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Pilot Feasibility of App-supported Vestibular Rehabilitation

Primary Purpose

Vestibular Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
App for vestibular rehabilitation
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vestibular Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants that will meet the following inclusion criteria were recruited to the study: between the ages of 18-75; diagnosis of vestibular dysfunction; fluent in Hebrew; own an Android smart-phone Exclusion Criteria: Exclusion criteria for the study group will be as follows: a medical condition that prevents participant from performing home vestibular rehabilitation practice - such as orthopedic, neurological, cardiac, visual impairment; individuals with dizziness who already have been given a home vestibular rehabilitation exercise program; diagnosis of central vestibular disorder due to brain structural damage.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group 1 - Vestibular rehabilitation - initially supported by the app

    Group 2 - Vestibular rehabilitation - initially without the support of the app

    Arm Description

    First two and a half weeks - conventional vestibular rehabilitation supported by an app Second two and a half weeks - conventional vestibular rehabilitation without an app

    First two and a half weeks - conventional vestibular rehabilitation without an app Second two and a half weeks - conventional vestibular rehabilitation supported by an app

    Outcomes

    Primary Outcome Measures

    Instrumented Timed Up and Go Test (iTUG) (Change)
    The Timed Up and Go Test (TUG) examine functional balance We will use the Instrumented Timed Up and Go Test (iTUG), for a combination of qualitative and quantitative assessment for this test. For the measurement, we will use Opal (APDM) sensors. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.
    State-Trait Anxiety Inventory (STAI) (Change)
    The STAI is a self-reported questionnaire designed to examine a person's general and current anxiety levels. We will use this questionnaire to better distinguish between the participant's general and momentary anxiety to assess vestibular rehabilitation's effect on anxiety levels. This is a questionnaire with a numerical score between 40-160, a higher score indicates more anxiety. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.
    Dizziness Handicap Inventory (DHI) (Change)
    The DHI is a 25-items questionnaire designed to assess the impact of dizziness on everyday life in people with vestibular disorders. This is a questionnaire with a numerical score between 0-100; a higher score indicates a higher level of handicap. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.
    Custom-made questionnaire
    The questionnaire includes questions regarding the user's experience with the application. We will use the questionnaire to get the participants' feedback on using the app and to examine the feasibility of using the app in vestibular rehabilitation. This questionnaire mostly includes open-ended questions in free text and a part that includes questions with a numerical rating between 5-30. A higher score indicates a better user experience in the app.
    User Satisfaction Evaluation Questionnaire (USEQ)
    We will use the questionnaire to get the participants' feedback on the use of the app, and to examine the feasibility of using the app in vestibular rehabilitation This is a questionnaire with a numerical score between 5-30; a higher score indicates a higher satisfaction level.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 16, 2023
    Sponsor
    University of Haifa
    Collaborators
    Ben-Gurion University of the Negev, Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05959278
    Brief Title
    Pilot Feasibility of App-supported Vestibular Rehabilitation
    Official Title
    Pilot Feasibility of App-supported Vestibular Rehabilitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 16, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2023 (Anticipated)
    Study Completion Date
    March 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Haifa
    Collaborators
    Ben-Gurion University of the Negev, Sheba Medical Center

    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
    The primary goal of the study is to examine the feasibility of accompanying vestibular practice supported by a phone app for vestibular rehabilitation. Feasibility will be established using the following parameters: (1) the User Satisfaction Evaluation Questionnaire (USEQ) (2) a custom-made questionnaire to collect feedback from participants, and (3) compliance measurements derived from app usage. The secondary goal of the study is to examine the effect of practice supported by the app on balance and anxiety indices. These will be measured using the following parameters: (1) Instrumented Timed Up and Go Test (iTUG), (2) Dizziness Handicap Inventory (DHI), (3) State-Trait Anxiety Inventory (STAI). The third goal is to assess the correlation between balance function (iTUG) and anxiety (STAI). A randomized crossover pilot study will be conducted with 24 participants. During the study, each group will undergo two and a half weeks of conventional vestibular rehabilitation and two and a half weeks of app-supported vestibular rehabilitation. Measurement sessions will be conducted at three-time points: upon enrollment in the study (T0), after two and a half weeks (T1), and at the end of the study (T2).

