Sunnaas International Network´s Stroke Study (SINs)

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Stroke
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • China Research rehabilitation center
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan 81 rehabilitation center
• Israel
  • Tel Aviv, Israel
    • Sheba Medical Center
• Norway
  • Nesoddtangen, Norway
    • Sunnaas rehabilitation hospital
• Palestinian Territory, occupied
  • Gaza, Palestinian Territory, occupied
    • El Wafa rehabilitation center
  • Palestine
    • Betlehem, Palestine, Palestinian Territory, occupied
      • Betlehem arab society rehabilitation
• Russian Federation
  • Petrozavodsk, Russian Federation
    • Petrozavodsk
• Sweden
  • Gothenburgh, Sweden
    • Sahlgrenska University Hospital
• United States
  • New York
    • New York, New York, United States
      • Rusk Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

stroke patients in need of specialised comprehensive rehabilitation

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: multidisciplinary specialised rehabilitation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Life Satisfaction checklist (LiSat-11)	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	patients will be followed 6 months from baseline testing

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of health stroke scale (NIHSS)	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	patients will be tested baseline and at discharge
Modified Rankin Scale	it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke	patients will be followed 6 months from baseline testing
Description of the psycho- social situation	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.	6 months after discharge
description of institution	a questionaire where the participants are required to describe the services available, methods used in rehabilitation, intensity of training, procedures for intake and discharge	baseline
registration data	questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication	baseline

Collaborators and Investigators

• Sponsor: Sunnaas Rehabilitation Hospital
• Collaborators: Sahlgrenska University Hospital, Sweden; Sheba Medical Center; 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; Al-Wafa Rehabilitation Hospital; Bethlehem Arab Society for Rehabilitation, Betlehem
• Investigators: Study Director: Johan K Stanghelle, PhD, MD, Sunnaas Rehabilitation Hospital, University of Oslo

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 23, 2012
• First Posted (Estimate): November 26, 2012

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: stroke, rehabilitation, multidisciplinary, description
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SINs stroke study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No