Motion SicknessNCT06056622
Motion Sickness Rehabilitation for Virtual Reality
A study testing Combined Exercises in people with Motion Sickness, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to investigate the effect of a rehabilitation program on motion sickness. A combined rehabilitation program will be given participants who showed motion sickness symptoms. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Combined Exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2022to 15 May 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having stereoacuity score of 3552 arc/s on the Titmus Fly Test
Who cannot join
- having partial or total vision loss
- being diagnosed with vertigo
- having previous experience of head mounted virtual reality devices
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abant Izzet Baysal University
Bolu, Merkez, 14100
About this study
Official title: Overcoming Motion Sickness in Immersive Virtual Reality
The objective of this study was to investigate the effect of a rehabilitation program on motion sickness. A combined rehabilitation program will be given participants who showed motion sickness symptoms.
Read the detailed description
In the realm of virtual environments and simulators, a significant hurdle that hampers user engagement resides in the manifestation of adverse effects. These deleterious consequences become apparent during prolonged exposure to virtual settings, with approximately 30% of users grappling with symptoms like nausea and up to 40% reporting eyestrain. Furthermore, users frequently describe a constellation of other discomforting sensations, including headaches, dizziness or vertigo, compromised postural stability, drowsiness, increased salivation, and perspiration. These adverse effects have been documented in scientific literature under various monikers, with 'cybersickness' and 'motion sickness' (MS) being the most prevalent designations.
Motion sickness, a vexing symptom characterized by discomfort experienced during movements unrelated to one's bodily motions, such as those encountered during travel by air, sea, or land, lies at the crux of this issue. The pathophysiological elucidation of the mechanisms underlying MS centers around the notion of sensory conflict or sensory mismatch. This conflict arises from disparities between the sensory information derived from kinaesthetic inputs, the vestibular and visual systems, and the sensory patterns engendered by the virtual environment
- Conditions
- Motion Sickness
- Being tested
- Combined Exercises, Placebo Exercise
- Keywords
- Rehabilitation, Balance, Reflex
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ExercisesOther
The treatment involving multisensory stimulation through active movement was structured into two distinct segments. The initial segment encompassed exercises executed on a wobble board, comprising tasks such as squats, passing a ball between hands and to another individual, maintaining a single-leg stance, and gently destabilizing each other's balance. The subsequent segment involved exercises performed on a soft mat, including activities such as jumping from a small box and landing with both knees flexed, passing the ball to a team member during a two-leg jump, executing a two-leg jump while rotating the trunk by 90 degrees, and leaping from a small box onto a soft mat while balancing on one leg. Each of these exercises was repeated ten times within each session.
Balance-related exercises were conducted with participants assuming a shoulder-width stance on both firm and soft surfaces.
Placebo ExerciseOther
Participants allocated to the control group will receive placebo treatment sessions, which entailed a 10-minute exposure to a visual evoked potential (VEP) measurement screen while holding a mouse. During this time, participants were given instructions to click the mouse whenever the screen exhibited a change in color. These activities were carried out while seated in a chair equipped with arm support
| Study group | Role | What they receive |
|---|---|---|
| Combined Exercise Group | Other | Multisensory stimulation with active range of motion movement, progressive Cawthorne-Cooksey exercises, and balance exercises with external perturbation on soft and hard surfaces while eyes are open or closed. Receives: Other: Combined Exercises |
| Control Group | Other | A placebo exercise program consist of 10 minute reaction time game which requires mouse clicking on screen color changes will be used in control group. Receives: Other: Placebo Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Reality Symptoms Questionnaire
- gauge motion sickness symptoms, a 9-question Likert scale was employed. Participants were directed to rate the extent to which each of the specified symptoms affected them, using a scale ranging from 0 (no impact) to 3 (severe impact). The total score for this assessment totaled 100, with scores derived from two distinct subsections: oculomotor symptoms and overall discomfort.
Measured: four weeks
Secondary outcomes (3)
Visual Analog Scale
Participants were instructed to express the level of their enjoyment using a 100-millimeter horizontal line. The intensity of their experience was determined by measuring the segment on the line that the individual marked, with a scale ranging from 0 (completely unenjoyable) to 10 (the most enjoyable experience).
Measured: four weeks
Biodex System Analysis
The Biodex System was utilized to record angular displacement of the platform in both the antero-posterior (AP) and medio-lateral (ML) axes, providing metrics for postural stability and balance. The medio-lateral stability index (MLSI) was derived from angular displacement in the frontal plane on a circular platform, while the antero-posterior stability index (APSI) was obtained from angular displacement in the sagittal plane on the same platform. The overall stability index (OSI) was calculated as a composite measure combining APSI and MLSI. During the measurements, participants were instructed to stand on the platform, either on one foot or both feet, following the prescribed protocol, and to maintain a static posture.
