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The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) (BPPV)

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Epley maneuver
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo

Eligibility Criteria

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

Inclusion Criteria:

  1. having posterior semicircular canal BPPV with upbeating-torsional nystagmus and positional vertigo as evaluated by the Dix-Hallpike Test
  2. agreeing to undergo the Epley maneuver after that test
  3. agreeing to participate in the study

Exclusion Criteria:

  1. having history or symptoms of vestibular system disorders other than BPPV or central nervous system disorders causing dizziness
  2. having cervical and/or lumbar pathology due to which the Epley maneuver could not be performed
  3. having lower extremity pain or an operation that prevented standing and/or weight bearing
  4. having anterior or horizontal canal BPPV
  5. having previously undergone a vestibular rehabilitation program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Epley maneuver

    Cawthorne-Cooksey exercises combined with the Epley maneuver

    Arm Description

    The Epley maneuver was performed for all patients (both EpleyM and EpleyM&Exe groups) included in this study until nystagmus had disappeared in each position. If nystagmus/vertigo was not seen, the Epley maneuver was not performed for patients at the 1st, 3rd, and 6th week assessments.

    Additional Cawthorne-Cooksey exercises were prescribed to the EpleyM&Exe group. The physiotherapist explained and demonstrated the exercises to each patient and the patients practiced the exercises until they performed them correctly. Then the exercises were prescribed twice a day and repeated 10 times for 6 weeks as a home exercise program.

    Outcomes

    Primary Outcome Measures

    Nintendo Wii Balance Board (WBB)
    COP displacement on double leg with eyes open/closed (%): Lower scores (approaching 50%) indicate better static balance. Frontal plane stability on dominant leg with eyes open/closed (%): The total score ranges between 0 and 100%. Higher scores indicate better static balance.
    Berg Balance Test (BBT)
    The minimum score of the BBT is 0 and the total maximum score of the BBT is 56. Higher scores indicate better dynamic balance.

    Secondary Outcome Measures

    Vertigo Symptom Scale (VSS)
    The total score ranges between 0 and 60 points, with higher scores indicating lower vertigo associated symptoms.
    Dizziness Handicap Inventory (DHI)
    The total score ranges between 0 and 100 points, with higher scores indicating lower quality of life.

    Full Information

    First Posted
    January 12, 2021
    Last Updated
    January 14, 2021
    Sponsor
    Istinye University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04715282
    Brief Title
    The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
    Acronym
    BPPV
    Official Title
    Effectiveness of the Epley Maneuver Versus Vestibular Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istinye 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
    Observation of the effects of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in BPPV patients.
    Detailed Description
    Study Objective: To observe the efficacy of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in patients with posterior canal BPPV. Study Design: Single-blind randomized controlled study Sample Size: Thirty-six patients were recruited in the study and were randomized equally into Epley maneuver (EpleyM) and Epley maneuver and exercise (EpleyM&Exe) groups. Study Method: All patients were treated with the Epley maneuver, while CawthorneCooksey exercises were given to the EpleyM&Exe group as home exercises for 6 weeks. Static and dynamic balance, vertigo and associated symptoms, and quality of life were assessed with the Nintendo Wii Balance Board, Berg Balance Test, Vertigo Symptom Scale, and Dizziness Handicap Inventory, respectively. The assessments were repeated at the 1st, 3rd, and 6th weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Benign Paroxysmal Positional Vertigo

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Epley maneuver
    Arm Type
    Other
    Arm Description
    The Epley maneuver was performed for all patients (both EpleyM and EpleyM&Exe groups) included in this study until nystagmus had disappeared in each position. If nystagmus/vertigo was not seen, the Epley maneuver was not performed for patients at the 1st, 3rd, and 6th week assessments.
    Arm Title
    Cawthorne-Cooksey exercises combined with the Epley maneuver
    Arm Type
    Other
    Arm Description
    Additional Cawthorne-Cooksey exercises were prescribed to the EpleyM&Exe group. The physiotherapist explained and demonstrated the exercises to each patient and the patients practiced the exercises until they performed them correctly. Then the exercises were prescribed twice a day and repeated 10 times for 6 weeks as a home exercise program.
    Intervention Type
    Procedure
    Intervention Name(s)
    Epley maneuver
    Intervention Description
    Epley maneuver
    Primary Outcome Measure Information:
    Title
    Nintendo Wii Balance Board (WBB)
    Description
    COP displacement on double leg with eyes open/closed (%): Lower scores (approaching 50%) indicate better static balance. Frontal plane stability on dominant leg with eyes open/closed (%): The total score ranges between 0 and 100%. Higher scores indicate better static balance.
    Time Frame
    one hour
    Title
    Berg Balance Test (BBT)
    Description
    The minimum score of the BBT is 0 and the total maximum score of the BBT is 56. Higher scores indicate better dynamic balance.
    Time Frame
    one hour
    Secondary Outcome Measure Information:
    Title
    Vertigo Symptom Scale (VSS)
    Description
    The total score ranges between 0 and 60 points, with higher scores indicating lower vertigo associated symptoms.
    Time Frame
    one hour
    Title
    Dizziness Handicap Inventory (DHI)
    Description
    The total score ranges between 0 and 100 points, with higher scores indicating lower quality of life.
    Time Frame
    one hour

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: having posterior semicircular canal BPPV with upbeating-torsional nystagmus and positional vertigo as evaluated by the Dix-Hallpike Test agreeing to undergo the Epley maneuver after that test agreeing to participate in the study Exclusion Criteria: having history or symptoms of vestibular system disorders other than BPPV or central nervous system disorders causing dizziness having cervical and/or lumbar pathology due to which the Epley maneuver could not be performed having lower extremity pain or an operation that prevented standing and/or weight bearing having anterior or horizontal canal BPPV having previously undergone a vestibular rehabilitation program
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ekin Taçalan
    Organizational Affiliation
    Dr. Sami Ulus Maternity, Children Health and Diseases Education and Research Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    H.Serap İnal
    Organizational Affiliation
    Istinye University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

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