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

Gérond'if

Status: Enrolling

Conditions: Autonomous Subjects, Aged 65 and Afraid of Falling

Treatments: Diagnostic Test: Rocking environment forward (B) followed by a translation environment; Diagnostic Test: Translation environment followed by a rocking environment

Study type: Interventional

Funder types: Other

Identifiers

NCT04717895

2020-A01999-30

Details and patient eligibility

About

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.

Full 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).

Enrollment: 44 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

1st Situation

Experimental group

Description:

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

Treatment:

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

2nd Situation

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Translation environment followed by a rocking environment