Abstract
IntroductionStroke and its long-term consequences pose major challenges for the lives of those affected and healthcare systems. Neurological rehabilitation therefore primarily attempts to improve function in order to increase independence in activities of daily living, and to enable social participation. There is only scarce data on dynamics of functional recovery after patients discharge from inpatient neurological rehabilitation. Even less is known about the patient’s perspective on long-term recovery from stroke. The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE) aims to address this knowledge gap by providing new insights into the dynamics and extent of functional recovery from stroke beyond inpatient rehabilitation treatment.MethodsWe provide the protocol for an observational, longitudinal, multicenter study conducted in an Universitary Stroke Center in cooperation with five Neurological Rehabilitation Centers in Northern Germany. Patients who suffered from ischemic or hemorrhagic stroke will be enrolled by the end of inpatient rehabilitation and followed up to 1 year. In addition, a group of chronic stroke patients and a group of craniocerebral trauma patients will be enrolled as a comparison group. Data on stroke characteristics, vascular risk factors, co-morbidities, social support, and demographics will be recorded. Comprehensive clinical evaluation will be performed at baseline, three, six, and twelve months after enrollment. The assessments and scores used reflect the three components of the International Classification of Functioning, Disability and Health (ICF), some of them are tests regularly used in rehabilitation settings. Tests of motor function, cognition, and mood are included, as are tests of self-reported health-related quality of life. Primary outcome measure is a hand motor score, built by the sum of the hand items of the Fugl-Meyer Assessment as an objective measurement of hand function at 12 months after enrollment. Predictors of the primary outcome will be analyzed using linear regression analysis.PerspectiveThe results of IMPROVE will inform about the long-term dynamics of functional stroke recovery after patients’ discharge from inpatient rehabilitation and will provide insights into the association of clinical and demographic factors with recovery of function.Trial registrationThe protocol is registered at ClinicalTrials.gov (NCT04119479).
Highlights
Stroke and its long-term consequences pose major challenges for the lives of those affected and healthcare systems
Perspective: The results of IMPROVE will inform about the long-term dynamics of functional stroke recovery after patients’ discharge from inpatient rehabilitation and will provide insights into the association of clinical and demographic factors with recovery of function
In parallel with the increasing incidence and decreasing mortality, it is above all the impairments caused by a stroke that are of great interest to health care practitioners and other health care actors [33, 41]
Summary
Aim of the study The overall goal of this study is to identify and understand factors that influence the course of recovery following focal brain lesions within the framework of standard neurorehabilitation in Germany. Abbreviations IMPROVE : The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients; ICF: International Classification of Functioning, Disability and Health; mRS: Modified Rankin Scale; UKE: University Medical Center Hamburg-Eppendorf; ICD: International Classification of Diseases; BAR: Bundesarbeitsgemeinschaft für Rehabilitation; SIS: The Stroke Impact Scale; ZAPA: Questionnaire assessing satisfaction with outpatient care with focus on patient participation - “Fragebogen zur Zufriedenheit in der ambulanten Versorgung – Schwerpunkt Patientenbeteiligung (ZAPA)”; TULIA: Test for Upper-Limb Apraxia; ASKU: Short scale for the measurement of self-efficacy – “Allgemeine Selbstwirksamkeit Kurzskala”; ICHOM: The International Consortium for Health Outcomes Measurements; PROMIS-10: Patient-reported Outcomes Measurements Information System 10-Question Short Form; AUDIT C: Alcohol Use Disorders Identification Test; SIS: Stroke impact scale; IMET: The Index of measurement of participation restrictions; EQ5D: European Quality of Life 5 Dimensions
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