The main aim of this study is to compare the fear of falling induced by each type of virtual scene (rocking and translation). Fear of falling will be assessed by a numerical fear of falling scale.
The benefits for the participants would be the discovery of Virtuel Reality, the awareness of their fear of falling and its repercussions on posture and, if necessary, referral to specialized rehabilitation centers. This study will provide evidence on the context of the emergence of the fear of falling in order to propose, in perspective, appropriate rehabilitation management procedures.
The benefits for the participants would be the discovery of Virtuel Reality, the awareness of their fear of falling and its repercussions on posture and, if necessary, referral to specialized rehabilitation centers. This study will provide evidence on the context of the emergence of the fear of falling in order to propose, in perspective, appropriate rehabilitation management procedures.
Detailed Description:
This bicentric study will proceed as follows:
* Complete clinical examination, carried out as part of your consultation in a day hospital.
* Perform a virtual reality session of about 2 hours. This session will take place as follows:
* Wear a virtual reality headset. The helmet is compatible with the wearing of glasses.
* View a virtual scene for two minutes in order to familiarize yourself with the device. This first viewing will be followed by a 10 minute break.
* Then the patient will be placed on a rectangular platform (Wii Balance Board - WBB)
* Give the virtual reality headset again to the patient, who will view a 2-minute series of a series of 2 minutes in a standing position comprising a moving virtual environment (one tilting forward and another in forward translation).
* After a 10 minute break, the session will continue with 4 other sets of 5 minutes duration (5 times 1 minute of a forward tilt or forward translation scene). These 4 series will be separated by 10 min break
* During each break, the patient participating in the study will complete a questionnaire on the possible side effects of virtual reality (cybermalaise).
* Complete clinical examination, carried out as part of your consultation in a day hospital.
* Perform a virtual reality session of about 2 hours. This session will take place as follows:
* Wear a virtual reality headset. The helmet is compatible with the wearing of glasses.
* View a virtual scene for two minutes in order to familiarize yourself with the device. This first viewing will be followed by a 10 minute break.
* Then the patient will be placed on a rectangular platform (Wii Balance Board - WBB)
* Give the virtual reality headset again to the patient, who will view a 2-minute series of a series of 2 minutes in a standing position comprising a moving virtual environment (one tilting forward and another in forward translation).
* After a 10 minute break, the session will continue with 4 other sets of 5 minutes duration (5 times 1 minute of a forward tilt or forward translation scene). These 4 series will be separated by 10 min break
* During each break, the patient participating in the study will complete a questionnaire on the possible side effects of virtual reality (cybermalaise).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: