Clinical trial NCT05002374: Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Peripheral Vestibular Dysfunction Patients
Official title: Application of Vestibular Rehabilitation Incorporated With Optokinetic Stimulation in Virtual Reality Environment in Patients With Peripheral Vestibular Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rehabilitation
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective visual vertical test
timeFrame: Before treatment
measure: Subjective visual vertical test
timeFrame: After the 5-day treatment
measure: Subjective visual vertical test
timeFrame: At four weeks after the treatment
measure: Subjective visual vertical test
timeFrame: At eight weeks after the treatment
measure: Postural stability
timeFrame: Before treatment
measure: Postural stability
timeFrame: After the 5-day treatment
measure: Postural stability
timeFrame: At four weeks after the treatment
measure: Postural stability
timeFrame: At eight weeks after the treatment
Secondary outcomes:
measure: The dizziness handicap inventory
timeFrame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
measure: The vestibular disorders activities of daily living scale
timeFrame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
measure: The hospital anxiety and depression scale
timeFrame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
measure: Gait performance
timeFrame: Prior and after the 5-day treatment, and follow up at four and eight weeks after the treatment
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Department of Physical Therapy
Study officials:
affiliation: National Cheng Kung University
name: Pei-Yun Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: