Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
Study NCT ID:
NCT04425928
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2020-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Activity Treatment on Vestibular Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-07', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from before and after treatment in the postural stability on Computerized Dynamic Posturography (CDP).', 'timeFrame': 'before and after treatment (4 weeks)', 'description': 'Computerized dynamic posturography (CDP) testing is a technique used to assess underlying sensory and motor control impairments associated with balance disorders.'}], 'primaryOutcomes': [{'measure': 'Change from before and after treatment in the severity of dizziness on Visual Analog scale (VAS).', 'timeFrame': 'before and after treatment (4 weeks)', 'description': 'VAS is a self-reported instrument assessing the severity of diziness.'}], 'secondaryOutcomes': [{'measure': 'Change from before and after treatment in the Independent level of activity in the daily life on Vestibular Disorders Activities of Daily Living Scale (VADL).', 'timeFrame': 'before and after treatment (4 weeks)', 'description': 'VADL is a questionnaire assessing the Independent level of activity in daily life.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vestibular Disorder']}, 'referencesModule': {'references': [{'pmid': '33529612', 'type': 'DERIVED', 'citation': 'Tekin Dal B, Bumin G, Aksoy S, Gunaydin RO. Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders. Arch Phys Med Rehabil. 2021 Jul;102(7):1300-1307. doi: 10.1016/j.apmr.2020.12.022. Epub 2021 Jan 30.'}]}, 'descriptionModule': {'briefSummary': 'In this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.', 'detailedDescription': 'The aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. Patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. Education was given to each group. İn addition, the activity group was performed a training activities program, the exercise group was performed in the Cawthorne-Cooksey exercises program. Therapy programs were prescribed once daily at home for 4 weeks. After demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). Dizziness severity was assessed by the Visual Analog Scale (VAS), activities of daily livings were assessed by Vestibular Disorders Activity Questionnaire (VADL) and balance was assessed by Sensory Organization Testing (SOT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients have dizziness complaint longer than 3 months,\n* History of at least one dizziness in a month\n* Patient has been diagnosed chronic unilateral peripheric vestibular disorder\n\nExclusion Criteria:\n\n* Patients with diagnosed benign paroxysmal positional vertigo, had Meniere's disease, had history of central nerve system impairments and/or psychiatric disorder, had uncontrolled hypertension and diabetes, had not understanding simple verbal instruction and following ability, not able to stand independent in the standstill position, had visual problems that cannot be treated with lenses or glasses, had movement limitation due to the orthopedic problem, using medication for dizziness."}, 'identificationModule': {'nctId': 'NCT04425928', 'briefTitle': 'Activity Treatment on Vestibular Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Comparison of Activity-Based Home Program and Cawthorne-Cooksey Exercises in Patients With Chronic Unilateral Peripheral Vestibular Disorders', 'orgStudyIdInfo': {'id': '5057087198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'activity group', 'description': 'Participants received an activity-based home program that was performed for 4 weeks.', 'interventionNames': ['Procedure: occupational therapy based activity training programs']}, {'type': 'EXPERIMENTAL', 'label': 'exercise group', 'description': 'Participants received an exercise-based home program was performed that was performed for 4 weeks.', 'interventionNames': ['Procedure: Physiotherapy based exercise training programs']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No intervention'}], 'interventions': [{'name': 'occupational therapy based activity training programs', 'type': 'PROCEDURE', 'otherNames': ['purposeful activities'], 'description': 'Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.', 'armGroupLabels': ['activity group']}, {'name': 'Physiotherapy based exercise training programs', 'type': 'PROCEDURE', 'otherNames': ['Cawthorne-cooksey exercises'], 'description': 'Cawthorne-cooksey exercises were performed at vestibular rehabilitation', 'armGroupLabels': ['exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Gonca Bumin, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bilgehan Tekin Dal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Bilgehan Tekin Dal', 'investigatorAffiliation': 'Gazi University'}}}}