ClinicalTrials.gg
CompletedNCT05430282Updated Jan 18, 2023

Cervical Exercise in Peripheral Vestibular Disorders

An interventional study of Only vestibular rehabilitation and Cervical exercises in addition to vestibular rehabilitation in Vestibular Disorder and Peripheral Vestibular Disorder, sponsored by Ege University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-18.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 15 studies in Vestibular Diseases with a site in Turkey — 1 open to participants now, 1 under way, none of them phase 3. Vestibular Diseases · Turkey.

Enrollment
4th of 12
70 · median 42
Started
2022
with 1 other
No phase
11 of 15
none open now
Registered
10th of 15
by date
Lead sponsor
1 of 15
Ege University

Among the 15 studies in Vestibular Diseases with a site in Turkey, this one is the 4th largest by enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2022, is one of 11 with no phase, and was the 10th registered.

Vestibular Diseases

170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.

Browse Vestibular Diseases studies →

Open to participants now

1 of the 15 studies in Vestibular Diseases with a site in Turkey is open now. Recruiting first, the newest first:

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 21 Vestibular Diseases studies recruiting now, 6 (29%) set no upper age limit and 9 (43%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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.

Read the 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.

03

Conditions studied

  • Vestibular Disorder
  • Peripheral Vestibular Disorder

Keywords

  • vestibular disorders
  • cervical exercises
  • vertigo
  • vestibular exercises
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    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.

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

  • Experimental
    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.

    Other: Cervical exercises in addition to vestibular rehabilitation

Interventions

  • OtherOnly vestibular rehabilitation

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

  • OtherCervical 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 4th week visit

  2. 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.

    Time frame: Baseline and 4th week visit

  3. 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.

    Time frame: Baseline and 4th week visit

  4. 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.

    Time frame: Baseline and 4th week visit

  5. 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.

    Time frame: Baseline and 4th week visit

  6. 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.

    Time frame: Baseline and 4th week visit

Secondary outcomes

  1. 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.

    Time frame: Baseline and 4th week visit

  2. 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.

    Time frame: Baseline and 4th week visit

07

Study locations

1 site
  • Ege University School of Medicine
    Bornova, Izmir 35100, Turkey
08

References and documents

Publications

  • Sulway S, Whitney SL. Advances in Vestibular Rehabilitation. Adv Otorhinolaryngol. 2019;82:164-169. doi: 10.1159/000490285. Epub 2019 Jan 15. PubMed 30947180 ↗
  • 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. PubMed 30461465 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Oct 2022, 4 months.

Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 4 months is below that.

Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2022
First posted
Jun 24, 2022
StartActual
Jun 25, 2022
Primary completionActual
Oct 25, 2022
CompletionActual
Dec 22, 2022
Last update
Jan 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05430282
Lead sponsor
Ege University
Responsible party
Ece Cinar (Principal investigator, Ege University) — Principal investigator
First posted
Jun 24, 2022
Start date
Jun 25, 2022
Primary completion
Oct 25, 2022
Completion
Dec 22, 2022
Last update
Jan 18, 2023

Study contacts

Yesim Kirazli, Prof
study chair · Ege University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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