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Completed

NCT Number: NCT05959278

Pilot Feasibility of App-supported Vestibular Rehabilitation

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).

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Key information

Conditions

Vestibular Disorder Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases Vestibular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Hospital

Ramat Gan, Center, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App for vestibular rehabilitation

Other

This app is a platform for performing conventional vestibular rehabilitation remotely

Primary outcomes

  1. Instrumented Timed Up and Go Test (iTUG) (Change)

    Time frame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks

    The Timed Up and Go Test (TUG) examine functional balance

    The investigators will use the Instrumented Timed Up and Go Test (iTUG), for a combination of qualitative and quantitative assessment for this test. For the measurement, the investigators will use Opal (APDM) sensors.

    Measurements will be repeated three times to determine whether any changes have occurred during the rehabilitation process.

  2. State-Trait Anxiety Inventory (STAI) (Change)

    Time frame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks

    The STAI is a self-reported questionnaire designed to examine a person's general and current anxiety levels. The investigators 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.

  3. Dizziness Handicap Inventory (DHI) (Change)

    Time frame: In each of the measurement sessions - baseline, after two and a half weeks, and after five weeks

    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.

  4. Custom-made questionnaire

    Time frame: After two and a half weeks of using the application

    The questionnaire includes questions regarding the user's experience with the application.

    The investigators 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.

  5. User Satisfaction Evaluation Questionnaire (USEQ)

    Time frame: After two and a half weeks of using the application

    The investigators 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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Sheba Medical Center

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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