Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04280302
Status:
UNKNOWN
Last Update Posted:
2020-02-21
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality-based Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change pre-post treatment in the Dizziness handicap inventory (DHI) (0-100)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}], 'secondaryOutcomes': [{'measure': 'Change pre-post treatment in Posturography (Wii+software RombergLab)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in Test up and go (TUG)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in Berg Scale (0-56)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in Tinneti Test (1-28)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in Simulator Sickness Questionnaire (SSQ) (0-14)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in the Video-head impulse test (vHIT)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in the Barthel Index (0-100)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}, {'measure': 'Change pre-post treatment in the SF 12 Test (0-100)', 'timeFrame': '4 weeks', 'description': 'Change within subjects from baseline to the end of week 4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vestibular', 'unilateral vestibular', 'virtual reality', 'rehabilitation'], 'conditions': ['Patients With Unilateral Peripheral Vestibular Deficits']}, 'descriptionModule': {'briefSummary': 'Vertigo / dizziness, imbalance and other symptoms related to vestibular pathology have a life prevalence of 7.4%. Peripheral and unilateral vestibulopathy are among the most common types, and in some patients the symptoms become chronic and disabling, which makes it difficult for them to lead a normal life and has a significant socio-economic impact. In recent years, the effect of vestibular rehabilitation with virtual reality has been studied and positive results have been obtained when compared with traditional rehabilitation, but despite rehabilitation there is patients who are still chronic, and the reasons for this prognostic variability are still unknown and require further treatment. Virtual reality-based stimulation can play a significant role as an adjunct to conventional vestibular rehabilitation, improving its effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Unilateral vestibular deficit\n* Vestibular neuritis\n* Sudden hearing loss with vestibular involvement\n* Labyrinthitis\n* Ménière's disease\n* Vestibular Shwannoma\n* Benign paroxysmal positional vertigo\n* Vestibular symptoms (vertigo, dizziness, imbalance, gait instability, kinosis and / or oscillopsy) chronic (more than 6 weeks of evolution)\n* Over 18 years old\n\nExclusion Criteria:\n\n* Failure to meet some of the inclusion criteria\n* Neurological, traumatological, rheumatological, ophthalmological or systemic pathology that may interfere with the balance\n* Inability to understand participation in the study\n* Non-acceptance to participate in the study"}, 'identificationModule': {'nctId': 'NCT04280302', 'acronym': 'VRVEST', 'briefTitle': 'Virtual Reality-based Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Universitat Pompeu Fabra'}, 'officialTitle': 'Realitat Virtual Com a Tractament Coadjuvant en rehabilitació Vestibular', 'orgStudyIdInfo': {'id': 'VESTHJXXIII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality based therapy', 'interventionNames': ['Behavioral: Virtual Reality-based Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Therapy', 'interventionNames': ['Behavioral: Conventional Therapy']}], 'interventions': [{'name': 'Virtual Reality-based Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'VR-based eye stabilization exercises and balance exercises', 'armGroupLabels': ['Virtual reality based therapy']}, {'name': 'Conventional Therapy', 'type': 'BEHAVIORAL', 'description': 'Conventional rehabilitation therapy based on eye stabilization exercises and balance exercises', 'armGroupLabels': ['Conventional Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43005', 'city': 'Tarragona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rosa Maria San Segundo Mozo', 'role': 'CONTACT', 'email': 'rosamaria.sansegundo@urv.cat', 'phone': '+34977295800'}], 'facility': 'Hospital Universitari de Tarragona Joan XXIII', 'geoPoint': {'lat': 41.11905, 'lon': 1.24544}}], 'centralContacts': [{'name': 'Sandra Sáez Felipe', 'role': 'CONTACT', 'email': 'ssaezfelipe@gmail.com', 'phone': '+34977295800'}, {'name': 'Rosa M San Segundo', 'role': 'CONTACT', 'email': 'rosamaria.sansegundo@urv.cat', 'phone': '+34977295800'}], 'overallOfficials': [{'name': 'Sandra Sáez Felipe', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ssaezfelipe@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitat Pompeu Fabra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Paul Verschure', 'investigatorAffiliation': 'Universitat Pompeu Fabra'}}}}