Motion Sickness Rehabilitation for Virtual Reality

NCT06056622 | Completed

• 1 other identifier: AIBU-FTR-RK-07
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness

Keywords

Rehabilitation; Balance; Reflex

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual Analog Scale

  four weeks

• Biodex System Analysis

  four weeks

• Flaming Balance Test

  four weeks

Study Arms (2)

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.

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.

Other: Placebo Exercise

Interventions

Combined Exercises 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.

Combined Exercise Group

Placebo Exercise 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

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• having partial or total vision loss
• being diagnosed with vertigo
• having previous experience of head mounted virtual reality devices

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramazan KURUL, PhD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Model Details: Two groups with a sham control. Assessments will be performed before intervention, and four months after the last session.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: December 4, 2022
• Primary Completion: April 23, 2023
• Study Completion: May 15, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data wil lbe available after study publication and it will be available indefinitely.
• Access Criteria: Data wil lbe uploaded to university's cloud servers and an online link will be shared

Locations

TU (1)