Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-06-25 @ 1:20 AM
Study NCT ID:
NCT02641405
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2015-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020233', 'term': 'Gait Disorders, Neurologic'}], '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'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-09', 'studyFirstSubmitDate': '2015-12-03', 'studyFirstSubmitQcDate': '2015-12-28', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Spatio-Temporal gait variables at 20 weeks', 'timeFrame': '20 weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in the Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) - at 20 weeks', 'timeFrame': '20 weeks'}, {'measure': 'Changes in the Parkinson Disease 39 Questionnaire (PDQ-39) at 20 weeks', 'timeFrame': '20 weeks'}, {'measure': 'Changes in the Activity Specific Balance Confidence Scale (ABC scale) at 20 weeks', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gait analysis', 'Proprioceptive focal stimulation', 'Parkinson'], 'conditions': ['Parkinson Disease', 'Gait, Shuffling', 'Effects of Vibration']}, 'descriptionModule': {'briefSummary': "It's already known the efficacy of Gait Analysis (GA) on evaluating gait modification on Parkinson's Disease (PD) Patients (1). On the other hand Proprioceptive Focal Stimulation seems be useful in symptoms amelioration in several neurological disease. Few studies have been performed in Parkinson's disease. A total of 126 patients suffering from PD will be recruited in 6 italian neurological centers. The study will be a cross-over multicenter study with the randomization of the sequence. The patients will be randomly assigned to 2 groups receiving for 8 weeks either the Equistasi medical device, or an equivalent placebo. Gait analysis will be recorded in each patient at the beginning and at the end of the treatment assigned. After 4 weeks of wash-out, the treatment will be crossed and a new gait analysis recording will be performed. Finally a last recording will be taken at the end of the last 8 weeks. Secondary outcome will be the MDS-UPDRS (Movement Disorder Society - Unified Parkinson Disease Rating Scale), PDQ-39 (Parkinson Disease 39 Questionnaire ), ABC (Activity Specific Balance Confidence Scale)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with rigid-acinetic bilateral PD form\n* At least 4 years of disease history\n* H\\&Y between 2-3\n* Stable drug therapy response without any change performed in the 3 months before the study.\n* Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy.\n* MMSE\\>24/30 (Mini-Mental State Examination)\n\nExclusion Criteria:\n\n* Systemic illness\n* Presence of cardiac pacemaker\n* Presence of deep brain stimulation\n* Presence of severe dysautonomia with marked hypotension\n* Obsessive-Compulsive disorder (OCD)\n* Major depression\n* Dementia\n* History or active neoplasia\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02641405', 'acronym': 'PAGE', 'briefTitle': 'Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study', 'organization': {'class': 'OTHER', 'fullName': 'I.R.C.C.S. Fondazione Santa Lucia'}, 'officialTitle': 'Efficacy of Proprioceptive Focal Stimulation (EQUISTASI) on Gait Parameters in Parkinson. Italian Multicentric Study', 'orgStudyIdInfo': {'id': 'CE/PROG.478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Equistasi', 'description': 'Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs.', 'interventionNames': ['Device: Equistasi']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs.', 'interventionNames': ['Device: Inactive Equistasi']}], 'interventions': [{'name': 'Equistasi', 'type': 'DEVICE', 'description': 'Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs.', 'armGroupLabels': ['Equistasi']}, {'name': 'Inactive Equistasi', 'type': 'DEVICE', 'description': 'Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00179', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'IRCCS Santa Lucia', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Pavia', 'state': 'PV', 'country': 'Italy', 'facility': 'IRCCS National Neurological Institute "C. Mondino" Foundation', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '28824', 'city': 'Oggebbio', 'state': 'Verbano-Cusio-Ossola', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano', 'geoPoint': {'lat': 45.99088, 'lon': 8.64663}}, {'city': 'Cassino', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 41.48581, 'lon': 13.82835}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'University of Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '30121', 'city': 'Venezia', 'country': 'Italy', 'facility': 'Ospedale S. Raffaele Arcangelo, Fatebenefratelli', 'geoPoint': {'lat': 44.42329, 'lon': 11.17365}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'I.R.C.C.S. Fondazione Santa Lucia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, {'name': 'IRCCS National Neurological Institute "C. Mondino" Foundation', 'class': 'OTHER'}, {'name': 'Ospedale S. Raffaele Arcangelo, Fatebenefratelli', 'class': 'OTHER'}, {'name': 'University of Genova', 'class': 'OTHER'}, {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Antonella Peppe', 'investigatorAffiliation': 'I.R.C.C.S. Fondazione Santa Lucia'}}}}