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

Autonomous Subjects, Aged 65 and Afraid of Falling Clinical Trial

— PREUV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04717895
• Other study ID #: 2020-A01999-30
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2022
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: Gérond'if
• Contact: Isabelle Dufour
• Phone: +33(0)185781010
• Email: isabelle.dufour[@]gerondif.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: February 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Autonomous Subjects, Aged 65 and Afraid of Falling

Intervention

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

Locations

Country	Name	City	State
France	Geriatric Department, Paul Brousse Hospital	Villejuif	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Gérond'if

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of fear of falling using a Numeric scale of fear of falling		2 Hours
Secondary	assess posture by recording the coordinates of center of pressure during exposure to Virtual Reality using the Wii Balance Board (WBB)		2 Hours
Secondary	Evaluate the subjective perception of stability which will be evaluated using a numerical scale of the perception of stability		2 Hours
Secondary	Cyber sickness will be assessed by the Simulator Sickness Questionnaire		2 Hours