ClinicalTrials.gg
CompletedNCT07272473Updated Oct 6, 2026

Effects of Cervical Mobilization on Dizziness, Balance, and Joint Position Sense in Patients With Meniere's Disease

An interventional study of Vestibular Rehabilitation + Cervical Mobilization and vestibular rehabilitation in Meniere Disease, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Treatment

Updated Oct 6, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The study will employ a stratified randomization method. Patients presenting to the Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose, and Throat Outpatient Clinic, with a definitive diagnosis of Meniere's disease, unilateral or bilateral involvement, and who consent to participate in the study will be divided into three groups. The control group will receive only their routine Betahistine. Their usual treatment will remain unchanged. The first study group will receive 20 minutes of Vestibular Rehabilitation (VR) and 10 minutes of cervical mobilization in addition to their routine Betahistine. The second study group will receive 30 minutes of VR in addition to Betahistine. The study will last 6 weeks. Participants will be assessed using a sociodemographic information questionnaire, the Dizziness Handicap Inventory (DHI), the Vertigo Symptom Scale (VSS), the Neck Disability Index (NDI), the International Tinnitus Inventory (ITI), balance assessment with the K-Force Plates, and joint position sense and proprioception assessment with the Kinvent Physio K-Move. All assessments will be conducted twice, before and after treatment.

Read the detailed description

Patients who have been diagnosed with Meniere's disease and who have applied to the Afyonkarahisar Health Sciences University Health Practice and Research Center, Ear, Nose, and Throat Outpatient Clinic will be included in the study.

The study will employ a stratified randomization method. Patients who have been diagnosed with Meniere's disease and have unilateral or bilateral involvement and who agree to participate in the study will be divided into three groups. The control group will only receive their routine Betahistine. Their usual treatments will remain unchanged. The first study group will receive 20 minutes of Vestibular Rehabilitation (VR) and 10 minutes of cervical mobilization in addition to their routine Betahistine. The second study group will receive 30 minutes of VR in addition to Betahistine. The study will last 6 weeks. During the VR sessions:

  1. Adaptation exercises
  2. Habituation exercises
  3. Compensation exercises. A 6-week exercise protocol will be developed. The exercises will gradually increase in difficulty each week. Adaptation exercises will include visual tracking of a moving object while the head is stationary, and tracking objects in different directions while walking. Habituation exercises will include challenging exercises such as coming from lying down to sitting quickly and rising from sitting to standing. Compensation exercises will include walking on surfaces of varying hardness, standing on a balance board, and balancing on a trampoline, each with increasing difficulty each week.

For cervical mobilization, participants will first undergo 3-4 minutes of suboccipital release while lying on their backs to relax, then 2-3 minutes of cervical traction will be applied, and then, while sitting, they will mobilize the C1 and C2 vertebrae using the Mulligan concept.

Participants will be assessed using a sociodemographic questionnaire, the The Dizziness Handicap Inventory (DHI), the Vertigo Symptom Scale (VSS), the Neck Disability Index (NDI), the International Tinnitus Inventory (ITI), balance assessment with the K-Force Plates, and joint position sense and proprioception assessment with the Kinvent Physio K-Move. All assessments will be conducted twice: at baseline and after 6 weeks. This will allow for comparison of the three groups and provide a pre- and post-treatment assessment.

02

Conditions studied

  • Meniere Disease

Keywords

  • Endolymphatic hydrops
  • Postural Balance
  • Tinnitus
  • Position Sense
  • Kinesthesis
  • Vestibular Sense
  • Neck Pains
03

In context

Meniere Disease

74 studies on the registry are indexed under Meniere Disease; 12 are open to participants now.

This study's enrollment of 48 is close to the median of 44 across 61 interventional studies indexed under Meniere Disease.

