Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients
- Conditions
- Stroke
- Registration Number
- NCT04119479
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Brief Summary
Observational study of functional recovery of stroke patients after discharge from rehabilitation
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
- 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)
- need for care prior stroke
- SAB, craniocerebral trauma, TIA as primary diagnosis
- Severe pre-existing psychiatric disease
- Participation in follow-up examination not possible
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compound score 12 months after discharge from rehabilitation Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test).
- Secondary Outcome Measures
Name Time Method Index for measuring restrictions on participation (IMET) 3, 6 and 12 months after discharge from rehabilitation 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).
Nine hole peg test (NHPT) 3, 6 and 12 months after discharge from rehabilitation 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.
Patient reported health status (EQ-5D) 3, 6 and 12 months after discharge from rehabilitation The EQ-5D questionnaire is a standardized, generic measure of health-related quality of life, it is a self-administered questionnaire.
Aphasia test 3, 6 and 12 months after discharge from rehabilitation Standardized test for differential diagnosis Aphasia - no aphasia.
Knowledge and information needs 3, 6 and 12 months after discharge from rehabilitation A questionnaire developed by the research group (including questions on informativeness and information needs on the topic of stroke).
National institutes of health stroke scale (NIHSS) 3, 6 and 12 months after discharge from rehabilitation 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.
Patient Health Questionnaire (PHQ-9) 3, 6 and 12 months after discharge from rehabilitation 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.
Apraxia screen of TULIA (AST) 3, 6 and 12 months after discharge from rehabilitation 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.
Autonomy and participation 3, 6 and 12 months after discharge from rehabilitation 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.
Fatigue scale for motor function and cognition (FSMC) 3, 6 and 12 months after discharge from rehabilitation 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).
Line bisection test (LBS) 3, 6 and 12 months after discharge from rehabilitation 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.
Grip and pinch force 3, 6 and 12 months after discharge from rehabilitation A dynamometer is used to measure grip strength and a pinch gauge to measure pinch force.
Modified Rankin Scale (MRS) 3, 6 and 12 months after discharge from rehabilitation 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).
Stroke impact scale (SIS) 3, 6 and 12 months after discharge from rehabilitation 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.
Fugl-Meyer assessment upper extremity (FMA) 3, 6 and 12 months after discharge from rehabilitation 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.
Time up and go test (TUG) 3, 6 and 12 months after discharge from rehabilitation The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling.
Montreal cognitive assessment (MoCA) 3, 6 and 12 months after discharge from rehabilitation The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment, a maximum of 30 points (no restrictions) can be achieved.
Return to work 3, 6 and 12 months after discharge from rehabilitation A questionnaire developed by the research group (including questions on occupation and lifestyle).
Trial Locations
- Locations (6)
Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation
🇩🇪Bad Bramstedt, Germany
Rehaklinik Damp - Neurologie
🇩🇪Damp, Germany
Rehaklinik Geesthacht - Neurologie
🇩🇪Geesthacht, Germany
RehaCentrum Hamburg - Neurologische Rehabilitation
🇩🇪Hamburg, Germany
Universitätsklinikum Hamburg-Eppendorf, Neurologie
🇩🇪Hamburg, Germany
MediClin Klinikum Soltau - Neurologische Rehabilitation
🇩🇪Soltau, Germany