Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-06 @ 1:28 PM
Study NCT ID:
NCT04830904
Status:
UNKNOWN
Last Update Posted:
2021-08-25
First Post:
2021-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lycra Garments in Ataxic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002524', 'term': 'Cerebellar Ataxia'}], 'ancestors': [{'id': 'D002526', 'term': 'Cerebellar Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Movement of the center of mass over GRAIL/no device', 'timeFrame': 'immediately before wearing the lycra garment', 'description': 'Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetitions lasting 1 minute'}, {'measure': 'Movement of the center of mass over GRAIL/ with lycra garments', 'timeFrame': 'immediately after wearing the lycra garment', 'description': 'Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetition lasting 1 minute'}, {'measure': 'Berg Balance Scale/no device', 'timeFrame': 'immediately before wearing the lycra garment', 'description': 'Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome)'}, {'measure': 'Berg Balance Scale/ with lycra garments', 'timeFrame': 'immediately after wearing the lycra garment', 'description': 'Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome)'}, {'measure': '6 Minute Walking Test/no device', 'timeFrame': 'immediately before wearing the lycra garment', 'description': 'a test to assess the walking resistance'}, {'measure': '6 Minute Walking Test/ with lycra garments', 'timeFrame': 'immediately after wearing the lycra garment', 'description': 'a test to assess the walking resistance'}, {'measure': 'Goal Attainment Scaling/no device', 'timeFrame': 'immediately before wearing the device', 'description': 'Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better)'}, {'measure': 'Goal Attainment Scaling/ with lycra garments', 'timeFrame': 'immediately after wearing the lycra garment', 'description': 'Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better)'}], 'secondaryOutcomes': [{'measure': 'Likert tolerability questionaire', 'timeFrame': '14 days after wearing the lycra garment', 'description': 'a likert tool designed to evaluate the tolerability of the lycra garments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ataxia, Cerebellar']}, 'descriptionModule': {'briefSummary': 'The aim of this study iss to analyze the effect of Lycra garments in the axial stabilization in subjects affected by ataxia, both in acquired cerebellar injuries and malformative etiology.\n\nImprovement are expected for what concerns:\n\n* greater stability during stance\n* smoother walking pattern\n* reduction of risk of fall.\n\nThe two groups (acquired and malformative) will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects recruited must show a framework of ataxia consequent to acquired brain injury or malformative etiology.\n* subjects must be able to walk autonomously without any device\n\nExclusion Criteria:\n\n* presence of spasticity or muscular contractures\n* subjects who already used lycra garments'}, 'identificationModule': {'nctId': 'NCT04830904', 'briefTitle': 'Efficacy of Lycra Garments in Ataxic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Eugenio Medea'}, 'officialTitle': 'Efficacy of Lycra Garments in Ataxic Subjects', 'orgStudyIdInfo': {'id': '760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Use of lycra garments', 'description': 'the subjects are assessed with and without wearing the device', 'interventionNames': ['Device: personalized Lycra garments']}], 'interventions': [{'name': 'personalized Lycra garments', 'type': 'DEVICE', 'description': 'the subjects wear lycra garments during the assessment time and for some days after the assessment', 'armGroupLabels': ['Use of lycra garments']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23842', 'city': 'Bosisio Parini', 'state': 'Lecco', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Panzeri', 'role': 'CONTACT', 'email': 'daniele.panzeri@lanostrafamiglia.it', 'phone': '031877878'}], 'facility': 'IRCCS E. Medea', 'geoPoint': {'lat': 45.80075, 'lon': 9.29}}], 'centralContacts': [{'name': 'Daniele Panzeri', 'role': 'CONTACT', 'email': 'daniele.panzeri@lanostrafamiglia.it', 'phone': '031877878'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Eugenio Medea', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}