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

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.

Study Overview

• Status: Recruiting
• Conditions: Autonomous Subjects, Aged 65 and Afraid of Falling
• Intervention / Treatment: Diagnostic test: Rocking environment forward (B) followed by a translation environment; Diagnostic test: Translation environment followed by a rocking environment

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Dufour; Phone Number: +33(0)185781010; Email: isabelle.dufour@gerondif.org
• Study Contact Backup: Name: Prisca Lucas, PhD; Phone Number: +33(0)185781010; Email: Prisca.lucas@gerondif.org

Study Locations

• France
  • Ile-de-France
    • Villejuif, Ile-de-France, France, 94804
      • Recruiting
      • Geriatric Department, Paul Brousse Hospital
      • Contact: Emmanuelle DURON, MD; Phone Number: +33(0)145593843; Email: emmanuelle.duron@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
measurement of fear of falling using a Numeric scale of fear of falling	2 Hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Emmanuelle DURON, MD, Geriatric Department, Paul Brousse Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Fear of falling; Postural changes; Stand upright without technical assistance
• Other Study ID Numbers: 2020-A01999-30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No