RehabilitationNCT05002374
Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Peripheral Vestibular Dysfunction Patients
A study testing Vestibular rehabilitation with optokinetic stimulation and Vestibular rehabilitation in people with Rehabilitation, run by National Cheng Kung University at 1 site in Taiwan.
Trial summary
Background Patients with peripheral vestibular dysfunction often complain of dizziness, blurred vision, imbalance and etc. Vestibular rehabilitation although has been proved to be an efficient method to improve the symptoms, the optimal treatment type, intensity and frequency is still unclear. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Vestibular rehabilitation with optokinetic stimulation and Vestibular rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Oct 2021to Jul 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed as peripheral vestibular dysfunction with bithermal caloric irrigation
- having one or more of the following subjective complains for longer than four weeks: vertigo/dizziness, disequilibrium, gait instability or motion sensitivity
Who cannot join
- central nervous system involvement
- active or poorly controlled migraine (more than one severe migraine a month)
- fluctuating symptoms e.g. Meniere's disease
- active benign paroxysmal positional vertigo (BPPV)
- have previous vestibular rehabilitation
- inability to attend sessions
- other medical conditions in the acute phase e.g. orthopaedic injury
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy
Tainan, 704
Pei-Yun Lee, PhD
About this study
Official title: Application of Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Virtual Reality Environment in Patients With Peripheral Vestibular Dysfunction
Background Patients with peripheral vestibular dysfunction often complain of dizziness, blurred vision, imbalance and etc. Vestibular rehabilitation although has been proved to be an efficient method to improve the symptoms, the optimal treatment type, intensity and frequency is still unclear. Base on the mechanisms of vestibular rehabilitation, vestibular adaptation, substitution, and habituation, repeated practice and exposure to symptom-provoked movement could improve the symptoms. However, the symptom-provoked movement generated by only head and eye movement might not create sufficient threshold to induce vestibulo-ocular reflex adaptation. Practicing vestibular exercises in the same environment might be difficult for the patients to transfer learned ability to the real world environment. Therefore, optokinetic stimulation could potentially provide stronger visual-vestibular mismatch, and when combining with a virtual reality system could also simulate real world environment. Furthermore, an intensive training protocol on a daily basis might possibly promote the mechanisms of vestibular rehabilitation to enhance recovery from peripheral vestibular lesions. The purpose of this study is to investigate the efficacy of an intense vestibular rehabilitation programme incorporated with optokinetic stimulation in virtual reality environment on both subjective and objective symptoms in patients with peripheral vestibular dysfunction in the short and long term.
Methods This study will be an assessor-blind randomised controlled trial. Patients diagnosed as peripheral vestibular dysfunction aged between 20-80 years will be recruited and randomly allocated into two groups: vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality (Group OKN) and vestibular rehabilitation only (Group C). Group C will receive customised vestibular rehabilitation, while Group OKN will receive the same exercise programme as Group C plus optokinetic stimulation provided in virtual environment. Both groups will receive vestibular rehabilitation intensively for five consecutive days with a trained physiotherapist, following with daily home exercise for two months. Self-perceived symptoms, spatial orientation, postural control and gait performance will be assessed prior to treatment (baseline), at the end of the five-day treatment, at four and eight weeks following the five-day training.
- Conditions
- Rehabilitation
- Being tested
- Vestibular rehabilitation with optokinetic stimulation, Vestibular rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitation with optokinetic stimulationOther
Vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days
Vestibular rehabilitationOther
Customized vestibular rehabilitation for five consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: Vestibular rehabilitation with optokinetic stimulation |
| Control Group | Active comparator | Not described Receives: Other: Vestibular rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective visual vertical test
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Measured: Before treatment
Subjective visual vertical test
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Measured: After the 5-day treatment
Subjective visual vertical test
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Measured: At four weeks after the treatment
Subjective visual vertical test
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Measured: At eight weeks after the treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
Measured: Before treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
Measured: After the 5-day treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
Measured: At four weeks after the treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
Measured: At eight weeks after the treatment
Secondary outcomes (4)
The dizziness handicap inventory
A 25-item self-report questionnaire assesses the impact of dizziness on daily life by measuring self-perceived handicap. The maximum score is 100. The higher the score, the more the perceived handicap due to dizziness.
Measured: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
The vestibular disorders activities of daily living scale
This scale is used to assess the effects of vertigo and balance disorders on independence in everyday activities of daily living. This scale contains 28 items of self reporting questionnaire. It is divided into 3 subscales, which are functional, ambulation, and instrumental. The higher the score indicates higher dependence on the activities of daily living.
Measured: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
The hospital anxiety and depression scale
This scale is used to assess depression and anxiety symptoms. It is a 14-item scale dividing into anxiety and depressive subscales. Scores of greater than or equal to 11 on either scale indicate a definitive case of anxiety or depression.
