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Cervical Exercise in Peripheral Vestibular Disorders

Primary Purpose

Vestibular Disorder, Peripheral Vestibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Only vestibular rehabilitation
Cervical exercises in addition to vestibular rehabilitation
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder focused on measuring vestibular disorders, cervical exercises, vertigo, vestibular exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ege University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Vestibular rehabilitation

Cervical exercise in addition to vestibular rehabilitation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 12, 2022
Last Updated
January 16, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05430282
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2022 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder, Peripheral Vestibular Disorder
Keywords
vestibular disorders, cervical exercises, vertigo, vestibular exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
Investigator responsible for clinical assessment will be blinded to subject's intervention group
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cervical exercise in addition to vestibular rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Only vestibular rehabilitation
Intervention Description
Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.
Intervention Type
Other
Intervention Name(s)
Cervical exercises in addition to vestibular rehabilitation
Intervention Description
Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.
Primary Outcome Measure Information:
Title
Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks
Description
A questionnaire that measures an individual's confidence during ambulatory activities. The scale is scored from 0 to 100. 100 indicates better outcome.
Time Frame
Baseline and 4th week visit
Title
Change from baseline Dizziness handicap inventory at 4 weeks
Description
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.
Time Frame
Baseline and 4th week visit
Title
Change from baseline Gait speed at 4 weeks
Description
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.
Time Frame
Baseline and 4th week visit
Title
Change from baseline Dynamic gait index at 4 weeks
Description
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.
Time Frame
Baseline and 4th week visit
Title
Change from baseline Functional gait assessment at 4 weeks
Description
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.
Time Frame
Baseline and 4th week visit
Title
Change from baseline Romberg test at 4 weeks
Description
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.
Time Frame
Baseline and 4th week visit
Secondary Outcome Measure Information:
Title
Change from baseline Visual analog scale for neck pain at 4 weeks
Description
Patient reported level of neck pain on a scale from 0 to 10 centimeters. 10 denotes severe pain and 0 denotes lack of pain.
Time Frame
Baseline and 4th week visit
Title
Change from baseline Visual analog scale for dizziness at 4 weeks
Description
Patient reported level of dizziness on a scale from 0 to 10 centimeters. 10 indicates severe dizziness.
Time Frame
Baseline and 4th week visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yesim Kirazli, Prof
Organizational Affiliation
Ege University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Ege University School of Medicine
City
Bornova
State/Province
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30947180
Citation
Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15.
Results Reference
background
PubMed Identifier
30461465
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.
Results Reference
background

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Cervical Exercise in Peripheral Vestibular Disorders

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