Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-04 @ 2:09 PM
Study NCT ID:
NCT03477695
Status:
UNKNOWN
Last Update Posted:
2018-05-08
First Post:
2018-03-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-06', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average trunk angle in the sagittal plane using a Postural Analysis Chart', 'timeFrame': '8 weeks', 'description': 'Postural Analysis'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction by VAS scores', 'timeFrame': '8 weeks', 'description': 'Results for the VAS scores with possible range 0 (worst) to 10 (best)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease and Parkinsonism", 'Postural Kyphosis']}, 'referencesModule': {'references': [{'pmid': '28802759', 'type': 'BACKGROUND', 'citation': "van Wegen EEH, de Goede CJT, Kwakkel G, van Kordelaar J. Sensor assisted self-management in Parkinson's disease: A feasibility study of ambulatory posture detection and feedback to treat stooped posture. Parkinsonism Relat Disord. 2018 Jan;46 Suppl 1:S57-S61. doi: 10.1016/j.parkreldis.2017.07.024. Epub 2017 Jul 25."}]}, 'descriptionModule': {'briefSummary': "A stooped posture is one of the characteristic motor symptoms of patients with Parkinson's disease, and has been linked to impairments in ADL and QOL. We aimed to test the efficacy, safety, practical utility and user-friendliness of a posture correction and vibrotactile trunk angle feedback device (the UpRight) in the home setting of patients with Parkinson's disease with a stooped posture.", 'detailedDescription': 'The subjects will be asked to arrive at the Gait laboratory for Mobility Research at Tel Aviv Medical Center. After a detailed explanation of the research procedure and after signing the consent form, they will be introduced to the UPRIGHT GO device. Participances will practice operating and placing the device on the body.\n\nWith the device attached to upper back, a number of short clinical tests will be performed:\n\n1. Complete demographic questionnaires and medical history\n2. Walking tests and balance:\n\n 1. Short walks at a comfortable speed with or without dual task.\n 2. Stairs\n 3. Performing daily tasks, such as entering and exiting a room, negotiating obstacles (shoebox), walking between obstacles, buttons, tying laces, carrying small objects on a tray, bringing a glass of water etc.\n 4. Timed "Get up and go test" All tests are supervised by a physiotherapist .\n\nUpon completion of the tests, the UPRIGHT device will be delivered for use and exercise for 2 months. Physiotherapist will guide to maintain the devices (such as charging devices and connecting to power).\n\nAt the end of the training period, the participans will be invited again to Gait Lab for post tests.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Diagnosis of Parkinson's disease, as defined in the UK Brain Bank criteria\n2. Hoehn and Yahr stage I-III\n3. Participants who are at stable medication regimen\n4. Able to walk independently for at least 5 minutes with or without support of accessory device.\n\nExclusion criteria:\n\n1\\. Mini Mental State Exam (MMSE) score\\< 24"}, 'identificationModule': {'nctId': 'NCT03477695', 'briefTitle': "Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': "Improving Posture in Parkinson's Patients Through Home-based Training and Biofeedback", 'orgStudyIdInfo': {'id': 'ASMC-17-NG-0728-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Upright device', 'description': 'Ambulatory use of the Upright device', 'interventionNames': ['Device: ambulatory use of the Upright device']}], 'interventions': [{'name': 'ambulatory use of the Upright device', 'type': 'DEVICE', 'description': 'Patients will wear the UpRight for a period of two month', 'armGroupLabels': ['Upright device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Jefferey Hausdorff', 'role': 'CONTACT', 'email': 'jhausdor@tasmc.health.gov.il', 'phone': '+97236947513'}, {'name': 'Jeffrey M Hausdorff, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Marina Brozgol', 'role': 'CONTACT', 'email': 'marina.brozgol@gmail.com', 'phone': '+97236947513'}, {'name': 'Nir Giladi, MD', 'role': 'CONTACT', 'email': 'nirg@tlvmc.gov.il', 'phone': '+97236947513'}], 'overallOfficials': [{'name': 'Nir Giladi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TASMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}