Measured: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Gait performance
Functional gait assessment, which is a 10-item gait assessment tool
Measured: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start25 Oct 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Yun Lee, National Cheng Kung University
- Investigators
- Pei-Yun Lee, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002374
- Sponsor's protocol ID
- A-ER-110-109
- Status last verified
- Nov 2023
- First submitted
- 22 Jul 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Virtual Reality Environment in Patients With Peripheral Vestibular Dysfunction
- ClinicalTrials.gov ID
- NCT05002374
- Acronym / sponsor ID
- A-ER-110-109
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 12 Aug 2021 (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.
Background Patients with peripheral vestibular dysfunction often complain of dizziness, blurred vision, imbalance and etc. Vestibular rehabilitation although has been proved to be an efficient method to improve the symptoms, the optimal treatment type, intensity and frequency is still unclear. Base on the mechanisms of vestibular rehabilitation, vestibular adaptation, substitution, and habituation, repeated practice and exposure to symptom-provoked movement could improve the symptoms. However, the symptom-provoked movement generated by only head and eye movement might not create sufficient threshold to induce vestibulo-ocular reflex adaptation. Practicing vestibular exercises in the same environment might be difficult for the patients to transfer learned ability to the real world environment. Therefore, optokinetic stimulation could potentially provide stronger visual-vestibular mismatch, and when combining with a virtual reality system could also simulate real world environment. Furthermore, an intensive training protocol on a daily basis might possibly promote the mechanisms of vestibular rehabilitation to enhance recovery from peripheral vestibular lesions. The purpose of this study is to investigate the efficacy of an intense vestibular rehabilitation programme incorporated with optokinetic stimulation in virtual reality environment on both subjective and objective symptoms in patients with peripheral vestibular dysfunction in the short and long term.
Methods This study will be an assessor-blind randomised controlled trial. Patients diagnosed as peripheral vestibular dysfunction aged between 20-80 years will be recruited and randomly allocated into two groups: vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality (Group OKN) and vestibular rehabilitation only (Group C). Group C will receive customised vestibular rehabilitation, while Group OKN will receive the same exercise programme as Group C plus optokinetic stimulation provided in virtual environment. Both groups will receive vestibular rehabilitation intensively for five consecutive days with a trained physiotherapist, following with daily home exercise for two months. Self-perceived symptoms, spatial orientation, postural control and gait performance will be assessed prior to treatment (baseline), at the end of the five-day treatment, at four and eight weeks following the five-day training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Vestibular rehabilitation with optokinetic stimulation |
| Control Group | Active comparator | Other: Vestibular rehabilitation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed as peripheral vestibular dysfunction with bithermal caloric irrigation
- having one or more of the following subjective complains for longer than four weeks: vertigo/dizziness, disequilibrium, gait instability or motion sensitivity
Key exclusion criteria (7 listed)
- central nervous system involvement
- active or poorly controlled migraine (more than one severe migraine a month)
- fluctuating symptoms e.g. Meniere's disease
- active benign paroxysmal positional vertigo (BPPV)
- have previous vestibular rehabilitation
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 with optokinetic stimulationVestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days | Other | Experimental Group |
| Vestibular rehabilitationCustomized vestibular rehabilitation for five consecutive days | Other | Control Group |
Primary outcome
Subjective visual vertical test
Time frame: Before treatment
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Subjective visual vertical test
Time frame: After the 5-day treatment
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Subjective visual vertical test
Time frame: At four weeks after the treatment
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Subjective visual vertical test
Time frame: At eight weeks after the treatment
This test is to assess a person's perception of verticality. In this test, the subject is instructed to align a tilted illuminated line to self-perceived verticality in a completely darkened room. Differences between the subject's adjusted orientation and true spatial vertical are calculated as the subjective visual vertical.
Postural stability
Time frame: Before treatment
Standing postural stability under various conditions measured by a force platform
Postural stability
Time frame: After the 5-day treatment
Standing postural stability under various conditions measured by a force platform
Postural stability
Time frame: At four weeks after the treatment
Standing postural stability under various conditions measured by a force platform
Postural stability
Time frame: At eight weeks after the treatment
Standing postural stability under various conditions measured by a force platform
4 secondary outcomes
The dizziness handicap inventory
Time frame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
The vestibular disorders activities of daily living scale
Time frame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
The hospital anxiety and depression scale
Time frame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Gait performance
Time frame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Pei-Yun Lee, PhD principal investigator
National Cheng Kung University
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 with optokinetic stimulation and Vestibular rehabilitation in people with Rehabilitation, run by National Cheng Kung University at 1 site in Taiwan.
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 7 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Yun Lee, PhD (886-6-2353535 ext. 5936, peiyunlee@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective visual vertical test (time frame: Before treatment). The study lists 8 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 27 Nov 2023.