- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06366542
Virtual Reality in People With Persistent Postural-Perceptual Dizziness
July 1, 2024 updated by: Alia A. Alghwiri, University of Jordan
The Effect of Using Virtual Reality on Balance in People With Persistent Postural-Perceptual Dizziness
This study aimed to compare the effectiveness of virtual reality (VR) and vestibular rehabilitation therapy (VRT) in enhancing balance in individuals with Persistent Postural-Perceptual Dizziness (PPPD).
The experimental group received VR combined with VRT and optokinetic stimulation, while the control group received VRT and optokinetic stimulation.
The study involved 42 individuals diagnosed with PPPD and administered ten intervention sessions over six weeks.
The study also examined the impact of VR on various aspects of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life.
Study Overview
Status
Completed
Conditions
Detailed Description
Persistent Postural-Perceptual Dizziness (PPPD) represents a relatively new vestibular diagnosis that has garnered recent attention within the medical community.
Consequently, there exists a pressing demand for efficacious and innovative management strategies.
The primary purpose of this study was to assess the comparative effectiveness of virtual reality (VR) versus vestibular rehabilitation therapy (VRT) in enhancing balance among individuals afflicted with PPPD.
A secondary purpose encompassed an investigation of VR's impact on various dimensions of PPPD, including dizziness, visual vertigo, mental well-being, sleep quality, fall risk, and overall quality of life.
Materials and Methods: A cohort comprising forty-two individuals conclusively diagnosed with PPPD was randomly assigned to two distinct groups.
The experimental cohort comprised twenty-one participants subjected to a combination of VR with optokinetic stimulation alongside VRT, whereas the control group, also consisting of twenty-one individuals, underwent solely optokinetic stimulation paired with VRT.
The intervention sessions were administered twice weekly over a span of six weeks, resulting in a total of ten intervention sessions.
Additionally, baseline and post-intervention assessments were conducted to gauge the efficacy of the interventions.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amman, Jordan
- Royal Medical Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with a confirmed diagnosis of the PPPD from a specialized physician, based on the diagnostic criteria published by the Barany Society.
- Patients who scored more than 27 on the Niigata PPPD Questionnaire (NPQ)
Exclusion Criteria:
- If they suffered from other neurological or orthopedic deficits that affected their balance and prevented them from moving independently.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Vestibular Rehabilitation Therapy (VRT)
Participants went through conventional VRT in addition to optokinetic exercise training.
The VRT exercises were composed of gaze stabilization, head motion, and postural stability exercises with static and dynamic balance exercises.
Ten repetitions of each VRT exercise were practiced in the same session for three sets.
Moreover, participants were instructed to watch optokinetic stimulation videos.
The optokinetic stimulation training was conducted using the following displays (a mobile and TV screen).
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Optokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders.
The VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises.
Other Names:
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Experimental: Virtual Reality
The same intervention program for the control group was implemented for participants in the experimental group, with the addition of using the VR split screen in Samsung Gear VR goggles in the last 4 sessions.
Using the VR goggles, participants started watching the videos for 30 seconds to 1 minute in the sitting position in the first two sessions, followed by 1-2 minutes in the standing position for the last 2 sessions.
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Optokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders.
The VR exercises included watching theraputic videos using the virtual reality goggles with static and dynamic balance exercises.
Other Names:
The VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)
Time Frame: Before intervention.
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self-reported questionnaire that was generated to screen for and assess the severity of Persistent Postural-Perceptual Dizziness.
Higher score is worse severity of Persistent Postural-Perceptual Dizziness.
Minimum score is 0 and maximum score is 72.
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Before intervention.
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The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)
Time Frame: After 6 weeks
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self-reported questionnaire that was generated to screen for and assess the severity of Persistent Postural-Perceptual Dizziness.
Higher score is worse severity of Persistent Postural-Perceptual Dizziness.
Minimum score is 0 and maximum score is 72.
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After 6 weeks
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The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)
Time Frame: After one year follow up.
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self-reported questionnaire that was generated to screen for and assess the severity of Persistent Postural-Perceptual Dizziness.
Higher score is worse severity of Persistent Postural-Perceptual Dizziness.
Minimum score is 0 and maximum score is 72.
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After one year follow up.
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Dizziness Handicap Inventory (DHI)
Time Frame: Before intervention.
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self- reported questionnaire that assesses the perceived disability from dizziness.
Higher score indicates worse disability from dizziness.
Minimum score is 0 and maximum score is 100.
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Before intervention.
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Dizziness Handicap Inventory (DHI)
Time Frame: After 6 weeks
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self- reported questionnaire that assesses the perceived disability from dizziness.
Higher score indicates worse disability from dizziness.
Minimum score is 0 and maximum score is 100.
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After 6 weeks
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Falls Efficacy Scale International (FES-I)
Time Frame: Before intervention.
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self-reported questionnaire that assesses fear of falling.
A higher score means worse concerns from falling.
Minimum score is 16 and maximum score is 64.
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Before intervention.
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Falls Efficacy Scale International (FES-I)
Time Frame: After 6 weeks
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self-reported questionnaire that assesses fear of falling.
A higher score means worse concerns from falling.
Minimum score is 16 and maximum score is 64.
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After 6 weeks
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Dynamic Gait Index (DGI)
Time Frame: Before intervention.
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A clinical performance-based tool that is used to evaluate dynamic postural stability.
A higher score indicates better dynamic balance and gait.
Minimum score is 0 and maximum score is 24.
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Before intervention.
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Dynamic Gait Index (DGI)
Time Frame: After 6 weeks
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A clinical performance-based tool that is used to evaluate dynamic postural stability.
A higher score indicates better dynamic balance and gait.
Minimum score is 0 and maximum score is 24.
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After 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Before intervention.
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A self-reported questionnaire that assesses quality of sleep.
A higher score indicates worse sleep quality.
Minimum score is 0 and maximum score is 21.
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Before intervention.
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: After 6 weeks
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A self-reported questionnaire that assesses quality of sleep.
A higher score indicates worse sleep quality.
Minimum score is 0 and maximum score is 21.
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After 6 weeks
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: Before intervention.
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a self-assessment scale that was developed to assess the severity of mood disturbances including depression and anxiety.
Higher scores mean worse severity in depression and anxiety.
Minimum score is 0 and maximum score is 21 for each subscale (depression and anxiety).
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Before intervention.
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: After 6 weeks
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a self-assessment scale that was developed to assess the severity of mood disturbances including depression and anxiety.
Higher scores mean worse severity in depression and anxiety.
Minimum score is 0 and maximum score is 21 for each subscale (depression and anxiety).
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After 6 weeks
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Medical Outcomes Study Short Form 12 (SF-12)
Time Frame: Before intervention.
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A self-reported questionnaire that assesses the impact of any health condition on the quality of life.
Higher scores indicate better quality of life.
Minimum score is 0 and maximum score is 100.
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Before intervention.
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Medical Outcomes Study Short Form 12 (SF-12)
Time Frame: After 6 weeks
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A self-reported questionnaire that assesses the impact of any health condition on the quality of life.
Higher scores indicate better quality of life.
Minimum score is 0 and maximum score is 100.
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After 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alia A Alghwiri, PhD, The University of Jordan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
March 1, 2024
Study Registration Dates
First Submitted
March 25, 2024
First Submitted That Met QC Criteria
April 13, 2024
First Posted (Actual)
April 16, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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