Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study (PEARL)

December 11, 2025 updated by: Parc de Salut Mar

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

213

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anna Guillen-Sola, MD, PhD
  • Phone Number: +34932674192 +34659527833
  • Email: aguillen@hmar.cat

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08006
        • Recruiting
        • Rehabilitation Research Group, IMIM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ischemic stroke patients admitted to the Stroke Unit

Description

Inclusion Criteria:> 18 a, first-ever intracerebral ischemic stroke

-

Exclusion Criteria:

  • intracranial haemorrhage, symptomatic hemorrhagic transformation, new infarcts after the initial stroke or other neurological or psychiatric conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High Intensity Rehabilitation program
NIHSS 3-13, MRS historic ( pre-Stroke)1-2, Cognitive status : preserved
Other: Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy
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.
Moderate Intensity Rehabilitation program
NIHSS >13 or MRS historic ( pre-Stroke)<3
Other: Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Barthel from Baseline to 6-month follow-up outcomes
Time Frame: From enrollment to 6-month after stroke event
To compare 6-month functional outcomes (Barthel Index) between AFRS and non-AFRS patients within high-intensity and moderate-intensity rehabilitation programs.
From enrollment to 6-month after stroke event
Functional outcomes pre and after rehabilitation program
Time Frame: From enrollment to 6-month follow-up.
To evaluate differences in occupational therapy, physiotherapy, speech therapy, and cognitive outcomes between AFRS and non-AFRS patients:
From enrollment to 6-month follow-up.
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
Ambulation ability classification. Ordinal category (0-5)
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
Assesses trunk control in stroke patients Score (0-100)
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
Assessment of static and dynamic balance. Score (0-56)
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
Functional mobility test: sit-to-stand, ambulation, turning, and return Unit of Measure: Seconds
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
Walking speed over 10 meters. Unit of Measure: Meters/second (m/s)
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
Fine motor dexterity test Unit of Measure: Seconds
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
Upper-limb strength measured via dynamometry. Unit of Measure: Kilograms (kg)
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
Cognitive screening for multiple domains. Unit of Measure: Score (0-30)
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
Quality-of-life measure including index score and VAS Unit of Measure: Index score and VAS (0-100)
Baseline (T0), six-month (T3) after the acute event
Dysphagia Assessment (Volume-Viscosity Swallow Test)
Time Frame: Baseline (T0)
Evaluation of swallowing safety and efficacy. Unit of Measure: Categorical (normal / impaired)
Baseline (T0)
Aphasia Presence
Time Frame: Baseline (T0)and six-month (T3) after the acute event
Aphasia recorded by speech-language pathology. Unit of Measure: Dichotomous (yes/no)
Baseline (T0)and six-month (T3) after the acute event
NIH Stroke Scale (NIHSS)
Time Frame: Baseline (T0)
Quantifies neurological deficit in acute stroke. Unit of Measure: Score (0-42)
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
Global disability scale Unit of Measure: Score (0-6)
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
Measures symptoms of anxiety and depression. Unit of Measure: Score (0-21 for anxiety; 0-21 for depression)
Baseline (T0), and follow-up at six months (T3) after the acute event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc de Salut Mar

Investigators

  • Principal Investigator: Anna Guillen-Sola, MD, PHd, Research Rehabilitation Group, IMIM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2024

Primary Completion (Estimated)

November 11, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Estimated)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/11172/I_PEARL
  • n.101136244 (Other Grant/Funding Number: European Union's Horizon Europe)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

November 2024-December 2027

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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