Sunnaas International Network´s Stroke Study

Cerebral Stroke Clinical Trial

— SINs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732679
• Other study ID #: SINs stroke study
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: April 24, 2017
• Start date: September 2012
• Est. completion date: October 2016

Study information

• Verified date: April 2017
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

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

Locations

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

Sponsors (9)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	Al-Wafa Rehabilitation Hospital, Bethlehem Arab Society for Rehabilitation, Betlehem, China Rehabilitation Research Center, City outpatient clinics ?2,Petrozavodsk, Petrozavodsk, NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York, Sahlgrenska University Hospital, Sweden, Sheba Medical Center, Sichuan 81 Rehabilitation Center, Chengdu

Countries where clinical trial is conducted

United States,  China,  Israel,  Norway,  Palestinian Territory, occupied,  Russian Federation,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	registration data	questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication	baseline
Primary	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	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