Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT06350669
Status:
RECRUITING
Last Update Posted:
2025-01-07
First Post:
2024-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
App-supported Vestibular Rehabilitation (RCT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-04', 'studyFirstSubmitDate': '2024-03-23', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence measures', 'timeFrame': 'At the end of Cycle 1 (each cycle is 4-6 weeks)', 'description': "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)"}, {'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)', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Demographics and medical history intake', 'timeFrame': 'At the beginning of Cycle 1 (each cycle is 4-6 weeks)', 'description': 'Characteristics of patients'}, {'measure': 'Vestibular functions- physical examination', 'timeFrame': 'At the the beginning of Cycle 1 (each cycle is 4-6 weeks)', 'description': "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)"}, {'measure': 'Oculomotor functions- physical examination', 'timeFrame': 'At the the beginning of Cycle 1 (each cycle is 4-6 weeks)', 'description': 'The routine assessment of oculomotor functions: Saccades, Smooth-Pursuit, Vestibulo-Ocular Reflex cancellation (VORc) test, Convergence, single cover and cover-uncover test'}, {'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)', 'description': 'Subjective ranking of the severity of symptoms of dizziness and nausea in sitting position, standing and walking'}, {'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)', 'description': 'The Hebrew version of the Dizziness Handicap Inventory (DHI) questionnaire'}, {'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)', 'description': "A questionnaire that measures the patient's level of balance confidence in performing daily activities"}, {'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)', 'description': "Assesses patient's ability to maintain balance while walking in the presence of external demands"}, {'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)', 'description': 'Estimates walking speed in meters per second of a short distance (10-meter walking distance)'}, {'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)', 'description': 'Measures the distance the subject can walk in two minutes, aiming to assess endurance, functional mobility and gait'}, {'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)', 'description': 'Tests visual acuity during head movement, which rely on the behavior of the Vestibulo-ocular reflex (VOR)'}, {'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)', 'description': 'A test to evaluate the angular VOR and the function of the superior and inferior vestibular nerves'}, {'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)', 'description': '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'}, {'measure': 'Exercise difficulty levels and symptoms severity', 'timeFrame': 'At the end of Cycle 1 (each cycle is 4-6 weeks)', 'description': "Quantitative data exercise difficulty levels and symptoms severity will be extracted from users' phone application database"}, {'measure': 'Cognitive reserve index questionnaire (CRIQ)', 'timeFrame': 'By the end of Cycle 1 (each cycle is 4-6 weeks)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular Rehabilitation', 'App-Assisted Rehabilitation', 'Rehabilitation Technologies', 'Adherence', 'Compliance'], 'conditions': ['Vestibular Disorder', 'Vestibular Diseases', 'Vestibular Abnormality']}, 'referencesModule': {'references': [{'pmid': '19468085', 'type': 'BACKGROUND', '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.'}, {'pmid': '27328962', 'type': 'BACKGROUND', '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.'}, {'pmid': '17613447', 'type': 'BACKGROUND', '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.'}, {'pmid': '19318888', 'type': 'BACKGROUND', '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.'}, {'pmid': '18607931', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'pmid': '10911413', 'type': 'BACKGROUND', '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.'}, {'pmid': '20070765', 'type': 'BACKGROUND', '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.'}, {'pmid': '16796772', 'type': 'BACKGROUND', '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.'}, {'pmid': '34864777', 'type': 'BACKGROUND', '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.'}, {'pmid': '35126289', 'type': 'BACKGROUND', '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.'}, {'pmid': '11207845', 'type': 'BACKGROUND', '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.'}, {'pmid': '21250408', 'type': 'BACKGROUND', '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.'}, {'pmid': '15991483', 'type': 'BACKGROUND', '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.'}, {'pmid': '20639762', 'type': 'BACKGROUND', '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.'}, {'pmid': '32153490', 'type': 'BACKGROUND', '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.'}, {'pmid': '24447966', 'type': 'BACKGROUND', 'citation': 'Mutlu B, Serbetcioglu B. Discussion of the dizziness handicap inventory. J Vestib Res. 2013;23(6):271-7. doi: 10.3233/VES-130488.'}, {'pmid': '30171827', 'type': 'BACKGROUND', '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.'}, {'pmid': '1991946', 'type': 'BACKGROUND', '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.'}, {'pmid': '28088930', 'type': 'BACKGROUND', '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.'}, {'pmid': '19786420', 'type': 'BACKGROUND', '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.'}, {'pmid': '10472037', 'type': 'BACKGROUND', '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.'}, {'pmid': '10939685', 'type': 'BACKGROUND', '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.'}, {'pmid': '15598995', 'type': 'BACKGROUND', '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.'}, {'pmid': '22674920', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes', 'detailedDescription': '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).\n\nTests and measurements for both groups will be done at three time points:\n\n1. Preliminary assessment session (Session 1)- An initial assessment test on the first visit;\n2. Secondary assessment session (Session 2)- After 5-6 weeks;\n3. Follow-up evaluation session (Session 3)- One month after the secondary assessment session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 and over\n* Diagnosis with any vestibular disorder that requires a vestibular rehabilitation exercise program\n* Physical and cognitive ability to perform vestibular physiotherapy\n\nExclusion Criteria:\n\n* A physical disability that does not allow for the performance of vestibular physiotherapy\n* A diagnosis of a central vestibular disorder caused by structural damage to the brain\n* Individuals who are not qualified to give informed consent'}, 'identificationModule': {'nctId': 'NCT06350669', 'briefTitle': 'App-supported Vestibular Rehabilitation (RCT)', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'App-supported Vestibular Rehabilitation (Randomized Controlled Trial)', 'orgStudyIdInfo': {'id': '9576-22-SMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'App-assisted vestibular rehabilitation', 'description': '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.', 'interventionNames': ['Device: Vestibular rehabilitation phone application']}, {'type': 'NO_INTERVENTION', 'label': 'Standard vestibular rehabilitation (no app)', 'description': 'The patients in this group will undergo standard vestibular rehabilitation treatment, without using the app.'}], 'interventions': [{'name': 'Vestibular rehabilitation phone application', 'type': 'DEVICE', 'description': 'The standard vestibular rehabilitation process, with the support of a phone app throughout the process', 'armGroupLabels': ['App-assisted vestibular rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yoav Gimmon, PT, Ph.D', 'role': 'CONTACT', 'email': 'yoavgimmon@gmail.com'}, {'name': 'Amit Wolfovitz, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Shelly Levy-Tzedek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Liran Kalderon, M.Sc.PT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Liran Kalderon, MScPT', 'role': 'CONTACT', 'email': 'lirankal@post.bgu.ac.il', 'phone': '+972-505822196'}, {'name': 'Yoav Gimmon, PhD', 'role': 'CONTACT', 'email': 'yoavgimmon@gmail.com'}], 'overallOfficials': [{'name': 'Yoav Gimmon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center; University of Haifa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Ben-Gurion University of the Negev', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yoav Gimon', 'investigatorAffiliation': 'University of Haifa'}}}}