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StrokeImPRoVeNCT04119479

Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

An observational study of Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Observational study of functional recovery of stroke patients after discharge from rehabilitation Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
How many people
227 participants
Where
6 sitesGermany
Study dates
27 Jun 2017to 31 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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)

Who cannot join

  • need for care prior stroke
  • SAB, craniocerebral trauma, TIA as primary diagnosis
  • Severe pre-existing psychiatric disease
  • Participation in follow-up examination not possible

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation

    Bad Bramstedt, 24576

  • Rehaklinik Damp - Neurologie

    Damp, 24351

  • Rehaklinik Geesthacht - Neurologie

    Geesthacht, 21502

  • RehaCentrum Hamburg - Neurologische Rehabilitation

    Hamburg, 20097

  • Universitätsklinikum Hamburg-Eppendorf, Neurologie

    Hamburg, 20246

  • MediClin Klinikum Soltau - Neurologische Rehabilitation

    Soltau, 29614

Other trials in Germany

About this study

Official title: 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

Read the 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.

Conditions
Stroke
Keywords
Functional recovery, Neurorehabilitation, Stroke
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compound score

    Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test).

    Measured: 12 months after discharge from rehabilitation

Secondary outcomes (18)

  1. Aphasia test

    Standardized test for differential diagnosis Aphasia - no aphasia.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  2. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  3. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  4. 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).

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  5. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  6. Grip and pinch force

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

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  7. 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).

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  8. Knowledge and information needs

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

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  9. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  10. 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).

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  11. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  12. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  13. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  14. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  15. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  16. Return to work

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

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  17. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

  18. 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.

    Measured: 3, 6 and 12 months after discharge from rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2019
  2. Study start27 Jun 2017
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04119479
Sponsor's protocol ID
IMPROVE
Acronym
ImPRoVe
Status last verified
Jan 2021
First submitted
26 Sep 2019
Last updated
3 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data sharing is planned after main publication of results.

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.

    PubMed 33324916

  • 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.

    PubMed 35510813

  • 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.

    PubMed 34955097

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compound score (time frame: 12 months after discharge from rehabilitation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04119479, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.

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