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
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
August 12, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedNovember 27, 2023
November 1, 2023
2.7 years
July 22, 2021
November 23, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
At eight weeks after the treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
Before treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
After the 5-day treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
At four weeks after the treatment
Postural stability
Standing postural stability under various conditions measured by a force platform
At eight weeks after the treatment
Secondary Outcomes (4)
The dizziness handicap inventory
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
Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
The hospital anxiety and depression scale
Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Gait performance
Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Study Arms (2)
Experimental Group
EXPERIMENTALControl Group
ACTIVE COMPARATORInterventions
Vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days
Customized vestibular rehabilitation for five consecutive days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Therapy
Tainan, 704, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Pei-Yun Lee, PhD
National Cheng Kung University
Central Study Contacts
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
- Assistant professor
Study Record Dates
First Submitted
July 22, 2021
First Posted
August 12, 2021
Study Start
October 25, 2021
Primary Completion
July 1, 2024
Study Completion
July 1, 2024
Last Updated
November 27, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share