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Sunnaas International Network´s Stroke Study (SINs)

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ClinicalTrials.gov Identifier: NCT01732679
Recruitment Status : Completed
First Posted : November 26, 2012
Last Update Posted : April 25, 2017
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Cerebral Stroke Other: 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

Study Design

Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.
Study Start Date : September 2012
Primary Completion Date : December 2014
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
stroke patients
specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
Other: rehabilitation
Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge
Other Name: multidisciplinary specialised rehabilitation

Outcome Measures

Primary Outcome Measures :
  1. activities of daily living [ Time Frame: patients will be followed 6 months from baseline testing ]
    Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.

Secondary Outcome Measures :
  1. The Life Satisfaction checklist (LiSat-11) [ Time Frame: patients will be followed 6 months from baseline testing ]
    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

Other Outcome Measures:
  1. National Institutes of health stroke scale (NIHSS) [ Time Frame: patients will be tested baseline and at discharge ]

    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

  2. Modified Rankin Scale [ Time Frame: patients will be followed 6 months from baseline testing ]
    it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke

  3. Description of the psycho- social situation [ Time Frame: 6 months after discharge ]
    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.

  4. description of institution [ Time Frame: baseline ]
    a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge

  5. registration data [ Time Frame: baseline ]
    questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
stroke patients in need of specialised comprehensive rehabilitation

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732679

United States, New York
Rusk Institute
New York, New York, United States
China, Sichuan
Sichuan 81 rehabilitation center
Chengdu, Sichuan, China
China Research rehabilitation center
Beijing, China
Sheba medical center
Tel Aviv, Israel
Sunnaas rehabilitation Hospital
Nesoddtangen, Norway
Palestinian Territory, occupied
Betlehem arab society rehabilitation
Betlehem, Palestine, Palestinian Territory, occupied
El Wafa rehabilitation center
Gaza, Palestinian Territory, occupied
Russian Federation
Petrozavodsk, Russian Federation
Sahlgrenska university hospital
Gothenburgh, Sweden
Sponsors and Collaborators
Sunnaas Rehabilitation Hospital
China Rehabilitation Research Center
Sichuan 81 Rehabilitation Center, Chengdu
NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York
City outpatient clinics №2,Petrozavodsk, Petrozavodsk
Sheba Medical Center
Al-Wafa Rehabilitation Hospital
Bethlehem Arab Society for Rehabilitation, Betlehem
Sahlgrenska University Hospital, Sweden
Study Director: Johan K Stanghelle, PhD, MD Sunnaas rehabilitation hospital, University of Oslo
More Information

Responsible Party: Birgitta Langhammer, Associate professor/ project manager, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01732679     History of Changes
Other Study ID Numbers: SINs stroke study
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Birgitta Langhammer, Sunnaas Rehabilitation Hospital:
stroke, rehabilitation, multidisciplinary, description

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases