Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 1:09 PM
Study NCT ID:
NCT04897256
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators involved in measuring outcomes and analyzing the data, will remain blinded to the group that participants are assigned to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in mini-Balance Evaluation Systems Test', 'timeFrame': '6 weeks', 'description': 'Clinical measure of four balance domains-anticipatory, reactive, sensory, and dynamic gait. Scores range from 0-28 with higher scores indicating worse balance'}, {'measure': 'Change in clinical global impression of change', 'timeFrame': '6 weeks', 'description': "Question of clinician's rating of participant mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility."}, {'measure': "Change in Parkinson's Disease Questionnaire-39", 'timeFrame': '6 weeks', 'description': "A 39 item self-report questionnaire to assess Parkinson's disease specific health related quality in eight domains of quality of life. Each item scores from 0 (never) to 4 (always). Sub-scale scores and a Parkinson's Disease summary index (PDSI; sum of eight subsections/8) representing the global health-related quality of life will be calculated, with higher scores representing worse quality of life"}, {'measure': "Change in Unified Parkinson's Disease Rating Scale, Part III", 'timeFrame': '6 weeks', 'description': "A clinical scale to assess severity of motor symptoms in Parkinson's disease. Each item is scored 0 (normal) to 4 (severe) with a score range from 0-132"}, {'measure': 'Change in Activities-Specific Balance Confidence Scale', 'timeFrame': '6 weeks', 'description': 'A 16-item self-report scale that participants rate their confidence in performing daily activities. Score range from 0-100% with 0% meaning no confidence and 100% completely confident'}, {'measure': 'Change in stride velocity', 'timeFrame': '6 weeks', 'description': 'Stride velocity during straight walking averaged from daily monitoring'}, {'measure': 'Change in stride length', 'timeFrame': '6 weeks', 'description': 'Stride length during straight walking averaged from daily monitoring'}, {'measure': 'Change in cadence', 'timeFrame': '6 weeks', 'description': 'The number of straight walking steps taken per minute averaged from daily monitoring'}, {'measure': 'Change in double support time', 'timeFrame': '6 weeks', 'description': 'The amount of time both feet were on the ground together during straight walking averaged from daily monitoring'}, {'measure': 'Change in angle of foot at heel strike', 'timeFrame': '6 weeks', 'description': 'The angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring'}, {'measure': 'Change in variability of angle of foot at heel strike', 'timeFrame': '6 weeks', 'description': 'Coefficient of variation of the angle between the foot and the ground at heel strike during straight walking averaged from daily monitoring'}, {'measure': 'Change in number of turns per hour', 'timeFrame': '6 weeks', 'description': 'The average number of turns per hour measured during daily monitoring'}, {'measure': 'Change in number of bouts of walking and steps per day', 'timeFrame': '6 weeks', 'description': 'The average number of walking bouts and number of steps per day, measured during daily monitoring'}, {'measure': 'Change in duration of longest walking bout per day', 'timeFrame': '6 weeks', 'description': 'The longest bout of straight walking per day averaged from daily monitoring'}], 'primaryOutcomes': [{'measure': 'Change in variability in number of steps to complete a turn', 'timeFrame': '6 weeks', 'description': 'Coefficient of variation in the number of steps in a turn, averaged from daily monitoring'}], 'secondaryOutcomes': [{'measure': 'Change in Falls Efficacy Scale International', 'timeFrame': '6 weeks', 'description': 'A 16 item self-administered questionnaire to assess fear of falling. Score range 16-64 with higher score indicating more fear of falling'}, {'measure': 'Change in prospective fall rate', 'timeFrame': '52 weeks', 'description': 'Number of prospective falls recorded for 12 months starting from the end of intervention'}, {'measure': 'Change in patient global impression of change', 'timeFrame': '6 weeks', 'description': "Question of participant's rating of mobility. Score range from 1-7 with 1-3 indicating improvement, 4 no change, and 5-7 worsening of mobility"}, {'measure': 'Change in number of steps to complete a turn', 'timeFrame': '6 weeks', 'description': 'Number of steps in a turning averaged from daily monitoring'}, {'measure': 'Change in turn peak velocity', 'timeFrame': '6 weeks', 'description': 'Peak velocity of turns averaged from daily monitoring'}, {'measure': 'Change in turn angle amplitude', 'timeFrame': '6 weeks', 'description': 'Peak size of turn angles averaged from daily monitoring'}, {'measure': 'Change in turn duration', 'timeFrame': '6 weeks', 'description': 'Time to complete turns averaged from daily monitoring'}, {'measure': 'Change in turn trunk jerk', 'timeFrame': '6 weeks', 'description': 'A measure of smoothness of turning; the rate of change of acceleration during a turn averaged from daily monitoring'}, {'measure': 'Change in variability of double-support time', 'timeFrame': '6 weeks', 'description': 'Coefficient of variation in time of double-support phase'}, {'measure': 'Change in lateral trunk range', 'timeFrame': '6 weeks', 'description': 'range of motion in the trunk during walking, in the lateral direction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '36443737', 'type': 'DERIVED', 'citation': "King LA, Carlson-Kuhta P, Wilhelm JL, Lapidus JA, Dale ML, Talman LS, Barlow N, Mancini M, Horak FB. TURN-IT: a novel turning intervention program to improve quality of turning in daily life in people with Parkinson's disease. BMC Neurol. 