## Protocol Section
### Identification Module
**NCT ID:** NCT04119479

**Acronym:** ImPRoVe

**Brief Title:** Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

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

#### Organization Study ID Info
**ID:** IMPROVE
#### Organization
**Class:** OTHER
**Full Name:** Universitätsklinikum Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2020-10-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-03

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-31

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-10-31

**Type:** ACTUAL

#### Start Date
**Date:** 2017-06-27

**Type:** ACTUAL

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2019-10-08
**Type:** ACTUAL
**Study First Submit Date:** 2019-09-26
**Study First Submit QC Date:** 2019-10-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Deutsche Rentenversicherung

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitätsklinikum Hamburg-Eppendorf

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Stroke

**Keywords:**

- Functional recovery

- Neurorehabilitation

- Stroke

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 227

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Compound score

**Time Frame:** 12 months after discharge from rehabilitation

#### Secondary Outcomes

**Description:** Standardized test for differential diagnosis Aphasia - no aphasia.

**Measure:** Aphasia test

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

**Description:** 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.

**Measure:** Apraxia screen of TULIA (AST)

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

**Description:** 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.

**Measure:** Autonomy and participation

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

**Description:** 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).

**Measure:** Fatigue scale for motor function and cognition (FSMC)

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

**Description:** 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.

**Measure:** Fugl-Meyer assessment upper extremity (FMA)

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

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

**Measure:** Grip and pinch force

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

**Description:** 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).

**Measure:** Index for measuring restrictions on participation (IMET)

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

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

**Measure:** Knowledge and information needs

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

**Description:** 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.

**Measure:** Line bisection test (LBS)

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

**Description:** 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).

**Measure:** Modified Rankin Scale (MRS)

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

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

**Measure:** Montreal cognitive assessment (MoCA)

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

**Description:** 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.

**Measure:** National institutes of health stroke scale (NIHSS)

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

**Description:** 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.

**Measure:** Nine hole peg test (NHPT)

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

**Description:** 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.

**Measure:** Patient Health Questionnaire (PHQ-9)

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

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

**Measure:** Patient reported health status (EQ-5D)

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

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

**Measure:** Return to work

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

**Description:** 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.

**Measure:** Stroke impact scale (SIS)

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

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

**Measure:** Time up and go test (TUG)

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

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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).

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bad Bramstedt

**Country:** Germany

**Facility:** Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation

**Zip:** 24576

**Location 2:**

**City:** Damp

**Country:** Germany

**Facility:** Rehaklinik Damp - Neurologie

**Zip:** 24351

**Location 3:**

**City:** Geesthacht

**Country:** Germany

**Facility:** Rehaklinik Geesthacht - Neurologie

**Zip:** 21502

**Location 4:**

**City:** Hamburg

**Country:** Germany

**Facility:** RehaCentrum Hamburg - Neurologische Rehabilitation

**Zip:** 20097

**Location 5:**

**City:** Hamburg

**Country:** Germany

**Facility:** Universitätsklinikum Hamburg-Eppendorf, Neurologie

**Zip:** 20246

**Location 6:**

**City:** Soltau

**Country:** Germany

**Facility:** MediClin Klinikum Soltau - Neurologische Rehabilitation

**Zip:** 29614

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Neurology, University Medical Center Hamburg-Eppendorf

**Name:** Götz Thomalla, Prof. Dr.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Department of Neurology, University Medical Center Hamburg-Eppendorf

**Name:** Christian Gerloff, Prof. Dr.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Access Criteria:** Personal login into UKE data repository.

**Description:** Data sharing is planned after main publication of results.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** Within 24 months after main publication.

### References Module

#### References

**Citation:** 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.

**PMID:** 33324916

**Citation:** 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.

**PMID:** 35510813

**Citation:** 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.

**PMID:** 34955097

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002561

- Term: Cerebrovascular Disorders

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: HIGH

- As Found: Stroke

- ID: M5810

- Name: Cerebrovascular Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000020521

- Term: Stroke

### Misc Info Module

- Version Holder: 2024-05-24
