## Protocol Section
### Identification Module
**NCT ID:** NCT01732679

**Acronym:** SINs

**Brief Title:** Sunnaas International Network´s Stroke Study

**Official Title:** A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.

#### Organization Study ID Info
**ID:** SINs stroke study
#### Organization
**Class:** OTHER
**Full Name:** Sunnaas Rehabilitation Hospital
### Status Module
#### Completion Date
**Date:** 2016-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-25

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Start Date
**Date:** 2012-09

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2012-11-26
**Type:** ESTIMATED
**Study First Submit Date:** 2012-11-08
**Study First Submit QC Date:** 2012-11-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** China Rehabilitation Research Center

**Class:** UNKNOWN

**Name:** Sichuan 81 Rehabilitation Center, Chengdu

**Class:** UNKNOWN

**Name:** NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York

**Class:** OTHER

**Name:** City outpatient clinics №2,Petrozavodsk, Petrozavodsk

**Class:** OTHER_GOV

**Name:** Sheba Medical Center

**Class:** OTHER

**Name:** Al-Wafa Rehabilitation Hospital

**Class:** UNKNOWN

**Name:** Bethlehem Arab Society for Rehabilitation, Betlehem

**Class:** OTHER

**Name:** Sahlgrenska University Hospital, Sweden

#### Lead Sponsor

**Class:** OTHER

**Name:** Sunnaas Rehabilitation Hospital

#### Responsible Party

**Investigator Affiliation:** Sunnaas Rehabilitation Hospital

**Investigator Full Name:** Birgitta Langhammer

**Investigator Title:** Associate professor/ project manager

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A descriptive study of the stroke rehabilitation content in specialized clinics in seven countries: procedures for admission to rehabilitation, services available and provided to patients, as well as duration of the stay and discharge routines. An observational study of changes in regard to the physical function, quality of life and psycho-social factors in stroke patients before and after specialized rehabilitation

**Detailed Description:** The descriptive study is two folded:

1) Description of the rehabilitation centers and the content the respective clinic presents as specialized rehabilitation.

A description of the expected change this input will result in in form of patients change in ADL and life satisfaction, with repeated measurements:

2a) reports of change in activities of daily living from baseline, to one fixed time (18-22 days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively fixed time) .

2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months after discharge.

Since the times for admission is expected to vary, which will be described under 1),we also want to measure if and how this difference might influence results. Therefore a fixed measure is inserted between admission and discharge. we have added a "relatively" fixed date at 6 months post stroke in order to see if change of function from specialized rehabilitation will differ in a longitudinal perspective, and if possible to see if the difference in time to admission (time from debut till admission in specialized rehabilitation)might influence results.

3) description of psycho- social factors at 6 and 12 months post discharge

### Conditions Module

**Conditions:**

- Cerebral Stroke

**Keywords:**

- stroke, rehabilitation, multidisciplinary, description

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 230

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** specialized rehabilitation in a multidisciplinary team, Sunnaas International Network

**Intervention Names:**

- Other: rehabilitation

**Label:** stroke patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- stroke patients

**Description:** Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge

**Name:** rehabilitation

**Other Names:**

- multidisciplinary specialised rehabilitation

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** NIHSS is a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients.

The timeframe for discharge will vary with the different clinics since this is one of the differences expected.

Length of stay is one of the outcomes

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

**Time Frame:** patients will be tested baseline and at discharge

**Description:** it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke

**Measure:** Modified Rankin Scale

**Time Frame:** patients will be followed 6 months from baseline testing

**Description:** A semi - structured interview, with focus on the psycho-social situation 6 months after rehabilitation, will be performed. Questions will focus on the work-, financial situation, what sort of follow-up services, recreational- and social activities are available, and what is considered the major change of life after stroke.

**Measure:** Description of the psycho- social situation

**Time Frame:** 6 months after discharge

**Description:** a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge

**Measure:** description of institution

**Time Frame:** baseline

**Description:** questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication

**Measure:** registration data

**Time Frame:** baseline

#### Primary Outcomes

**Description:** Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.

**Measure:** activities of daily living

**Time Frame:** patients will be followed 6 months from baseline testing

#### Secondary Outcomes

**Description:** LiSat-11 consists of patients estimations of satisfaction with life as a whole as well as satisfaction in ten specific domains: vocation, economy, leisure, contacts, sexual life, activities of daily living (ADL), family life, partner relationship, somatic health, psychological health

**Measure:** The Life Satisfaction checklist (LiSat-11)

**Time Frame:** patients will be followed 6 months from baseline testing

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* primary diagnosis of stroke, in need of specialized comprehensive rehabilitation, voluntary participation

Exclusion Criteria:

* sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with stroke that will influence outcomes

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** stroke patients in need of specialised comprehensive rehabilitation

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Rusk Institute

**State:** New York

**Location 2:**

**City:** Chengdu

**Country:** China

**Facility:** Sichuan 81 rehabilitation center

**State:** Sichuan

**Location 3:**

**City:** Beijing

**Country:** China

**Facility:** China Research rehabilitation center

**Location 4:**

**City:** Tel Aviv

**Country:** Israel

**Facility:** Sheba medical center

**Location 5:**

**City:** Nesoddtangen

**Country:** Norway

**Facility:** Sunnaas rehabilitation Hospital

**Location 6:**

**City:** Betlehem

**Country:** Palestinian Territory, occupied

**Facility:** Betlehem arab society rehabilitation

**State:** Palestine

**Location 7:**

**City:** Gaza

**Country:** Palestinian Territory, occupied

**Facility:** El Wafa rehabilitation center

**Location 8:**

**City:** Petrozavodsk

**Country:** Russian Federation

**Facility:** Petrozavodsk

**Location 9:**

**City:** Gothenburgh

**Country:** Sweden

**Facility:** Sahlgrenska university hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Sunnaas rehabilitation hospital, University of Oslo

**Name:** Johan K Stanghelle, PhD, MD

**Role:** STUDY_DIRECTOR

## 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

#### Removed Countries

- Country: Palestinian Territories, Occupied

- Version Holder: 2024-05-24
