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

NCT04717895 | Unknown DMC

• 1 other identifier: 2020-A01999-30
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomous Subjects, Aged 65 and Afraid of Falling

Keywords

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

Outcome Measures

Primary Outcomes (1)

• measurement of fear of falling using a Numeric scale of fear of falling

  2 Hours

Secondary Outcomes (3)

• 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

Study Arms (2)

1st Situation

EXPERIMENTAL

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

2nd Situation

ACTIVE COMPARATOR

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

Interventions

Rocking environment forward (B) followed by a translation environment DIAGNOSTIC_TEST

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

1st Situation

Translation environment followed by a rocking environment DIAGNOSTIC_TEST

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

2nd Situation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gérond'if: lead

Study Sites (1)

Geriatric Department, Paul Brousse Hospital

Villejuif, Île-de-France Region, 94804, France

RECRUITING

Study Officials

• Emmanuelle DURON, MD

  Geriatric Department, Paul Brousse Hospital

  STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+33(0)185781010; isabelle.dufour@gerondif.org

Prisca Lucas, PhD

CONTACT

+33(0)185781010; Prisca.lucas@gerondif.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 22, 2021
• Study Start: April 24, 2022
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

FR (1)