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Clinical Trials/NCT06366542
NCT06366542CompletedNot Applicable

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

University of Jordan1 site in 1 country42 target enrollmentStarted: May 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Locations
1
Primary Endpoint
The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ)

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Vestibular Rehabilitation Therapy (VRT)

Active Comparator

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).

Intervention: Vestibular Rehabilitation Therapy (VRT) (Other)

Vestibular Rehabilitation Therapy (VRT)

Active Comparator

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).

Intervention: Optokinetic Stimulation exercises (Other)

Virtual Reality

Experimental

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.

Intervention: Vestibular Rehabilitation Therapy (VRT) (Other)

Virtual Reality

Experimental

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.

Intervention: Virtual reality exercises (Other)

Virtual Reality

Experimental

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.

Intervention: Optokinetic Stimulation exercises (Other)

Outcomes

Primary Outcomes

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: 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: 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: 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.

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.

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.

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.

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.

Secondary Outcomes

  • Pittsburgh Sleep Quality Index (PSQI)(After 6 weeks)
  • Medical Outcomes Study Short Form 12 (SF-12)(After 6 weeks)
  • Hospital Anxiety and Depression Scale (HADS)(After 6 weeks)
  • Pittsburgh Sleep Quality Index (PSQI)(Before intervention.)
  • Hospital Anxiety and Depression Scale (HADS)(Before intervention.)
  • Medical Outcomes Study Short Form 12 (SF-12)(Before intervention.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alia A. Alghwiri

Professor

University of Jordan

Study Sites (1)

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