Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-01-01 @ 8:30 PM
Study NCT ID:
NCT07177768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Prolonged Walking on Hallux Valgus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-09-10', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'Baseline, immediately after intervention, 20 minutes after intervention', 'description': 'Pain intensity will be evaluated with visual analog scale (VAS). Patients will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means the worst pain.'}, {'measure': 'Pressure pain threshold', 'timeFrame': 'Baseline, immediately after intervention, 20 minutes after intervention', 'description': 'It will be measured with algometer. Higher values indicate a higher perceived pain threshold.'}, {'measure': 'Single-leg stance test', 'timeFrame': 'Baseline, immediately after intervention, 20 minutes after intervention', 'description': 'The single leg stability will be assessed by using Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability.'}, {'measure': 'Postural Assessment', 'timeFrame': 'Baseline, immediately after intervention, 20 minutes after intervention', 'description': 'Posture will be assessed using mobile application. It marks and measures angles at the ear, shoulder, anterior superior iliac spine (ASIS), knee, and ankle alignment to identify any pathological deviations or asymmetries.'}, {'measure': 'Gait analysis', 'timeFrame': 'Baseline, immediately after intervention, 20 minutes after intervention', 'description': 'Gait analysis will be performed using mobile application. Subjects are asked to walk at their normal walking speed over a 10-meter surface, and measurements are taken using video recording and evaluated using the software. The assessment records right and left step lengths, double step length, stride width, and walking speed.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hallux Valgus']}, 'descriptionModule': {'briefSummary': 'Hallux valgus is a progressive foot deformity characterized by lateral deviation of the great toe and medial displacement of the first metatarsal head. While pain is a common symptom among individuals with HV, alterations in plantar pressure distribution and impaired balance are also frequently observed. These symptoms and biomechanical changes can negatively impact posture and gait mechanics. The aim of this study is to investigate the acute effects of prolonged walking on pain, balance, posture, and gait in individuals with hallux valgus deformity.', 'detailedDescription': 'Hallux valgus is a progressive foot deformity commonly seen in adults. Patients typically report pain, most prominently in the first metatarsophalangeal joint, which is often exacerbated by weight-bearing activities such as walking. Due to the deformity, alterations in plantar pressure distribution occur, which in turn affect plantar sensory input and postural control. This may lead to decreased postural stability, impaired balance, and compromised control during walking. HV is also thought to accelerate biomechanical changes that negatively impact gait patterns. The aim of this study is to evaluate the acute effects of prolonged walking on pain, balance, posture, and gait in individuals with hallux valgus deformity. A total of 32 participants, including individuals with HV and healthy controls, will be included in the study. All participants will walk on a treadmill for 60 minutes. Assessments will be conducted at three time points: before walking, immediately after walking, and 20 minutes post-walking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHallux Valgus Group Criteria:\n\n* Individuals aged between 18 and 55 years\n* Being diagnosed with hallux valgus\n\nControl Group Criteria:\n\n* Individuals aged between 18 and 55 years\n* Classified as grade A according to the Manchester Scale\n* Being a volunteer\n\nExclusion Criteria:\n\n* History of previous foot or ankle surgery\n* Having a systemic diseases\n* Having a neurological disorders\n* Having a vestibular pathologies that may affect balance'}, 'identificationModule': {'nctId': 'NCT07177768', 'briefTitle': 'Acute Effects of Prolonged Walking on Hallux Valgus', 'organization': {'class': 'OTHER', 'fullName': 'Bezmialem Vakif University'}, 'officialTitle': 'Acute Effects of Prolonged Walking on Pain, Balance and Posture in Individuals With Hallux Valgus Deformity', 'orgStudyIdInfo': {'id': 'KA25-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hallux Valgus Group', 'description': 'Individuals with hallux valgus deformity', 'interventionNames': ['Other: Prolonged walking']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Healthy controls', 'interventionNames': ['Other: Prolonged walking']}], 'interventions': [{'name': 'Prolonged walking', 'type': 'OTHER', 'description': 'walking on a treadmill for 60 minutes', 'armGroupLabels': ['Control Group', 'Hallux Valgus Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'state': 'Eyup', 'country': 'Turkey (Türkiye)', 'facility': 'Bezmialem Vakif University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Kubra Alpay, PhD', 'role': 'CONTACT', 'email': 'kalpay@bezmialem.edu.tr', 'phone': '+902124012600', 'phoneExt': '4638'}], 'overallOfficials': [{'name': 'Ozgur Serbest, Pt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bezmialem Vakif University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bezmialem Vakif University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Pysiotherapy and Rehabilitation Department', 'investigatorFullName': 'Kübra Alpay', 'investigatorAffiliation': 'Bezmialem Vakif University'}}}}