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

NCT ID: NCT04717895

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-24
• Study Completion Date: 2024-02-29

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.

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).

Conditions

Autonomous Subjects, Aged 65 and Afraid of Falling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Rocking environment forward (B) followed by a translation environment

Intervention Type: DIAGNOSTIC_TEST

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

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

Group Type: ACTIVE_COMPARATOR

Translation environment followed by a rocking environment

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gérond'if

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle DURON, MD

Role: STUDY_CHAIR

Geriatric Department, Paul Brousse Hospital

Locations

Geriatric Department, Paul Brousse Hospital

Villejuif, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle Dufour

Role: CONTACT

isabelle.dufour@gerondif.org

+33(0)185781010

Prisca Lucas, PhD

Role: CONTACT

Prisca.lucas@gerondif.org

+33(0)185781010

Facility Contacts

Emmanuelle DURON, MD

Role: primary

emmanuelle.duron@aphp.fr

+33(0)145593843

Other Identifiers

2020-A01999-30

Identifier Type: -

Identifier Source: org_study_id