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Clinical Trials/NCT04119479
NCT04119479
Completed
Not Applicable

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

Universitätsklinikum Hamburg-Eppendorf6 sites in 1 country227 target enrollmentJune 27, 2017
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
227
Locations
6
Primary Endpoint
Compound score
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 27, 2017
End Date
October 31, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • Index for measuring restrictions on participation (IMET)(3, 6 and 12 months after discharge from rehabilitation)
  • Nine hole peg test (NHPT)(3, 6 and 12 months after discharge from rehabilitation)
  • Patient reported health status (EQ-5D)(3, 6 and 12 months after discharge from rehabilitation)
  • Aphasia test(3, 6 and 12 months after discharge from rehabilitation)
  • Knowledge and information needs(3, 6 and 12 months after discharge from rehabilitation)
  • National institutes of health stroke scale (NIHSS)(3, 6 and 12 months after discharge from rehabilitation)
  • Patient Health Questionnaire (PHQ-9)(3, 6 and 12 months after discharge from rehabilitation)
  • Apraxia screen of TULIA (AST)(3, 6 and 12 months after discharge from rehabilitation)
  • Autonomy and participation(3, 6 and 12 months after discharge from rehabilitation)
  • Fatigue scale for motor function and cognition (FSMC)(3, 6 and 12 months after discharge from rehabilitation)
  • Line bisection test (LBS)(3, 6 and 12 months after discharge from rehabilitation)
  • Grip and pinch force(3, 6 and 12 months after discharge from rehabilitation)
  • Modified Rankin Scale (MRS)(3, 6 and 12 months after discharge from rehabilitation)
  • Stroke impact scale (SIS)(3, 6 and 12 months after discharge from rehabilitation)
  • Fugl-Meyer assessment upper extremity (FMA)(3, 6 and 12 months after discharge from rehabilitation)
  • Time up and go test (TUG)(3, 6 and 12 months after discharge from rehabilitation)
  • Montreal cognitive assessment (MoCA)(3, 6 and 12 months after discharge from rehabilitation)
  • Return to work(3, 6 and 12 months after discharge from rehabilitation)

Study Sites (6)

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