Measured: four weeks
Flaming Balance Test
This test was employed to evaluate participants' static balance, with trials conducted under both eyes-closed and eyes-open conditions. Each participant was guided to place the ankle of their non-tested leg behind the knee of the tested leg while standing on one leg for a duration of 1 minute. The number of observable body sways was documented throughout the test duration.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Dec 2022
- Primary completion23 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with a sham control. Assessments will be performed before intervention, and four months after the last session.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramazan KURUL, Abant Izzet Baysal University
- Investigators
- Ramazan KURUL, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056622
- Sponsor's protocol ID
- AIBU-FTR-RK-07
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study publication reasonable requests for systematic reviews can be accepted for detailed data sharing rest of the data will be available on online link.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Motion Sickness in Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT06056622
- Acronym / sponsor ID
- AIBU-FTR-RK-07
- Conditions
- Motion Sickness
- Keywords
- Rehabilitation, Balance, Reflex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 4 Dec 2022 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 28 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.
The objective of this study was to investigate the effect of a rehabilitation program on motion sickness. A combined rehabilitation program will be given participants who showed motion sickness symptoms.
Detailed description
In the realm of virtual environments and simulators, a significant hurdle that hampers user engagement resides in the manifestation of adverse effects. These deleterious consequences become apparent during prolonged exposure to virtual settings, with approximately 30% of users grappling with symptoms like nausea and up to 40% reporting eyestrain. Furthermore, users frequently describe a constellation of other discomforting sensations, including headaches, dizziness or vertigo, compromised postural stability, drowsiness, increased salivation, and perspiration. These adverse effects have been documented in scientific literature under various monikers, with 'cybersickness' and 'motion sickness' (MS) being the most prevalent designations.
Motion sickness, a vexing symptom characterized by discomfort experienced during movements unrelated to one's bodily motions, such as those encountered during travel by air, sea, or land, lies at the crux of this issue. The pathophysiological elucidation of the mechanisms underlying MS centers around the notion of sensory conflict or sensory mismatch. This conflict arises from disparities between the sensory information derived from kinaesthetic inputs, the vestibular and visual systems, and the sensory patterns engendered by the virtual environment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with a sham control. Assessments will be performed before intervention, and four months after the last session.
| Arm | Type | Receives |
|---|---|---|
| Combined Exercise Group | Other | Other: Combined ExercisesMultisensory stimulation with active range of motion movement, progressive Cawthorne-Cooksey exercises, and balance exercises with external perturbation on soft and hard surfaces while eyes are open or closed. |
| Control Group | Other | Other: Placebo ExerciseA placebo exercise program consist of 10 minute reaction time game which requires mouse clicking on screen color changes will be used in control group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having stereoacuity score of 3552 arc/s on the Titmus Fly Test
Key exclusion criteria (3 listed)
- having partial or total vision loss
- being diagnosed with vertigo
- having previous experience of head mounted virtual reality devices
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 |
|---|---|---|
| Combined ExercisesThe treatment involving multisensory stimulation through active movement was structured into two distinct segments. The initial segment encompassed exercises executed on a wobble board, comprising tasks such as squats, passing a ball between hands and to another individual, maintaining a single-leg stance, and gently destabilizing each other's balance. The subsequent segment involved exercises performed on a soft mat, including activities such as jumping from a small box and landing with both knees flexed, passing the ball to a team member during a two-leg jump, executing a two-leg jump while rotating the trunk by 90 degrees, and leaping from a small box onto a soft mat while balancing on one leg. Each of these exercises was repeated ten times within each session. Balance-related exercises were conducted with participants assuming a shoulder-width stance on both firm and soft surfaces. | Other | Combined Exercise Group |
| Placebo ExerciseParticipants allocated to the control group will receive placebo treatment sessions, which entailed a 10-minute exposure to a visual evoked potential (VEP) measurement screen while holding a mouse. During this time, participants were given instructions to click the mouse whenever the screen exhibited a change in color. These activities were carried out while seated in a chair equipped with arm support | Other | Control Group |
Primary outcome
Virtual Reality Symptoms Questionnaire
Time frame: four weeks
o gauge motion sickness symptoms, a 9-question Likert scale was employed. Participants were directed to rate the extent to which each of the specified symptoms affected them, using a scale ranging from 0 (no impact) to 3 (severe impact). The total score for this assessment totaled 100, with scores derived from two distinct subsections: oculomotor symptoms and overall discomfort.
3 secondary outcomes
Visual Analog Scale
Time frame: four weeks
Biodex System Analysis
Time frame: four weeks
Flaming Balance Test
Time frame: four weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: Yes. After study publication reasonable requests for systematic reviews can be accepted for detailed data sharing rest of the data will be available on online link.
Related trials for Motion Sickness
Enrolling by invitationObservational study
Virtual Reality Sickness Questionnaire: Psychometrics in Stroke Patients
Motion Sickness
Not yet recruiting
Vagal Auricular Stimulation for Motion Sickness
Chronic Nausea
Recruiting
StableEyes With Active Neurofeedback
Vestibular Disorder, Vestibular Schwannoma
Not yet recruitingObservational study
Motion Sickness Severity and Sensorimotor Performance
Motion Sickness, Somatosensory Disorders
Not yet recruiting
OKT With Gaze and Postural Stabilization on Vertigo, MS and QOL in VBH
Vestibular Disorder
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.
Ramazan KURUL, PhD principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Exercises in people with Motion Sickness, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 28 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virtual Reality Symptoms Questionnaire (time frame: four weeks). 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 28 Sep 2023.