Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT02425332
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Novel Robot-aided Assessment of Gait Ability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraclass Correlation Coefficient between Lokomat score.', 'timeFrame': 'up to one week', 'description': 'Reliability of Lokomat assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal Cord Injury', 'adaptive control', 'assessment', 'assist-as-needed', 'walking ability', 'Lokomat'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '37735690', 'type': 'DERIVED', 'citation': 'Maggioni S, Lunenburger L, Riener R, Curt A, Bolliger M, Melendez-Calderon A. Assessing walking ability using a robotic gait trainer: opportunities and limitations of assist-as-needed control in spinal cord injury. J Neuroeng Rehabil. 2023 Sep 21;20(1):121. doi: 10.1186/s12984-023-01226-4.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is the validation of a novel gait assessment method implemented in the Lokomat gait trainer with respect to established clinical gait assessment methods. The walking assessment method is based on the progressive reduction of the support of the device. The outcome measures of this algorithm will be the support needed in the different gait phases (guidance force of hip and knee joints) and the support required to the body weight support system (unloading). The hypothesis is that the guidance force and the support of the device will converge to a profile individual for each subject that is representative of one's impairment in the different gait phases. The reliability of the method will be tested collecting data from two sessions of Lokomat training. The validity of the method will be tested comparing the outcome of the assessment task with established clinical walking assessment measures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* individuals \\>1 year post Spinal Cord Injury or able bodied persons\n\nExclusion Criteria:\n\n* presence of contraindications to Lokomat training, inability or unwillingness to provide written informed consent or follow study procedures'}, 'identificationModule': {'nctId': 'NCT02425332', 'briefTitle': 'Validation of a Novel Robot-aided Assessment of Gait Ability', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Validation of Lokomat-aided Assessment of Gait Ability', 'orgStudyIdInfo': {'id': 'KEK-ZH-2015 0020/PB_2016-00466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lokomat assessment', 'interventionNames': ['Device: Lokomat gait trainer']}], 'interventions': [{'name': 'Lokomat gait trainer', 'type': 'DEVICE', 'armGroupLabels': ['Lokomat assessment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitätsklinik Balgrist', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}