Clinical trial NCT05430282: Cervical Exercise in Peripheral Vestibular Disorders
Official title: Effect of Cervical Exercises in Addition to Vestibular Rehabilitation in the Treatment of Peripheral Vestibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Disorder
Peripheral Vestibular Disorder
Keywords: vestibular disorders
cervical exercises
vertigo
vestibular exercises
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks
timeFrame: Baseline and 4th week visit
measure: Change from baseline Dizziness handicap inventory at 4 weeks
timeFrame: Baseline and 4th week visit
measure: Change from baseline Gait speed at 4 weeks
timeFrame: Baseline and 4th week visit
measure: Change from baseline Dynamic gait index at 4 weeks
timeFrame: Baseline and 4th week visit
measure: Change from baseline Functional gait assessment at 4 weeks
timeFrame: Baseline and 4th week visit
measure: Change from baseline Romberg test at 4 weeks
timeFrame: Baseline and 4th week visit
Secondary outcomes:
measure: Change from baseline Visual analog scale for neck pain at 4 weeks
timeFrame: Baseline and 4th week visit
measure: Change from baseline Visual analog scale for dizziness at 4 weeks
timeFrame: Baseline and 4th week visit
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University School of Medicine
state: Izmir
Study officials:
affiliation: Ege University School of Medicine
name: Yesim Kirazli, Prof
role: STUDY_CHAIR
References:
citation: Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
citation: Dunlap PM, Holmberg JM, Whitney SL. Vestibular rehabilitation: advances in peripheral and central vestibular disorders. Curr Opin Neurol. 2019 Feb;32(1):137-144. doi: 10.1097/WCO.0000000000000632.