App-supported Vestibular Rehabilitation (RCT)

Vestibular Disorder Clinical Trial

Official title:

App-supported Vestibular Rehabilitation (Randomized Controlled Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06350669
• Other study ID #: 9576-22-SMC
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: March 2026

Study information

• Verified date: May 2024
• Source: University of Haifa
• Contact: Liran Kalderon, MScPT
• Phone: +972-505822196
• Email: lirankal[@]post.bgu.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Central nervous system (CNS) disease affecting balance

• Individuals who are not qualified to give informed consent

Related Conditions & MeSH terms

• Vestibular Abnormality
• Vestibular Diseases
• Vestibular Disorder

Intervention

Device:
• Vestibular rehabilitation phone application
The standard vestibular rehabilitation process, with the support of a phone app throughout the process

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (3)

Lead Sponsor	Collaborator
University of Haifa	Ben-Gurion University of the Negev, Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (25)

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. Erratum In: Arch Intern Med. 2009 Aug 10;169(15):1419. — View 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. — View 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. — View 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. — View 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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Mutlu B, Serbetcioglu B. Discussion of the dizziness handicap inventory. J Vestib Res. 2013;23(6):271-7. doi: 10.3233/VES-130488. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	Demographics and medical history intake	Characteristics of patients	At the beginning of Cycle 1 (each cycle is 4-6 weeks)
Secondary	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)	At the the beginning of Cycle 1 (each cycle is 4-6 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)