STROKEPEARLNCT07253974
Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study
An observational study of STROKE and Rehabilitation Outcome, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- STROKE, Rehabilitation Outcome, Brain Disease
- What is being tested?
- Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy
- How many people
- 213 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2024to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ischemic stroke patients admitted to the Stroke Unit
Who may be able to join
None listed.
Who cannot join
- intracranial haemorrhage, symptomatic hemorrhagic transformation, new infarcts after the initial stroke or other neurological or psychiatric conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ester Marco Navarro, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Rehabilitation Research Group, IMIM
Barcelona, 08006
Anna Guillen-Sola, MD,PhD, 93 3674214 ext. 4192, aguillen@hmar.cat
About this study
Official title: Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study. TARGET: Health Virtual Twins for the Personalised Management of Stroke Related to Atrial Fibrillation".
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.
Read the detailed description
Introduction: Rehabilitation is recognised as a cornerstone of the recovery stroke care period. The intensity of therapy is related to functional recovery. Longitudinal studies investigating differences in short- and long-term outcomes of ischemic and hemorrhagic strokes are scarce. The investigators do not know whether AFRS have specific rehabilitation needs or different functional outcomes from non-AFRS. Identifying differences in aetiology and stroke recovery can help the scientific community to develop predictive models of recovery optimizing available resources.
Methods and analysis: In this prospective observational study stroke patients will be recruited in the Stroke Unit of one tertiary hospital. Patients discharged from the Stroke Unit who need inpatient rehabilitation will be allocated to two rehabilitation centers with programs of different intensity: High-intensity (3-5 session daily) or Moderate-intensity (1session daily) based on Rehabilitation Catalan Stroke Rehabilitation Plan.
Screening criteria are based on Current clinical items: age, prior functional level, neurological impairment and cognitive and medical status.
After discharge from the stroke unit, the post-acute inpatient care services for stroke patients include rehabilitation facilities and long-term care hospitals. Intensive inpatient programs provide hospital-level care and offer rehabilitation (RHB) at least 3 sessions of therapy per day 6 days a week, aiming at regaining lost body functions and recovering autonomy in basic activities of daily life. Patients treated in these inpatient rehabilitation facilities have better functional outcomes and higher rates of return to community living than those treated in general wards or long-term care hospitals. Long-term care centres and Nursing Facilities offer Moderate-intensity programs, which consist of 1 session of rehabilitation daily.
In patients with moderate-to-severe post-stroke acute deficits, there is high inter-individual variability in recovery which makes predicting outcomes much more difficult. Accumulated evidence suggests that both initial motor impairment and long-term motor outcome depend on the severity of corticospinal tract (CST) damage and the integrity of alternative motor fibres. Measurements extracted from magnetic resonance imaging (MRI), diffusion tensor (DTI), and functional imaging (fMRI) provide comprehensive in vivo metrics of local microstructural and functional connectivity properties of brain tissue. Despite these advances, in clinical practice, there is no validated gold standard for predicting functional outcomes after stroke. Nevertheless, to date 21 stroke registries across 19 different countries have been documented; and some clinical trials aimed at developing data-driven prediction models are currently underway, These efforts reflect a growing interest among RHB- teams in optimizing interventions throughout the stroke care continuum.
Differences between aetiology Typically published studies do not differentiate between stroke aetiology, at most they may define ischaemic or haemorrhagic events. Longitudinal studies investigating differences in short- and long-term outcomes of strokes according to their aetiology are scarce. Atrial fibrillation (AF) affects approximately 1-2% of the general population and is associated with a 5-fold increased risk of stroke.
In the Nationwide Danish Stroke Registry analysing 14.662 patients with atrial fibrillation related stroke (AFRS) experienced more severe strokes and higher morbidity and mortality rates, with a final greater disability at discharge. However, the investigators do not have information on the rehabilitation needs and final functional results in specific AFRS, but some recent studies suggests that AF type and related cardiac markers could serve as predictors for poor functional and cognitive outcomes. Identifying differences in aetiology and stroke recovery can help the scientific community to develop predictive models of recovery optimizing available resources.
The PEARL study is part of the TARGET project, a Horizon Europe funded programme which includes risk prediction, diagnosis and management of AF-related stroke (https://target-horizon.eu/). One of the aims of the project focuses on identifying predictors of functional independence and quality of life in AFRS survivors and facilitating personalisation of rehabilitation.
