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Physiotherapy in Vestibular Disorders

Primary Purpose

Vestibular Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: Cawthorne and Cooksey exercises group
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with with unilateral peripheral vestibular disorders

Exclusion Criteria:

  • Bilateral vestibular disorders
  • Fluctuating or active unilateral vestibular disease
  • Or other medical conditions in the acute phase were excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cawthorne and Cooksey exercises group

    control group

    Arm Description

    Intervention: Participants allocated in both control and experimental groups were receiving treatment for their specific vestibular disorders. Patients assigned to the experimental group also performed the Cawthorne and Cooksey exercises for vestibular rehabilitation during a six week of treatment period.

    intervention: The control group will not perform the active exercise that will be applied to intervention group.

    Outcomes

    Primary Outcome Measures

    Activities-specific Balance Confidence scale (ABC)
    Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady. This scale is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.

    Secondary Outcome Measures

    UCLA Dizziness Questionnaire (UCLA-DQ)
    UCLA Dizziness Questionnaire (UCLA-DQ), used to measure the severity and frequency of dizziness and its impact on quality of life. This questionnaire is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.
    Dizziness Handicap Inventory (DHI),
    Dizziness Handicap Inventory (DHI), to assess the level of disability and handicap.This questionnaire is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    April 20, 2016
    Sponsor
    University of Jaén
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02746770
    Brief Title
    Physiotherapy in Vestibular Disorders
    Official Title
    Physiotherapy in Vestibular Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2016 (undefined)
    Primary Completion Date
    April 2016 (Anticipated)
    Study Completion Date
    April 2016 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Spanish population with unilateral peripheral vestibular disorders.
    Detailed Description
    Participants with peripheral vestibular disorders will be allocated to a Cawthorne and Cooksey exercises protocol or control group. The Cawthorne and Cooksey exercises consist in some head mobilization and positioning tasks which are related with a restoration of vestibular disorders.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Cawthorne and Cooksey exercises group
    Arm Type
    Experimental
    Arm Description
    Intervention: Participants allocated in both control and experimental groups were receiving treatment for their specific vestibular disorders. Patients assigned to the experimental group also performed the Cawthorne and Cooksey exercises for vestibular rehabilitation during a six week of treatment period.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    intervention: The control group will not perform the active exercise that will be applied to intervention group.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental: Cawthorne and Cooksey exercises group
    Intervention Description
    Experimental: intervention group. Patients assigned to the experimental group will perform the Cawthorne and Cooksey exercises for vestibular rehabilitation in addition to their habitual treatment.
    Primary Outcome Measure Information:
    Title
    Activities-specific Balance Confidence scale (ABC)
    Description
    Activities-specific Balance Confidence scale (ABC), to quantify the level of confidence in performing a specific task without losing balance or becoming unsteady. This scale is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.
    Time Frame
    Baseline and after 6 weeks of intervention
    Secondary Outcome Measure Information:
    Title
    UCLA Dizziness Questionnaire (UCLA-DQ)
    Description
    UCLA Dizziness Questionnaire (UCLA-DQ), used to measure the severity and frequency of dizziness and its impact on quality of life. This questionnaire is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.
    Time Frame
    Baseline and after 6 weeks of intervention
    Title
    Dizziness Handicap Inventory (DHI),
    Description
    Dizziness Handicap Inventory (DHI), to assess the level of disability and handicap.This questionnaire is applied to assess the change due to intervention between the baseline and 6 weeks of treatment. So the data will be collected at baseline and after 6 weeks of treatment.
    Time Frame
    Baseline and after 6 weeks of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants with with unilateral peripheral vestibular disorders Exclusion Criteria: Bilateral vestibular disorders Fluctuating or active unilateral vestibular disease Or other medical conditions in the acute phase were excluded from the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Physiotherapy in Vestibular Disorders

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