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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05430282
Other study ID # 19-9.1Y/54
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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