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临床试验/NCT07253974
NCT07253974招募中不适用

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".

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2024年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
213
试验地点
1
主要终点
Barthel improvement

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •> 18 a, first-ever intracerebral ischemic stroke

排除标准

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

结局指标

主要结局

Barthel improvement

时间窗: 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)

次要结局

  • Montreal Cognitive Assessment (MoCA)(Baseline (T0), follow-up at 3-month (T2) and six-month (T3) after the acute event)
  • 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)
  • Timed Up and Go (TUG)(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)(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)(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(Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event)
  • EQ-5D-5L(Baseline (T0), six-month (T3) after the acute event)
  • Dysphagia Assessment (Volume-Viscosity Swallow Test)(Baseline (T0))
  • Aphasia Presence(Baseline (T0)and six-month (T3) after the acute event)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline (T0), and follow-up at six months (T3) after the acute event)
  • NIH Stroke Scale (NIHSS)(Baseline (T0))
  • Modified Rankin Scale (mRS)(Baseline (T0), 1-mo follow-up (discharge--T1) and follow-up at 3-month (T2) and six-month (T3) after the acute event)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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