Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 5:54 PM
Study NCT ID:
NCT05455957
Status:
COMPLETED
Last Update Posted:
2022-07-13
First Post:
2022-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Neuromuscular and Vestibulo-Ocular Training on Balance,Isokinetic Strength and Proprioception in Chronic Ankle Instability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-10', 'studyFirstSubmitDate': '2022-06-10', 'studyFirstSubmitQcDate': '2022-07-10', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'balance,isokinetic muscle strength,proprioception', 'timeFrame': '1 hours', 'description': 'Dynamic balance evaluation with star excursion balance test recorded in centimeters.'}, {'measure': 'isokinetic muscle strength', 'timeFrame': '1 hours', 'description': 'ankle evertor- inverter concentric muscle strength by using isokinetic dynamometer at angular velocities of 60 degree/s, 120 degree /s and 180 degree/s were recorded.'}, {'measure': 'proprioception', 'timeFrame': '1 hours', 'description': 'Proprioception was evaluated by measuring joint position sense with a goniometer, and deviations in proprioception were recorded as degrees.'}], 'secondaryOutcomes': [{'measure': 'weight', 'timeFrame': '1 hours', 'description': 'kilogram'}, {'measure': 'height', 'timeFrame': '1 hours', 'description': 'meter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ankle instability, balance, neuromuscular,vestibulo-ocular'], 'conditions': ['Chronic Ankle Instability']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability.The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance and isokinetic muscle strength in subjects with ankle instability.\n\nHypotheses of the study; H0: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has an effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.\n\nH1: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has no effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.', 'detailedDescription': 'The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability. This study was conducted in Sportomed Athlete Health and Orthopedic Rehabilitation clinic in February 2020, September 2022.A total of 20 participants aged 18-30 were included in the study on a voluntary basis..Participants were randomly seperated to 2 groups. Demographic information and informed consent forms were filled into all subjects who volunteered to participate in the study and in accordance with the research criteria. After the evaluation, the subjects in the first group were included in the vestibulo-ocular exercise program in addition to the neuromuscular exercise programs with the same physiotherapist. Subjects in the second group were included in neuromuscular training programs. The trainings were applied three days a week for four weeks and each training session lasted approximately 60 minutes. Functional limitations of the participants before and after the treatment were evaluated with the Foot and Ankle Ability Measure Daily Living Subscale (FAAM-ADL) and Sports Subscale (FAAM-S). Dynamic balance evaluation with star excursion balance test, proprioception evaluation by measuring joint position sense with goniometer, and ankle evertor and inverter concentric muscle strength were evaluated using isokinetic dynamometer at angular velocities of 60/s, 120/s and 180/s, and the results were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being 18-30 years old\n* At least 2 lateral sprains to the same ankle in the past\n* At least 1 episode of "giving way" that had occurred within the past 6 months\n* The presence of residual symptoms during functional activities and had to be free from symptoms of any other previous injury to the lower extremity.\n* No other injuries to the lower limbs\n\nExclusion Criteria:\n\n* Having a bilateral ankle instability\n* Having a history of ankle fracture\n* Having a history of fracture or surgery to the involved lower extremity\n* Having a history of balance and vestibular disorders'}, 'identificationModule': {'nctId': 'NCT05455957', 'briefTitle': 'The Effect of Neuromuscular and Vestibulo-Ocular Training on Balance,Isokinetic Strength and Proprioception in Chronic Ankle Instability', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University'}, 'officialTitle': 'The Effect of Neuromuscular and Vestibulo-Ocular Reflex Training Program on Balance, Isokinetic Muscle Strength and Proprioception in Subjects With Chronic Ankle Instability', 'orgStudyIdInfo': {'id': 'YeditepeU1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuromuscular Training', 'description': 'The neuromuscular exercise training group includes single-leg stance, single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.The neuromuscular group included supervised, strength, balance and hop stabilization exercises on the different surfaces that focus on the restoring of static and dynamic balance. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities.', 'interventionNames': ['Other: exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Vestibulo-Ocular Reflex Training', 'description': 'The vestibulo ocular reflex training group includes head and gaze stability exercises in addition to single le stance,single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.In the vestibulo- ocular exercise program, individuals tried to maintain their balance with head and eye movements in addition to balance and hop stabilization activities. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities.', 'interventionNames': ['Other: exercise']}], 'interventions': [{'name': 'exercise', 'type': 'OTHER', 'description': 'neuromuscular and vestibulo-ocular training', 'armGroupLabels': ['Neuromuscular Training', 'Vestibulo-Ocular Reflex Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Sportomed', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}