Cervical Exercise in Peripheral Vestibular Disorders

NCT05430282 | Completed

• 1 other identifier: 19-9.1Y/54
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Disorder; Peripheral Vestibular Disorder

Keywords

vestibular disorders; cervical exercises; vertigo; vestibular exercises

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

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

  Baseline and 4th week visit

• Change from baseline Visual analog scale for dizziness at 4 weeks

  Baseline and 4th week visit

Study Arms (2)

Vestibular rehabilitation

ACTIVE COMPARATOR

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.

Other: Only vestibular rehabilitation; Other: Cervical exercises in addition to vestibular rehabilitation

Cervical exercise in addition to vestibular rehabilitation

EXPERIMENTAL

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.

Other: Cervical exercises in addition to vestibular rehabilitation

Interventions

Only vestibular rehabilitation OTHER

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

Vestibular rehabilitation

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.

Cervical exercise in addition to vestibular rehabilitation; Vestibular rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of peripheral vestibular disease
• Being older than 18 years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University School of Medicine

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Related Publications (2)

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

  PMID: 30947180 BACKGROUND

• 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.

  PMID: 30461465 BACKGROUND

MeSH Terms

Conditions

Vestibular Diseases; Vertigo

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yesim Kirazli, Prof

  Ege University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator responsible for clinical assessment will be blinded to subject's intervention group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 24, 2022
• Study Start: June 25, 2022
• Primary Completion: October 25, 2022
• Study Completion: December 22, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)