Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT06394635
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2024-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2024-04-28', 'studyFirstSubmitQcDate': '2024-04-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement Analysis', 'timeFrame': 'Baseline', 'description': 'Reflective signs will be placed on certain anatomical points on the participants and the participants will be asked to walk at a distance of 5 meters. The three-dimensional positions of these reflective signs will be captured with the 8-camera Vicon motion capture system and recorded on the computer using Blade software.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Stroke']}, 'referencesModule': {'references': [{'pmid': '27136122', 'type': 'BACKGROUND', 'citation': 'Kobayashi T, Orendurff MS, Singer ML, Gao F, Daly WK, Foreman KB. Reduction of genu recurvatum through adjustment of plantarflexion resistance of an articulated ankle-foot orthosis in individuals post-stroke. Clin Biomech (Bristol). 2016 Jun;35:81-5. doi: 10.1016/j.clinbiomech.2016.04.011. Epub 2016 Apr 23.'}, {'pmid': '31871367', 'type': 'BACKGROUND', 'citation': 'Bae DY, Shin JH, Kim JS. Effects of dorsiflexor functional electrical stimulation compared to an ankle/foot orthosis on stroke-related genu recurvatum gait. J Phys Ther Sci. 2019 Nov;31(11):865-868. doi: 10.1589/jpts.31.865. Epub 2019 Nov 26.'}, {'pmid': '34695721', 'type': 'BACKGROUND', 'citation': 'Geerars M, Minnaar-van der Feen N, Huisstede BMA. Treatment of knee hyperextension in post-stroke gait. A systematic review. Gait Posture. 2022 Jan;91:137-148. doi: 10.1016/j.gaitpost.2021.08.016. Epub 2021 Aug 24.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis 1:\n\nHo: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait.\n\nH1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on knee hyperextension control in stroke patients with genurecurvatum gait.\n\nHypothesis 2:\n\nHo: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on pelvic movements in stroke patients with genurecurvatum gait.\n\nH1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on pelvic movements in stroke patients with genurecurvatum gait.', 'detailedDescription': 'Kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. Patients will be asked to walk at a normal walking pace for a distance of only 5 meters. Patients will walk the 5-meter distance first without the Ankle-Foot Orthosis, then with the Ankle-Foot Orthosis adjusted at 3 degrees of dorsiflexion, and then with the Ankle-Foot Orthosis adjusted at 5 degrees of dorsiflexion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke Patients with Genurecurvatum Gait', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 6 months have passed since the stroke incident\n* Ambulating with or without a walking aid (walker, cane or tripod)\n* Being between 0-3 points according to the Modified Rankin Scoring\n* Getting a score of 24 or above from the Mini Mental Test\n* Presence of hyperextension in the stance phase of gait\n* Volunteering to participate in the study\n\nExclusion Criteria:\n\n* Having a history of more than one stroke\n* Known presence of dementia\n* Having a known orthopedic, psychiatric or other neurological disease\n* There is a situation that prevents communication\n* Having a history of surgery involving the lower extremities and gait'}, 'identificationModule': {'nctId': 'NCT06394635', 'briefTitle': 'Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Effect of Using Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait', 'orgStudyIdInfo': {'id': '349c6c25d7a64a22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke Patients with Genurecurvatum Gait', 'description': 'Stroke patients with genurecurvatum gait will be included.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Süleyman Korkusuz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atılım University'}, {'name': 'Büşra Seçkinoğulları Korkusuz, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ayşenur Özcan, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Çankırı Karatekin University'}, {'name': 'Ferdi Yavuz, Assoc.Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'European University of Lefke'}, {'name': 'Nihat Özgören, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Serdar Arıtan, Assisst.Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suleyman Korkusuz', 'investigatorAffiliation': 'Hacettepe University'}}}}