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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04717895
Acronym
PREUV
Enrollment
44
Registered
2021-01-22
Start date
2022-04-24
Completion date
2024-02-29
Last updated
2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomous Subjects, Aged 65 and Afraid of Falling

Keywords

Fear of falling, Postural changes, Stand upright without technical assistance

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).

Interventions

DIAGNOSTIC_TESTRocking environment forward (B) followed by a translation environment

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

DIAGNOSTIC_TESTTranslation environment followed by a rocking environment

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

Sponsors

Gérond'if
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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 environment

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
measurement of fear of falling using a Numeric scale of fear of falling2 Hours

Secondary

MeasureTime 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 stability2 Hours
Cyber sickness will be assessed by the Simulator Sickness Questionnaire2 Hours

Countries

France

Contacts

Primary ContactIsabelle Dufour
isabelle.dufour@gerondif.org+33(0)185781010
Backup ContactPrisca Lucas, PhD
Prisca.lucas@gerondif.org+33(0)185781010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026