Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 2:40 PM
Study NCT ID:
NCT04672057
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010291', 'term': 'Paresis'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2020-12-06', 'studyFirstSubmitQcDate': '2020-12-11', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of gait between in right and left hemiparetics', 'timeFrame': 'Measurement time is 10 minutes. Only one measurement was made.', 'description': "A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique."}], 'secondaryOutcomes': [{'measure': 'assessment of gait between in hemiparetic and healthy individuals', 'timeFrame': 'Measurement time is 10 minutes. Only one measurement was made.', 'description': "A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemiparesis', 'Lateralization', 'Spatio-temporal analysis', 'Gait'], 'conditions': ['Hemiparesis']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.', 'detailedDescription': 'A total of 108 individuals within the age range of 20-65 and 36 of whom are right hemiparetic (Group1; 16F, 20M), 36 of whom are left hemiparetic (Group2; 16F, 20M) and 36 of whom are healthy (Group3; 19F, 17M) have been included in the study. BTS G-Walk Gait Analysis System has been used to assess the spatio-temporal gait characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfor the hemiparetic individuals\n\n* Being between the ages of 20-65,\n* Having a stroke for the first time and one-sidedly,\n* Having a stable clinical state,\n* Having no cognitive disorder (Hodkinson Mental Test ≥ 8),\n* Having ≤ 3 from Modified Rankin Score,\n* Having no problems with vision and hearing.\n\nfor the healthy control group;\n\n* Being between the ages of 20-65\n* Having no neurological, musculosceletal, cardiac and cognitive problems that was undergone before and may affect walking.\n\nExclusion Criteria:\n\n* The existence of vision and hearing problems in both study and control groups,\n* The existence of orthopedic, neurological and psychiatric problems that may affect walking.'}, 'identificationModule': {'nctId': 'NCT04672057', 'briefTitle': 'Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization', 'orgStudyIdInfo': {'id': 'Gait Parameter In Hemiparetics'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Right hemiparetics', 'description': 'right-sided affected hemiparetic individuals', 'interventionNames': ['Other: assessment of gait parameters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Left hemiparetics', 'description': 'left-sided affected hemiparetic individuals', 'interventionNames': ['Other: assessment of gait parameters']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'healthy individuals', 'interventionNames': ['Other: assessment of gait parameters']}], 'interventions': [{'name': 'assessment of gait parameters', 'type': 'OTHER', 'description': 'Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.', 'armGroupLabels': ['Control', 'Left hemiparetics', 'Right hemiparetics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20100', 'city': 'Denizli', 'country': 'Turkey (Türkiye)', 'facility': 'Pamukkale University', 'geoPoint': {'lat': 37.77417, 'lon': 29.0875}}], 'overallOfficials': [{'name': 'Gulsum Tikac, MSc Pt', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pamukkale University'}, {'name': 'Filiz Altuğ, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gulsum Tikac', 'investigatorAffiliation': 'Pamukkale University'}}}}