Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:08 PM
Study NCT ID:
NCT07411534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 567}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-06', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score', 'timeFrame': 'Prior to discharge or at 28 days post-enrollment, whichever comes first.', 'description': "Final PT assessment score. Assessments are conducted by PTs during every session on 6 mobility items: 1) turning over in bed 2) moving from lying to sitting edge of bed 3) moving from bed to chair 4) standing up from chair 5) walking in hospital room 6) climbing 3-5 steps. Therapists rate the patient's difficulty performing specified activities using a 4-point scale, with 1 indicating total assistance and 4 indicating no assistance needed. Scores from each of the 6 activities are totaled. Final scores range from 6-24, with lower scores indicating more severe impairment."}, {'measure': 'Final Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Score', 'timeFrame': 'Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.', 'description': 'Final OT assessment score. Assessments are conducted by OTs during every session on 6 activities including: 1) lower body dressing, 2) upper body dressing, 3) toileting, 4) grooming, 5) eating, 6) bathing. Therapists rate difficulty performing specified activities using a 4-point scale, with 1 indicating total assistance and 4 indicating no assistance needed. Scores from each of the 6 activities are totaled. Final scores range from 6-24, with lower scores indicating more severe impairment'}], 'secondaryOutcomes': [{'measure': 'Discharge Disposition', 'timeFrame': 'At time of discharge.', 'description': 'The final discharge destination of the patient when they leave the hospital, including discharge to home and post-acute care facilities.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Stroke Acute']}, 'referencesModule': {'references': [{'pmid': '38264914', 'type': 'BACKGROUND', 'citation': 'Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024 Feb 20;149(8):e347-e913. doi: 10.1161/CIR.0000000000001209. Epub 2024 Jan 24.'}, {'pmid': '34819908', 'type': 'BACKGROUND', 'citation': 'E Wurzinger H, Abzhandadze T, Rafsten L, Sunnerhagen KS. Dependency in Activities of Daily Living During the First Year After Stroke. Front Neurol. 2021 Nov 8;12:736684. doi: 10.3389/fneur.2021.736684. eCollection 2021.'}, {'pmid': '26888985', 'type': 'BACKGROUND', 'citation': 'Bernhardt J, Churilov L, Ellery F, Collier J, Chamberlain J, Langhorne P, Lindley RI, Moodie M, Dewey H, Thrift AG, Donnan G; AVERT Collaboration Group. Prespecified dose-response analysis for A Very Early Rehabilitation Trial (AVERT). Neurology. 2016 Jun 7;86(23):2138-45. doi: 10.1212/WNL.0000000000002459. Epub 2016 Feb 17.'}, {'pmid': '33125475', 'type': 'BACKGROUND', 'citation': 'Wang CY, Chen YC, Wang CH. Early Rehabilitation in Acute Care Inpatient Wards May Be Crucial to Functional Recovery 3 Months After Ischemic Stroke. Phys Ther. 2021 Jan 4;101(1):pzaa197. doi: 10.1093/ptj/pzaa197.'}, {'type': 'BACKGROUND', 'citation': 'O\'Brien, Peter C., and Thomas R. Fleming. "A Multiple Testing Procedure for Clinical Trials." Biometrics. 1979;35(3):549-56.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center, pragmatic, randomized trial comparing the effectiveness of two commonly used approaches (co-treatment and individual treatment) in acute care rehabilitation.', 'detailedDescription': 'Individual and co-treatment are both widely used to deliver physical therapy (PT) and occupational therapy (OT) for patients admitted to the hospital for acute stroke. Studies have shown that patients with stroke who participate in hospital PT and OT have improved function upon discharge. However, there is a lack of evidence informing which patients are best suited for individual versus co-treatment, or which delivery method more effectively improves functional outcomes.\n\nThis gap in knowledge presents a unique opportunity to advance stroke rehabilitation. This study aims to compare the two approaches and their resulting functional outcomes through a randomized trial-an approach never previously undertaken-to determine whether individual or co-treatment leads to better patient recovery. The findings have the potential to optimize rehabilitation and the delivery of PT and OT for future patients with acute stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatient admission to the neurology stroke service AND\n* Orders placed for both PT and OT within 96 hours of admission to the service\n\nExclusion Criteria:\n\n* Patient is known to be \\<18 years\n* Patient is known to be a prisoner\n* Patient is known to be pregnant\n* Prior evaluation or treatment by PT and/or OT while admitted under the stroke service before study enrollment\n* Clinician determines that either individual PT and OT or co-treatment is required or contraindicated for the optimal care of the patient'}, 'identificationModule': {'nctId': 'NCT07411534', 'acronym': 'ICARE', 'briefTitle': 'Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation', 'orgStudyIdInfo': {'id': '251290'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Co-treatment', 'interventionNames': ['Other: Co-treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Treatment', 'interventionNames': ['Other: Individual Treatment']}], 'interventions': [{'name': 'Co-treatment', 'type': 'OTHER', 'description': 'Patients in this arm will be evaluated and treated by PT and OT at the same time for the duration of their hospitalization.', 'armGroupLabels': ['Co-treatment']}, {'name': 'Individual Treatment', 'type': 'OTHER', 'description': 'Participants in this arm will be evaluated and treated by PT and OT individually for the duration of their hospitalization.', 'armGroupLabels': ['Individual Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'contacts': [{'name': 'Kaitlyn R Whitaker, MS', 'role': 'CONTACT', 'email': 'Katie.r.whitaker@vumc.org', 'phone': '615-421-4224'}, {'name': 'Sydney Lagalante, MPH', 'role': 'CONTACT', 'email': 'sydney.vidrine@vumc.org', 'phone': '615-875-8024'}, {'name': 'Sarah A Welch, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Sarah A Welch, DO, MPH', 'role': 'CONTACT', 'email': 'sarah.welch@vumc.org', 'phone': '615-322-1294'}, {'name': 'Kaitlyn R Whitaker, MS', 'role': 'CONTACT', 'email': 'katie.r.whitaker@vumc.org', 'phone': '(615) 421-4224'}], 'overallOfficials': [{'name': 'Sarah A Welch, DO, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The data will become available 3 months following publication of outcomes and will remain available for at least 5 years.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported will be made available (including data dictionaries) after de-identification.', 'accessCriteria': 'Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Vanderbilt Institutional Review Board and the study executive committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sarah Welch', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}