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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorParc de Salut Mar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial population

Ischemic stroke patients admitted to the Stroke Unit

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Rehabilitation program based on Physiotherapy, occupational therapy and swallow and language therapy

    Other intervention

    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.

Treatment groups

213 Participants
are divided into 2 treatment groups
Group A: High Intensity Rehabilitation program1 intervention
Group B: Moderate Intensity Rehabilitation program1 intervention

Trial outcomes

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)

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.

Secondary outcomes

1

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:

Time frame
From enrollment to 6-month follow-up.
2

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.

Time frame
From enrollment to 6-month after stroke event
3

Functional Ambulation Category (FAC)

Ambulation ability classification. Ordinal category (0-5)

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
4

Trunk Control Test (TCT)

Assesses trunk control in stroke patients Score (0-100)

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

Other outcomes

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