Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-22 @ 11:06 AM
Study NCT ID:
NCT02051556
Status:
UNKNOWN
Last Update Posted:
2014-02-17
First Post:
2014-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Working on Asymmetry in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-11-10', 'releaseDate': '2015-10-10'}], 'estimatedResultsFirstSubmitDate': '2015-10-10'}}, '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': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-14', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Short physical performance battery', 'timeFrame': '24 weeks'}], 'primaryOutcomes': [{'measure': 'Motor Symptoms', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Freezing of gait', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Freezing of gait', 'Asymmetry', 'Rehabilitation', 'Physical therapy'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '21103799', 'type': 'RESULT', 'citation': "Modugno N, Iaconelli S, Fiorlli M, Lena F, Kusch I, Mirabella G. Active theater as a complementary therapy for Parkinson's disease rehabilitation: a pilot study. ScientificWorldJournal. 2010 Nov 16;10:2301-13. doi: 10.1100/tsw.2010.221."}]}, 'descriptionModule': {'briefSummary': "Freezing of gait (FOG) is a disabling episodic gait disturbance that is common among patients with Parkinson's disease (PD). The symptoms of PD generally show an asymmetric onset and progression.\n\nIn particular, impairments in rhythmicity, symmetry, and bilateral coordination have been reported to be associated with FOG episodes. As the maintenance of gait depends on the precise alternating movements of both legs, irregularities in rhythm, symmetry, and bilateral coordination may impair gait sequence, potentially causing freezing.\n\nResults of recent studies strongly suggest that bilateral uncoordinated gait and marked gait asymmetry are associated with FOG. Moreover, it has recently been hypothesized that this may lead to a degree of asymmetric motor function, and that FOG in parkinsonian patients is triggered by a breakdown in the bilateral co-ordination underlying the normal timing of gait. Aim of the study was to evaluate how the modulation of asymmetry through physical therapy might improve gait and FOG.", 'detailedDescription': "The patients will be'blind' to the study protocol and will be randomly assigned to one of the three study arms: 1) physiotherapy aimed to potentiate the more affected body side (worst side improvement, WSI); 2) physiotherapy aimed to potentiate the less affected body side (best side improvement, BSI); 3) physiotherapy aimed to potentiate both sides equally (standard treatment, ST). Each group will be undergo physiotherapy twice a week for three months. Each session will have duration of one hour and include a first part of warming up, a final part of cooling down (these two parts are the same for all the groups) and an active part (which is different from group to group). The active part includes exercises which are alike for all the groups but with a number of repetitions different from group to group according to the aim of potentiating the most affected side (WSI) or the least affected side (BSI) or both sides equally (in this case the number of repetitions was the same for both sides; ST). Medical treatment will be kept stable through all the study duration; medications are expressed as levodopa daily dose equivalent (LEDD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Parkinson's disease, freezing of gait history, informed consent\n\nExclusion Criteria:\n\n* depression, severe orthopedic diseases"}, 'identificationModule': {'nctId': 'NCT02051556', 'briefTitle': "Working on Asymmetry in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Neuromed IRCCS'}, 'officialTitle': "Working on Asymmetry in Parkinson's Disease: a Double Blind, Randomized, Controlled Rehabilitation Trial.", 'orgStudyIdInfo': {'id': 'ASPD-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Best Side Improvement', 'description': 'Physical Therapy BSI (Best Side Improvement), aimed to potentiate the less affected body side.', 'interventionNames': ['Behavioral: Physical Therapy BSI']}, {'type': 'EXPERIMENTAL', 'label': 'Worse side improvement', 'description': 'Physical Therapy WSI (Worst Side Improvement), aimed to potentiate the most affected body side.', 'interventionNames': ['Behavioral: Physical Therapy WSI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard treatment', 'description': 'Physical Therapy ST (Standard Treatment), aimed to potentiate both sides equally.', 'interventionNames': ['Behavioral: Physical Therapy ST']}], 'interventions': [{'name': 'Physical Therapy WSI', 'type': 'BEHAVIORAL', 'description': 'Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the most affected side (WSI).', 'armGroupLabels': ['Worse side improvement']}, {'name': 'Physical Therapy BSI', 'type': 'BEHAVIORAL', 'description': 'Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the least affected side (BSI).', 'armGroupLabels': ['Best Side Improvement']}, {'name': 'Physical Therapy ST', 'type': 'BEHAVIORAL', 'description': 'Each session has duration of one hour and includes a first part of warming up, a final part of cooling down and an active part that includes exercises with a number of repetitions according to the aim of potentiating both sides equally (ST). In this case the number of repetitions was the same for both sides.', 'armGroupLabels': ['Standard treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86170', 'city': 'Pozzilli', 'state': 'Isernia', 'country': 'Italy', 'facility': 'Irccs Neuromed', 'geoPoint': {'lat': 41.51142, 'lon': 14.06252}}], 'centralContacts': [{'name': 'Nicola Modugno, MD, PhD', 'role': 'CONTACT', 'email': 'nicusmod@gmail.com'}], 'overallOfficials': [{'name': 'Nicola Modugno, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS NEUROMED'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuromed IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Nicola Modugno', 'investigatorAffiliation': 'Neuromed IRCCS'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-10-10', 'type': 'RELEASE'}, {'date': '2015-11-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nicola Modugno, MD, PhD, Neuromed IRCCS'}}}}