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Vestibular Rehabilitation in Patients With Vestibular Migraine

Primary Purpose

Vestibular Migraine, Vestibular Disorder, Migraine Variant

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Control
Vestibular Rehabilitation
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Migraine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises

Exclusion Criteria:

  • History of psychiatric disorder which might interfere with compliance to study
  • Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc)
  • Anatomical defects of the inner ear or vestibular system
  • Patients who are unable to stand up straight or walk

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Vestibular Rehabilitation

    Vestibular Rehabilitation+Pharmacological Therapy

    Pharmacological Therapy only

    Arm Description

    Adaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day. Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around. Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides. The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit.

    Same exercises that were applied in first group were also applied to this group. For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.

    Patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.

    Outcomes

    Primary Outcome Measures

    Dizziness Handicap Inventory
    A standardized inventory to assess the impact of dizziness in patients' life.
    Activities-specific balance confidence scale
    A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.
    Static Posturography
    Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)

    Secondary Outcome Measures

    Vertigo attack severity
    Self reported outcome in which patients give insight about their vertigo attack severity

    Full Information

    First Posted
    January 14, 2018
    Last Updated
    January 24, 2018
    Sponsor
    Ege University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03417596
    Brief Title
    Vestibular Rehabilitation in Patients With Vestibular Migraine
    Official Title
    Efficacy of Vestibular Rehabilitation in Patients With Vestibular Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 10, 2015 (Actual)
    Primary Completion Date
    April 10, 2016 (Actual)
    Study Completion Date
    April 15, 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Abstract: Introduction: Vestibular migraine(VM) is a disease that manifests with episodic vertigo attacks in patients with or without migraine type headaches, when present accompanying the headaches. Its prevalence was found out as %1 in a study in Germany. It usually involves middle aged women. VM can make a huge impact on quality of life, therefore advances in its diagnosis and management are valuable. While pharmacotherapy that is being used in migraine can be beneficial, vestibular rehabilitation(VR) programmes are predicted to be one of the most important types of treatment in management of VM. This study compares the results of pharmacological management options and vestibular rehabilitation programmes in the context of dizziness, balance problems and headache. Material and methods: 77 patients with VM were included in study, and 60 of them completed it. While one group took only VR programme, and another took only pharmacological prophylaxis. The third group took a combined therapy, and the groups were consisted of 20 patients. Patients were assessed with caloric tests, audiometric studies, static posturography, Dizziness Handicap Inventory(DHI), and Activities Specific Balance Confidence(ABC) scales. All of the assessments were applied 3 times throughout the study, and the results were compared with relevant statistical tests.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vestibular Migraine, Vestibular Disorder, Migraine Variant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    77 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vestibular Rehabilitation
    Arm Type
    Experimental
    Arm Description
    Adaptation Exercises The exercises were performed in horizontal and vertical planes, for a period of one minute each, three times a day. Substitution Exercises Standing dynamic balance exercises: The patient stands and moves without walking. The patient might march in place, step forward or backward, step to the side, step up or down, or turn around. Habituation exercises: These exercises that cause mild to moderate difficulty in daily life was given as an exercise to the patient. These exercises involved movements and positions sufficient to cause mild-to-moderate symptoms during the patient's daily activities Ambulation exercises: Exercises that include walking with head moving towards different sides. The exercise program consisted of one session per week for a period of eight weeks. Each session lasted approximately 30-45 minutes and was conducted in the rehabilitation unit.
    Arm Title
    Vestibular Rehabilitation+Pharmacological Therapy
    Arm Type
    Experimental
    Arm Description
    Same exercises that were applied in first group were also applied to this group. For pharmacological therapy, patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.
    Arm Title
    Pharmacological Therapy only
    Arm Type
    Other
    Arm Description
    Patients were assessed by a neurologist and appropriate drug options were applied based on patients' needs and features. Propranolol was selected primarily and other prophylactic drugs were used in the case of its' being contraindicated.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Routine treatment
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vestibular Rehabilitation
    Intervention Description
    Exercise and rehabilitation programme was individualized
    Primary Outcome Measure Information:
    Title
    Dizziness Handicap Inventory
    Description
    A standardized inventory to assess the impact of dizziness in patients' life.
    Time Frame
    6 months
    Title
    Activities-specific balance confidence scale
    Description
    A scale which is used to evaluate balance confidence of patients in some specific activities. Confidence in daily activities requiring balance is rated by subject as percentage(from %0 to %100). Higher percentage relates to better confidence in balance.
    Time Frame
    6 months
    Title
    Static Posturography
    Description
    Static posturography was performed using the NeuroCom System Version 8.0.3 (NeuroCom International Inc., Clackamas, OR, USA). Mean center of gravity (COG) sway velocity (°/s) was recorded on a static platform with eyes open (ST-EO) and closed (ST-EC) and on foam with eyes open (FO-EO) and closed (FO-EC)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Vertigo attack severity
    Description
    Self reported outcome in which patients give insight about their vertigo attack severity
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1-Vestibular Migraine diagnosis according to International Classification of Headache Disorders (3 rd edition-Beta version) 2- No history of vestibular rehabilitation or exercises Exclusion Criteria: History of psychiatric disorder which might interfere with compliance to study Other diagnosis that might possibly cause vestibular disorder(cerebellar disorders, Meniere disease etc) Anatomical defects of the inner ear or vestibular system Patients who are unable to stand up straight or walk

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Vestibular Rehabilitation in Patients With Vestibular Migraine

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