The PEARL study, as part of the TARGET project, is a prospective observational cohort study conducted over a two-year period in a tertiary Rehabilitation department. The study aims to collect data on the recovery trajectory of patients with acute stroke, with a particular focus on comparing individuals with atrial fibrillation-related stroke (AFRS) to those without, in terms of functional outcomes following admission to either high- or moderate-intensity rehabilitation programmes.
Ethics and dissemination: National and international research ethics guidelines will be followed, including the Deontological Code of Ethics, Declaration of Helsinki, and Spain's confidentiality law concerning personal data (Ley Orgánica 15/1999, 13 December, Protección de Datos de Carácter Personal). The study has received approval by the local Ethics Committee (N. 2023/11172/I) and participants will give written consent prior to study inclusion.It has been registered on clinicaltrials.gov
- Conditions
- STROKE, Rehabilitation Outcome, Brain Disease, Cardiovascular Disease Acute, Hemiplegia and/or Hemiparesis Following Stroke, Disability Physical
- Being tested
- Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy
- Keywords
- functional outcomes, stroke, disability, rehabilitation, high intensity rehabilitation program
- Medical subject headings
- Stroke, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Rehabilitation program | NIHSS 3-13, MRS historic ( pre-Stroke)1-2, Cognitive status : preserved Receives: Other: Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy | |
| Moderate Intensity Rehabilitation program | NIHSS >13 or MRS historic ( pre-Stroke)<3 Receives: Other: Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
To evaluate differences in occupational therapy, physiotherapy, speech therapy, and cognitive outcomes between AFRS and non-AFRS patients:
Measured: From enrollment to 6-month follow-up.
Change Barthel from Baseline to 6-month follow-up outcomes
To compare 6-month functional outcomes (Barthel Index) between AFRS and non-AFRS patients within high-intensity and moderate-intensity rehabilitation programs.
Measured: From enrollment to 6-month after stroke event
Functional Ambulation Category (FAC)
Ambulation ability classification. Ordinal category (0-5)
Measured: 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)
Assesses trunk control in stroke patients Score (0-100)
Measured: 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)
Assessment of static and dynamic balance. Score (0-56)
Measured: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Timed Up and Go (TUG)
Functional mobility test: sit-to-stand, ambulation, turning, and return Unit of Measure: Seconds
Measured: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Gait Velocity (10-Meter Walk Test)
Walking speed over 10 meters. Unit of Measure: Meters/second (m/s)
Measured: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
9-Hole Peg Test (9HPT)
Fine motor dexterity test Unit of Measure: Seconds
Measured: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Handgrip Strength
Upper-limb strength measured via dynamometry. Unit of Measure: Kilograms (kg)
Measured: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Montreal Cognitive Assessment (MoCA)
Cognitive screening for multiple domains. Unit of Measure: Score (0-30)
Measured: Baseline (T0), follow-up at 3-month (T2) and six-month (T3) after the acute event
EQ-5D-5L
Quality-of-life measure including index score and VAS Unit of Measure: Index score and VAS (0-100)
Measured: Baseline (T0), six-month (T3) after the acute event
Dysphagia Assessment (Volume-Viscosity Swallow Test)
Evaluation of swallowing safety and efficacy. Unit of Measure: Categorical (normal / impaired)
Measured: Baseline (T0)
Aphasia Presence
Aphasia recorded by speech-language pathology. Unit of Measure: Dichotomous (yes/no)
Measured: Baseline (T0)and six-month (T3) after the acute event
NIH Stroke Scale (NIHSS)
Quantifies neurological deficit in acute stroke. Unit of Measure: Score (0-42)
Measured: Baseline (T0)
Modified Rankin Scale (mRS)
Global disability scale Unit of Measure: Score (0-6)
Measured: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Hospital Anxiety and Depression Scale (HADS)
Measures symptoms of anxiety and depression. Unit of Measure: Score (0-21 for anxiety; 0-21 for depression)
Measured: Baseline (T0), and follow-up at six months (T3) after the acute event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start11 Nov 2024
- Primary completion11 Nov 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for STROKEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Guillen-Sola, MD, PHd, Principal investigator, Research Rehabilitation Group, IMIM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253974
- Sponsor's protocol ID
- 2023/11172/I_PEARL
- Other IDs
- n.101136244, 2023
- Acronym
- PEARL
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36834183Alcusky 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.
