Pilot Feasibility of App-supported Vestibular Rehabilitation

December 4, 2024 updated by: Yoav Gimon, University of Haifa

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • Center
      • Ramat Gan, Center, Israel
        • Sheba Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants that will meet the following inclusion criteria were recruited to the study:

  1. between the ages of 18-75;
  2. diagnosis of vestibular dysfunction;
  3. fluent in Hebrew;
  4. own an Android smart-phone

Exclusion Criteria:

Exclusion criteria for the study group will be as follows:

  1. a medical condition that prevents participant from performing home vestibular rehabilitation practice - such as orthopedic, neurological, cardiac, visual impairment;
  2. individuals with dizziness who already have been given a home vestibular rehabilitation exercise program;
  3. diagnosis of central vestibular disorder due to brain structural damage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Collaborators

Sheba Medical Center
Ben-Gurion University of the Negev

Investigators

  • Principal Investigator: Amit Wolfovitz, Dr., Sheba Meical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2023

Primary Completion (Actual)

July 4, 2024

Study Completion (Actual)

July 4, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-23--957622-AW-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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