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

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

Observational study of functional recovery of stroke patients after discharge from rehabilitation

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 227

Contacts and Locations

Study Locations

• Germany
  • Bad Bramstedt, Germany, 24576
    • Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation
  • Damp, Germany, 24351
    • Rehaklinik Damp - Neurologie
  • Geesthacht, Germany, 21502
    • Rehaklinik Geesthacht - Neurologie
  • Hamburg, Germany, 20097
    • RehaCentrum Hamburg - Neurologische Rehabilitation
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf, Neurologie
  • Soltau, Germany, 29614
    • MediClin Klinikum Soltau - Neurologische Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compound score	Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test).	12 months after discharge from rehabilitation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aphasia test	Standardized test for differential diagnosis Aphasia - no aphasia.	3, 6 and 12 months after discharge from rehabilitation
Apraxia screen of TULIA (AST)	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, 6 and 12 months after discharge from rehabilitation
Autonomy and participation	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.	3, 6 and 12 months after discharge from rehabilitation
Fatigue scale for motor function and cognition (FSMC)	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).	3, 6 and 12 months after discharge from rehabilitation
Fugl-Meyer assessment upper extremity (FMA)	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.	3, 6 and 12 months after discharge from rehabilitation
Grip and pinch force	A dynamometer is used to measure grip strength and a pinch gauge to measure pinch force.	3, 6 and 12 months after discharge from rehabilitation
Index for measuring restrictions on participation (IMET)	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).	3, 6 and 12 months after discharge from rehabilitation
Knowledge and information needs	A questionnaire developed by the research group (including questions on informativeness and information needs on the topic of stroke).	3, 6 and 12 months after discharge from rehabilitation
Line bisection test (LBS)	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.	3, 6 and 12 months after discharge from rehabilitation
Modified Rankin Scale (MRS)	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).	3, 6 and 12 months after discharge from rehabilitation
Montreal cognitive assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment, a maximum of 30 points (no restrictions) can be achieved.	3, 6 and 12 months after discharge from rehabilitation
National institutes of health stroke scale (NIHSS)	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.	3, 6 and 12 months after discharge from rehabilitation
Nine hole peg test (NHPT)	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.	3, 6 and 12 months after discharge from rehabilitation
Patient Health Questionnaire (PHQ-9)	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.	3, 6 and 12 months after discharge from rehabilitation
Patient reported health status (EQ-5D)	The EQ-5D questionnaire is a standardized, generic measure of health-related quality of life, it is a self-administered questionnaire.	3, 6 and 12 months after discharge from rehabilitation
Return to work	A questionnaire developed by the research group (including questions on occupation and lifestyle).	3, 6 and 12 months after discharge from rehabilitation
Stroke impact scale (SIS)	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.	3, 6 and 12 months after discharge from rehabilitation
Time up and go test (TUG)	The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling.	3, 6 and 12 months after discharge from rehabilitation

Collaborators and Investigators

• 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: October 6, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Functional recovery; Neurorehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: IMPROVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data sharing is planned after main publication of results.
• IPD Sharing Time Frame: Within 24 months after main publication.
• IPD Sharing Access Criteria: Personal login into UKE data repository.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No