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Motion Sickness Rehabilitation for Virtual Reality

Primary Purpose

Motion Sickness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Combined Exercises
Placebo Exercise
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motion Sickness focused on measuring Rehabilitation, Balance, Reflex

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Abant Izzet Baysal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Combined Exercise Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
September 21, 2023
Last Updated
September 21, 2023
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT06056622
Brief Title
Motion Sickness Rehabilitation for Virtual Reality
Official Title
Overcoming Motion Sickness in Immersive Virtual Reality
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2022 (Actual)
Primary Completion Date
April 23, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
Keywords
Rehabilitation, Balance, Reflex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups with a sham control. Assessments will be performed before intervention, and four months after the last session.
Masking
ParticipantOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combined Exercise Group
Arm Type
Other
Arm Description
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.
Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Combined Exercises
Intervention Description
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
Intervention Name(s)
Placebo Exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Virtual Reality Symptoms Questionnaire
Description
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.
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
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).
Time Frame
four weeks
Title
Biodex System Analysis
Description
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.
Time Frame
four weeks
Title
Flaming Balance Test
Description
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.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramazan KURUL, PhD
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data wil lbe available after study publication and it will be available indefinitely.
IPD Sharing Access Criteria
Data wil lbe uploaded to university's cloud servers and an online link will be shared

Learn more about this trial

Motion Sickness Rehabilitation for Virtual Reality

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