Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:38 PM
Study NCT ID:
NCT05609461
Status:
WITHDRAWN
Last Update Posted:
2023-06-22
First Post:
2022-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Necessary equipment could not be provided.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-18', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kinematic Analysis', 'timeFrame': 'Baseline', 'description': 'At the specified anatomical sites of the participants, reflective signs will be placed. The participants will be required to walk 5 meters. The three-dimensional positions of these reflective marks will be captured by the 8-camera Vicon motion capture system. Using the blade software, it will be moved to the computer environment and kinematic data will be collected.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gait Analysis', 'Foot-Ankle Orthosis', 'Knee Hyperextension', 'Kinematic Analysis'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'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.'}, {'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': '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.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine the effect of using foot-ankle orthosis at different angles on hyperextension control in stroke patients.\n\nThe hypotheses of the study are:\n\nHypothesis 1:\n\nHo: The foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has no effect on the control of knee hyperextension.\n\nH1: Foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has an effect on the control of knee hyperextension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke Patients with Knee Hyperextension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 40 and 65\n* Six months must have passed since the stroke.\n* Ambulation regardless of the use of a walking aid (walker, cane, or tripod)\n* Obtaining between 0 and 3 Modified Rankin Score points\n* A score of 24 or higher on the Mini Mental Test is required to pass.\n* Hyperextension during the stance phase of gait.\n* Participating voluntarily in the study\n\nExclusion Criteria:\n\n* Having a history of more than one stroke\n* Dementia is known to exist\n* Having a diagnosed orthopedic, mental, or neurological condition\n* Having a circumstance that impedes communication\n* Having a history of lower extremity and gait-related surgeries'}, 'identificationModule': {'nctId': 'NCT05609461', 'briefTitle': 'Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients by Kinematic Analysis', 'orgStudyIdInfo': {'id': 'E-59394181-604.01.02-47710'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic stroke patients with knee hyperextension'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Altındağ', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.96673, 'lon': 32.92254}}], 'overallOfficials': [{'name': 'Kadriye Armutlu, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Süleyman Korkusuz, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University'}, {'name': 'Sibel Kibar, Assoc. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Atılım University'}, {'name': 'Serdar Arıtan, Asst.Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Nihat Özgören, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Büşra Seçkinoğulları, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}, {'name': 'Ayla Fil Balkan, Assoc.Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Hacettepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Atılım University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Suleyman Korkusuz', 'investigatorAffiliation': 'Hacettepe University'}}}}