Trials / Recruiting

RecruitingNCT07253974

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

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".

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 213 (estimated)

Sponsor: Parc de Salut Mar · Academic / Other
Sex: All
Age: 18 Years – 99 Years
Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

Start date: 2024-11-11
Primary completion: 2026-11-11
Completion: 2027-12-01
First posted: 2025-11-28
Last updated: 2025-12-15

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07253974. Inclusion in this directory is not an endorsement.