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Pilot Feasibility of App-supported Vestibular Rehabilitation

Pilot Feasibility of App-supported Vestibular Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05959278
Enrollment
26
Registered
2023-07-25
Start date
2023-07-16
Completion date
2024-07-04
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Disorder

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).

Interventions

OTHERApp for vestibular rehabilitation

This app is a platform for performing conventional vestibular rehabilitation remotely

Sponsors

Ben-Gurion University of the Negev
CollaboratorOTHER
Sheba Medical Center
CollaboratorOTHER_GOV
University of Haifa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Instrumented Timed Up and Go Test (iTUG) (Change)In each of the measurement sessions - baseline, after two and a half weeks, and after five weeksThe 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 weeksThe 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.
Dizziness Handicap Inventory (DHI) (Change)In each of the measurement sessions - baseline, after two and a half weeks, and after five weeksThe 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 questionnaireAfter two and a half weeks of using the applicationThe 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.
User Satisfaction Evaluation Questionnaire (USEQ)After two and a half weeks of using the applicationThe 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026