Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02718560
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2016-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Handwriting Rehabilitation in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007839', 'term': 'Functional Laterality'}], 'ancestors': [{'id': 'D004292', 'term': 'Dominance, Cerebral'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-03-20', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'letters size', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'writing speed (time spent to write every single letter and word, measured in milliseconds)', 'timeFrame': '4 weeks'}, {'measure': 'centimeters away from a straight line during writing', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Neurorehabilitation', 'Handwriting']}, 'descriptionModule': {'briefSummary': "The aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.", 'detailedDescription': "The investigators aimed to understand whether an intensive handwriting treatment with cognitive engagement is more effective than a treatment exploiting only the passive wrist joint mobilization in Parkinson's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's Disease patients\n\nExclusion Criteria:\n\n* Mini Mental State Examination (MMSE) score \\< 24\n* Left handed subjects\n* Subjects with dyskinesias\n* Subjects with Deep Brain Stimulation"}, 'identificationModule': {'nctId': 'NCT02718560', 'acronym': 'HRPD', 'briefTitle': 'Handwriting Rehabilitation in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Generale Di Zona Moriggia-Pelascini'}, 'officialTitle': "Effectiveness of Intensive Handwriting Rehabilitation in Subjects With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'Handwriting rehab in PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - Writing with 1 cm cue', 'description': 'This group uses to write space of 1 cm size', 'interventionNames': ['Behavioral: Writing']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - Writing with 1.5 cm cue', 'description': 'This group uses to write space of 1.5 cm size', 'interventionNames': ['Behavioral: Writing']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 - Writing without cue', 'description': 'This group writes without using cues', 'interventionNames': ['Behavioral: Writing']}, {'type': 'NO_INTERVENTION', 'label': 'Group 4 - no writing', 'description': 'This group do not write. Only wrist mobilization is performed.'}], 'interventions': [{'name': 'Writing', 'type': 'BEHAVIORAL', 'description': 'Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks', 'armGroupLabels': ['Group 1 - Writing with 1 cm cue', 'Group 2 - Writing with 1.5 cm cue', 'Group 3 - Writing without cue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22015', 'city': 'Gravedona Ed Uniti', 'state': 'Como', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paola Ortelli, PsyD', 'role': 'CONTACT', 'email': 'ortellipaola73@gmail.com', 'phone': '+393332974872'}], 'facility': 'Ospedale Generale di zona Moriggia Pelascini'}], 'centralContacts': [{'name': 'Paola Ortelli, PsyD', 'role': 'CONTACT', 'email': 'ortellipaola73@gmail.com', 'phone': '+393332974872'}], 'overallOfficials': [{'name': 'Giuseppe Frazzitta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ospedale Generale Di Zona Moriggia-Pelascini'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Generale Di Zona Moriggia-Pelascini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ilaria Zivi', 'investigatorAffiliation': 'Ospedale Generale Di Zona Moriggia-Pelascini'}}}}