PubMed 28965738Shah 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.
PubMed 2760661Ortega-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.
PubMed 39401519Vinding 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.
PubMed 35156393Stinear 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.
PubMed 23280267Deutsch 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.
PubMed 16627797Wang 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.
PubMed 25569470Chan 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.
PubMed 23124133Miller 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.
PubMed 20813995Winstein 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.
PubMed 27145936MacDonald 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.
PubMed 38078378Donkor 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.
PubMed 30598741Feigin 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.
PubMed 34986727Guillen-Sola A, Duarte E, Boza-Gomez R, Ramirez-Fuentes C, Claria A, Lopez-Guirado C, Ortega-Martorell S, Welters I; TARGET consortium. Prospective evaluation of atrial fibrillation-related stroke patients in rehabilitation programme (PEARL), clinical study for the 'Health virtual twins for the personalised management of stroke related to atrial fibrillation (TARGET)' project: a protocol for a prospective cohort analysis. BMJ Open. 2026 Jun 30;16(6):e118823. doi: 10.1136/bmjopen-2026-118823.
PubMed 42379717
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study. TARGET: Health Virtual Twins for the Personalised Management of Stroke Related to Atrial Fibrillation".
- ClinicalTrials.gov ID
- NCT07253974
- Acronym / sponsor ID
- PEARL / 2023/11172/I_PEARL
- Conditions
- STROKE, Rehabilitation Outcome, Brain Disease, Cardiovascular Disease Acute, Hemiplegia and/or Hemiparesis Following Stroke, Disability Physical
- Keywords
- functional outcomes, stroke, disability, rehabilitation, high intensity rehabilitation program
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 11 Nov 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Rehabilitation is recognised as a cornerstone of the recovery stroke care period. The intensity of therapy is related to functional recovery. Longitudinal studies investigating differences in short- and long-term outcomes of ischemic and hemorrhagic strokes are scarce. The investigators do not know whether AFRS have specific rehabilitation needs or different functional outcomes from non-AFRS. Identifying differences in aetiology and stroke recovery can help the scientific community to develop predictive models of recovery optimizing available resources.
Methods and analysis: In this prospective observational study stroke patients will be recruited in the Stroke Unit of one tertiary hospital. Patients discharged from the Stroke Unit who need inpatient rehabilitation will be allocated to two rehabilitation centers with programs of different intensity: High-intensity (3-5 session daily) or Moderate-intensity (1session daily) based on Rehabilitation Catalan Stroke Rehabilitation Plan.
Screening criteria are based on Current clinical items: age, prior functional level, neurological impairment and cognitive and medical status.
After discharge from the stroke unit, the post-acute inpatient care services for stroke patients include rehabilitation facilities and long-term care hospitals. Intensive inpatient programs provide hospital-level care and offer rehabilitation (RHB) at least 3 sessions of therapy per day 6 days a week, aiming at regaining lost body functions and recovering autonomy in basic activities of daily life. Patients treated in these inpatient rehabilitation facilities have better functional outcomes and higher rates of return to community living than those treated in general wards or long-term care hospitals. Long-term care centres and Nursing Facilities offer Moderate-intensity programs, which consist of 1 session of rehabilitation daily.
In patients with moderate-to-severe post-stroke acute deficits, there is high inter-individual variability in recovery which makes predicting outcomes much more difficult. Accumulated evidence suggests that both initial motor impairment and long-term motor outcome depend on the severity of corticospinal tract (CST) damage and the integrity of alternative motor fibres. Measurements extracted from magnetic resonance imaging (MRI), diffusion tensor (DTI), and functional imaging (fMRI) provide comprehensive in vivo metrics of local microstructural and functional connectivity properties of brain tissue. Despite these advances, in clinical practice, there is no validated gold standard for predicting functional outcomes after stroke. Nevertheless, to date 21 stroke registries across 19 different countries have been documented; and some clinical trials aimed at developing data-driven prediction models are currently underway, These efforts reflect a growing interest among RHB- teams in optimizing interventions throughout the stroke care continuum.
Differences between aetiology Typically published studies do not differentiate between stroke aetiology, at most they may define ischaemic or haemorrhagic events. Longitudinal studies investigating differences in short- and long-term outcomes of strokes according to their aetiology are scarce. Atrial fibrillation (AF) affects approximately 1-2% of the general population and is associated with a 5-fold increased risk of stroke.