    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
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 - Vestibular rehabilitation - initially supported by the app
    Arm Type
    Experimental
    Arm Description
    First two and a half weeks - conventional vestibular rehabilitation supported by an app Second two and a half weeks - conventional vestibular rehabilitation without an app
    Arm Title
    Group 2 - Vestibular rehabilitation - initially without the support of the app
    Arm Type
    Experimental
    Arm Description
    First two and a half weeks - conventional vestibular rehabilitation without an app Second two and a half weeks - conventional vestibular rehabilitation supported by an app
    Intervention Type
    Other
    Intervention Name(s)
    App for vestibular rehabilitation
    Intervention Description
    This app is a platform for performing conventional vestibular rehabilitation remotely
    Primary Outcome Measure Information:
    Title
    Instrumented Timed Up and Go Test (iTUG) (Change)
    Description
    The Timed Up and Go Test (TUG) examine functional balance We will use the Instrumented Timed Up and Go Test (iTUG), for a combination of qualitative and quantitative assessment for this test. For the measurement, we will use Opal (APDM) sensors. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.
    Time Frame
    In each of the measurement sessions - the beginning of the study, after two and a half weeks, and after five weeks
    Title
    State-Trait Anxiety Inventory (STAI) (Change)
    Description
    The STAI is a self-reported questionnaire designed to examine a person's general and current anxiety levels. We will use this questionnaire to better distinguish between the participant's general and momentary anxiety to assess vestibular rehabilitation's effect on anxiety levels. This is a questionnaire with a numerical score between 40-160, a higher score indicates more anxiety. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.
    Time Frame
    In each of the measurement sessions - the beginning of the study, after two and a half weeks, and after five weeks
    Title
    Dizziness Handicap Inventory (DHI) (Change)
    Description
    The DHI is a 25-items questionnaire designed to assess the impact of dizziness on everyday life in people with vestibular disorders. This is a questionnaire with a numerical score between 0-100; a higher score indicates a higher level of handicap. Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.
    Time Frame
    In each of the measurement sessions - the beginning of the study, after two and a half weeks, and after five weeks
    Title
    Custom-made questionnaire
    Description
    The questionnaire includes questions regarding the user's experience with the application. We will use the questionnaire to get the participants' feedback on using the app and to examine the feasibility of using the app in vestibular rehabilitation. This questionnaire mostly includes open-ended questions in free text and a part that includes questions with a numerical rating between 5-30. A higher score indicates a better user experience in the app.
    Time Frame
    After two and a half weeks of using the application
    Title
    User Satisfaction Evaluation Questionnaire (USEQ)
    Description
    We will use the questionnaire to get the participants' feedback on the use of the app, and to examine the feasibility of using the app in vestibular rehabilitation This is a questionnaire with a numerical score between 5-30; a higher score indicates a higher satisfaction level.
    Time Frame
    After two and a half weeks of using the application

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants that will meet the following inclusion criteria were recruited to the study: between the ages of 18-75; diagnosis of vestibular dysfunction; fluent in Hebrew; own an Android smart-phone Exclusion Criteria: Exclusion criteria for the study group will be as follows: a medical condition that prevents participant from performing home vestibular rehabilitation practice - such as orthopedic, neurological, cardiac, visual impairment; individuals with dizziness who already have been given a home vestibular rehabilitation exercise program; diagnosis of central vestibular disorder due to brain structural damage.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Azriel Kaplan
    Phone
    +972546387098
    Email
    azrielk@post.bgu.ac.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amit Wolfovitz, Dr.
    Organizational Affiliation
    Sheba Meical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34864777
    Citation
    Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.
    Results Reference
    result
    PubMed Identifier
    33774661
    Citation
    Kim KJ, Gimmon Y, Millar J, Brewer K, Serrador J, Schubert MC. The Instrumented Timed "Up & Go" Test Distinguishes Turning Characteristics in Vestibular Hypofunction. Phys Ther. 2021 Jul 1;101(7):pzab103. doi: 10.1093/ptj/pzab103.
    Results Reference
    result
    PubMed Identifier
    33048219
    Citation
    Meldrum D, Burrows L, Cakrt O, Kerkeni H, Lopez C, Tjernstrom F, Vereeck L, Zur O, Jahn K. Vestibular rehabilitation in Europe: a survey of clinical and research practice. J Neurol. 2020 Dec;267(Suppl 1):24-35. doi: 10.1007/s00415-020-10228-4. Epub 2020 Oct 13.
    Results Reference
    result
    PubMed Identifier
    19832817
    Citation
    Polensek SH, Tusa RJ, Sterk CE. The challenges of managing vestibular disorders: a qualitative study of clinicians' experiences associated with low referral rates for vestibular rehabilitation. Int J Clin Pract. 2009 Nov;63(11):1604-12. doi: 10.1111/j.1742-1241.2009.02104.x.
    Results Reference
    result
    PubMed Identifier
    30714985
    Citation
    Rosiak O, Krajewski K, Woszczak M, Jozefowicz-Korczynska M. Evaluation of the effectiveness of a Virtual Reality-based exercise program for Unilateral Peripheral Vestibular Deficit. J Vestib Res. 2018;28(5-6):409-415. doi: 10.3233/VES-180647.
    Results Reference
    result
    PubMed Identifier
    27638071
    Citation
    Whitney SL, Alghwiri AA, Alghadir A. An overview of vestibular rehabilitation. Handb Clin Neurol. 2016;137:187-205. doi: 10.1016/B978-0-444-63437-5.00013-3.
    Results Reference
    result

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    Pilot Feasibility of App-supported Vestibular Rehabilitation

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