- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05002374
Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Peripheral Vestibular Dysfunction Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pei-Yun Lee, PhD
- Phone Number: 5936 886-6-2353535
- Email: peiyunlee@mail.ncku.edu.tw
Study Locations
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Tainan, Taiwan, 704
- Recruiting
- Department of Physical Therapy
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Contact:
- Pei-Yun Lee, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
|
Vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days
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Active Comparator: Control Group
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Customized vestibular rehabilitation for five consecutive days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before treatment
|
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.
|
After the 5-day treatment
|
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.
|
At four weeks after the treatment
|
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.
|
At eight weeks after the treatment
|
Postural stability
Time Frame: Before treatment
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Standing postural stability under various conditions measured by a force platform
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Before treatment
|
Postural stability
Time Frame: After the 5-day treatment
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Standing postural stability under various conditions measured by a force platform
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After the 5-day treatment
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Postural stability
Time Frame: At four weeks after the treatment
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Standing postural stability under various conditions measured by a force platform
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At four weeks after the treatment
|
Postural stability
Time Frame: At eight weeks after the treatment
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Standing postural stability under various conditions measured by a force platform
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At eight weeks after the treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The dizziness handicap inventory
Time Frame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
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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.
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Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
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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
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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.
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Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
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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
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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.
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Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
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Gait performance
Time Frame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
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Functional gait assessment, which is a 10-item gait assessment tool
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Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pei-Yun Lee, PhD, National Cheng Kung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A-ER-110-109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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