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Vestibular DisorderNCT06350669

App-supported Vestibular Rehabilitation (RCT)

A study testing Vestibular rehabilitation phone application in people with Vestibular Disorder and Vestibular Diseases, run by University of Haifa at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Vestibular rehabilitation phone application
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIsrael
Study dates
15 Aug 2024to 2 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

About this study

Official title: 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

Read the 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.
Being tested
Vestibular rehabilitation phone application
Keywords
Vestibular Rehabilitation, App-Assisted Rehabilitation, Rehabilitation Technologies, Adherence, Compliance
Medical subject headings
Vestibular Diseases, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vestibular rehabilitation phone applicationDevice

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

Study groups in NCT06350669
Study groupRoleWhat they receive
App-assisted vestibular rehabilitationExperimentalThe 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.
Receives: Device: Vestibular rehabilitation phone application
Standard vestibular rehabilitation (no app)No interventionThe patients in this group will undergo standard vestibular rehabilitation treatment, without using the app.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence measures

    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)

    Measured: At the end of Cycle 1 (each cycle is 4-6 weeks)

  2. Timed up and go (TUG)

    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

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

Secondary outcomes (14)

  1. Demographics and medical history intake

    Characteristics of patients

    Measured: At the beginning of Cycle 1 (each cycle is 4-6 weeks)

  2. Vestibular functions- physical examination

    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)

    Measured: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)

  3. Oculomotor functions- physical examination

    The routine assessment of oculomotor functions: Saccades, Smooth-Pursuit, Vestibulo-Ocular Reflex cancellation (VORc) test, Convergence, single cover and cover-uncover test

    Measured: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)

  4. Visual Analogue Scale (VAS)

    Subjective ranking of the severity of symptoms of dizziness and nausea in sitting position, standing and walking

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  5. Dizziness Handicap Inventory (DHI)

    The Hebrew version of the Dizziness Handicap Inventory (DHI) questionnaire

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  6. Activities-specific Balance Confidence Scale (ABC)

    A questionnaire that measures the patient's level of balance confidence in performing daily activities

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  7. Dynamic Gait Index (DGI)

    Assesses patient's ability to maintain balance while walking in the presence of external demands

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  8. 10-Meters Walk Test (10MWT)

    Estimates walking speed in meters per second of a short distance (10-meter walking distance)

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  9. 2-Minute Walk Test (2MWT)

    Measures the distance the subject can walk in two minutes, aiming to assess endurance, functional mobility and gait

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  10. Dynamic Visual Acuity (DVA)

    Tests visual acuity during head movement, which rely on the behavior of the Vestibulo-ocular reflex (VOR)

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  11. Video Head Impulse Test (vHIT)

    A test to evaluate the angular VOR and the function of the superior and inferior vestibular nerves

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  12. Suppression Head Impulse Test (SHIMP)

    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

    Measured: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)

  13. Exercise difficulty levels and symptoms severity

    Quantitative data exercise difficulty levels and symptoms severity will be extracted from users' phone application database

    Measured: At the end of Cycle 1 (each cycle is 4-6 weeks)

  14. Cognitive reserve index questionnaire (CRIQ)

    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.

    Measured: By the end of Cycle 1 (each cycle is 4-6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start15 Aug 2024
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06350669
Sponsor's protocol ID
9576-22-SMC
Status last verified
Feb 2026
First submitted
23 Mar 2024
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agrawal Y, Carey JP, Della Santina CC, Schubert MC, Minor LB. Disorders of balance and vestibular function in US adults: data from the National Health and Nutrition Examination Survey, 2001-2004. Arch Intern Med. 2009 May 25;169(10):938-44. doi: 10.1001/archinternmed.2009.66.

    PubMed 19468085

  • Alhabib SF, Saliba I. Video head impulse test: a review of the literature. Eur Arch Otorhinolaryngol. 2017 Mar;274(3):1215-1222. doi: 10.1007/s00405-016-4157-4. Epub 2016 Jun 21.

    PubMed 27328962

  • Brooks D, Davis AM, Naglie G. The feasibility of six-minute and two-minute walk tests in in-patient geriatric rehabilitation. Can J Aging. 2007 Summer;26(2):159-62. doi: 10.3138/cja.26.2.009.

