Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-11 @ 11:33 PM
Study NCT ID:
NCT04181918
Status:
UNKNOWN
Last Update Posted:
2019-12-02
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Action Observation Treatment in Parkinson's Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-26', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the functional status of the patient', 'timeFrame': "Before treatment, within one week after treatment, two months' follow up", 'description': "to assess the change in the functional status of the patient, the Functional Independence Measure (FIM) will be used. FIM consists in a 7-point scale (1 = \\<25% independence; total assistance required, 7 = 100% independence), and it can detect changes in the patient's status in 18 categories, focusing on motor and cognitive function. Functional patients' status will assess before treatment, within one week after the end of the treatment (after treatment) and two months' follow up."}, {'measure': 'change in Parkinson disease motor symptoms', 'timeFrame': "Before treatment, within one week after treatment, two months' follow up", 'description': "to assess the change in motor status of the patient, the Unified Parkinson's Disease Rating Scale (UPDRS) will be used, and it consists in a 5-point scale (0 = no signs; 4 = severe). UPDRS will be administered before treatment, within one week after the end of the treatment (after treatment) and two months' follow up."}, {'measure': 'change in kinematic parameters of the gait (velocity, footing, pace, step length)', 'timeFrame': "Before treatment, within one week after treatment, two months' follow up", 'description': "to assess the change of patient's gait parameters, the kinematic analysis will be used (i.e. gait analysis). The gait analysis allows to detect fine-grain changes in kinematic parameters of the movement, through a non-invasive methodology. Gait analysis will be performed before treatment, within one week after the end of the treatment (after treatment) and two months' follow up."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Action Observation Treatment', 'Motor Imagery', 'Randomized Controlled Study'], 'conditions': ['Parkinson']}, 'descriptionModule': {'briefSummary': "The aim of the study is to assess the role of Action Observation Treatment (AOT) and Motor Imagery (MI) in the rehabilitation of Parkinson's disease patients, as compared to a control condition. Main outcome measures will be the results in two functional scales (FIM, UPDRS) and kinematics parameters obtained from gait analysis. Data at two months and six months follow up, respectively, will be also collected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parkinson disease patients on Hoehn and Yahr 3-4\n\nExclusion Criteria:\n\n* Mini-Mental State Examination \\< 24\n* Fluent aphasic patients\n* Apraxia\n* Neglect\n* major neuropsychiatric disorders'}, 'identificationModule': {'nctId': 'NCT04181918', 'acronym': 'AOT-PA', 'briefTitle': "Action Observation Treatment in Parkinson's Patients", 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': "Action Observation Treatment and Motor Imagery as Rehabilitation Tools in Parkinson's Disease Patients", 'orgStudyIdInfo': {'id': 'AOTPRFDG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOT', 'description': 'This group will observe videos depicting daily actions and afterwards they will execute the seen actions', 'interventionNames': ['Behavioral: AOT']}, {'type': 'EXPERIMENTAL', 'label': 'MI', 'description': 'This group will imagine motorically the same action as the first group and afterwards they will execute the imagined actions', 'interventionNames': ['Behavioral: MI']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'This group will neither observe nor imagine actions, but simply observe videos with no motor content. Afterwards they will execute the same actions as in AOT and MI.'}], 'interventions': [{'name': 'AOT', 'type': 'BEHAVIORAL', 'description': 'During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.', 'armGroupLabels': ['AOT']}, {'name': 'MI', 'type': 'BEHAVIORAL', 'description': 'During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output', 'armGroupLabels': ['MI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43123', 'city': 'Parma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Grazia Burinato', 'role': 'CONTACT', 'email': 'mburinato@dongnocchi.it', 'phone': '00390521205589'}], 'facility': 'Fondazione Don Carlo Gnocchi', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'centralContacts': [{'name': 'Giovanni Buccino', 'role': 'CONTACT', 'email': 'neurofis.buccino@gmail.com', 'phone': '00390521205683', 'phoneExt': '0039'}, {'name': 'Claudio Rovacchi', 'role': 'CONTACT', 'email': 'crovacchi@dongnocchi.it', 'phone': '00390521205683', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'Giovanni Buccino', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Don Gnocchi'}, {'name': 'Claudio Rovacchi', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Don Gnocchi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}