Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 2:13 AM
Study NCT ID:
NCT06306768
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Therapeutic Monitoring Exercise Tracking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-02-22', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity Metric 1', 'timeFrame': 'Daily, through study completion, average 1 year', 'description': 'steps per day'}, {'measure': 'Physical Activity Metric 2', 'timeFrame': 'Daily, through study completion, average 1 year', 'description': 'Minutes of aerobic physical activity per day (moderate to vigorous physical activity)'}], 'secondaryOutcomes': [{'measure': 'Exercise Self Efficacy', 'timeFrame': 'Completed every other month, through study completion, average of 1 year', 'description': 'sums of 9 items with total scores ranging from 0-90; higher scores indicating higher self-efficacy.'}, {'measure': 'Quality of Life from PROMIS 10-b', 'timeFrame': 'Completed every 3 months, through study completion, average of 1 year', 'description': 'PROMIS 10-b short form which is 10 items measuring mobility difficulty, scores are summed and then translated to t-score.'}, {'measure': 'Quality of Life from PROMIS-29', 'timeFrame': 'Completed every 3 months, through study completion, average of 1 year', 'description': 'PROMIS-29 measures seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and sleep disturbance).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity', 'exercise tracking', 'remote therapeutic monitoring', 'quality of life', 'self-efficacy'], 'conditions': ['Parkinson Disease', 'Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '27124611', 'type': 'BACKGROUND', 'citation': 'Block VA, Pitsch E, Tahir P, Cree BA, Allen DD, Gelfand JM. Remote Physical Activity Monitoring in Neurological Disease: A Systematic Review. PLoS One. 2016 Apr 28;11(4):e0154335. doi: 10.1371/journal.pone.0154335. eCollection 2016.'}, {'pmid': '35084560', 'type': 'BACKGROUND', 'citation': 'Proschinger S, Kuhwand P, Rademacher A, Walzik D, Warnke C, Zimmer P, Joisten N. Fitness, physical activity, and exercise in multiple sclerosis: a systematic review on current evidence for interactions with disease activity and progression. J Neurol. 2022 Jun;269(6):2922-2940. doi: 10.1007/s00415-021-10935-6. Epub 2022 Jan 27.'}, {'pmid': '21750523', 'type': 'BACKGROUND', 'citation': 'Speelman AD, van de Warrenburg BP, van Nimwegen M, Petzinger GM, Munneke M, Bloem BR. How might physical activity benefit patients with Parkinson disease? Nat Rev Neurol. 2011 Jul 12;7(9):528-34. doi: 10.1038/nrneurol.2011.107.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to examine physical activity and exercise behaviors in people with Parkinson's Disease and Multiple Sclerosis over the course of 1-year using a cloud-based remote monitoring platform.", 'detailedDescription': 'Remote therapeutic monitoring (RTM) is a reimbursable clinical service. Pilot investigation conducted by our lab demonstrated promise that this service is feasible to add to clinical care. It is unclear still if RTM is able to provide clinical benefit to patients including improving and sustaining physical activity (PA) and exercise behaviors over a longer period of time (\\>1 year). Our central hypothesis is that the addition of RTM to physical activity, both in a skilled rehabilitation program and within a home program, will improve long term outcomes related to physical activity including self-efficacy for exercise, consistent participation in home exercise recommendations, and quality of life in people living with PD and MS. Thus the specific aims of this study are as follows:\n\n1. To assess PA and exercise behaviors over 1-year period using a remote therapeutic monitoring platform\n\n a. We will track steps per day, minutes of aerobic activity per week, and frequency of workouts including flexibility, balance, and resistance training.\n2. To understand how engagement with RTM for PA tracking affects overall self-efficacy for exercise, readiness for exercise behavior change, and quality of life.\n\n 1. Assessed through monthly self-report of usability survey for RTM and self-efficacy for exercise survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Are ambulatory as their primary means of mobility without an assistive device except for single point cane or walking sticks in community\n* Have a diagnosis of Parkinson's disease (Hoehn and Yahr 1-3), Parkinsonism, or Multiple Sclerosis\n* Personal goal and willingness to address physical activity\n* Have a smart phone (Datos Health app is compatible with any Smart phone device)\n* Willing to accept Datos' Terms and Conditions\n\nExclusion Criteria:\n\n* Individuals with cognitive or communication disorders (including dementia) which would limit their ability to interact with the RTM"}, 'identificationModule': {'nctId': 'NCT06306768', 'briefTitle': 'Remote Therapeutic Monitoring Exercise Tracking', 'organization': {'class': 'OTHER', 'fullName': 'Shirley Ryan AbilityLab'}, 'officialTitle': "Remote Therapeutic Monitoring for Longitudinal Exercise and Self-Efficacy Tracking in Persons With Parkinson's Disease and Multiple Sclerosis.", 'orgStudyIdInfo': {'id': 'STU00219979'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Remote Therapeutic Monitoring', 'description': 'Participants will receive 1 year of remote therapeutic monitoring via a connected health app and personal activity tracker to monitor their physical activity and exercise behaviors.', 'interventionNames': ['Device: Activity Monitoring']}], 'interventions': [{'name': 'Activity Monitoring', 'type': 'DEVICE', 'otherNames': ['Datos Health App'], 'description': 'Tracking participants step activity, workout frequency, minutes in target heart rate zone, and type of exercises completed over 1 year period. Goals will be set and customized by a research physical therapist to participants based on best practice recommendations.', 'armGroupLabels': ['Remote Therapeutic Monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hannah Redd, DPT', 'role': 'CONTACT', 'email': 'hredd@sralab.org'}, {'name': 'Kristen Hohl, DPT', 'role': 'CONTACT', 'email': 'khohl@sralab.org'}], 'facility': 'Shirley Ryan AbilityLab', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Miriam Rafferty, PT, PhD', 'role': 'CONTACT', 'email': 'mrafferty@sralab.org', 'phone': '312-238-7233'}, {'name': 'Hannah Redd, PT, DPT', 'role': 'CONTACT', 'email': 'hredd@sralab.org', 'phone': '312-238-1688'}], 'overallOfficials': [{'name': 'Miriam Rafferty, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shirley Ryan AbilityLab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Miriam Rafferty', 'investigatorAffiliation': 'Shirley Ryan AbilityLab'}}}}