    PubMed 17613447

  • Dannenbaum E, Paquet N, Chilingaryan G, Fung J. Clinical evaluation of dynamic visual acuity in subjects with unilateral vestibular hypofunction. Otol Neurotol. 2009 Apr;30(3):368-72. doi: 10.1097/MAO.0b013e31819bda35.

    PubMed 19318888

  • Des Courtis A, Castrillon R, Haenggeli CA, Delaspre O, Liard P, Guyot JP. Evaluation of subjectivity in the interpretation of videonystagmography. Acta Otolaryngol. 2008 Aug;128(8):892-5. doi: 10.1080/00016480701784957.

    PubMed 18607931

  • Gaikwad, S. B., Mukherjee, T., Shah, P. V., Ambode, O. I., Johnsonb, E. G., & Daher, N. S. (2016). Home exercise program adherence strategies in vestibular rehabilitation: a systematic review. Physical therapy rehabilitation science, 5(2), 53-62

  • Gill-Body KM, Beninato M, Krebs DE. Relationship among balance impairments, functional performance, and disability in people with peripheral vestibular hypofunction. Phys Ther. 2000 Aug;80(8):748-58.

    PubMed 10911413

  • Gopinath B, McMahon CM, Rochtchina E, Mitchell P. Dizziness and vertigo in an older population: the Blue Mountains prospective cross-sectional study. Clin Otolaryngol. 2009 Dec;34(6):552-6. doi: 10.1111/j.1749-4486.2009.02025.x.

    PubMed 20070765

  • Hall CD, Herdman SJ. Reliability of clinical measures used to assess patients with peripheral vestibular disorders. J Neurol Phys Ther. 2006 Jun;30(2):74-81. doi: 10.1097/01.npt.0000282571.55673.ed.

    PubMed 16796772

  • Hall CD, Herdman SJ, Whitney SL, Anson ER, Carender WJ, Hoppes CW, Cass SP, Christy JB, Cohen HS, Fife TD, Furman JM, Shepard NT, Clendaniel RA, Dishman JD, Goebel JA, Meldrum D, Ryan C, Wallace RL, Woodward NJ. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Updated Clinical Practice Guideline From the Academy of Neurologic Physical Therapy of the American Physical Therapy Association. J Neurol Phys Ther. 2022 Apr 1;46(2):118-177. doi: 10.1097/NPT.0000000000000382.

    PubMed 34864777

  • Harrell RG, Schubert MC, Oxborough S, Whitney SL. Vestibular Rehabilitation Telehealth During the SAEA-CoV-2 (COVID-19) Pandemic. Front Neurol. 2022 Jan 20;12:781482. doi: 10.3389/fneur.2021.781482. eCollection 2021.

    PubMed 35126289

  • Kao AC, Nanda A, Williams CS, Tinetti ME. Validation of dizziness as a possible geriatric syndrome. J Am Geriatr Soc. 2001 Jan;49(1):72-5. doi: 10.1046/j.1532-5415.2001.49012.x.

    PubMed 11207845

  • Kaplan DM, Friger M, Racover NK, Peleg A, Kraus M, Puterman M. [The Hebrew dizziness handicap inventory]. Harefuah. 2010 Nov;149(11):697-700, 750, 749. Hebrew.

    PubMed 21250408

  • Legters K, Whitney SL, Porter R, Buczek F. The relationship between the Activities-specific Balance Confidence Scale and the Dynamic Gait Index in peripheral vestibular dysfunction. Physiother Res Int. 2005;10(1):10-22. doi: 10.1002/pri.20.

    PubMed 15991483

  • Lempert T, Bronstein A. Management of common central vestibular disorders. Curr Opin Otolaryngol Head Neck Surg. 2010 Oct;18(5):436-40. doi: 10.1097/MOO.0b013e32833dbd69.

    PubMed 20639762

Questions about this trial

What is this clinical trial studying?

A study testing Vestibular rehabilitation phone application in people with Vestibular Disorder and Vestibular Diseases, run by University of Haifa at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence measures (time frame: At the end of Cycle 1 (each cycle is 4-6 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350669, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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