Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-02 @ 4:42 AM
Study NCT ID:
NCT04283357
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2019-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus
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', 'interventionModelDescription': 'One group only are treated with short foot exercises. Second group are treated with short foot exercises and virtual reality.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2019-07-05', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison of exercise and virtual reality treatment on balance', 'timeFrame': '15 minute', 'description': 'Y balance test measure with second (sn)'}], 'secondaryOutcomes': [{'measure': 'Effect of exercise on performance', 'timeFrame': '10 minute', 'description': '10 step test measure with minute'}, {'measure': 'Navicular Drop Test', 'timeFrame': '5 minute', 'description': 'Measure of navicular tubercul from floor measure with santimeter(cm)'}, {'measure': 'Femoral anteversion test', 'timeFrame': '5 minute', 'description': 'measure of hip internal rotation movement actively measure with universal goniometer (degree)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'foot posture', 'navicular drop', 'short foot exercise'], 'conditions': ['Virtual Reality']}, 'referencesModule': {'references': [{'pmid': '33962115', 'type': 'DERIVED', 'citation': 'Yildirim Sahan T, Aydogan Arslan S, Demirci C, Oktas B, Sertel M. Comparison Of Short-Term Effects Of Virtual Reality and Short Foot Exercises In Pes Planus. Foot (Edinb). 2021 Jun;47:101778. doi: 10.1016/j.foot.2021.101778. Epub 2021 Jan 21.'}], 'seeAlsoLinks': [{'url': 'http://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0036-1580616', 'label': 'Spring ligament complex and posterior tibial tendon: MR anatomy and findings in acquired adult flatfoot deformity'}, {'url': 'http://journals.humankinetics.com/view/journals/jsr/21/4/article-p327.xml', 'label': 'Differences in Static- and Dynamic-Balance Task Performance After 4 Weeks of Intrinsic-Foot-Muscle Training: The Short-Foot Exercise Versus the Towel-Curl Exercise'}, {'url': 'http://www.ijhsr.org/IJHSR_Vol.10_Issue.2_Feb2020/IJHSR_Abstract.030.html', 'label': 'Quality of Life in Adult Population with Flat Feet'}]}, 'descriptionModule': {'briefSummary': 'Virtual reality exercises have become increasingly popular in recent years. After the increase in usage areas in daily life, its use in healthcare has become widespread. Flatfoot is one of the orthopedic problems with high prevalence, especially in young individuals. In the literature, conservative treatment methods of flat soles are mentioned as exercise, shoe modifications, and orthotic methods. In the study, it is planned to investigate whether individuals with flat-footed virtual reality exercises contribute to conservative treatment.\n\nThe aim of this study was to investigate the effect of virtual reality exercises on individuals with pes planus.', 'detailedDescription': 'To show whether virtual reality exercises will contribute to decrease of flat footing, improvement of balance and increase of performance of individuals with flat foot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have pes planus,\n* Volunteer for this study,\n* Climb 10 stairs independently,\n* Can stand one single leg\n\nExclusion Criteria:\n\n* History of trauma, fracture or operation of the foot, knee, and hip that will affect the foot\n* Having visual, hearing and mental problems that prevent participation in virtual reality exercises,\n* Being diagnosed with orthopedic or neurological problems that prevent standing on a single leg'}, 'identificationModule': {'nctId': 'NCT04283357', 'briefTitle': 'Comparison Of Effects Virtual Reality and Short Foot Exercises On Balance and Performance in Pes Planus', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effect of Virtual Reality on Pes Planus', 'orgStudyIdInfo': {'id': '2019.06.10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Group', 'description': 'One group only treated with short foot exercises.', 'interventionNames': ['Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual Reality Group', 'description': 'The second group treated with virtual reality', 'interventionNames': ['Device: Virtual Reality']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'Short Foot Exercises', 'armGroupLabels': ['Exercise Group']}, {'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'Exercise with virtual reality', 'armGroupLabels': ['Virtual Reality Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71140', 'city': 'Kırıkkale', 'state': 'Yahşihan', 'country': 'Turkey (Türkiye)', 'facility': 'Kırıkkale University', 'geoPoint': {'lat': 39.84528, 'lon': 33.50639}}], 'overallOfficials': [{'name': 'Cevher Demirci, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kırıkkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The subjects were randomly assigned to one of the groups using an online random allocation software program. All groups were taken into a 4-week treatment program. At the end of the treatment process, it was given to subjects including VR and SF program aiming foot muscles.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kırıkkale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Tezel Yıldırım Şahan', 'investigatorAffiliation': 'Hacettepe University'}}}}