Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

Study Overview
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Brief Summary
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Observational study of functional recovery of stroke patients after discharge from rehabilitation

Detailed Description
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Cerebrovascular diseases, such as stroke, are among the greatest challenges in healthcare. This proves the importance of neuro-rehabilitative research. Stroke research is often focused on the acute treatment phase as well as the inpatient rehabilitation. A remaining question is how do stroke patients clinically develop after being discharged from the hospital? How stable are the achieved rehabilitation effects and how much more clinical improvement is seen in the following time period, especially with regard to ICF functionality? In this observational longitudinal study, the current practice of neurorehabilitation will be investigated and the influence of motor skills, cognition, care situation, depression, information and fatigue on functional recovery as well as participation, autonomy and quality of life will be evaluated. Stroke patients will be examined at the end of rehabilitation, after three, six and 12 months. In addition, a group of chronic patients undergoes the same examinations and thereby represents a comparison group.

Official Title
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Interdisziplinäre Plattform für Rehabilitationsforschung Und Innovative Versorgung Von SchlaganfallpatientInnen - ImPRoVe Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients - ImPRoVe

Conditions
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Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or haemorrhagic stroke according to ICD 10 I61-I69 Patients in or after completion of rehabilitation phases C and D according to BAR criteria Age >= 18 Sufficient knowledge of German Existing declaration of consent Deficit still existing (Rankin score of at least 1 at inclusion) Exclusion Criteria: need for care prior stroke SAB, craniocerebral trauma, TIA as primary diagnosis Severe pre-existing psychiatric disease Participation in follow-up examination not possible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compound score | Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test). | 12 months after discharge from rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aphasia test | Standardized test for differential diagnosis Aphasia - no aphasia. | 3, 6 and 12 months after discharge from rehabilitation | 
| Apraxia screen of TULIA (AST) | The Apraxia Screen from TULIA is a short assessment to diagnose apraxia with 12 hand movements, dichotomous scale: 0 = not fulfilled, 1 = fulfilled motion task. | 3, 6 and 12 months after discharge from rehabilitation | 
| Autonomy and participation | Autonomy and participation is measured via different tools, for example with the Index for the Assessment of Health Impairments (IMET) or the subscale Participation/Role function extracted from the Stroke Impact Scale. | 3, 6 and 12 months after discharge from rehabilitation | 
| Fatigue scale for motor function and cognition (FSMC) | Fatigue scale for motor and cognitive functions, an assessment of fatigue, containing two subscales (mental and physical fatigue), ranging from 20 (no fatigue at all) to 100 (severest grade of fatigue). | 3, 6 and 12 months after discharge from rehabilitation | 
| Fugl-Meyer assessment upper extremity (FMA) | The section motor function of upper limb is one of five domains, a three-point scale is used for rating performance as 0=cannot perform, 1=performs partially and 2=performs fully, max. possible score: 66 points. | 3, 6 and 12 months after discharge from rehabilitation | 
| Grip and pinch force | A dynamometer is used to measure grip strength and a pinch gauge to measure pinch force. | 3, 6 and 12 months after discharge from rehabilitation | 
| Index for measuring restrictions on participation (IMET) | The Index of measurement of participation restrictions (IMET) records patient-related participation as a self-evaluation tool, on a scale from 0 (no impairment) to 10 (no more activity possible). | 3, 6 and 12 months after discharge from rehabilitation | 
| Knowledge and information needs | A questionnaire developed by the research group (including questions on informativeness and information needs on the topic of stroke). | 3, 6 and 12 months after discharge from rehabilitation | 
| Line bisection test (LBS) | The line bisection test (LBS) is a test to detect the presence of unilateral spatial neglect. To complete the test, the middle of several horizontal lines must be marked. | 3, 6 and 12 months after discharge from rehabilitation | 
| Modified Rankin Scale (MRS) | The modified Rankin scale (MRS) is a standardized measure that describes the extent of disability after a stroke. It ranges from 0 (no symptoms) to 6 (death due to stroke). | 3, 6 and 12 months after discharge from rehabilitation | 
| Montreal cognitive assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment, a maximum of 30 points (no restrictions) can be achieved. | 3, 6 and 12 months after discharge from rehabilitation | 
| National institutes of health stroke scale (NIHSS) | The National Institutes of Health Stroke Scale, NIHSS, is a score system to quantify the impairment caused by a stroke. The sum of the values from the investigations results in a maximum of 42 points. The higher the score, the more extensive the stroke. | 3, 6 and 12 months after discharge from rehabilitation | 
| Nine hole peg test (NHPT) | A timed measure of fine manual dexterity where the patient is instructed to first take nine pegs out of a container and place them afterwards back into the empty holes of the container as quickly as possible. | 3, 6 and 12 months after discharge from rehabilitation | 
| Patient Health Questionnaire (PHQ-9) | The Patient Health Questionnaire 9 (PHQ-9) is a screening tool for diagnosing depressivity and includes questions on the nine DSM-IV criteria for the diagnosis of major depression. | 3, 6 and 12 months after discharge from rehabilitation | 
| Patient reported health status (EQ-5D) | The EQ-5D questionnaire is a standardized, generic measure of health-related quality of life, it is a self-administered questionnaire. | 3, 6 and 12 months after discharge from rehabilitation | 
| Return to work | A questionnaire developed by the research group (including questions on occupation and lifestyle). | 3, 6 and 12 months after discharge from rehabilitation | 
| Stroke impact scale (SIS) | Measurement of subjective stroke-specific health status, 64 items in eight domains, domain scores range between 0-100, with higher scores represent better health status. | 3, 6 and 12 months after discharge from rehabilitation | 
| Time up and go test (TUG) | The Timed Up and Go test is a clinical test to assess a patient's mobility and risk of falling. | 3, 6 and 12 months after discharge from rehabilitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional recovery, Neurorehabilitation, Stroke