In the Nationwide Danish Stroke Registry analysing 14.662 patients with atrial fibrillation related stroke (AFRS) experienced more severe strokes and higher morbidity and mortality rates, with a final greater disability at discharge. However, the investigators do not have information on the rehabilitation needs and final functional results in specific AFRS, but some recent studies suggests that AF type and related cardiac markers could serve as predictors for poor functional and cognitive outcomes. Identifying differences in aetiology and stroke recovery can help the scientific community to develop predictive models of recovery optimizing available resources.
The PEARL study is part of the TARGET project, a Horizon Europe funded programme which includes risk prediction, diagnosis and management of AF-related stroke (https://target-horizon.eu/). One of the aims of the project focuses on identifying predictors of functional independence and quality of life in AFRS survivors and facilitating personalisation of rehabilitation.
The PEARL study, as part of the TARGET project, is a prospective observational cohort study conducted over a two-year period in a tertiary Rehabilitation department. The study aims to collect data on the recovery trajectory of patients with acute stroke, with a particular focus on comparing individuals with atrial fibrillation-related stroke (AFRS) to those without, in terms of functional outcomes following admission to either high- or moderate-intensity rehabilitation programmes.
Ethics and dissemination: National and international research ethics guidelines will be followed, including the Deontological Code of Ethics, Declaration of Helsinki, and Spain's confidentiality law concerning personal data (Ley Orgánica 15/1999, 13 December, Protección de Datos de Carácter Personal). The study has received approval by the local Ethics Committee (N. 2023/11172/I) and participants will give written consent prior to study inclusion.It has been registered on clinicaltrials.gov
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Rehabilitation program | – | Other: Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapyNIHSS 3-13, MRS historic ( pre-Stroke)1-2, Cognitive status : preserved |
| Moderate Intensity Rehabilitation program | – | Other: Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapyNIHSS >13 or MRS historic ( pre-Stroke)<3 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ischemic stroke patients admitted to the Stroke Unit
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- intracranial haemorrhage, symptomatic hemorrhagic transformation, new infarcts after the initial stroke or other neurological or psychiatric conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapyRehabilitation 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. | Other | High Intensity Rehabilitation program, Moderate Intensity Rehabilitation program |
Primary outcome
Barthel improvement
Time frame: 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.
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)
16 secondary outcomes
Functional outcomes pre and after rehabilitation program
Time frame: From enrollment to 6-month follow-up.
Change Barthel from Baseline to 6-month follow-up outcomes
Time frame: From enrollment to 6-month after stroke event
Functional Ambulation Category (FAC)
Time frame: 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)
Time frame: 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)
Time frame: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Timed Up and Go (TUG)
Time frame: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Gait Velocity (10-Meter Walk Test)
Time frame: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
9-Hole Peg Test (9HPT)
Time frame: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Handgrip Strength
Time frame: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (T0), follow-up at 3-month (T2) and six-month (T3) after the acute event
EQ-5D-5L
Time frame: Baseline (T0), six-month (T3) after the acute event
Dysphagia Assessment (Volume-Viscosity Swallow Test)
Time frame: Baseline (T0)
Aphasia Presence
Time frame: Baseline (T0)and six-month (T3) after the acute event
NIH Stroke Scale (NIHSS)
Time frame: Baseline (T0)
Modified Rankin Scale (mRS)
Time frame: Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (T0), and follow-up at six months (T3) after the acute event
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 36834183Tracz 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.
- Results publication: PubMed 28965738Alcusky 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.
- Results publication: PubMed 2760661Shah 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.
- Results publication: PubMed 39401519Ortega-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.
- Results publication: PubMed 35156393Vinding 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.
- Results publication: PubMed 23280267Stinear 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.
- Results publication: PubMed 16627797Deutsch 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.
- Results publication: PubMed 25569470Wang 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.
- Results publication: PubMed 23124133Chan 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.
- Results publication: PubMed 20813995Miller 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.
- Results publication: PubMed 27145936Winstein 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.
- Results publication: PubMed 38078378MacDonald 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ester Marco Navarro, MD, PhD contact
Anna Guillen-Sola, MD, PHd principal investigator
Research Rehabilitation Group, IMIM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STROKE and Rehabilitation Outcome, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Guillen-Sola, MD, PhD (+34659527833 ext. +34932674192, aguillen@hmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel improvement (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07253974, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.