Motion Sickness Rehabilitation for Virtual Reality

Motion Sickness Clinical Trial

Official title:

Overcoming Motion Sickness in Immersive Virtual Reality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06056622
• Other study ID #: AIBU-FTR-RK-07
• Status: Completed
• Phase: N/A
• Start date: December 4, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: September 2023
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: May 15, 2023
• Est. primary completion date: April 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• having stereoacuity score of 3552 arc/s on the Titmus Fly Test

Exclusion Criteria:

• having partial or total vision loss

• being diagnosed with vertigo

• having previous experience of head mounted virtual reality devices

Related Conditions & MeSH terms

• Motion Sickness

Intervention

Other:
• Combined Exercises
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 Exercise
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

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virtual Reality Symptoms Questionnaire	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.	four weeks
Secondary	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).	four weeks
Secondary	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.	four weeks
Secondary	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.	four weeks