Women's Health Initiative Strong and Healthy Study
NCT02425345
Arterial Occlusive Diseases, Arteriosclerosis
View Trial DetailsNCT Number: NCT04119479
Observational study of functional recovery of stroke patients after discharge from rehabilitation
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Notify Me18 year and older
All sexes
Observational
Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation, Bad Bramstedt, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 3, 6 and 12 months after discharge from rehabilitation
Standardized test for differential diagnosis Aphasia - no aphasia.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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 frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3, 6 and 12 months after discharge from rehabilitation
A questionnaire developed by the research group (including questions on occupation and lifestyle).
Time frame: 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.
Time frame: 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.
Universitätsklinikum Hamburg-Eppendorf
Other
Interdisziplinäre Plattform für Rehabilitationsforschung Und Innovative Versorgung Von SchlaganfallpatientInnen - ImPRoVe Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients - ImPRoVe
Acronym: ImPRoVe
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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