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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04687371
Other study ID # 2020/190
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 10, 2021
Est. completion date June 25, 2021

Study information

Verified date February 2021
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 25, 2021
Est. primary completion date June 18, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Proprioceptive vestibular exercise
To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions
Standard vestibular rehabilitation exercises
To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions
Controlled
First and last measurement will be taken. There will be no intervention. study will include 9 patients.

Locations

Country Name City State
Turkey Inonu University Malatya Battalgazi/MALATYA

Sponsors (1)

Lead Sponsor Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dizziness handicap inventory It used to assess the quality of life in patients with vertigo 8 weeks
Primary Tinetti balance test It used to asses the balance (questionnaire, score) 8 weeks
Primary Time up and go test It used to assses the functionality (sec) 8 weeks
Primary Adolescent/Adult Sensory Profile 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
Primary Mobile application for Posture Analyze It used to assess Posture (Degree) 8 weeks
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