App-supported Vestibular Rehabilitation (RCT)
- Conditions
- Vestibular AbnormalityVestibular DiseasesVestibular Disorder
- Interventions
- Device: Vestibular rehabilitation phone application
- Registration Number
- NCT06350669
- Lead Sponsor
- University of Haifa
- Brief Summary
A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description App-assisted vestibular rehabilitation Vestibular rehabilitation phone application 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.
- Primary Outcome Measures
Name Time Method Adherence measures 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)
Timed up and go (TUG) 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 Outcome Measures
Name Time Method Vestibular functions- physical examination 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)
Oculomotor functions- physical examination 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
Activities-specific Balance Confidence Scale (ABC) 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
Dynamic Gait Index (DGI) 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
Video Head Impulse Test (vHIT) 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
Cognitive reserve index questionnaire (CRIQ) 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.
10-Meters Walk Test (10MWT) 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)
2-Minute Walk Test (2MWT) 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
Demographics and medical history intake At the beginning of Cycle 1 (each cycle is 4-6 weeks) Characteristics of patients
Dynamic Visual Acuity (DVA) 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)
Suppression Head Impulse Test (SHIMP) 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
Visual Analogue Scale (VAS) 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
Dizziness Handicap Inventory (DHI) 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
Exercise difficulty levels and symptoms severity 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
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gan, Israel