App-supported Vestibular Rehabilitation (RCT)

February 5, 2026 updated by: Yoav Gimon, University of Haifa

App-supported Vestibular Rehabilitation (Randomized Controlled Trial)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

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
      • Ramat Gan, Israel
        • Sheba Medical Center

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:

  • 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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Vestibular rehabilitation phone application
The standard vestibular rehabilitation process, with the support of a phone app throughout the process
No Intervention: Standard vestibular rehabilitation (no app)
The patients in this group will undergo standard vestibular rehabilitation treatment, without using the app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence measures
Time Frame: At the end of Cycle 1 (each cycle is 4-6 weeks)
Quantitative data on adherence to home exercise will be extracted from users' phone application database (intervention group) or from records in a diary / logs (control group)
At the end of Cycle 1 (each cycle is 4-6 weeks)
Timed up and go (TUG)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Assesses balance, walking ability and also used as a screening test for the risk of falls by assessing the function of the lower limbs. The individual is required to get up from sitting on a chair, walk 3 meter forward at a normal pace, turn around and return to a sitting position. The examiner times this sequence
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics and medical history intake
Time Frame: At the beginning of Cycle 1 (each cycle is 4-6 weeks)
Characteristics of patients
At the beginning of Cycle 1 (each cycle is 4-6 weeks)
Vestibular functions- physical examination
Time Frame: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
The routine assessment of vestibular functions, with fixation and without fixation. These functions include observation of gait, posture, gaze / detection of spontaneous nystagmus and it's characteristics, Vestibulo-Ocular reflex (VOR), head impulse test, head shaking nystagmus, dix-hallpike test, supine roll test and dynamic visual acuity (DVA)
At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
Oculomotor functions- physical examination
Time Frame: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
The routine assessment of oculomotor functions: Saccades, Smooth-Pursuit, Vestibulo-Ocular Reflex cancellation (VORc) test, Convergence, single cover and cover-uncover test
At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
Dizziness Handicap Inventory (DHI)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
The Hebrew version of the Dizziness Handicap Inventory (DHI) questionnaire
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Activities-specific Balance Confidence Scale (ABC)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
A questionnaire that measures the patient's level of balance confidence in performing daily activities
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Dynamic Gait Index (DGI)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Assesses patient's ability to maintain balance while walking in the presence of external demands
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
10-Meters Walk Test (10MWT)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Estimates walking speed in meters per second of a short distance (10-meter walking distance)
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
2-Minute Walk Test (2MWT)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Measures the distance the subject can walk in two minutes, aiming to assess endurance, functional mobility and gait
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Video Head Impulse Test (vHIT)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
A test to evaluate the angular VOR and the function of the superior and inferior vestibular nerves
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Suppression Head Impulse Test (SHIMP)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
To provide the examiner with complementary information about peripheral vestibular function. This is a sensitive indicator of residual vestibular function as well as the usual VOR (Vestibulo-ocular reflex) gain measure
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Exercise difficulty levels and symptoms severity
Time Frame: At the end of Cycle 1 (each cycle is 4-6 weeks)
Quantitative data exercise difficulty levels and symptoms severity will be extracted from users' phone application database
At the end of Cycle 1 (each cycle is 4-6 weeks)
Visual Analogue Scale (VAS)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Subjective ranking of the severity of symptoms of dizziness and nausea in sitting position, standing and walking
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Dynamic Visual Acuity (DVA)
Time Frame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Tests visual acuity during head movement, which rely on the behavior of the Vestibulo-ocular reflex (VOR)
At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
Cognitive reserve index questionnaire (CRIQ)
Time Frame: By the end of Cycle 1 (each cycle is 4-6 weeks)
A questionnaire for assessing the degree of cognitive reserve. Cognitive reserve describes the resilience of the brain to damage, and is used to interpret individual differences in susceptibility to cognitive impairment in the presence of brain changes associated with age or disease.
By the end of Cycle 1 (each cycle is 4-6 weeks)

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: Yoav Gimmon, PhD, Sheba Medical Center; University of Haifa

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)

August 15, 2024

Primary Completion (Actual)

February 2, 2026

Study Completion (Actual)

February 2, 2026

Study Registration Dates

First Submitted

March 23, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9576-22-SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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