Pilot Feasibility of App-supported Vestibular Rehabilitation

Study Overview
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Brief Summary
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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).

Official Title
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Pilot Feasibility of App-supported Vestibular Rehabilitation

Conditions
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Vestibular Disorder

Intervention / Treatment
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* Other: App for vestibular rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 - Vestibular rehabilitation - initially supported by the app<br>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 | Other: App for vestibular rehabilitation<br>* This app is a platform for performing conventional vestibular rehabilitation remotely<br>|
| Experimental: Group 2 - Vestibular rehabilitation - initially without the support of the app<br>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 | Other: App for vestibular rehabilitation<br>* This app is a platform for performing conventional vestibular rehabilitation remotely<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | In each of the measurement sessions - the beginning of the study, after two and a half weeks, and after five weeks | 
| 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. | In each of the measurement sessions - the beginning of the study, after two and a half weeks, and after five weeks | 
| 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. | In each of the measurement sessions - the beginning of the study, after two and a half weeks, and after five weeks | 
| 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. | After two and a half weeks of using the application | 
| 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. | After two and a half weeks of using the application |