Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03549793
Status:
UNKNOWN
Last Update Posted:
2018-06-08
First Post:
2018-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?
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': 'D003614', 'term': 'Dance Therapy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The investigator are neurologists, blinded to the treatment received by the patient'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to experimental group or control group. Both of the groups undergo a rehabilitation treatment. The experimental group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + dance therapy. The control group undergoes 4-week MIRT (Multidisciplinary Intensive Rehabilitation Treatment) + exercises'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2018-06-07', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'delayed recall of items', 'timeFrame': '4 weeks', 'description': 'number of specific items correctly performed in recall phase'}], 'primaryOutcomes': [{'measure': 'Timed Up and Go Test (TUG)', 'timeFrame': '4 weeks', 'description': 'To determine fall risk and measure the progress of balance, sit to stand, and walking.'}], 'secondaryOutcomes': [{'measure': '6 Minutes Walking Test (6MWT)', 'timeFrame': '4 weeks', 'description': 'The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.'}, {'measure': 'Balance Berg Scale (BBS)', 'timeFrame': '4 weeks', 'description': "to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'In order to find the most effective rehabilitative therapies for Parkinsonian patients, the present study is aimed to evaluate whether, in a multidisciplinary intensive rehabilitation treatment, the dance therapy, applied to the motor learning, promote additional benefits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage 2.5-3 according to the Hoehn and Yahr scale (H\\&Y);\n* Stable pharmacological treatment for the last 6 weeks before the enrolment and during the hospitalization;\n\nExclusion Criteria:\n\n* Any focal brain lesion detected in brain imaging studies (CT or MRI) performed in the previous 12 months;\n* Drug-induced dyskinesias;\n* Disturbing resting and/or action tremor, corresponding to scores 2-4 in the specific items of UPDRS III;\n* Behavioral disturbances (evaluated with Neuropsychiatric Inventory);\n* Visual and auditory dysfunctions according to the general clinical evaluation and medical history;\n* cognitive decline (MMSE correct score \\< 24)'}, 'identificationModule': {'nctId': 'NCT03549793', 'briefTitle': "Can Dance Therapy Improve Motor Learning in Parkinson's Disease (PD)?", 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Generale Di Zona Moriggia-Pelascini'}, 'officialTitle': "Can Dance Therapy Improve Motor Learning in Parkinson's Disease?", 'orgStudyIdInfo': {'id': 'dance therapy in PD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dance thrapy', 'description': '4-week Multidisciplinary Rehabilitation Treatment + Dance Therapy Treatment (2 hours par week)', 'interventionNames': ['Behavioral: Dance Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'exercises without dance', 'description': '4-week Multidisciplinary Rehabilitation Treatment + Exercises without music (2 hours par week)', 'interventionNames': ['Behavioral: exercises without dance']}], 'interventions': [{'name': 'Dance Therapy', 'type': 'BEHAVIORAL', 'description': 'the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing', 'armGroupLabels': ['dance thrapy']}, {'name': 'exercises without dance', 'type': 'BEHAVIORAL', 'description': 'the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing', 'armGroupLabels': ['exercises without dance']}]}, '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': '+39 0344 82706'}], 'facility': "Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital"}], 'centralContacts': [{'name': 'Paola Ortelli, PsyD', 'role': 'CONTACT', 'email': 'ortellipaola73@gmail.com', 'phone': '3332974872'}], 'overallOfficials': [{'name': 'Giuseppe Frazzitta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Parkinson\'s disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Generale Di Zona Moriggia-Pelascini', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}