Sunnaas International Network´s Stroke Study (SINs)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Sunnaas Rehabilitation Hospital
Sponsor:
Collaborators:
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
El Wafa rehabilitation hospital, Gaza
Bethlehem Arab Society for Rehabilitation, Betlehem
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Birgitta Langhammer, Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01732679
First received: November 8, 2012
Last updated: November 23, 2012
Last verified: November 2012
  Purpose

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 Intervention
Stroke Rehabilitation in Specialised Rehabilitation Clinics
Other: multidisciplinary rehabilitation

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Sunnaas Rehabilitation Hospital:

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


Secondary Outcome Measures:
  • The Life Satisfaction checklist (LiSat-11) [ Time Frame: patients will be followed 6 months from baseline testing ] [ Designated as safety issue: No ]
    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:
  • National Institutes of health stroke scale (NIHSS) [ Time Frame: patients will be tested baseline and at discharge ] [ Designated as safety issue: No ]

    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


  • Modified Rankin Scale [ Time Frame: patients will be followed 6 months from baseline testing ] [ Designated as safety issue: No ]
    it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke

  • Description of the psycho- social situation [ Time Frame: 6 months after discharge ] [ Designated as safety issue: No ]
    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.

  • description of institution [ Time Frame: baseline ] [ Designated as safety issue: No ]
    a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge

  • registration data [ Time Frame: baseline ] [ Designated as safety issue: No ]
    questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication


Estimated Enrollment: 270
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
stroke patients
specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
Other: multidisciplinary 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. This is reported once.

So follows 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) and at discharge (which will vary) and at 6 months after discharge (relatively fixed time) .

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

stroke patients in need of specialised comprehensive rehabilitation

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732679

Contacts
Contact: Birgitta M Langhammer, PhD RPT +4722452510 Birgitta.Langhammer@hioa.no
Contact: Johan K Stanghelle, PhD, MD +4766969173 johan.stanghelle@sunnaas.no

Locations
United States, New York
Rusk Institute Not yet recruiting
New York, New York, United States
Contact: Tamara Buschnik, PhD OT    212-263-6547    Tamara.Bushnik@nyumc.org   
Sub-Investigator: Annika Ginsberg         
China, Sichuan
Sichuan 81 rehabilitation center Recruiting
Chengdu, Sichuan, China
Contact: Xie Li, MD    +862813981865226    444158175@qq.com   
Contact: Wu Yuru       766497867@qq.com   
China
China Research rehabilitation center Recruiting
Beijing, China
Contact: Zhang Tong, PhD MD    +8613701395491    zhangtongzt61611@sohu.com   
Contact: Xiaoxia Du, PhD MD    +8615010930096    DUxiaoxia2005@gmail.com   
Sub-Investigator: Li Chao Jinzi, Msc         
Israel
Sheba medical center Not yet recruiting
Tel Aviv, Israel
Contact: Ofer Keren, MD    +35305183    ofkeren@zahav.net.il   
Contact: Fabiana Jachniuk, MD    +35305183    fabijach@gmail.com   
Sub-Investigator: Yael Amzallag, OT         
Norway
Sunnaas rehabilitation Hospital Recruiting
Nesoddtangen, Norway
Contact: Frank Becker, PhD, MD    +4766969000    Frank.Becker@sunnaas.no   
Contact: Anne Marthe Sanders, Msc    +4766969000    Anne-Marthe.Sanders@sunnaas.no   
Principal Investigator: Frank Becker, PhD Md         
Palestinian Territories, Occupied
Betlehem arab society rehabilitation Recruiting
Betlehem, Palestine, Palestinian Territories, Occupied
Contact: Elias Saba, MD       Elias-saba@hotmail.com   
Contact: Edmund Shehadeh       Basr@basr.org   
Sub-Investigator: Samir Banura         
El Wafa rehabilitation center Recruiting
Gaza, Palestinian Territories, Occupied
Contact: Khamis Elessi, MD    +00970599868034    Khamis1000000@googlemail.com   
Contact: Fuad Luzon, Msc OT    +00970599485898    fuadluzon@yahoo.com   
Russian Federation
Petrozavodsk Recruiting
Petrozavodsk, Russian Federation
Contact: Maria Panchenko, MD       Pan-maria@yandex.ru   
Contact: Svetlana Berlogina, MD    +79095726864    sharparsv@yandex.ru   
Sub-Investigator: Elena Retner, ST         
Sweden
Sahlgrenska university hospital Recruiting
Gothenburgh, Sweden
Contact: Åsa Lundgren Nilsson, PhD OT    +46313422414    Asa.Lundgren-Nilsson@neuro.gu.se   
Contact: Karin Blomqvist, MD    +46704534332    karin.blomqvist@vgregion.se   
Sub-Investigator: Linda Johnsson         
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
El Wafa rehabilitation hospital, Gaza
Bethlehem Arab Society for Rehabilitation, Betlehem
Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

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
Study First Received: November 8, 2012
Last Updated: November 23, 2012
Health Authority: Norway: Sunnaas International Network

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 15, 2014