The Effect of Proprioseptive Vestibular Rehabilitation in Patients With Peripheral Vestibular Hypofunction

April 18, 2022 updated by: Burcu Talu, Inonu University

The Effect of Proprioseptive Vestibular Rehabilitation on the Balance, Functional Mobility, Posture, Sensory Profile and Quality of Life in Patients With Vertigo Due to Peripheral Vestibular Hypofunction

The aim of this study was to investigate the effect of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life in patients with vertigo due to peripheral vestibular hypofunction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Peripheral vestibular system; It forms the part extending from the structures in the inner ear to the vestibular nuclei in the brainstem. Peripheral vestibular hypofunction is a chronic disease affecting one or both sides of the vestibular system, which occurs when the function of the vestibular organs, vestibular nerve, or both is reduced or destroyed. Many patients with peripheral vestibular hypofunction develop symptoms such as dizziness, vertigo, imbalance, gait disturbance. Many different exercise methods have been tried so far to relieve these symptoms and increase the functionality of the patient. In this study, we aimed to examine the effect of proprioceptive vestibular rehabilitation on balance, quality of life, posture, sensory profile and functional mobility in patients with vertigo due to peripheral vestibular hypofunction aged 18-65 years. Patients with vertigo due to peripheral vestibular hypofunction between the ages of 18-65 will be included in our study. The population of the research will be created by the cluster sampling method and the randomization of the patients to be recruited will be determined using the "research ramdomizer" computer program; Patients will be divided into 3 groups as experimental and control groups. A randomized controlled, single-blind study will be planned. Group I (experiment): Glance stabilization exercises, Cawthorne Cooksey Exercises and Proprioceptive vestibular rehabilitation exercises, Group II (experiment): Glance stabilization exercises and Cawthorne Cooksey Exercises and Group III (control): no exercise will be given, they will be asked to continue daily life. Exercises will be applied to each group for 8 weeks, 4 days a week, 30 minutes, in the presence of 1 set of physiotherapists and as a home exercise program every day of the week. Individuals will be evaluated before and 8 weeks after the treatment. Tinetti Balance Test for balance assessment, One leg stand test; timed up and go test for functional mobility assessment; Dizziness Disability Inventory for quality of life; mobile posture assessment application for posture assessment; Adult / Adolescent Sensory profile will be used for sensory assessment. Pre- and post-treatment and intergroup evaluations will be compared, and the effectiveness of proprioceptive vestibular rehabilitation on balance, functional mobility, posture, sensory profile and quality of life, and its superiority over standard exercises will be interpreted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Battalgazi/MALATYA
      • Malatya, Battalgazi/MALATYA, Turkey, 44280
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Between 18-65 years
  • Diagnosis of vertigo according to the clinical examination performed by an Otorhinolaryngologist, Vestibular Evoked Myogenic Potentials (VEMP), Video Head Impulse Test (VHIT)
  • Patients with Unilateral Peripheral Hypofunction
  • After giving detailed information about the research, agreeing to participate in the study.

Exclusion Criteria:

  • Severe hearing / vision impairment-loss
  • Patients with neurological, orthopedic, circulatory system problems that may cause vertigo, dizziness and balance disorders
  • Having severe hypertension / diabetes
  • Previous participation in a vestibular rehabilitation program
  • Being healthy
  • Patients using drugs that may affect the treatment negatively
  • Refusing to participate in a clinical trial
  • Patients who cannot adapt to the training program
  • Patients who discontinued their treatment
  • Patients with different diagnoses that may disrupt the treatment during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Grup I
Proprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises,
Other: Proprioceptive vestibular exercise
To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions
Other Names:
  • Cawthorne cooksey exercises
  • Gaze stabilization exercises
Experimental: Grup II
Cawthorne Cooksey Exercises and Gaze Stabilization exercises
Other: Standard vestibular rehabilitation exercises
To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions
Other Names:
  • Cawthorne Cooksey Exercises, Gaze Stabilization Exercises
Other: Grup III
No intervention will be made, patients will be asked to continue their daily life
Other: Controlled
First and last measurement will be taken. There will be no intervention. study will include 9 patients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dizziness handicap inventory
Time Frame: 8 weeks
It used to assess the quality of life in patients with vertigo
8 weeks
Tinetti balance test
Time Frame: 8 weeks
It used to asses the balance (questionnaire, score)
8 weeks
Time up and go test
Time Frame: 8 weeks
It used to assses the functionality (sec)
8 weeks
Adolescent/Adult Sensory Profile
Time Frame: 8 weeks
In the test, 6 different sensory processing processes are evaluated. Includes assessments of taste/smell process, movement process, visual processing, touch process, activity level and auditory processing. Each item is scored with likert measurements between 1 and 5 points determined by the person.
8 weeks
Mobile application for Posture Analyze
Time Frame: 8 weeks
It used to assess Posture (Degree)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Burcu TALU, Assoc. Prof., Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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