2022 Nov 28;22(1):442. doi: 10.1186/s12883-022-02934-5."}]}, 'descriptionModule': {'briefSummary': "The goal of this intervention is to explore the effectiveness of a Turning Intervention (TURN-IT) to improve quality of turning in participants with Parkinson's Disease (PD). An unique exercise program has been developed - TURN-IT - in which participants practice exercises that focus on physiological constraints that impair turning ability, such as axial rigidity, narrow base of support, bradykinesia, and inflexible set-shifting. The 60 participants with PD and a history of falls in the previous 12 months, will be randomized into a 6-week, 3x/week, one-on-one TURN-IT group or No-Intervention Control group. This pilot intervention study will determine the number of subjects needed for a future clinical trial and will determine the sensitivity to change with rehabilitation our daily-life turning quality measures (such as, mean and variability of number of steps to turn, turn amplitude, turn velocity). The investigators predict that the TURN-IT program will improve turning in daily life enough to justify a larger clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with 1 or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions\n2. Responsive to levodopa\n3. Hoehn \\& Yahr stages II-IV\n4. Age range 55-85 years old\n5. self-report of one or more falls in past 12 months\n6. willing and able to attend exercise intervention sessions at OHSU campus, and also refrain from changes in anti-parkinson medications and exercise levels.\n\nExclusion Criteria:\n\n1. Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD\n2. no medical condition that precludes exercise\n3. MoCA ≤ 21 or inability to follow directions\n4. excessive use of alcohol or recreational drugs\n5. recent change in medication\n6. inability to stand and walk for 2 minutes without an assistive device'}, 'identificationModule': {'nctId': 'NCT04897256', 'briefTitle': "Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation", 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': "Mobility in Daily Life and Falls in Parkinson's Disease: Potential for Rehabilitation", 'orgStudyIdInfo': {'id': 'R01HD100383', 'link': 'https://reporter.nih.gov/quickSearch/R01HD100383', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01HD100383', 'link': 'https://reporter.nih.gov/quickSearch/R01HD100383', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TURN-IT group', 'description': 'Participants in the treatment group will attend supervised, 1-hour classes, 3 times per week for 6 weeks, one-on-one with the same exercise trainer, overseen by a physical therapist investigator.', 'interventionNames': ['Behavioral: TURN-IT exercise program']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention Control Group', 'description': 'Participants in this group will be tested at baseline and 6 weeks later. They will go about their normal daily life during the 6 week period.'}], 'interventions': [{'name': 'TURN-IT exercise program', 'type': 'BEHAVIORAL', 'description': 'Based on the exercise motor learning principles, participants spend 10-15 minutes at each Exercise Station that focuses on particular constraints of turning ability. The stations will focus on important underlying aspects of turning, such as weight-shifting and increasing axial rotation during functional turning tasks. Each station will be progressed across levels to make more challenging (such as adding a dual task). Initially participants will be supported in an overhead body-weight support system (ZeroG) to allow them to practice challenging exercises without the risk of falling.', 'armGroupLabels': ['TURN-IT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Fay Horak, PhD, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data would be available 6 months after the end of data collection. Data will be stored in our laboratory data repository and so will be available indefinitely.', 'ipdSharing': 'YES', 'description': 'Upon reasonable request, we can share de-identified data related to study outcomes measures.', 'accessCriteria': 'Data will not be stored on a public website, however researchers may contact us for access to the data. We will send data electronically via a secure server.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Martina Mancini', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}