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Completed

NCT Number: NCT05853562

Effects of Structured Exercise Program in Bilateral Vestibular Hypofunction

Background: The vestibular rehabilitation is an exercise-based method, aiming to maximize central nervous system(CNS) compensation at vestibular nuclear and other CNS levels for vestibular pathology. A minimal number of studies have documented the impact of Vestibular rehabilitation on the recovery rate of patients with Bilateral Vestibular Hypofunction(BVH).

Objective: The purpose of this study was to investigate the effectiveness of structured vestibular rehabilitation (VR) programs on severity of dizziness, kinesiophobia, balance, fatigue, quality of sleep, activities of daily living( ADL) and quality of life(QoL) in subjects with chronic BVH.

Method: Twenty-five participants diagnosed with BVH were included in the study. A structured VR program was applied in 50-minute sessions once a week and as a home exercise program 3 days a week over 8 weeks. Participants were evaluated for severity of dizziness with the Visual Analog Scale (VAS), for kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), for balance with the Semitandem, tandem, and standing tests, for quality of sleep with the Pittsburgh Sleep Quality Index (PSQI), for ADL with the Vestibular Disorders Activities of Daily Life (VADL), for QoL with Dizziness Handicap Inventory (DHI) and for fatigue with the Fatigue Severity Scale (FSS) at the baseline (T0), at 4th week (T1), 8th week (T2), and 20th week (T3) after study started.

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Key information

Conditions

Bilateral Vestibular Hypofunction Anxiety Disorders Dizziness Dyssomnias Kinesiophobia Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Phobic Disorders Sensation Disorders Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Beykoz, 34820, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being between 20-80 years old
  • Diagnosed with bilateral peripheral vestibular hypofunction by videonystagmography
  • Have symptoms for more than three months from onset of illness

Exclusion criteria

  • having no symptoms of bilateral peripheral vestibular hypofunction
  • having Meniere's disease, vestibular migraine and other undulating vestibular disorders, cognitive, visual, neurological or general motor impairment
  • having previously received vestibular rehabilitation

Treatment and study plan

structured vestibular rehabilitation program

Other

The structured Vestibular rehabilitation protocol consisted of a structured vestibular rehabilitation program that included vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises, and posture exercises.

Primary outcomes

  1. Visual Analog Scale

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    It is a validated, subjective scale used to measure the intensity or frequency of various symptoms. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no symptom" on the left end (0 cm) of the scale and the "worst symptom" on the right end of the scale (10 cm). We used this scale to measure the severity of dizziness

  2. Tampa Scale of Kinesiophobia

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    It is a 17 items self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale ranges from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia

  3. Semitandem, Tandem, and Standing tests

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    Semitandem, Tandem, and Standing tests were used to evaluate balance. Semitandem test 30 , Tandem test 30 , Standing tests 30 Equilibrium times (sec) with eyes open-closed were recorded on hard and soft surfaces

  4. Pittsburgh Sleep Quality Index

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    It is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The seven component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

  5. Dizziness Handicap Inventory

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    It is used to assess the impact of dizziness on quality of life. It consists of 25 clauses which determine the aggravating factors associated with dizziness and shakiness and also the emotional and functional results of vestibular system diseases. The inventory consists of 3 sub-dimensions, intended to determine physical, emotional and functional effects of the vestibular system diseases

  6. Fatigue Severity Scale

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    It was used to assess fatigue. There are 9 questions in the scale and each question consists of 7 points. An increase in the scale score indicates an increase in the level of fatigue. It detects the state of fatigue in the last month

  7. Vestibular Disorders Activities of Daily Life

    Time frame: Change from Baseline Systolic Blood Pressure at 4 / 8 / 12 / 16 weeks

    This scale is used to determine the degree of independence of patients with vestibular disorders, perceived inadequacies and vestibular complaints in daily activities. The scale consists of 28 items. The subscales are evaluated under three sub-headings as Functional-F- Ambulation-A- and Instrumental-E

Sponsors and collaborators

Lead sponsor

Miray Budak

Other

Registry information

Official study title

Effects of Structured Exercise Program on Severity of Dizziness, Kinesiophobia, Balance, Fatigue, Quality of Sleep, Activities of Daily Living and Quality Of Life in Bilateral Vestibular Hypofunction

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 10, 2023
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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