Motion Sickness Rehabilitation for Virtual Reality

NCT ID: NCT06056622

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-04

Study Completion Date

2023-05-15

Brief Summary

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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

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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

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Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups with a sham control. Assessments will be performed before intervention, and four months after the last session.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The intervention group will receive combined exercise program and the control group will receive a sham exercise using reaction time games. Outcome assessment will be performed by an investigator who was unaware of group allocation

Study Groups

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Combined Exercise Group

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.

Group Type OTHER

Combined Exercises

Intervention Type OTHER

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.

Control Group

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.

Group Type OTHER

Placebo Exercise

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Ramazan KURUL

Assist. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ramazan KURUL, PhD

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

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Abant Izzet Baysal University

Bolu, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AIBU-FTR-RK-07

Identifier Type: -

Identifier Source: org_study_id

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