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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
| Ben-Gurion University of the Negev | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-assisted vestibular rehabilitation | Experimental | 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. |
|
| Standard vestibular rehabilitation (no app) | No Intervention | The patients in this group will undergo standard vestibular rehabilitation treatment, without using the app. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular rehabilitation phone application | Device | The standard vestibular rehabilitation process, with the support of a phone app throughout the process |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics and medical history intake | Characteristics of patients | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoav Gimmon, PhD | Sheba Medical Center; University of Haifa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19468085 | Background | 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. | |
| 27328962 | Background | 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. |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010342 | Patient Acceptance of Health Care |
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The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app)
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| 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 | At the the beginning of Cycle 1 (each cycle is 4-6 weeks) |
| Visual Analogue Scale (VAS) | 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) |
| Dizziness Handicap Inventory (DHI) | 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) | 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) | 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) | 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) | 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) |
| Dynamic Visual Acuity (DVA) | 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) |
| Video Head Impulse Test (vHIT) | 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) | 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 | 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) |
| 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. | By the end of Cycle 1 (each cycle is 4-6 weeks) |
| 17613447 | Background | 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. |
| 19318888 | Background | 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. |
| 18607931 | Background | 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. |
| Background | 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 |
| 10911413 | Background | 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. |
| 20070765 | Background | 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. |
| 16796772 | Background | 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. |
| 34864777 | Background | 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. |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |