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Completed

NCT Number: NCT05430282

Cervical Exercise in 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.

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Key information

Conditions

Vestibular Disorder Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Peripheral Vestibular Disorder Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University School of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Only vestibular rehabilitation

Other

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

Cervical exercises in addition to vestibular rehabilitation

Other

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

Primary outcomes

  1. Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks

    Time frame: Baseline and 4th week visit

    A questionnaire that measures an individual's confidence during ambulatory activities. The scale is scored from 0 to 100. 100 indicates better outcome.

  2. Change from baseline Dizziness handicap inventory at 4 weeks

    Time frame: Baseline and 4th week visit

    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.

  3. Change from baseline Gait speed at 4 weeks

    Time frame: Baseline and 4th week visit

    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.

  4. Change from baseline Dynamic gait index at 4 weeks

    Time frame: Baseline and 4th week visit

    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.

  5. Change from baseline Functional gait assessment at 4 weeks

    Time frame: Baseline and 4th week visit

    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.

  6. Change from baseline Romberg test at 4 weeks

    Time frame: Baseline and 4th week visit

    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 outcomes

  1. Change from baseline Visual analog scale for neck pain at 4 weeks

    Time frame: Baseline and 4th week visit

    Patient reported level of neck pain on a scale from 0 to 10 centimeters. 10 denotes severe pain and 0 denotes lack of pain.

  2. Change from baseline Visual analog scale for dizziness at 4 weeks

    Time frame: Baseline and 4th week visit

    Patient reported level of dizziness on a scale from 0 to 10 centimeters. 10 indicates severe dizziness.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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