Clinical trial NCT04119479: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Functional recovery
Neurorehabilitation
Stroke
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Deutsche Rentenversicherung
First posted: 2019-10-08
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Compound score
timeFrame: 12 months after discharge from rehabilitation
Secondary outcomes:
measure: Aphasia test
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Apraxia screen of TULIA (AST)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Autonomy and participation
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Fatigue scale for motor function and cognition (FSMC)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Fugl-Meyer assessment upper extremity (FMA)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Grip and pinch force
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Index for measuring restrictions on participation (IMET)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Knowledge and information needs
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Line bisection test (LBS)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Modified Rankin Scale (MRS)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Montreal cognitive assessment (MoCA)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: National institutes of health stroke scale (NIHSS)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Nine hole peg test (NHPT)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Patient reported health status (EQ-5D)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Return to work
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Stroke impact scale (SIS)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
measure: Time up and go test (TUG)
timeFrame: 3, 6 and 12 months after discharge from rehabilitation
Other outcomes:
Locations:
city: Bad Bramstedt
country: Germany
facility: Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation
city: Damp
country: Germany
facility: Rehaklinik Damp - Neurologie
city: Geesthacht
country: Germany
facility: Rehaklinik Geesthacht - Neurologie
city: Hamburg
country: Germany
facility: RehaCentrum Hamburg - Neurologische Rehabilitation
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, Neurologie
city: Soltau
country: Germany
facility: MediClin Klinikum Soltau - Neurologische Rehabilitation
Study officials:
affiliation: Department of Neurology, University Medical Center Hamburg-Eppendorf
name: Götz Thomalla, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, University Medical Center Hamburg-Eppendorf
name: Christian Gerloff, Prof. Dr.
role: STUDY_CHAIR
References:
citation: Birke G, Wolf S, Ingwersen T, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Protocol for a multicenter observational prospective study of functional recovery from stroke beyond inpatient rehabilitation - The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE). Neurol Res Pract. 2020 Apr 6;2:10. doi: 10.1186/s42466-020-00056-2. eCollection 2020.
citation: Wolf S, Holm SE, Ingwersen T, Bartling C, Bender G, Birke G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Pre-stroke socioeconomic status predicts upper limb motor recovery after inpatient neurorehabilitation. Ann Med. 2022 Dec;54(1):1265-1276. doi: 10.1080/07853890.2022.2059557.
citation: Ingwersen T, Wolf S, Birke G, Schlemm E, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Long-term recovery of upper limb motor function and self-reported health: results from a multicenter observational study 1 year after discharge from rehabilitation. Neurol Res Pract. 2021 Dec 27;3(1):66. doi: 10.1186/s42466-021-00164-7.