Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:35 PM
Study NCT ID:
NCT05959967
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2023-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction
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': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to one of two groups: the VRE group or the GFT group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks', 'timeFrame': 'Changes between Baseline and 8 weeks', 'description': 'This outcome is the difference in scores on the Vertigo Symptom Scale (VSS), a validated vestibular symptom questionnaire, from baseline to 8 weeks. The VSS has two components: a vertigo/balance scale, with a score range of 0-36, and an autonomic/anxiety scale, with a score range of 0-28. Higher scores on both scales indicate more severe symptoms.'}, {'measure': 'Change in Biodex Balance System Scores from Baseline to 8 Weeks', 'timeFrame': 'Baseline and 8 weeks', 'description': "This outcome is the difference in scores on the Biodex Balance System, a validated tool for balance assessment, from baseline to 8 weeks. The Biodex Balance System assesses participants' ability to maintain postural control through a variety of tests, including the Stability Index, Fall Risk Test, and Postural Stability Test. Lower scores on the Stability Index indicate better balance, while lower scores on the Fall Risk and Postural Stability tests indicate lower risk of falling and better postural stability, respectively."}], 'secondaryOutcomes': [{'measure': 'Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks', 'timeFrame': 'Baseline and 8 weeks', 'description': 'This outcome is the difference in the distance covered during the Six-Minute Walk Test (6MWT) from baseline to 8 weeks. The 6MWT assesses the maximum distance that can be walked in 6 minutes. A greater distance indicates better cardiovascular fitness.'}, {'measure': 'Change in Flexibility Test Scores from Baseline to 8 Weeks', 'timeFrame': 'Baseline and 8 weeks', 'description': 'This outcome is the difference in scores on a standard flexibility test, such as the Sit and Reach Test, from baseline to 8 weeks. The test assesses the flexibility of the lower back and hamstring muscles. A greater reach distance or score indicates better flexibility.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vestibular Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effectiveness of Vestibular Rehabilitation Exercises (VRE) and General Fitness Training (GFT) in adults diagnosed with vestibular disorders. The main questions it aims to answer are:\n\nDoes VRE lead to better improvements in gaze stabilization, balance, and gait than GFT? Does GFT lead to more improvements in overall fitness than VRE? Participants will be randomly assigned to either the VRE or GFT group and will participate in 60-minute exercise sessions twice weekly for 8 weeks. Researchers will compare the improvements in the two groups to see which intervention is more effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants aged 18 - 60 years.\n* Diagnosis of a vestibular disorder confirmed by a healthcare professional.\n* Able to walk unassisted for at least 10 meters.\n* Able to understand and comply with the procedures of this study.\n* Willing to provide informed consent.\n\nExclusion Criteria:\n\n* Severe cardiovascular, respiratory, or metabolic disease that contraindicates physical exercise.\n* Neuromuscular disorders that may affect balance and mobility other than the diagnosed vestibular disorder.\n* History of orthopedic surgery within the past 6 months.\n* Currently participating in another interventional clinical trial.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT05959967', 'briefTitle': 'Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction', 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': 'The Efficacy of Vestibular Rehabilitation Exercises and General Fitness Training pn Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VRGFT2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular Rehabilitation Exercises (VRE)', 'description': 'The VRE arm will be engaged in vestibular exercises including gaze stabilization, balance, and gait training.', 'interventionNames': ['Behavioral: Vestibular Rehabilitation Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Fitness Training (GFT)', 'description': 'The GFT arm will participate in general fitness exercises including cardiovascular, strength, and flexibility training.', 'interventionNames': ['Behavioral: General Fitness Training']}], 'interventions': [{'name': 'Vestibular Rehabilitation Exercises', 'type': 'BEHAVIORAL', 'description': 'The VRE group will receive exercises aimed at improving gaze stability, postural control, and balance. This includes activities like gaze stabilization exercises, balance training on different surfaces, and walking with head movements.', 'armGroupLabels': ['Vestibular Rehabilitation Exercises (VRE)']}, {'name': 'General Fitness Training', 'type': 'BEHAVIORAL', 'description': 'The GFT group will undertake exercises to enhance cardiovascular fitness, strength, and flexibility, such as light aerobic exercises, resistance training, and stretching. The exercise sessions will be 60 minutes in duration, consisting of a warm-up phase, the main exercise phase, and a cool-down phase.', 'armGroupLabels': ['General Fitness Training (GFT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '01064442032'}], 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'centralContacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '+201064442032'}], 'overallOfficials': [{'name': 'Amal Fawzy, Ph.d', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy and Director of Electromyography Lab', 'investigatorFullName': 'Mohamed Magdy ElMeligie', 'investigatorAffiliation': 'Ahram Canadian University'}}}}