Pilot Feasibility of App-supported Vestibular Rehabilitation

Not Applicable

Completed

• Conditions: Vestibular Disorder
• Interventions: Other: App for vestibular rehabilitation

• Registration Number: NCT05959278
• Lead Sponsor: University of Haifa

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-06
• Study Start: 2023-07-16
• Study First Submitted QC: 2023-07-16
• Study First Posted: 2023-07-25
• Primary Completion: 2024-07-04
• Study Completion: 2024-07-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2 - Vestibular rehabilitation - initially without the support of the app	App for vestibular rehabilitation	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
Group 1 - Vestibular rehabilitation - initially supported by the app	App for vestibular rehabilitation	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

Primary Outcome Measures

Name	Time	Method
Custom-made questionnaire	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.
Dizziness Handicap Inventory (DHI) (Change)	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.
Instrumented Timed Up and Go Test (iTUG) (Change)	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.
State-Trait Anxiety Inventory (STAI) (Change)	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.
User Satisfaction Evaluation Questionnaire (USEQ)	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.

Trial Locations

Locations (1)

Sheba Hospital; 🇮🇱 Ramat Gan, Center, Israel