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Completed

NCT Number: NCT04119479

Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation, Bad Bramstedt, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Aphasia test

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    Standardized test for differential diagnosis Aphasia - no aphasia.

  2. Apraxia screen of TULIA (AST)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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. Autonomy and participation

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  4. Fatigue scale for motor function and cognition (FSMC)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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).

  5. Fugl-Meyer assessment upper extremity (FMA)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  6. Grip and pinch force

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    A dynamometer is used to measure grip strength and a pinch gauge to measure pinch force.

  7. Index for measuring restrictions on participation (IMET)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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).

  8. Knowledge and information needs

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    A questionnaire developed by the research group (including questions on informativeness and information needs on the topic of stroke).

  9. Line bisection test (LBS)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  10. Modified Rankin Scale (MRS)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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).

  11. Montreal cognitive assessment (MoCA)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    The Montreal Cognitive Assessment (MoCA) is a screening assessment for detecting cognitive impairment, a maximum of 30 points (no restrictions) can be achieved.

  12. National institutes of health stroke scale (NIHSS)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  13. Nine hole peg test (NHPT)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  14. Patient Health Questionnaire (PHQ-9)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  15. Patient reported health status (EQ-5D)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    The EQ-5D questionnaire is a standardized, generic measure of health-related quality of life, it is a self-administered questionnaire.

  16. Return to work

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    A questionnaire developed by the research group (including questions on occupation and lifestyle).

  17. Stroke impact scale (SIS)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    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.

  18. Time up and go test (TUG)

    Time frame: 3, 6 and 12 months after discharge from rehabilitation

    The Timed "Up and Go" test is a clinical test to assess a patient's mobility and risk of falling.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Deutsche Rentenversicherung

Registry information

Official study title

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

Acronym: ImPRoVe

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 8, 2019
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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