Autonomous Subjects, Aged 65 and Afraid of FallingPREUVNCT04717895
Psychological and Postural Effects of Exposure to Both Types of Virtual Environments
A study testing Rocking environment forward (B) followed by a translation environment and Translation environment followed by a rocking environment in people with Autonomous Subjects, Aged 65 and Afraid of Falling, run by Gérond'if at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autonomous Subjects, Aged 65 and Afraid of Falling
- What is being tested?
- Rocking environment forward (B) followed by a translation environment and Translation environment followed by a rocking environment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geriatric Department, Paul Brousse Hospital
Villejuif, Île-de-France Region, 94804
Emmanuelle DURON, MD, +33(0)145593843, emmanuelle.duron@aphp.fr
About this study
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.
Read the 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).
- Being tested
- Rocking environment forward (B) followed by a translation environment, Translation environment followed by a rocking environment
- Keywords
- Fear of falling, Postural changes, Stand upright without technical assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocking environment forward (B) followed by a translation environmentDiagnostic test
Start by the virtual reality session by viewing a rocking environment followed by a translation environment
Translation environment followed by a rocking environmentDiagnostic test
Start by the virtual reality session by viewing a translation environment followed by a rocking environment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Translation environment followed by a rocking environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of fear of falling using a Numeric scale of fear of falling
Measured: 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)
Measured: 2 Hours
Evaluate the subjective perception of stability which will be evaluated using a numerical scale of the perception of stability
Measured: 2 Hours
Cyber sickness will be assessed by the Simulator Sickness Questionnaire
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start24 Apr 2022
- Primary completionOct 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomous Subjects, Aged 65 and Afraid of FallingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle DURON, MD, Study chair, Geriatric Department, Paul Brousse Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717895
- Sponsor's protocol ID
- 2020-A01999-30
- Acronym
- PREUV
- Status last verified
- Jan 2023
- First submitted
- 18 Dec 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Postural Effects of Exposure to Both Types of Virtual Environments
- ClinicalTrials.gov ID
- NCT04717895
- Acronym / sponsor ID
- PREUV / 2020-A01999-30
- Keywords
- Fear of falling, Postural changes, Stand upright without technical assistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 24 Apr 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 1st Situation | Experimental | Diagnostic Test: Rocking environment forward (B) followed by a translation environmentSubjects 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 |
| 2nd Situation | Active comparator | Diagnostic Test: Translation environment followed by a rocking environmentSubjects 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocking environment forward (B) followed by a translation environmentStart by the virtual reality session by viewing a rocking environment followed by a translation environment | Diagnostic test | 1st Situation |
| Translation environment followed by a rocking environmentStart by the virtual reality session by viewing a translation environment followed by a rocking environment | Diagnostic test | 2nd Situation |
Primary outcome
measurement of fear of falling using a Numeric scale of fear of falling
Time frame: 2 Hours
3 secondary outcomes
assess posture by recording the coordinates of center of pressure during exposure to Virtual Reality using the Wii Balance Board (WBB)
Time frame: 2 Hours
Evaluate the subjective perception of stability which will be evaluated using a numerical scale of the perception of stability
Time frame: 2 Hours
Cyber sickness will be assessed by the Simulator Sickness Questionnaire
Time frame: 2 Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle DURON, MD study chair
Geriatric Department, Paul Brousse Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocking environment forward (B) followed by a translation environment and Translation environment followed by a rocking environment in people with Autonomous Subjects, Aged 65 and Afraid of Falling, run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Dufour (+33(0)185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of fear of falling using a Numeric scale of fear of falling (time frame: 2 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.