Cervical Exercise in Peripheral Vestibular Disorders

Study Overview
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Brief Summary
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70 patients with peripheral vestibular disorders will be included in the study. Half of the subjects will receive vestibular rehabilitation exercises and the other half will receive additional cervical exercises. Results from the two groups will be compared.

Detailed Description
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70 patients with a diagnosis of peripheral vestibular disease will be enrolled in the study. Patient selection will be carried out in the physiatry, otorhinolaryngology and neurology outpatient clinics of our university hospital. Eligible patients will be informed about the study and those that accept to take part in the study will be referred to an investigator for history taking and physical examination. Demographic data, medical history and examination findings will be recorded. After initial assessment, all patients will receive a short education regarding vestibular exercises that they will be asked to do at home. A second investigator will be responsible for the randomization of subjects into two groups according to a computer generated randomization table and that same investigator will prescribe the second group additional cervical exercises to do in addition to the vestibular rehabilitation exercises. After one months, patients will be reassessed and their measurements will be recorded. Statistical analyses will be carried out to compare the outcome scores of the two groups.

Official Title
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Effect of Cervical Exercises in Addition to Vestibular Rehabilitation in the Treatment of Peripheral Vestibular Disorders

Conditions
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Vestibular Disorder, Peripheral Vestibular Disorder

Intervention / Treatment
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* Other: Only vestibular rehabilitation
* Other: Cervical exercises in addition to vestibular rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of peripheral vestibular disease Being older than 18 years of age Exclusion Criteria: Psychostimulant or psychotropic drug use that might alter vestibular functions Severe neurological, psychiatric or orthopedic disorder that might alter patients' ability to comply with the exercise program.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vestibular rehabilitation<br>Patients in the vestibular rehabilitation group will be asked to do vestibular exercises 3 times a day for 20 minutes, every day for one month. | Other: Only vestibular rehabilitation<br>* Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.<br>Other: Cervical exercises in addition to vestibular rehabilitation<br>* Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.<br>|
| Experimental: Cervical exercise in addition to vestibular rehabilitation<br>Patients in this group will receive the same vestibular exercise program and will be asked to do additional neck exercises and they will be asked to do these exercises twice a day for ten minutes. | Other: Cervical exercises in addition to vestibular rehabilitation<br>* Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks | A questionnaire that measures an individual's confidence during ambulatory activities. The scale is scored from 0 to 100. 100 indicates better outcome. | Baseline and 4th week visit | 
| Change from baseline Dizziness handicap inventory at 4 weeks | A 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. The scale is scored from 0 to 100. 100 indicates better outcome. | Baseline and 4th week visit | 
| Change from baseline Gait speed at 4 weeks | Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. Gait speed has different reference values according to age and sex. | Baseline and 4th week visit | 
| Change from baseline Dynamic gait index at 4 weeks | An inventory that assesses individual's ability to modify balance while walking in the presence of external demands. Highest possible score is 24 points and lower scores indicate worse outcome. | Baseline and 4th week visit | 
| Change from baseline Functional gait assessment at 4 weeks | An index that is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Highest score is 30 points and higher scores denote better outcome. | Baseline and 4th week visit | 
| Change from baseline Romberg test at 4 weeks | A balance test that challenges the vestibular, proprioceptive and visual systems. Subject is asked to stand erect with eyes open/closed, on a hard/smooth surface and with feet side by side/ in tandem.Normally a person is expected to be able to stand in these positions for 30 seconds. | Baseline and 4th week visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Visual analog scale for neck pain at 4 weeks | Patient reported level of neck pain on a scale from 0 to 10 centimeters. 10 denotes severe pain and 0 denotes lack of pain. | Baseline and 4th week visit | 
| Change from baseline Visual analog scale for dizziness at 4 weeks | Patient reported level of dizziness on a scale from 0 to 10 centimeters. 10 indicates severe dizziness. | Baseline and 4th week visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vestibular disorders, cervical exercises, vertigo, vestibular exercises