Browse Meniere Disease studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
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

  • Definitive clinical diagnosis of unilateral or bilateral Meniere's disease
  • Age between 18 and 60 years
  • Presence of fluctuating symptoms or chronic imbalance for at least 3 months
  • Cognitive ability to participate in balance rehabilitation tasks ( score ≥ 24)
  • Willingness to participate in the study and provide

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of vertigo not associated with Meniere's disease
  • Presence of another acute medical condition
  • Neurological, psychological, or cognitive dysfunction
  • History of orthopedic surgery within the last 3 months
  • Planned surgical intervention during the rehabilitation program
  • Cervical spine instability
  • Acute cervical trauma
  • Vertebral artery insufficiency
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Vestibular Rehabilitation + Cervical Mobilization

    Participants receive both vestibular rehabilitation and cervical mobilization interventions.

    Other: Vestibular Rehabilitation + Cervical Mobilization

  • Active comparator
    Vestibular Rehabilitation Alone

    Participants receive vestibular rehabilitation only, administered for 30 minutes per session, twice a week for 6 weeks.The program will include adaptation exercises, habituation exercises, and compensation exercises.

    Other: vestibular rehabilitation

  • No intervention
    Control Group

    Participants receive standard therapy only and do not receive vestibular rehabilitation or cervical mobilisation.

Interventions

  • OtherVestibular Rehabilitation + Cervical Mobilization

    Treatment will be administered twice a week for 6 weeks, consisting of 20 minutes of vestibular rehabilitation and 10 minutes of cervical mobilization, each lasting 30 minutes. Vestibular rehabilitation will include adaptation exercises, habituation exercises, and compensation exercises. For cervical mobilization, participants will first undergo 3-4 minutes of suboccipital relaxation while lying supine to help them relax, then 2-3 minutes of cervical traction will be applied, and then, while sitting, they will mobilize the C1 and C2 vertebrae using the Mulligan concept.

  • Othervestibular rehabilitation

    Vestibular rehabilitation will be applied for 30 minutes, twice a week, for 6 weeks. Adaptation exercises, habituation exercises, and compensation exercises will be applied as vestibular rehabilitation.

06

What researchers measure

Primary outcomes

  1. Balance assessments

    Balance assessments will be conducted statically and dynamically using K-Force Plates. Both bilateral and unilateral balance tests will be conducted for static balance assessments. In the bilateral balance test, participants will be tested on both feet, first with their eyes open and then with their eyes closed. In the unilateral test, participants will first be asked to stand on their right and left legs for 10 seconds, with their eyes open, and then three repetitions, with the average calculated. They will then be asked to stand on their right and left legs, again, with their eyes closed. In the dynamic balance test, participants will be asked to jump and descend from a step placed 19 cm above the force plate. (Both feet will be suspended before landing.) They will then be asked to balance with their hands on their hips for 15 seconds. If the participant moves their foot or loses their balance completely, the trial will be cancelled and repeated.

    Time frame: From enrollment to the end of treatment at 6 weeks

Secondary outcomes

  1. Dizziness assesment

    The Dizziness Handicap Inventory (DHI) will be used to assess dizziness. DHI was developed by Jacobson and Newman in 1990. The DHI consists of 25 items that identify factors that aggravate dizziness and balance disorders in patients, as well as the sensory and functional consequences of vestibular system disorders. Sub-inventories are designed to determine the physical, sensory, and functional effects of vestibular system disorders. Each question has a yes (4 points), no (0 points), and sometimes (2) response. When scoring the sub-items of the inventory, a score of 28 is recommended as the threshold for determining physical disability, and a score of 36 is recommended as the threshold for determining functional and sensory disability. High scores are interpreted as indicating that the patient's dizziness complaint significantly impedes their life. The Turkish validity and reliability test of the inventory was conducted.

    Time frame: From enrollment to the end of treatment at 6 weeks

  2. Vertigo Symptom Assesment

    The Vertigo Symptom Scale (VSS) is used to assess the frequency of symptoms such as imbalance, somatic symptoms, autonomic symptoms, anxiety, and panic, which are commonly encountered in patients with vertigo and feelings of imbalance. The scale consists of two subsections: the Vertigo Symptom Scale-Vertigo Section (VSS-V), which relates to vertigo and balance disorders, and the Vertigo Symptom Scale-Anxiety Section, which relates to autonomic disorders and anxiety symptoms. The VSS-V consists of 8 questions (0-32 points), and the VSS-A consists of 7 questions (0-28 points). Symptom frequency is scored from 0= never, 1= very infrequently, 2= often, 3= often (every week), and 4= very often (more than 1 day per week on average). Patients are asked to answer these questions about their dizziness, thinking back to the past month. Higher scores (maximum 60) indicate an increased frequency of experiencing vertigo-related symptoms. A score of ≥12 is defined as severe dizziness.

