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

Primary Purpose

Vertigo, Peripheral, Vestibular Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Proprioceptive vestibular exercise
Standard vestibular rehabilitation exercises
Controlled
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertigo, Peripheral focused on measuring Vertigo, Peripheral Vestibular Hypofunction, Exercises, Balance, Functional Mobility, Quality of Life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Inonu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Grup I

Grup II

Grup III

Arm Description

Proprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises,

Cawthorne Cooksey Exercises and Gaze Stabilization exercises

No intervention will be made, patients will be asked to continue their daily life

Outcomes

Primary Outcome Measures

Dizziness handicap inventory
It used to assess the quality of life in patients with vertigo
Tinetti balance test
It used to asses the balance (questionnaire, score)
Time up and go test
It used to assses the functionality (sec)
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.
Mobile application for Posture Analyze
It used to assess Posture (Degree)

Secondary Outcome Measures

Full Information

First Posted
December 18, 2020
Last Updated
April 18, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04687371
Brief Title
The Effect of Proprioseptive Vestibular Rehabilitation in Patients With Peripheral Vestibular Hypofunction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertigo, Peripheral, Vestibular Disease
Keywords
Vertigo, Peripheral Vestibular Hypofunction, Exercises, Balance, Functional Mobility, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, Randomized Controlled Study
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grup I
Arm Type
Experimental
Arm Description
Proprioceptive vestibular rehabilitation exercises, Cawthorne Cooksey Exercises and Gaze Stabilization exercises,
Arm Title
Grup II
Arm Type
Experimental
Arm Description
Cawthorne Cooksey Exercises and Gaze Stabilization exercises
Arm Title
Grup III
Arm Type
Other
Arm Description
No intervention will be made, patients will be asked to continue their daily life
Intervention Type
Other
Intervention Name(s)
Proprioceptive vestibular exercise
Other Intervention Name(s)
Cawthorne cooksey exercises, Gaze stabilization exercises
Intervention Description
To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions
Intervention Type
Other
Intervention Name(s)
Standard vestibular rehabilitation exercises
Other Intervention Name(s)
Cawthorne Cooksey Exercises, Gaze Stabilization Exercises
Intervention Description
To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions
Intervention Type
Other
Intervention Name(s)
Controlled
Intervention Description
First and last measurement will be taken. There will be no intervention. study will include 9 patients.
Primary Outcome Measure Information:
Title
Dizziness handicap inventory
Description
It used to assess the quality of life in patients with vertigo
Time Frame
8 weeks
Title
Tinetti balance test
Description
It used to asses the balance (questionnaire, score)
Time Frame
8 weeks
Title
Time up and go test
Description
It used to assses the functionality (sec)
Time Frame
8 weeks
Title
Adolescent/Adult Sensory Profile
Description
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.
Time Frame
8 weeks
Title
Mobile application for Posture Analyze
Description
It used to assess Posture (Degree)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu TALU, Assoc. Prof.
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inonu University
City
Malatya
State/Province
Battalgazi/MALATYA
ZIP/Postal Code
44280
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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