Cervical Exercise in Peripheral Vestibular Disorders

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

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Disorder; Peripheral Vestibular Disorder
• Intervention / Treatment: Other: Only vestibular rehabilitation; Other: Cervical exercises in addition to vestibular rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir
    • Bornova, Izmir, Turkey, 35100
      • Ege University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vestibular rehabilitation; 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; Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.; Other: Cervical exercises in addition to vestibular rehabilitation; Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.
Experimental: Cervical exercise in addition to vestibular rehabilitation; 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; Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ege University
• Investigators: Study Chair: Yesim Kirazli, Prof, Ege University School of Medicine

Publications and helpful links

General Publications

• Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2022
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: vertigo; vestibular disorders; cervical exercises; vestibular exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Otorhinolaryngologic Diseases; Labyrinth Diseases; Disease; Vestibular Diseases; Ear Diseases
• Other Study ID Numbers: 19-9.1Y/54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No