    Time frame: From enrollment to the end of treatment at 6 weeks

  3. Neck Disability Assessment

    The Neck Disability Index (NDI) is a 10-item assessment tool covering pain severity, personal care, weightlifting, reading, headache, concentration, working, driving, sleep, and rest. It measures the level of functional limitations associated with the neck. Each item is scored from 0 (no disability) to 5 (maximum disability). The highest total score is 50. It is accepted that as an individual's score increases, the level of disability due to neck pain also increases. A total score of 0 indicates no disability, while a score of 50 indicates maximum disability. According to the assessment, scores between 0 and 4 are classified as "no disability", 5-14 as "mild disability", 15-24 as "moderate disability," 25-34 as "severe disability," and 35 and above as "complete disability."

    Time frame: From enrollment to the end of treatment at 6 weeks

  4. Tinnitus Assessment

    The International Tinnitus Inventory (ITI), aims to assess the multidimensional effects of tinnitus on individuals.This assessment encompasses perceptions of hearing, general health status, sleep patterns, inner peace, social relationships, daily living activities, enjoyment of life, and the level of discomfort caused by tinnitus. The inventory consists of eight items, and each item is scored from 1 to 5; the total score ranges from 8 to 40. Lower total scores indicate a greater perception of the negative effects of tinnitus on the individual.

    Time frame: From enrollment to the end of treatment at 6 weeks

  5. Proprioception Assessment

    The Kinvent Physio K-Move device is a wireless, portable motion sensor developed for the objective assessment of movement. This device is used specifically in physiotherapy and rehabilitation processes to precisely measure and monitor joint range of motion (ROM) and joint position sense. Validity and reliability of the device for assessing joint position sense and proprioception have been established. The device measures head flexion, extension, lateral flexion, and rotation angles. During the measurements, participants' cervical joint range of motion will be assessed first. Participants will be seated in a comfortable sitting position with their feet flat on the floor and their heads in a neutral position, arms at their sides. Participants will be instructed and demonstrated on all movements they will perform before the assessment.

    Time frame: From enrollment to the end of treatment at 6 weeks

07

Study locations

1 site
  • Afyonkarahisar Health Sciences University Health Application and Research Center, Ear, Nose and Throat Polyclinic
    Afyonkarahisar, Afyonkarahisar 03030, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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 Sep 2025 to primary completion in Jul 2026, 10 months.

Of 14 interventional studies with no phase under Meniere Disease, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's 10 months is below that.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Mar 2026 → Jul 2026 and completion May 2026 → Jul 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Nov 27, 2025
First posted
Dec 9, 2025
StartActual
Sep 20, 2025
Primary completionActual
Jul 23, 2026was Mar 2026
CompletionActual
Jul 23, 2026was May 2026
Last update
Oct 6, 2026
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.
Status
Recruiting→Completed
changed Oct 6, 2026
Primary completion
Mar 30, 2026→Jul 23, 2026 (actual)
Oct 6, 2026
Study completion
May 5, 2026→Jul 23, 2026 (actual)
Oct 6, 2026
Enrollment
33 (estimated)→48 (actual)
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Recruiting→Completed
    Primary completion Mar 30, 2026→Jul 23, 2026 (now actual)
    Study completion May 5, 2026→Jul 23, 2026 (now actual)
    Enrollment 33 (estimated)→48 (actual)
    + 4 other changes: verification date, design details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07272473
Responsible party
Ömer Osman Pala (ASSOCIATE PROFESSOR, Abant Izzet Baysal University) — Principal investigator
First posted
Dec 9, 2025
Start date
Sep 20, 2025
Primary completion
Jul 23, 2026
Completion
Jul 23, 2026
Last update
Oct 6, 2026

Study contacts

omer pala, associate professor
study director · Abant Izzet Baysal University

Oversight

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

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