Royal Medical Services
Amman, Jordan
Completed
NCT Number: NCT06366542
Virtual Reality 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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Vestibular Rehabilitation Therapy (VRT)
OtherThe VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises.
Other names: VRT
Virtual Reality Exercises
OtherThe VR exercises included watching theraputic videos using the virtual reality goggles with static and dynamic balance exercises.
Other names: VR
Optokinetic Stimulation exercises
OtherOptokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders.
Primary outcomes
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The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)
Time frame: Before intervention.
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.
-
The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)
Time frame: After 6 weeks
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.
-
The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)
Time frame: After one year follow up.
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.
-
Dizziness Handicap Inventory (DHI)
Time frame: Before intervention.
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.
-
Dizziness Handicap Inventory (DHI)
Time frame: After 6 weeks
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.
-
Falls Efficacy Scale International (FES-I)
Time frame: Before intervention.
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.
-
Falls Efficacy Scale International (FES-I)
Time frame: After 6 weeks
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.
-
Dynamic Gait Index (DGI)
Time frame: Before intervention.
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.
-
Dynamic Gait Index (DGI)
Time frame: After 6 weeks
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.
Secondary outcomes
-
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Before intervention.
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.
-
Pittsburgh Sleep Quality Index (PSQI)
Time frame: After 6 weeks
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.
-
Hospital Anxiety and Depression Scale (HADS)
Time frame: Before intervention.
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).
-
Hospital Anxiety and Depression Scale (HADS)
Time frame: After 6 weeks
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).
-
Medical Outcomes Study Short Form 12 (SF-12)
Time frame: Before intervention.
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.
-
Medical Outcomes Study Short Form 12 (SF-12)
Time frame: After 6 weeks
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.
Sponsors and collaborators
Lead sponsor
University of Jordan
Other
Registry information
Official study title
The Effect of Using Virtual Reality on Balance in People With Persistent Postural-Perceptual Dizziness
Important dates
- Study start
- 2022
- Primary completion
- 2023
- Study completion
- 2024
- First posted
- Apr 16, 2024
- Registry last updated
- Jul 3, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.