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Completed

NCT Number: NCT06350669

App-supported Vestibular Rehabilitation (RCT)

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

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Key information

Conditions

Vestibular Disorder Behavior Ear Diseases Health Behavior Labyrinth Diseases Otorhinolaryngologic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vestibular Abnormality Vestibular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Israel

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular rehabilitation phone application

Device

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

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. Demographics and medical history intake

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

    Characteristics of patients

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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)

  11. 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

  12. 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

  13. 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

  14. 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.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Ben-Gurion University of the Negev
  • Sheba Medical Center

Registry information

Official study title

App-supported Vestibular Rehabilitation (Randomized Controlled Trial)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 5, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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