A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
The standard vestibular rehabilitation process, with the support of a phone app throughout the process
Sheba Medical Center
Ramat Gan, Israel
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)
Time frame: At the end of Cycle 1 (each cycle is 4-6 weeks)
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
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)
Demographics and medical history intake
Characteristics of patients
Time frame: At the beginning of Cycle 1 (each cycle is 4-6 weeks)
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)
Time frame: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
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
Time frame: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
Visual Analogue Scale (VAS)
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Subjective ranking of the severity of symptoms of dizziness and nausea in sitting position, standing and walking
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)
Dizziness Handicap Inventory (DHI)
The Hebrew version of the Dizziness Handicap Inventory (DHI) questionnaire
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)
Activities-specific Balance Confidence Scale (ABC)
A questionnaire that measures the patient's level of balance confidence in performing daily activities
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)
Dynamic Gait Index (DGI)
Assesses patient's ability to maintain balance while walking in the presence of external demands
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)
10-Meters Walk Test (10MWT)
Estimates walking speed in meters per second of a short distance (10-meter walking distance)
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)
2-Minute Walk Test (2MWT)
Measures the distance the subject can walk in two minutes, aiming to assess endurance, functional mobility and gait
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)
Dynamic Visual Acuity (DVA)
Tests visual acuity during head movement, which rely on the behavior of the Vestibulo-ocular reflex (VOR)
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)
Video Head Impulse Test (vHIT)
A test to evaluate the angular VOR and the function of the superior and inferior vestibular nerves
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)
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
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)
Exercise difficulty levels and symptoms severity
Quantitative data exercise difficulty levels and symptoms severity will be extracted from users' phone application database
Time frame: At the end of Cycle 1 (each cycle is 4-6 weeks)
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.
Time frame: By the end of Cycle 1 (each cycle is 4-6 weeks)