Stroke RehabilitationVR-REACTNCT06053970
Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Stroke Rehabilitation Setting
A study testing Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR) in people with Stroke Rehabilitation and Postural Equilibrium, run by FondationbHopale at 1 site in France.
Trial summary
This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge. Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Stroke Rehabilitation, Postural Equilibrium
- What is being tested?
- Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2023to Oct 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: over 18
- Adult patient in rehabilitation stay (day or full hospitalization) following a first stroke less than 6 months old.
- One of the rehabilitation objectives is to improve balance
- Ability to understand exercise instructions
- Ability to stand for at least one minute with eyes closed, safely and without technical assistance
- Ability to walk at least with technical assistance and/or supervision
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- Patient having given their informed consent
- Patient affiliated to a social security scheme
- Non -inclusion criteria :
- Patients with epilepsy, controlled or not
- Patients undergoing rehabilitation following a stroke in the posterior fossa
- Known history of vestibular or cerebellar balance disorders
- Patients with orthopedic or traumatological impairment preventing stabilometric measurement on a force platform without footwear
- Patient under legal protection measure
- Severe phasic disorders that may prevent the expression of the will to stop viewing virtual scenes or to respond to numerical scales
- Pregnant or breastfeeding woman
- Known history of motion sickness
- Patient participating or having participated in the balance rehabilitation program with virtual reality within the rehabilitation center during their stay
Who cannot join
- Cyberkinetosis represented by a score greater than or equal to 15 on the Fast Motion Sickness scale
- Poor tolerance for wearing a virtual reality headset
- Significant visual impairment preventing the perception of the stimulus visual
Trial locations and contacts
1 site in 1 country.
France1 site
FONDATION HOPALE - Centre de rééducation Ste Barbe
Fouquières-lès-Lens, 62740
Gautier Saviard, gautier.saviard@fondation-hopale.org
About this study
Official title: Prospective, Randomized, Exploratory Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Subacute Stroke Rehabilitation Setting
This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge.
Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and transpose improvements into everyday life.
Read more
The main objective of this study is to investigate the influence of different moving virtual scenes on the general spatiotemporal parameters of pressure centers, in a sub-acute stroke rehabilitation context.
This would help health professionals to assess the most suitable VR exercise in function of patient's difficulties.
During this study, patient movements while viewing 8 different virtual reality scenes will be recorded using a motion platform during a single session.
- Conditions
- Stroke Rehabilitation, Postural Equilibrium
- Being tested
- Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)Other
The intervention will last 60 minutes and will include an assessment of the Berg Balance Scale (BBS), the collection of stabilometric data, the collection of the numerical difficulty scale, the Fast Motion Sickness Scale (FMS) and will end with a break after exposure to VR.
The various conditions will be carried out in this order:
- Eyes open with VR headset simulating a static environment
- Eyes closed with VR helmet off
- Eight measurements on a stabilometry platform will be taken for each of the VR signals, in random order
| Study group | Role | What they receive |
|---|---|---|
| Random order of virtual scenes | Other | Eight measurements on a stabilometry platform will be performed for each of the VR signals, in random order:
Signal A Direction: anteroposterior Speed: 5 m/s
Signal B Direction: anterior-posterior Speed: 5 m/s
Signal C Direction: Oblique forward and downward Speed: 5 m/s
Signal D Direction: Oblique forwards and upwards Speed: 5 m/s
Signal E Direction: Oblique forwards and to the right Speed: 5 m/s
Signal F Direction: Oblique forward and left Speed: 5 m/s
Signal G Direction: antero-posterior + Clockwise tunnel rotation at 10°/s Speed: 5 m/s
Signal H Direction: antero-posterior + Counter-clockwise tunnel rotation at 10°/s Speed: 5 m/s Receives: Other: Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total length of pressure center displacement (in mm)
Length of pressure will be recorded on a force platform under different conditions:
- Eyes open with VR headset simulating a static environment
- Eyes closed with VR helmet off
- In 8 VR conditions simulating movement (in random order)
Measured: During the procedure (virtual reality session).
