Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study
PEARL
2 other identifiers
observational
213
1 country
1
Brief Summary
The goal of this observational study is to determine if rehabilitation program intensity impacts functional recovery and specific needs in adult ischemic stroke patients who require inpatient rehabilitation. The main questions it aims to answer are: Do patients with stroke of Atrial-related subtypes (AFRS) have distinct rehabilitation needs and functional outcomes compared to non-AFRS patients? Does higher-intensity inpatient rehabilitation (3-5 sessions/day) result in better functional recovery at six months (measured by the Barthel Index) than moderate-intensity programs (1 session/day)? The study is non-invasive, does not interfere with usual care. The investigators' ultimate goal is to enhance the understanding of recovery after following different rehabilitation usual programs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2024
CompletedFirst Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
December 15, 2025
November 1, 2025
2 years
November 19, 2025
December 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Barthel improvement
To compare 6-month functional outcomes (Barthel Index) between AFRS and non-AFRS patients within high-intensity and moderate-intensity rehabilitation programs. Unit of Measure: Score (0-100)
The assessment will be performed at inpatient rehabilitation at Baseline, at admission to the rehabilitation dept (T0), at 1-month follow-up (T1-discharge), and at 3-month (T2) and 6-month (T3) follow-ups after the acute event.
Secondary Outcomes (16)
Functional outcomes pre and after rehabilitation program
From enrollment to 6-month follow-up.
Change Barthel from Baseline to 6-month follow-up outcomes
From enrollment to 6-month after stroke event
Functional Ambulation Category (FAC)
Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Trunk Control Test (TCT)
Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Berg Balance Scale (BBS)
Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
- +11 more secondary outcomes
Study Arms (2)
High Intensity Rehabilitation program
NIHSS 3-13, MRS historic ( pre-Stroke)1-2, Cognitive status : preserved
Moderate Intensity Rehabilitation program
NIHSS \>13 or MRS historic ( pre-Stroke)\<3
Interventions
Rehabilitation will begin in the acute care setting. After discharge from the stroke unit, all patients needing inpatient rehabilitation will undergo standard therapies (physiotherapy, occupational therapy, speech therapy, social work and neuropsychology) in an Intensive Inpatient Rehabilitation Facilities (IRF) or a Skilled Nursing Facilities (SNF). The choice of setting will depend on age, functional level before stroke, stroke impairment severity and cognitive and medical status. In the High-Intensity Rehabilitation program in IRF, patients will undergo at least 3 sessions of Inpatient Physiotherapy (PT), Occupational Therapy (OT) and Speech-Language Pathologist (SLT). In the moderate-intensity rehabilitation program delivered in SNFs, patients will receive approximately one or two session of therapy per day, including PT, OT, and SLT, when indicated.
Eligibility Criteria
Ischemic stroke patients admitted to the Stroke Unit
You may not qualify if:
- intracranial haemorrhage, symptomatic hemorrhagic transformation, new infarcts after the initial stroke or other neurological or psychiatric conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Research Group, IMIM
Barcelona, 08006, Spain
Related Publications (14)
Tracz J, Gorczyca-Glowacka I, Rosolowska A, Wozakowska-Kaplon B. Long-Term Outcomes after Stroke in Patients with Atrial Fibrillation: A Single Center Study. Int J Environ Res Public Health. 2023 Feb 16;20(4):3491. doi: 10.3390/ijerph20043491.
PMID: 36834183BACKGROUNDAlcusky M, Ulbricht CM, Lapane KL. Postacute Care Setting, Facility Characteristics, and Poststroke Outcomes: A Systematic Review. Arch Phys Med Rehabil. 2018 Jun;99(6):1124-1140.e9. doi: 10.1016/j.apmr.2017.09.005. Epub 2017 Sep 28.
PMID: 28965738RESULTShah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.
