Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 7:55 PM
Study NCT ID:
NCT07092293
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studying Rehabilitation Treatments Using Video to Improve Recovery for Adults With Physical Disabilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009788', 'term': 'Occupational Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-22', 'size': 810806, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-17T15:08', 'hasProtocol': True}, {'date': '2024-11-22', 'size': 303948, 'label': 'Informed Consent Form: Patient Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-17T15:07', 'hasProtocol': False}, {'date': '2024-11-22', 'size': 253612, 'label': 'Informed Consent Form: OT Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-06-17T15:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Spent on Different Types of Treatment Activities', 'timeFrame': 'Through study completion, Up to 24 months', 'description': 'We will quantify time spent in different treatment types during standard care occupational therapy, as specified in the Rehabilitation Treatment Specification System.'}], 'secondaryOutcomes': [{'measure': 'Feasibility of Video Recording Intervention', 'timeFrame': 'Following participant data collection/video recording through study completion, up to 24 months', 'description': 'Feasibility of Intervention Measure - Participants will rate their acceptability of being video recorded through various questions on a 1-5 Likert scale where 1 is completely disagree and 5 is completely agree.'}, {'measure': 'Acceptability of Video Recording Intervention', 'timeFrame': 'Following participant data collection/video recording through study completion, up to 24 months', 'description': 'Acceptability of Intervention Measure (AIM) - Participants will gauge their acceptability and comfort with being video recorded. Participants will rate their acceptability of being video recorded through various questions on a 1-5 Likert scale where 1 is completely disagree and 5 is completely agree.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['occupational therapy', 'stroke', 'spinal cord injury'], 'conditions': ['Stroke', 'Spinal Cord Injury', 'Occupational Therapy']}, 'descriptionModule': {'briefSummary': "This study aims to better understand how occupational therapists provide rehabilitation for adults recovering from stroke or spinal cord injury (SCI), with a focus on improving arm and hand function. Using video recordings of real outpatient therapy sessions, researchers will identify the key elements of treatment, such as the types of activities, the therapist's techniques, and how patients respond. The study will use the Rehabilitation Treatment Specification System (RTSS), a framework designed to clearly describe rehabilitation methods. By analyzing these sessions, the research team will develop a practical toolkit to help therapists and researchers deliver and study more effective rehabilitation treatments in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A purposive sample of OT practitioners working in an outpatient rehabilitation at OSUWMC will be recruited for this study.\n\nA purposive sample of stroke patients receiving OT at an OSU outpatient rehabilitation clinic will be recruited for this study.\n\nA purposive sample of SCI patients receiving OT at an OSU outpatient rehabilitation clinic will be recruited for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Occupational Therapy Inclusion Criteria:\n\n* Must be a licensed OT practitioner (occupational therapist or occupational therapy assistant),\n* The OT practitioner must treat at least one adult stroke or spinal cord injury patient with UE sensorimotor impairment per month\n* The OT practitioner must be willing to be video recorded while treating their enrolled stroke or SCI patients.\n\nStroke Patients Inclusion Criteria:\n\n* Must have a medical diagnosis of ischemic or hemorrhagic stroke\n* Must be ≥ 18 years old\n* Must have at least one OT goal related to UE hemiparesis\n* Must have at least one remaining OT treatment session after enrollment\n* The patient's OT must be enrolled in the study.\n\nSpinal Cord Injury (SCI) Patients Inclusion Criteria:\n\n* Must have a medical diagnosis of cervical spinal cord injury\n* Must be ≥ 18 years old\n* Must have at least one OT goal related to UE sensorimotor impairment\n* Must have at least one remaining OT treatment session after enrollment\n* The patient's OT must be enrolled in the study."}, 'identificationModule': {'nctId': 'NCT07092293', 'briefTitle': 'Studying Rehabilitation Treatments Using Video to Improve Recovery for Adults With Physical Disabilities', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Using the Rehabilitation Treatment Specification System (RTSS) to Maximize Rehabilitation Research Impact: A Video-Based Observational Study', 'orgStudyIdInfo': {'id': '2024H0351'}, 'secondaryIdInfos': [{'id': 'GR138505', 'type': 'OTHER_GRANT', 'domain': 'American Occupational Therapy Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Occupational Therapy Practitioners', 'description': 'Occupational therapists and occupational therapy assistants employed by OSU Wexner Medical Center', 'interventionNames': ['Other: occupational therapy']}, {'label': 'Spinal Cord Injury', 'description': 'Spinal cord injury patients receiving outpatient OT at OSUMC', 'interventionNames': ['Other: occupational therapy']}, {'label': 'Stroke', 'description': 'Stroke patients receiving outpatient OT at OSUMC', 'interventionNames': ['Other: occupational therapy']}], 'interventions': [{'name': 'occupational therapy', 'type': 'OTHER', 'description': 'N/A as there is no intervention for this study', 'armGroupLabels': ['Occupational Therapy Practitioners', 'Spinal Cord Injury', 'Stroke']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Wengerd, PhD', 'role': 'CONTACT', 'email': 'lauren.wengerd@osumc.edu', 'phone': '330-464-9171'}, {'name': 'Lauren Wengerd, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Lauren Wengerd, PhD', 'role': 'CONTACT', 'email': 'lauren.wengerd@osumc.edu', 'phone': '330-464-9171'}, {'name': 'Peyton Miller, OTD', 'role': 'CONTACT', 'email': 'peyton.miller@osumc.edu', 'phone': '419-455-5928'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Occupational Therapy Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lauren Wengerd', 'investigatorAffiliation': 'Ohio State University'}}}}