Cervical Exercise in Peripheral Vestibular Disorders

Vestibular Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430282
• Other study ID #: 19-9.1Y/54
• Status: Completed
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: December 22, 2022

Study information

• Verified date: January 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 22, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Ear Diseases
• Peripheral Vestibular Disorder
• Vestibular Diseases
• Vestibular Disorder

Intervention

Other:
• Only vestibular rehabilitation
Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.
• 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.

Locations

Country	Name	City	State
Turkey	Ege University School of Medicine	Bornova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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