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Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Peripheral Vestibular Dysfunction Patients

NCT ID: NCT05002374

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental Group

Group Type EXPERIMENTAL

Vestibular rehabilitation with optokinetic stimulation

Intervention Type OTHER

Vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days

Control Group

Group Type ACTIVE_COMPARATOR

Vestibular rehabilitation

Intervention Type OTHER

Customized vestibular rehabilitation for five consecutive days

Interventions

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Vestibular rehabilitation with optokinetic stimulation

Vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days

Intervention Type OTHER

Vestibular rehabilitation

Customized vestibular rehabilitation for five consecutive days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Pei-Yun Lee

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pei-Yun Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

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Department of Physical Therapy

Tainan City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pei-Yun Lee, PhD

Role: CONTACT

[email protected]
886-6-2353535 ext. 5936

Facility Contacts

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Pei-Yun Lee, PhD

Role: primary

Other Identifiers

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A-ER-110-109

Identifier Type: -

Identifier Source: org_study_id