Displacement speed of the center of pressure (in mm.s-1)
Displacement speed of the center of pressure will be recorded on a force platform under different conditions:
- Eyes open with VR headset simulating a static environment
- Eyes closed with VR helmet off
- In 8 VR conditions simulating movement (in random order)
Measured: During the procedure (virtual reality session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke RehabilitationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Recruitment of twenty patients. The order of the virtual reality scenes will be randomly selected.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FondationbHopale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053970
- Sponsor's protocol ID
- HOP23-RIPH2-10
- Acronym
- VR-REACT
- Status last verified
- Jul 2023
- First submitted
- 30 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Exploratory Study Evaluating the Effect of Moving Virtual Scenes on Postural Balance in a Subacute Stroke Rehabilitation Setting
- ClinicalTrials.gov ID
- NCT06053970
- Acronym / sponsor ID
- VR-REACT / HOP23-RIPH2-10
- Conditions
- Stroke Rehabilitation, Postural Equilibrium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- FondationbHopaleUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 26 Sep 2023 (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.
This is an interventional, prospective, randomized, monocentric study designed to develop medical knowledge.
Virtual reality is increasingly used in rehabilitation. The aim of virtual reality is to investigate motor interactions in a fictitious, configurable environment, in order to train specific functions and transpose improvements into everyday life.
The main objective of this study is to investigate the influence of different moving virtual scenes on the general spatiotemporal parameters of pressure centers, in a sub-acute stroke rehabilitation context.
This would help health professionals to assess the most suitable VR exercise in function of patient's difficulties.
During this study, patient movements while viewing 8 different virtual reality scenes will be recorded using a motion platform during a single session.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recruitment of twenty patients. The order of the virtual reality scenes will be randomly selected.
| Arm | Type | Receives |
|---|---|---|
| Random order of virtual scenes | Other | Other: Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)Eight measurements on a stabilometry platform will be performed for each of the VR signals, in random order: Signal A Direction: anteroposterior Speed: 5 m/s Signal B Direction: anterior-posterior Speed: 5 m/s Signal C Direction: Oblique forward and downward Speed: 5 m/s Signal D Direction: Oblique forwards and upwards Speed: 5 m/s Signal E Direction: Oblique forwards and to the right Speed: 5 m/s Signal F Direction: Oblique forward and left Speed: 5 m/s Signal G Direction: antero-posterior + Clockwise tunnel rotation at 10°/s Speed: 5 m/s Signal H Direction: antero-posterior + Counter-clockwise tunnel rotation at 10°/s Speed: 5 m/s |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age: over 18
- Adult patient in rehabilitation stay (day or full hospitalization) following a first stroke less than 6 months old.
- One of the rehabilitation objectives is to improve balance
- Ability to understand exercise instructions
- Ability to stand for at least one minute with eyes closed, safely and without technical assistance
Key exclusion criteria (3 listed)
- Cyberkinetosis represented by a score greater than or equal to 15 on the Fast Motion Sickness scale
- Poor tolerance for wearing a virtual reality headset
- Significant visual impairment preventing the perception of the stimulus visual
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 |
|---|---|---|
| Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR)The intervention will last 60 minutes and will include an assessment of the Berg Balance Scale (BBS), the collection of stabilometric data, the collection of the numerical difficulty scale, the Fast Motion Sickness Scale (FMS) and will end with a break after exposure to VR. The various conditions will be carried out in this order: * Eyes open with VR headset simulating a static environment * Eyes closed with VR helmet off * Eight measurements on a stabilometry platform will be taken for each of the VR signals, in random order | Other | Random order of virtual scenes |
Primary outcome
Total length of pressure center displacement (in mm)
Time frame: During the procedure (virtual reality session).
Length of pressure will be recorded on a force platform under different conditions: * Eyes open with VR headset simulating a static environment * Eyes closed with VR helmet off * In 8 VR conditions simulating movement (in random order)
Displacement speed of the center of pressure (in mm.s-1)
Time frame: During the procedure (virtual reality session).
Displacement speed of the center of pressure will be recorded on a force platform under different conditions: * Eyes open with VR headset simulating a static environment * Eyes closed with VR helmet off * In 8 VR conditions simulating movement (in random order)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessing postural responses induced by visual stimulation (Visual Evoked postural responses, VEPR) in people with Stroke Rehabilitation and Postural Equilibrium, run by FondationbHopale 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 18 inclusion and 3 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 26 Sep 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 Marine Deseur (03 62 88 27 80, marine.deseur@fondation-hopale.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total length of pressure center displacement (in mm) (time frame: During the procedure (virtual reality session).). The study lists 2 primary outcomes in all. 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 26 Sep 2023.