Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

Stroke Clinical Trial

— ImPRoVe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119479
• Other study ID #: IMPROVE
• Status: Completed
• Start date: June 27, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Germany	Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation	Bad Bramstedt
Germany	Rehaklinik Damp - Neurologie	Damp
Germany	Rehaklinik Geesthacht - Neurologie	Geesthacht
Germany	RehaCentrum Hamburg - Neurologische Rehabilitation	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf, Neurologie	Hamburg
Germany	MediClin Klinikum Soltau - Neurologische Rehabilitation	Soltau

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Deutsche Rentenversicherung

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Aphasia test	Standardized test for differential diagnosis Aphasia - no aphasia.	3, 6 and 12 months after discharge from rehabilitation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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