Virtual Reality in People With Persistent Postural-Perceptual Dizziness: RCT

Vestibular Dizziness Clinical Trial

Official title:

The Effect of Using Virtual Reality on Balance in People With Persistent Postural-Perceptual Dizziness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06366542
• Other study ID #: 2/2024
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: April 2024
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dizziness
• Vertigo
• Vestibular Dizziness

Intervention

Other:
• Vestibular rehabilitation therapy
The VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises.
• Virtual reality exercises
The VR exercises included watching theraputic videos using the virtual reality goggles with static and dynamic balance exercises.
• Optokinetic Stimulation exercises
Optokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders.

Locations

Country	Name	City	State
Jordan	Royal Medical Services	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)	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.	Before intervention.
Primary	The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)	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.	After 6 weeks
Primary	The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)	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.	After one year follow up.
Primary	Dizziness Handicap Inventory (DHI)	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.	Before intervention.
Primary	Dizziness Handicap Inventory (DHI)	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.	After 6 weeks
Primary	Falls Efficacy Scale International (FES-I)	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.	Before intervention.
Primary	Falls Efficacy Scale International (FES-I)	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.	After 6 weeks
Primary	Dynamic Gait Index (DGI)	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.	Before intervention.
Primary	Dynamic Gait Index (DGI)	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.	After 6 weeks
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	Before intervention.
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	After 6 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	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).	Before intervention.
Secondary	Hospital Anxiety and Depression Scale (HADS)	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).	After 6 weeks
Secondary	Medical Outcomes Study Short Form 12 (SF-12)	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.	Before intervention.
Secondary	Medical Outcomes Study Short Form 12 (SF-12)	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.	After 6 weeks