App-supported Vestibular Rehabilitation (RCT)

NCT ID: NCT06350669

Last Updated: 2026-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2026-02-02

Brief Summary

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A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes

Detailed Description

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Vestibular Rehabilitation (VR) home exercises, prescribed by physiotherapists, are the main treatment for vestibular dysfunction. However, reports by clinicians indicate that patients do not fully comply with the treatment. Advances in technology and tele-rehabilitation have the potential to facilitate adherence to home exercise, if they are designed to overcome the barriers for practice. We plan to continue and expand our previous feasibility study with the vestibular phone app, in order to examine the effects of an app-assisted VR program on adherence and treatment outcomes. The patients in this study will be randomly assigned to the intervention (app-assisted vestibular rehabilitation) or the control group (standard vestibular rehabilitation, no app).

Tests and measurements for both groups will be done at three time points:

1. Preliminary assessment session (Session 1)- An initial assessment test on the first visit;
2. Secondary assessment session (Session 2)- After 5-6 weeks;
3. Follow-up evaluation session (Session 3)- One month after the secondary assessment session.

Conditions

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Vestibular Disorder Vestibular Diseases Vestibular Abnormality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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App-assisted vestibular rehabilitation

The patients in this group will undergo standard vestibular rehabilitation treatment with the addition of a phone app that support the treatment program, e.g., providing reminders for exercise, documentation of exercise performance, communication with the therapist, etc.

Group Type EXPERIMENTAL

Vestibular rehabilitation phone application

Intervention Type DEVICE

The standard vestibular rehabilitation process, with the support of a phone app throughout the process

Standard vestibular rehabilitation (no app)

The patients in this group will undergo standard vestibular rehabilitation treatment, without using the app.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vestibular rehabilitation phone application

The standard vestibular rehabilitation process, with the support of a phone app throughout the process

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18 and over
* Diagnosis with any vestibular disorder that requires a vestibular rehabilitation exercise program
* Physical and cognitive ability to perform vestibular physiotherapy

Exclusion Criteria

* A physical disability that does not allow for the performance of vestibular physiotherapy
* A diagnosis of a central vestibular disorder caused by structural damage to the brain
* Individuals who are not qualified to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

University of Haifa

OTHER

Sponsor Role lead

Responsible Party

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Yoav Gimon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoav Gimmon, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center; University of Haifa

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

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Israel

References

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Other Identifiers

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9576-22-SMC

Identifier Type: -

Identifier Source: org_study_id

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