Clinical trial NCT06350669: App-supported Vestibular Rehabilitation (RCT)
Official title: App-supported Vestibular Rehabilitation (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Vestibular Diseases
Vestibular Abnormality
Keywords: Vestibular Rehabilitation
App-Assisted Rehabilitation
Rehabilitation Technologies
Adherence
Compliance
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
name: Ben-Gurion University of the Negev
First posted: 2024-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence measures
timeFrame: At the end of Cycle 1 (each cycle is 4-6 weeks)
measure: Timed up and go (TUG)
timeFrame: 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:
measure: Demographics and medical history intake
timeFrame: At the beginning of Cycle 1 (each cycle is 4-6 weeks)
measure: Vestibular functions- physical examination
timeFrame: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
measure: Oculomotor functions- physical examination
timeFrame: At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
measure: Visual Analogue Scale (VAS)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Dizziness Handicap Inventory (DHI)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Activities-specific Balance Confidence Scale (ABC)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Dynamic Gait Index (DGI)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: 10-Meters Walk Test (10MWT)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: 2-Minute Walk Test (2MWT)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Dynamic Visual Acuity (DVA)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Video Head Impulse Test (vHIT)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Suppression Head Impulse Test (SHIMP)
timeFrame: At the beginning of Cycle 1, the end of Cycle 1 and the end of Cycle 2 (each cycle is 4-6 weeks)
measure: Exercise difficulty levels and symptoms severity
timeFrame: At the end of Cycle 1 (each cycle is 4-6 weeks)
measure: Cognitive reserve index questionnaire (CRIQ)
timeFrame: By the end of Cycle 1 (each cycle is 4-6 weeks)
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center; University of Haifa
name: Yoav Gimmon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Millar JL, Gimmon Y, Roberts D, Schubert MC. Improvement After Vestibular Rehabilitation Not Explained by Improved Passive VOR Gain. Front Neurol. 2020 Feb 20;11:79. doi: 10.3389/fneur.2020.00079. eCollection 2020.
citation: Mutlu B, Serbetcioglu B. Discussion of the dizziness handicap inventory. J Vestib Res. 2013;23(6):271-7. doi: 10.3233/VES-130488.
citation: Nussbaum R, Kelly C, Quinby E, Mac A, Parmanto B, Dicianno BE. Systematic Review of Mobile Health Applications in Rehabilitation. Arch Phys Med Rehabil. 2019 Jan;100(1):115-127. doi: 10.1016/j.apmr.2018.07.439. Epub 2018 Aug 29.
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
citation: Soto-Varela A, Faraldo-Garcia A, Del-Rio-Valeiras M, Rossi-Izquierdo M, Vaamonde-Sanchez-Andrade I, Gayoso-Diz P, Lirola-Delgado A, Santos-Perez S. Adherence of older people with instability in vestibular rehabilitation programmes: prediction criteria. J Laryngol Otol. 2017 Mar;131(3):232-238. doi: 10.1017/S0022215116009932. Epub 2017 Jan 16.
citation: Tyson S, Connell L. The psychometric properties and clinical utility of measures of walking and mobility in neurological conditions: a systematic review. Clin Rehabil. 2009 Nov;23(11):1018-33. doi: 10.1177/0269215509339004. Epub 2009 Sep 28.
citation: Whitney SL, Hudak MT, Marchetti GF. The activities-specific balance confidence scale and the dizziness handicap inventory: a comparison. J Vestib Res. 1999;9(4):253-9.
citation: Whitney SL, Hudak MT, Marchetti GF. The dynamic gait index relates to self-reported fall history in individuals with vestibular dysfunction. J Vestib Res. 2000;10(2):99-105.
citation: Whitney SL, Marchetti GF, Schade A, Wrisley DM. The sensitivity and specificity of the Timed "Up & Go" and the Dynamic Gait Index for self-reported falls in persons with vestibular disorders. J Vestib Res. 2004;14(5):397-409.
citation: Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P. Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial. BMJ. 2012 Jun 6;344:e2237. doi: 10.1136/bmj.e2237.