Cervical Exercise in Peripheral Vestibular Disorders

NCT ID: NCT05430282

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-25

Study Completion Date

2022-12-22

Brief Summary

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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

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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.

Conditions

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Vestibular Disorder Peripheral Vestibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Investigator responsible for clinical assessment will be blinded to subject's intervention group

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Only vestibular rehabilitation

Intervention Type OTHER

Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.

Cervical exercises in addition to vestibular rehabilitation

Intervention Type OTHER

Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.

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.

Group Type EXPERIMENTAL

Cervical exercises in addition to vestibular rehabilitation

Intervention Type OTHER

Cervical range of motion exercises, stretching exercises for the trapezius muscle, isometric and isotonic strengthening exercises in addition to conventional vestibular rehabilitation exercises.

Interventions

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Only vestibular rehabilitation

Vestibular adaptation exercises, static and dynamic balance exercises, proprioceptive and conditioning exercises.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Ece Cinar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yesim Kirazli, Prof

Role: STUDY_CHAIR

Ege University School of Medicine

Locations

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Ege University School of Medicine

Bornova, İzmir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND
PMID: 30947180 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30461465 (View on PubMed)

Other Identifiers

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19-9.1Y/54

Identifier Type: -

Identifier Source: org_study_id

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