Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-03-08 @ 5:51 AM
Study NCT ID:
NCT03135093
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2017-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Upper Limb Function and Visuospatial Exploration After Stroke
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': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2017-04-26', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Upper limb movement quality', 'timeFrame': 'One day', 'description': 'Fugl-Meyer Assessment of the upper extremity (FMA-UE), kinematic data (e.g. joint angles, hand workspace)'}, {'measure': 'Visuospatial exploration', 'timeFrame': 'One day', 'description': 'Eye-tracking data (e.g. area of interest, eye movements: saccades, fixations) and to rule out stroke-related deficits of visuospatial attention, clinical tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['synergies', 'upper limb', 'vision'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '35016694', 'type': 'DERIVED', 'citation': 'Schwarz A, Bhagubai MMC, Nies SHG, Held JPO, Veltink PH, Buurke JH, Luft AR. Characterization of stroke-related upper limb motor impairments across various upper limb activities by use of kinematic core set measures. J Neuroeng Rehabil. 2022 Jan 12;19(1):2. doi: 10.1186/s12984-021-00979-0.'}, {'pmid': '33585418', 'type': 'DERIVED', 'citation': 'Schwarz A, Veerbeek JM, Held JPO, Buurke JH, Luft AR. Measures of Interjoint Coordination Post-stroke Across Different Upper Limb Movement Tasks. Front Bioeng Biotechnol. 2021 Jan 28;8:620805. doi: 10.3389/fbioe.2020.620805. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'This project is a cross-sectional, observational mono-center study with prospective data collecting.\n\nThis study aims to further explore quality of upper limb movement in relation to characteristics of visuospatial exploration in stroke subjects and healthy subjects by a applying comprehensive measurements of clinical scales and kinematic data in capacity- and performance-based activities. The results will contribute to assessing and monitoring quality of upper limb movements and visuospatial attention and their relationship.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stroke subjects', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects of 18 years and older with chronic ischemic stroke (\\> 6 month) restricted to one hemisphere (confirmed by CT/MRI)\n* With impairments in upper limb function and at least partial ability to lift the arm against gravity, flex and extend the fingers\n* Without relevant pre-existing limitations in arm and hand function (orthopaedic, muscular, neurologic)\n* Written informed consent after participants's information\n\nExclusion Criteria:\n\n* Increased muscle tone in the upper limb with limited rang of motion\n* Severe sensory deficits in the upper limb\n* Clinically significant concomitant disease (affecting the upper limb or impaired vision, e.g. due to glaucoma etc.)\n* Contraindications on ethical grounds (vulnerable persons)\n* Known or suspected non-compliance, drug or alcohol abuse\n* Severe communication or cognitive deficits, that cause inability to follow the procedures"}, 'identificationModule': {'nctId': 'NCT03135093', 'briefTitle': 'Upper Limb Function and Visuospatial Exploration After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Assessing Pathological Synergies of Upper Limb Function and the Relationship to Visuospatial Exploration After Stroke', 'orgStudyIdInfo': {'id': '2016-02075'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke subjects', 'interventionNames': ['Other: No intervention']}, {'label': 'Healthy subjects', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No Intervention', 'armGroupLabels': ['Healthy subjects', 'Stroke subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6345', 'city': 'Vitznau', 'state': 'Canton of Lucerne', 'country': 'Switzerland', 'facility': 'cereneo Schweiz AG', 'geoPoint': {'lat': 47.01014, 'lon': 8.4842}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The anonymized project data will be shared within the partners of the European Horizon2020 - SoftPro (No.688857) project.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}