Vestibular DizzinessNCT06366542
Virtual Reality in People With Persistent Postural-Perceptual Dizziness
A study testing Vestibular Rehabilitation Therapy (VRT), Virtual reality exercises and Optokinetic Stimulation exercises in people with Vestibular Dizziness, run by University of Jordan at 1 site in Jordan.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Dizziness
- What is being tested?
- Vestibular Rehabilitation Therapy (VRT), Virtual reality exercises and Optokinetic Stimulation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- If they suffered from other neurological or orthopedic deficits that affected their balance and prevented them from moving independently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vestibular Dizziness
- Being tested
- Vestibular Rehabilitation Therapy (VRT), Virtual reality exercises, Optokinetic Stimulation exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation Therapy (VRT)Other
Also called VRT
The VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises.
Virtual reality exercisesOther
Also called VR
The VR exercises included watching theraputic videos using the virtual reality goggles with static and dynamic balance exercises.
Optokinetic Stimulation exercisesOther
Optokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Vestibular Rehabilitation Therapy (VRT); Other: Virtual reality exercises; Other: Optokinetic Stimulation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 6 weeks
Secondary outcomes (6)
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.
Measured: Before intervention.
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.
Measured: After 6 weeks
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).
Measured: Before intervention.
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).
Measured: After 6 weeks
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.
Measured: Before intervention.
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.
Measured: After 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alia A. Alghwiri, University of Jordan
- Investigators
- Alia A Alghwiri, PhD, Principal investigator, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366542
- Sponsor's protocol ID
- 2/2024
- Status last verified
- Jul 2024
- First submitted
- 25 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Reality on Balance in People With Persistent Postural-Perceptual Dizziness
- ClinicalTrials.gov ID
- NCT06366542
- Acronym / sponsor ID
- 2/2024
- Conditions
- Vestibular Dizziness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Therapy (VRT) | Active comparator | Other: Vestibular Rehabilitation Therapy (VRT), Other: Optokinetic Stimulation exercisesParticipants 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). |
| Virtual Reality | Experimental | Other: Vestibular Rehabilitation Therapy (VRT), Other: Virtual reality exercises, Other: Optokinetic Stimulation exercisesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- If they suffered from other neurological or orthopedic deficits that affected their balance and prevented them from moving independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation Therapy (VRT)Also: VRTThe VRT exercises were composed of gaze stabilization, head motion and postural stability exercises with static and dynamic balance exercises. | Other | Vestibular Rehabilitation Therapy (VRT), Virtual Reality |
| Virtual reality exercisesAlso: VRThe VR exercises included watching theraputic videos using the virtual reality goggles with static and dynamic balance exercises. | Other | Virtual Reality |
| Optokinetic Stimulation exercisesOptokinetic Stimulation is a type of visual stimulation used to improve visual function and balance in patients with vestibular disorders. | Other | Vestibular Rehabilitation Therapy (VRT), Virtual Reality |
Primary outcome
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.
6 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Before intervention.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: After 6 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Before intervention.
Hospital Anxiety and Depression Scale (HADS)
Time frame: After 6 weeks
Medical Outcomes Study Short Form 12 (SF-12)
Time frame: Before intervention.
Medical Outcomes Study Short Form 12 (SF-12)
Time frame: After 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request.
Related trials for Vestibular Dizziness
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Not yet recruitingObservational study
Validation of the Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM-PATHI) for Adolescents
Vestibular Migraine
RecruitingEarly Phase 1
Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness
Persistent Postural Perceptual Dizziness, Vestibular Migraine
RecruitingObservational study
Cisplatin-induced Cochlear and Vestibular Damage in Head and Neck Cancer
Ototoxic Hearing Loss, Ototoxicity, Drug-Induced
Active, not recruiting
VertiGO! - Get up and GO! With the Vestibular Implant
Bilateral Vestibular Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alia A Alghwiri, PhD principal investigator
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation Therapy (VRT), Virtual reality exercises and Optokinetic Stimulation exercises in people with Vestibular Dizziness, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Niigata Persistent Postural-Perceptual Dizziness Questionnaire (NPQ) (time frame: Before intervention.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.