PMID: 2760661RESULTOrtega-Martorell S, Olier I, Ohlsson M, Lip GYH; TARGET Consortium. TARGET: A Major European Project Aiming to Advance the Personalised Management of Atrial Fibrillation-Related Stroke via the Development of Health Virtual Twins Technology and Artificial Intelligence. Thromb Haemost. 2025 Jan;125(1):7-11. doi: 10.1055/a-2438-5671. Epub 2024 Oct 14. No abstract available.
PMID: 39401519RESULTVinding NE, Kristensen SL, Rorth R, Butt JH, Ostergaard L, Olesen JB, Torp-Pedersen C, Gislason GH, Kober L, Kruuse C, Johnsen SP, Fosbol EL. Ischemic Stroke Severity and Mortality in Patients With and Without Atrial Fibrillation. J Am Heart Assoc. 2022 Feb 15;11(4):e022638. doi: 10.1161/JAHA.121.022638. Epub 2022 Feb 12.
PMID: 35156393RESULTStinear CM, Ward NS. How useful is imaging in predicting outcomes in stroke rehabilitation? Int J Stroke. 2013 Jan;8(1):33-7. doi: 10.1111/j.1747-4949.2012.00970.x.
PMID: 23280267RESULTDeutsch A, Granger CV, Heinemann AW, Fiedler RC, DeJong G, Kane RL, Ottenbacher KJ, Naughton JP, Trevisan M. Poststroke rehabilitation: outcomes and reimbursement of inpatient rehabilitation facilities and subacute rehabilitation programs. Stroke. 2006 Jun;37(6):1477-82. doi: 10.1161/01.STR.0000221172.99375.5a. Epub 2006 Apr 20.
PMID: 16627797RESULTWang H, Camicia M, DiVita M, Mix J, Niewczyk P. Early inpatient rehabilitation admission and stroke patient outcomes. Am J Phys Med Rehabil. 2015 Feb;94(2):85-96; quiz 97-100. doi: 10.1097/PHM.0000000000000226.
PMID: 25569470RESULTChan L, Sandel ME, Jette AM, Appelman J, Brandt DE, Cheng P, Teselle M, Delmonico R, Terdiman JF, Rasch EK. Does postacute care site matter? A longitudinal study assessing functional recovery after a stroke. Arch Phys Med Rehabil. 2013 Apr;94(4):622-9. doi: 10.1016/j.apmr.2012.09.033. Epub 2012 Nov 1.
PMID: 23124133RESULTMiller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
PMID: 20813995RESULTWinstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PMID: 27145936RESULTMacDonald SL, Linkewich E, Bayley M, Jeong IJ, Fang J, Fleet JL. The association between inpatient rehabilitation intensity and outcomes after stroke in Ontario, Canada. Int J Stroke. 2024 Apr;19(4):431-441. doi: 10.1177/17474930231215005. Epub 2023 Dec 11.
PMID: 38078378RESULTDonkor ES. Stroke in the 21st Century: A Snapshot of the Burden, Epidemiology, and Quality of Life. Stroke Res Treat. 2018 Nov 27;2018:3238165. doi: 10.1155/2018/3238165. eCollection 2018.
PMID: 30598741RESULTFeigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.
PMID: 34986727RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Guillen-Sola, MD, PHd
Research Rehabilitation Group, IMIM
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
November 11, 2024
Primary Completion (Estimated)
November 11, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
December 15, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- November 2024-December 2027
This study is part of the EU Horizon 2020 TARGET project, following its DMP to ensure data is handled ethically, legally, and sustainably in line with FAIR principles (Findability, Accessibility, Interoperability, Reusability). The plan ensures systematic organization, quality consistency via standardized procedures, and compliance with GDPR, national laws, and EU requirements. Personal data is processed securely, only when necessary for project objectives, with approvals and written consent from participants. Methods include interviews, surveys, workshops, and questionnaires. Data is stored with robust backup and preservation strategies to prevent loss and ensure future usability. Sharing is (currently) restricted to the consortium under a signed data transfer agreement, with external sharing undecided. Data not publicly available includes: third-party data without permission for public release, data compromising IP protection, and participant data that cannot be fully anonymized.