Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-28 @ 2:25 PM
Study NCT ID:
NCT05646966
Status:
COMPLETED
Last Update Posted:
2022-12-12
First Post:
2017-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trunkstability: a Predisposition for Armfunction
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-02', 'studyFirstSubmitDate': '2017-06-13', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electromyography to analyze muscle activation', 'timeFrame': '2 hours', 'description': 'which muscle is active during a reaching movement'}, {'measure': 'kinematics to analyze trunk involvement', 'timeFrame': '2 hours', 'description': 'when is the trunk involved in a reaching movement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'reaching', 'ADL'], 'conditions': ['Trunk Stability']}, 'descriptionModule': {'briefSummary': 'Trunk stability is supposed to be an important predisposition for arm function. To the investors knowledge this is never been demonstrated.', 'detailedDescription': 'Fifty healthy subjects will execute a reaching movement in sitting. They will reach to a cone at a distance of little more than armlength.\n\nElectromyogram (EMG) and kinematics will be the outcome measures. Secondary outcome measures are: sex, dexterity, skillfulness, Fifty first time stroke patients will execute the same movements. Primery outcome is EMG and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\< 30\n* no orthopedic, neurologic disorder that can influence the reaching\n* age between 18 and 70 yrs\n\nExclusion Criteria:\n\n* BMI\\>30\n* orthopedic, neurologic disorder that can influence the reaching\n* \\< 18 yrs of age\n* \\>70 yrs of age'}, 'identificationModule': {'nctId': 'NCT05646966', 'briefTitle': 'Trunkstability: a Predisposition for Armfunction', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Trunkstability: a Predisposition for Armfunction', 'orgStudyIdInfo': {'id': 'EC2016/0808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'healthy subjects', 'description': 'healthy subjects', 'interventionNames': ['Other: one time testing']}, {'type': 'NO_INTERVENTION', 'label': 'stroke patients', 'description': 'first time stroke patients'}], 'interventions': [{'name': 'one time testing', 'type': 'OTHER', 'armGroupLabels': ['healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'Revaki Ugent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}