Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT03465267
Status:
UNKNOWN
Last Update Posted:
2018-03-14
First Post:
2018-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparisons of Two Types of Armeo Robot for Upper Extremities
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessor does not know the allocation of participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2018-03-01', 'studyFirstSubmitQcDate': '2018-03-07', 'lastUpdatePostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Wolf motor function test', 'timeFrame': 'change from baseline at 4 weeks', 'description': 'Change of Wolf motor function test'}], 'secondaryOutcomes': [{'measure': 'Fugl-Meyer Assessment', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Fugl-Meyer Assessment'}, {'measure': 'Stroke impact scale', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Stroke impact scale (Health-related quality of life measurements in stroke patients)'}, {'measure': 'Motor activity log', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Motor activity log'}, {'measure': 'Mean velocity of upper extremity during reaching task', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Curvature of the magnetic sensor trajectory (Kinematics of upper extremity)during reaching task'}, {'measure': 'Curvature of upper extremity during reaching task', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Curvature of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task'}, {'measure': 'Jerk of upper extremity during reaching task', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Jerk of the magnetic sensor trajectory (Kinematics of upper extremity during) reaching task'}, {'measure': '% maximal voluntary contraction of upper extremity muscles during reaching task', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'surface EMG of upper extremity during reaching task'}, {'measure': 'Behavioral activation system/behavioral inhibition system scale', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Behavioral activation system subscale, behavioral inhibition system subscale'}, {'measure': 'Beck depression index', 'timeFrame': 'baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Beck depression index'}, {'measure': 'Intrinsic motivation inventory', 'timeFrame': 'baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Intrinsic motivation inventory'}, {'measure': 'Stroke rehabilitation motivation scale', 'timeFrame': 'baseline, 4 weeks after baseline, 8 weeks after baseline', 'description': 'Stroke rehabilitation motivation scale'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'upper extremity rehabilitation robot', 'stroke rehabilitation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '33076952', 'type': 'DERIVED', 'citation': 'Park JH, Park G, Kim HY, Lee JY, Ham Y, Hwang D, Kwon S, Shin JH. A comparison of the effects and usability of two exoskeletal robots with and without robotic actuation for upper extremity rehabilitation among patients with stroke: a single-blinded randomised controlled pilot study. J Neuroeng Rehabil. 2020 Oct 19;17(1):137. doi: 10.1186/s12984-020-00763-6.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function', 'detailedDescription': 'The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist.\n\nThus the results from this study might suggest usefulness of motorized robot.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiplegic patients secondary to first cerebrovascular accidents\n* Onset ≥ 3 months\n* 26 ≤ Fugl-Meyer Assessment score ≤ 50\n* 3 ≤ Shoulder or elbow MRC scale ≤ 4\n* Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+\n* Cognitively intact enough to understand and follow the instructions from the investigator\n\nExclusion Criteria:\n\n* History of surgery of affected upper limb\n* Fracture of affected upper limb'}, 'identificationModule': {'nctId': 'NCT03465267', 'briefTitle': 'Comparisons of Two Types of Armeo Robot for Upper Extremities', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Rehabilitation Center, Seoul, Korea'}, 'officialTitle': 'Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NRC-2017-01-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Armeo power', 'description': 'Armeo power robot for upper extremity', 'interventionNames': ['Device: Armeo power']}, {'type': 'EXPERIMENTAL', 'label': 'Armeo spring', 'description': 'Armeo spring robot for upper extremity', 'interventionNames': ['Device: Armeo spring']}], 'interventions': [{'name': 'Armeo power', 'type': 'DEVICE', 'description': 'Intervention with Armeo power rehabilitation robot for upper extremity (made by Hocoma), which provide assistive force.\n\nThe intervention was done 4 weeks, 5 times/week, 30 minutes/day.', 'armGroupLabels': ['Armeo power']}, {'name': 'Armeo spring', 'type': 'DEVICE', 'description': 'Intervention with Armeo spring rehabilitation robot for upper extremity (made by Hocoma), which is operated only by participants, without any assistive force from robot.\n\nThe intervention was done 4 weeks, 5 times/week, 30 minutes/day.', 'armGroupLabels': ['Armeo spring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '142884', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joon-Ho Shin, MS', 'role': 'CONTACT'}, {'name': 'Joon-Ho Shin, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Rehabilitation Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joon-Ho Shin, MS', 'role': 'CONTACT', 'email': 'asfreelyas@gmail.com', 'phone': '82-2-901-1884'}], 'overallOfficials': [{'name': 'Joon-Ho Shin, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Rehabilitation Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Rehabilitation Center, Seoul, Korea', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Team manager', 'investigatorFullName': 'Joon-Ho Shin', 'investigatorAffiliation': 'National Rehabilitation Center, Seoul, Korea'}}}}