Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT06815302
Status:
RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-03', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient- Perceived Freezing of Gait Severity', 'timeFrame': 'From enrollment/randomization through intervention; 8 weeks', 'description': 'Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)'}, {'measure': 'Clinician- Perceived Freezing of Gait Severity', 'timeFrame': 'From enrollment/randomization through intervention; 8 weeks', 'description': 'Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse'}, {'measure': 'Sensors-based Freezing of gait severity', 'timeFrame': 'From enrollment/randomization through intervention; 8 weeks', 'description': 'Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.'}], 'secondaryOutcomes': [{'measure': 'Time Spent in FOG during daily life', 'timeFrame': 'From enrollment/randomization through intervention; 8 weeks', 'description': '% time spent FOG compared to walking during daily life calculated from wearable sensors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Freezing of Gait Symptoms in Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.\n\nParticipants will:\n\n* Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)\n* Have one-on-one training sessions three times per week for 6 weeks\n* Perform in-lab assessments before beginning and after completing the study intervention\n* Use wearable mobility sensors during daily life to measure their walking and balance"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions\n* reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)\n* Hoehn \\& Yahr stages II-IV\n* ages 50-80 years old\n* cognitive ability sufficient to participate in testing procedures and exercise classes\n* be willing and able to participate in exercise intervention 3x/week for 6 weeks\n\nExclusion Criteria:\n\n* Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease)\n* medical condition or medications that precludes moderate-intensity exercise\n* Montreal Cognitive Assessment (MoCA) ≤21 or inability to follow directions\n* excessive use of alcohol or recreational drugs\n* recent change in medication\n* inability to stand and walk for 2 minutes without an assistive device'}, 'identificationModule': {'nctId': 'NCT06815302', 'briefTitle': 'TURN-IT FOG: Improving Turning and Freezing of Gait in People With PD', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait', 'orgStudyIdInfo': {'id': 'MJFF-024692'}, 'secondaryIdInfos': [{'id': 'MJFF-024692', 'type': 'OTHER_GRANT', 'domain': "Michael J. Fox Foundation for Parkinson's Research"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dynamic balance exercise intervention group', 'description': 'Six weeks of exercise intervention to improve gait disturbances.\n\nSpecific participant procedures in experimental and active control interventions are simplified to preserve study blinding.', 'interventionNames': ['Behavioral: Experimental intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Strength training exercise intervention group', 'description': 'Six weeks of exercise intervention to improve gait disturbances.\n\nSpecific participant procedures in experimental and active control interventions are simplified to preserve study blinding.', 'interventionNames': ['Behavioral: Active intervention']}], 'interventions': [{'name': 'Experimental intervention', 'type': 'BEHAVIORAL', 'description': 'Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.', 'armGroupLabels': ['Dynamic balance exercise intervention group']}, {'name': 'Active intervention', 'type': 'BEHAVIORAL', 'description': 'Specific participant procedures in experimental and active control interventions are simplified to preserve study blinding.', 'armGroupLabels': ['Strength training exercise intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arizona State University', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17012-230', 'city': 'Bauru', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'facility': 'University of São Paulo, Bauru Campus', 'geoPoint': {'lat': -22.31472, 'lon': -49.06056}}], 'centralContacts': [{'name': 'Graham R Harker, MPH', 'role': 'CONTACT', 'email': 'harkerg@ohsu.edu', 'phone': '(503) 418-2601'}], 'overallOfficials': [{'name': 'Martina Mancini, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'url': 'https://zenodo.org/records/12548174', 'timeFrame': 'Data would be available 6 months after publication.', 'ipdSharing': 'YES', 'description': 'De-identified data related to study outcomes measures will be publicly shared', 'accessCriteria': 'Data will be deposited on Zenodo https://zenodo.org/records/12548174'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Martina Mancini', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}