Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-31 @ 4:22 AM
Study NCT ID:
NCT00716261
Status:
UNKNOWN
Last Update Posted:
2008-07-16
First Post:
2008-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bio-Feedback to Improving Stability in Elderly Population
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-15', 'studyFirstSubmitDate': '2008-07-14', 'studyFirstSubmitQcDate': '2008-07-15', 'lastUpdatePostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Audio feedback', 'postural control'], 'conditions': ["Parkinson's Disease Patients"]}, 'descriptionModule': {'briefSummary': "Our hypothesis is that intensive training with positive biofeedback may enhance postural control and stability in Parkinson's disease patients and in elderly fallers.", 'detailedDescription': "The aim of the study is to treat Parkinson's patients and elderly fallers. The intervention is intensive training with Biofeedback to try to correct stooped posture, and to improve stability in standing and in walking."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Idiopathic PD for \\>2 yrs\n* Between 50-90 Yrs\n* On anti-Parkinsonian medication\n* Hoehn \\& Yahr 2-3 in "ON"\n* Free of serious co-morbidities\n* Able to walk but reports difficulties in gait\n* Can use assistive device\n\nExclusion Criteria:\n\n* Significant orthopedic disturbances or pain\n* Major depression (DSM IV)\n* Dementia (MMSE\\<24)\n* Clinically significant hearing problems\n* Unstable medical condition (2 wks from meds change)\n* Deep Brain Stimulation'}, 'identificationModule': {'nctId': 'NCT00716261', 'briefTitle': 'Bio-Feedback to Improving Stability in Elderly Population', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Using Bio-Feedback for Improving Stability in Walking and Everyday Activity', 'orgStudyIdInfo': {'id': '0204-08-TLV'}}, 'armsInterventionsModule': {'interventions': [{'name': 'McROB Hybrid node 3-axes accelerometers and 3-axes gyroscopes', 'type': 'DEVICE', 'otherNames': ['AUDIO-BIOFEEDBACK SYSTEM', 'DEIS, Università di Bologna', 'Bologna, Italy(Chiari et al., 2005)'], 'description': 'Training with the Audio-feedback device for about 30 minutes, 3 times per week for 6 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Jeffrey M Hausdorff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratory for gait and neurodynamics, Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Laboratory for gait and neurodynamics, Tel Aviv Sourasky Medical center', 'oldOrganization': 'Tel Aviv Sourasky Medical Center'}}}}