Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT03183856
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2017-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ambulatory and Functional Improvement by Morning Walk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-27', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change of ROM', 'timeFrame': '1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention', 'description': 'range of motion of the operated knee'}, {'measure': 'Change of drug consumption', 'timeFrame': '5 day, and 10 day after the initiation of intervention', 'description': 'weekly amount of tridol consumption'}, {'measure': 'Change of 6 minute walk test', 'timeFrame': '1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention', 'description': '6 minute walk test'}], 'primaryOutcomes': [{'measure': 'Change of WOMAC index', 'timeFrame': '1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Index'}], 'secondaryOutcomes': [{'measure': 'Change of VAS', 'timeFrame': '1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention', 'description': 'visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee', 'Robotics']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.', 'detailedDescription': 'pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent Unilateral or both Total Knee Arthroplasty\n\nExclusion Criteria:\n\n* brain disease, spinal cord injury, peripheral neuropathy, myopathy\n* Inability to ambulate fully due to muscukoskeletal disorders\n* MMSE\\<23\n* history of arthroplasty surgery on either of legs\n* Cardiac pacemaker\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT03183856', 'briefTitle': 'Comparison of Ambulatory and Functional Improvement by Morning Walk', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk', 'orgStudyIdInfo': {'id': 'chhwang7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morning walk', 'description': '200 steps of gait rehabilitation using an end-effector typed gait robot with 5 minute break, 3 times a day for 10 weekdays: the end-effector type gait robot (Morning Walk®, Hyundai Heavy Industry, Republic of Korea)', 'interventionNames': ['Device: Morning walk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No Morning walk', 'description': '200 steps by themselves or with a help of a walker on a even floor at a comfortable pace with 5 minute break, three times a day for 10 weekdays', 'interventionNames': ['Other: no Morning walk']}], 'interventions': [{'name': 'Morning walk', 'type': 'DEVICE', 'description': 'a end-effector typed gait robot with a saddle', 'armGroupLabels': ['Morning walk']}, {'name': 'no Morning walk', 'type': 'OTHER', 'description': 'ambulation voluntary or with a help of walker', 'armGroupLabels': ['No Morning walk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Chang Ho Hwang, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ulsan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health & Welfare, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD and MD', 'investigatorFullName': 'Chang Ho Hwang', 'investigatorAffiliation': 'Ulsan University Hospital'}}}}