Virtual Reality in People With Persistent Postural-Perceptual Dizziness

NCT06366542 | Completed DMC

• 1 other identifier: 2/2024
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Dizziness

Outcome Measures

Primary Outcomes (9)

• 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.

• 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

• 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.

• 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.

• 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

• 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.

• 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

• 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.

• 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 Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI)

  Before intervention.

• Pittsburgh Sleep Quality Index (PSQI)

  After 6 weeks

• Hospital Anxiety and Depression Scale (HADS)

  Before intervention.

• Hospital Anxiety and Depression Scale (HADS)

  After 6 weeks

• Medical Outcomes Study Short Form 12 (SF-12)

  Before intervention.

Study Arms (2)

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).

Other: Vestibular Rehabilitation Therapy (VRT); Other: Optokinetic Stimulation exercises

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.

Other: Vestibular Rehabilitation Therapy (VRT); Other: Virtual reality exercises; Other: Optokinetic Stimulation exercises

Interventions

Vestibular Rehabilitation Therapy (VRT) OTHER

The VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises.

Also known as: VRT

Vestibular Rehabilitation Therapy (VRT); Virtual Reality

Virtual reality exercises OTHER

The VR exercises included watching theraputic videos using the virtual reality goggles with static and dynamic balance exercises.

Also known as: VR

Virtual Reality

Optokinetic Stimulation exercises OTHER

Optokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders.

Vestibular Rehabilitation Therapy (VRT); Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• If they suffered from other neurological or orthopedic deficits that affected their balance and prevented them from moving independently.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Royal Medical Services

Amman, Jordan

Location

MeSH Terms

Interventions

Exergaming

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alia A Alghwiri, PhD

  The University of Jordan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 16, 2024
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)