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Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04119479
Acronym
ImPRoVe
Enrollment
227
Registered
2019-10-08
Start date
2017-06-27
Completion date
2020-10-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Functional recovery, Neurorehabilitation, Stroke

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.

Interventions

None listed

Sponsors

Deutsche Rentenversicherung
CollaboratorOTHER
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compound score12 months after discharge from rehabilitationCompound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test).

Secondary

MeasureTime frameDescription
Aphasia test3, 6 and 12 months after discharge from rehabilitationStandardized test for differential diagnosis Aphasia - no aphasia.
Apraxia screen of TULIA (AST)3, 6 and 12 months after discharge from rehabilitationThe 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 participation3, 6 and 12 months after discharge from rehabilitationAutonomy 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)3, 6 and 12 months after discharge from rehabilitationFatigue 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)3, 6 and 12 months after discharge from rehabilitationThe 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 force3, 6 and 12 months after discharge from rehabilitationA dynamometer is used to measure grip strength and a pinch gauge to measure pinch force.
Index for measuring restrictions on participation (IMET)3, 6 and 12 months after discharge from rehabilitationThe 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 needs3, 6 and 12 months after discharge from rehabilitationA questionnaire developed by the research group (including questions on informativeness and information needs on the topic of stroke).
Montreal cognitive assessment (MoCA)3, 6 and 12 months after discharge from rehabilitationThe Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment, a maximum of 30 points (no restrictions) can be achieved.
Modified Rankin Scale (MRS)3, 6 and 12 months after discharge from rehabilitationThe 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).
National institutes of health stroke scale (NIHSS)3, 6 and 12 months after discharge from rehabilitationThe 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)3, 6 and 12 months after discharge from rehabilitationA 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)3, 6 and 12 months after discharge from rehabilitationThe 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)3, 6 and 12 months after discharge from rehabilitationThe EQ-5D questionnaire is a standardized, generic measure of health-related quality of life, it is a self-administered questionnaire.
Return to work3, 6 and 12 months after discharge from rehabilitationA questionnaire developed by the research group (including questions on occupation and lifestyle).
Stroke impact scale (SIS)3, 6 and 12 months after discharge from rehabilitationMeasurement 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)3, 6 and 12 months after discharge from rehabilitationThe Timed Up and Go test is a clinical test to assess a patient's mobility and risk of falling.
Line bisection test (LBS)3, 6 and 12 months after discharge from rehabilitationThe 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026