Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT01502995
Status:
COMPLETED
Last Update Posted:
2012-01-02
First Post:
2011-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D051346', 'term': 'Mobility Limitation'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-30', 'studyFirstSubmitDate': '2011-12-21', 'studyFirstSubmitQcDate': '2011-12-30', 'lastUpdatePostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete walking task', 'timeFrame': 'Two hours', 'description': 'Time in seconds for subject to complete the designated walking task.'}], 'secondaryOutcomes': [{'measure': 'Number of steps', 'timeFrame': 'Two hours', 'description': 'Number of steps taken to complete the designated walking task.'}, {'measure': 'Number of freezing episodes', 'timeFrame': 'Two hours', 'description': 'Number of freezing episodes that occur during walking task.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Assistive devices', 'Freezing of gait', 'Gait disorders', 'Gait hesitation', 'Gait ignition failure', 'Laser light', "Parkinson's disease", 'Rolling walker', 'Visual Cue', 'Walker'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes in patients with Parkinson's disease.", 'detailedDescription': "Freezing of gait is a debilitating feature of Parkinson's disease. This study aims to determine whether a laser light beam, attached to a rolling walker and projected onto the floor, reduces freezing episodes. Patients will perform two trials of 3 timed walking tasks: once with the laser beam and once without. For each trial, the time to complete, number of steps, and number of freezing episodes will be recorded. Patients will be randomized to perform the first trial either with the light or without the light, to control for fatigue."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* idiopathic PD confirmed by a movement disorders neurologist\n* a Mini-Mental Status Examination (MMSE)\\[13\\] score ≥ 24 to ensure competence to participate in informed consent and an ability to learn procedurally the use of the rolling walker with laser beam\n* functional visual acuity for recognizing the laser beam on the rolling walker\n* FOG in both on and off medication states, as indicated by a score of ≥ 2 on Item 14 of the Unified Parkinson's Disease Rating Scale (UPDRS) and/or ≥1 on Item 3 of the Freezing of Gait Questionnaire (FOGQ)\n* ability to ambulate for at least household distances with or without an assistive device as indicated by scoring 0, 1, or 2 on Items 15 and 29 of the UPDRS.\n\nExclusion Criteria:\n\n* diagnosis of a gait disorder other than Parkinson's disease"}, 'identificationModule': {'nctId': 'NCT01502995', 'briefTitle': "Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease", 'organization': {'class': 'FED', 'fullName': "Parkinson's Disease Research, Education, and Clinical Center, Philadelphia"}, 'officialTitle': "Laser Light Visual Cueing for Freezing of Gait in Parkinson's Disease", 'orgStudyIdInfo': {'id': '00583'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'With laser light', 'description': 'Trial of walking tasks using laser light on walker.', 'interventionNames': ['Device: Laser light (U-Step Walking Stabilizer with laser light)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Without laser light', 'description': 'Trial of walking task without laser light on walker.', 'interventionNames': ['Device: Laser light (U-Step Walking Stabilizer with laser light)']}], 'interventions': [{'name': 'Laser light (U-Step Walking Stabilizer with laser light)', 'type': 'DEVICE', 'otherNames': ['U-Step Walking Stabilizer with laser light'], 'description': 'Use of a laser light on a rolling walker during episodes of freezing of gait.', 'armGroupLabels': ['With laser light', 'Without laser light']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia VA Medical Center PADRECC', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Lisette Bunting-Perry, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philadelphia VAMC PADRECC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Parkinson's Disease Research, Education, and Clinical Center, Philadelphia", 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}