Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 1:16 AM
Study NCT ID:
NCT01912794
Status:
UNKNOWN
Last Update Posted:
2013-08-01
First Post:
2013-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postural Responses to External Perturbation in Post-Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-08-21', 'releaseDate': '2015-07-24'}], 'estimatedResultsFirstSubmitDate': '2015-07-24'}}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-30', 'studyFirstSubmitDate': '2013-07-26', 'studyFirstSubmitQcDate': '2013-07-29', 'lastUpdatePostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Muscle activation latency', 'timeFrame': '2 months', 'description': 'This outcome measure is time between the time of release and the first load value 3 standard deviations above the mean magnitude in the 200 ms prior to postural disturbance, with subsequent values increasing.'}], 'primaryOutcomes': [{'measure': 'Displacement amplitude of the CP to the anterior-posterior and medial-lateral', 'timeFrame': '2 months', 'description': 'This outcome measure quantified by the difference between the maximum values of the anterior-posterior and medial-lateral after the start of trial and average position in the axis anteroposterior and mediolateral, respectively, in the 200 ms prior to the onset of the trial.'}], 'secondaryOutcomes': [{'measure': 'Coordination between the hip and ankle joint', 'timeFrame': '2 months', 'description': 'Coordination between the hip and ankle joints, which is evaluated by adjusting the angle displacement data, hip and ankle angle within 95% of an ellipse surrounding the values of the disturbance moment until the end of the trial. Will be carried out a regression analysis to identify the slope of the fitted ellipse. Slopes greater indicate a greater share of the ankle in relation to the hip'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebrovascular Accident', 'Rehabilitation', 'Sensory System'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'To maintain stable body balance in daily activities, the ability to respond to external perturbations is an essential factor. Such capacity is limited in pathological conditions, such as in stroke, in which postural control is impaired due to lesions to the central nervous system. Impairment to postural control increases body sway during upright posture and leads to augmented frequency of falls. In this sense, the identification of mechanisms involved in body balance disorders after stroke is particularly important in situations of postural perturbation. The purpose of this project is to evaluate reactive postural responses to unpredictable external perturbations, analyzing postural dysfunctions caused by lesion to different brain areas as a result of stroke, and test principles of dynamic body balance rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion criteria are as follows. Healthy participants: absence of detectable neurological or physical malfunction which might affect postural control, no use of drugs affecting body balance and preserved mental capacity. Stroke patients: capacity to sustain independently orthostatic posture for at least 5 min. and preserved mental capacity.\n\nExclusion Criteria:\n\n* Exclusion Criteria are: no orthopedic malfunction, no clinical instability associated with systemic disease, no use of drugs affecting body balance and presence of "pusher syndrome".'}, 'identificationModule': {'nctId': 'NCT01912794', 'briefTitle': 'Postural Responses to External Perturbation in Post-Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation', 'orgStudyIdInfo': {'id': 'SMH-2011/18173-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sensory Conditions', 'interventionNames': ['Other: Sensory Intervention']}], 'interventions': [{'name': 'Sensory Intervention', 'type': 'OTHER', 'description': '1. full sensory information, whose participants will practice balancing tasks without constraint sensory body;\n2. sensory constraint, whose participants will practice the same balance tasks with constraint body of visual and tactile information from the soles of the feet;\n3. control, whose participants will exercise activities involving cognitive and upper limbs.', 'armGroupLabels': ['Sensory Conditions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Alessandra R Martinelli, Master', 'role': 'CONTACT', 'email': 'lerezendemartinelli@yahoo.com.br', 'phone': '+55113091-8795'}, {'name': 'Alessandra R Martinelli, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Escola de Educação física e Esporte, Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Alessandra R Martinelli, Master', 'role': 'CONTACT', 'email': 'lerezendemartinelli@yahoo.com.br', 'phone': '+551681490337'}], 'overallOfficials': [{'name': 'Luis A Teixeira, PhD', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Alessandra Rezende Martinelli', 'investigatorAffiliation': 'University of Sao Paulo'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-07-24', 'type': 'RELEASE'}, {'date': '2015-08-21', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alessandra Rezende Martinelli, PhD student, University of Sao Paulo'}}}}