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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

Tracking Information
First Submitted Date September 26, 2019
First Posted Date October 8, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date June 27, 2017
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2019)
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).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 6, 2019)
  • Aphasia test [ Time Frame: 3, 6 and 12 months after discharge from rehabilitation ]
    Standardized test for differential diagnosis Aphasia - no aphasia.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients
Official Title Interdisziplinäre Plattform für Rehabilitationsforschung Und Innovative Versorgung Von SchlaganfallpatientInnen - ImPRoVe Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients - ImPRoVe
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: October 6, 2019)
227
Original Actual Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04119479
Other Study ID Numbers IMPROVE
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators Deutsche Rentenversicherung
Investigators
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
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date October 2019