PREUV: Psychological and Postural Effects of Exposure to Both Types of Virtual Environments

Sponsor

Gérond'if (Other)

Overall Status

Recruiting

CT.gov ID

NCT04717895

Collaborator

(none)

Enrollment

Location

Arms

7.3

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autonomous Subjects, Aged 65 and Afraid of Falling	Diagnostic Test: Rocking environment forward (B) followed by a translation environment Diagnostic Test: Translation environment followed by a rocking environment	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomization will be carried out after inclusion and allocation of a selection / inclusion number of subjects and will be carried out as follows: Subjects included and who will be identified with an even selection number will begin the virtual reality session by viewing a rocking environment followed by a translation environment Subjects included and who will be identified with an odd selection number will start the virtual reality session by viewing a translation environment followed by a rocking environmentRandomization will be carried out after inclusion and allocation of a selection / inclusion number of subjects and will be carried out as follows:Subjects included and who will be identified with an even selection number will begin the virtual reality session by viewing a rocking environment followed by a translation environment Subjects included and who will be identified with an odd selection number will start the virtual reality session by viewing a translation environment followed by a rocking environment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Psychological and Postural Effects of Exposure to Both Types of Virtual Environments

Actual Study Start Date :

Apr 24, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1st Situation Subjects included will be identified with an even selection number will begin the virtual reality session by viewing a rocking environment followed by a translation environment	Diagnostic Test: Rocking environment forward (B) followed by a translation environment Start by the virtual reality session by viewing a rocking environment followed by a translation environment
Active Comparator: 2nd Situation Subjects included will be identified with an odd selection number will start the virtual reality session by viewing a translation environment followed by a rocking environment	Diagnostic Test: Translation environment followed by a rocking environment Start by the virtual reality session by viewing a translation environment followed by a rocking environment

Arm

Intervention/Treatment

Experimental: 1st Situation

Subjects included will be identified with an even selection number will begin the virtual reality session by viewing a rocking environment followed by a translation environment

Diagnostic Test: Rocking environment forward (B) followed by a translation environment

Start by the virtual reality session by viewing a rocking environment followed by a translation environment

Active Comparator: 2nd Situation

Subjects included will be identified with an odd selection number will start the virtual reality session by viewing a translation environment followed by a rocking environment

Diagnostic Test: Translation environment followed by a rocking environment

Start by the virtual reality session by viewing a translation environment followed by a rocking environment

Outcome Measures

Primary Outcome Measures

measurement of fear of falling using a Numeric scale of fear of falling [2 Hours]

Secondary Outcome Measures

assess posture by recording the coordinates of center of pressure during exposure to Virtual Reality using the Wii Balance Board (WBB) [2 Hours]
Evaluate the subjective perception of stability which will be evaluated using a numerical scale of the perception of stability [2 Hours]
Cyber sickness will be assessed by the Simulator Sickness Questionnaire [2 Hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age ≥ 65 years old
Declaring to be able to maintain the upright station without technical assistance for at least 5 minutes
Being afraid of falling with a score greater than or equal to 23 on the Falls Efficacy Scale-International questionnaire (Yardley et al., 2005)
Good understanding of the French language
Benefiting from a social security system
Have read the information notice and have consented to participate in the study by signing a written consent

Exclusion Criteria:

Severe cognitive impairment according to DMS-5 criteria
Medical diagnosis of neurological disease
Trauma dating less than 6 months to the lower limb
Symptoms of vestibular or cerebellar involvement
Major visual disorder defined by visual acuity of one or both eyes less than or equal to 3 / 10th without correction
History of epileptic seizure: this is a total contraindication due to proximity to a screen (Virtual Reality Ethics Committee, 2019)
Psychiatric disorders (Schizophrenia, dissociative disorders, borderline state, paranoia)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geriatric Department, Paul Brousse Hospital	Villejuif	Ile-de-France	France	94804

Sponsors and Collaborators

Gérond'if

Investigators

Study Chair: Emmanuelle DURON, MD, Geriatric Department, Paul Brousse Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gérond'if

ClinicalTrials.gov Identifier:

NCT04717895

Other Study ID Numbers:

2020-A01999-30

First Posted:

Jan 22, 2021

Last Update Posted:

May 17, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gérond'if

Fear of falling

Postural changes

Stand upright without technical assistance

Study Results

No Results Posted as of May 17, 2022