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Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (ImPRoVe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119479
Recruitment Status : Active, not recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Deutsche Rentenversicherung
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

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

Condition or disease
Stroke

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.

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Study Type : Observational
Actual Enrollment : 227 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Interdisziplinäre Plattform für Rehabilitationsforschung Und Innovative Versorgung Von SchlaganfallpatientInnen - ImPRoVe Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients - ImPRoVe
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. Compound score [ 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).


Secondary Outcome Measures :
  1. Aphasia test [ Time Frame: 3, 6 and 12 months after discharge from rehabilitation ]
    Standardized test for differential diagnosis Aphasia - no aphasia.

  2. Apraxia screen of TULIA (AST) [ 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.

  3. Autonomy and participation [ 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.

  4. Fatigue scale for motor function and cognition (FSMC) [ 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).

  5. Fugl-Meyer assessment upper extremity (FMA) [ 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.

  6. Grip and pinch force [ 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.

  7. Index for measuring restrictions on participation (IMET) [ 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).

  8. Knowledge and information needs [ 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).

  9. Line bisection test (LBS) [ 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.

  10. Modified Rankin Scale (MRS) [ 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).

  11. Montreal cognitive assessment (MoCA) [ 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.

  12. National institutes of health stroke scale (NIHSS) [ 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.

  13. Nine hole peg test (NHPT) [ 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.

  14. Patient Health Questionnaire (PHQ-9) [ 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.

  15. Patient reported health status (EQ-5D) [ 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.

  16. Return to work [ Time Frame: 3, 6 and 12 months after discharge from rehabilitation ]
    A questionnaire developed by the research group (including questions on occupation and lifestyle).

  17. Stroke impact scale (SIS) [ 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.

  18. Time up and go test (TUG) [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with the diagnoses cerebral infarction and/or cerebral hemorrhage corresponding to the diagnoses of ICD 10 I61-I69 from rehabilitation phases C and D according to the criteria of the Bundesarbeitsgemeinschaft für Rehabilitation (BAR) shall be included at the end of inpatient rehabilitation therapy. The spectrum of patients recruited should focus on patients who are still of working age (up to the age of 67).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119479


Locations
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Germany
Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation
Bad Bramstedt, Germany, 24576
Rehaklinik Damp - Neurologie
Damp, Germany, 24351
Rehaklinik Geesthacht - Neurologie
Geesthacht, Germany, 21502
RehaCentrum Hamburg - Neurologische Rehabilitation
Hamburg, Germany, 20097
Universitätsklinikum Hamburg-Eppendorf, Neurologie
Hamburg, Germany, 20246
MediClin Klinikum Soltau - Neurologische Rehabilitation
Soltau, Germany, 29614
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Deutsche Rentenversicherung
Investigators
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Principal Investigator: Götz Thomalla, Prof. Dr. Department of Neurology, University Medical Center Hamburg-Eppendorf
Study Chair: Christian Gerloff, Prof. Dr. Department of Neurology, University Medical Center Hamburg-Eppendorf
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04119479    
Other Study ID Numbers: IMPROVE
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing is planned after main publication of results.
Supporting Materials: Study Protocol
Time Frame: Within 24 months after main publication.
Access Criteria: Personal login into UKE data repository.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Functional recovery
Neurorehabilitation
Stroke
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases