<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732679</url>
  </required_header>
  <id_info>
    <org_study_id>SINs stroke study</org_study_id>
    <nct_id>NCT01732679</nct_id>
  </id_info>
  <brief_title>Sunnaas International Network´s Stroke Study</brief_title>
  <acronym>SINs</acronym>
  <official_title>A Prospective Multicenter Study of Stroke Rehabilitation in Seven Countries: Norway, China, USA, Russia, Israel, Palestine, and Sweden.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnaas Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>China Rehabilitation Research Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sichuan 81 Rehabilitation Center, Chengdu</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NYU Langoon medical center; The Rusk Institute of Rehabilitation Medicine, New York</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>City outpatient clinics №2,Petrozavodsk, Petrozavodsk</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Al-Wafa Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bethlehem Arab Society for Rehabilitation, Betlehem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sunnaas Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A descriptive study of the stroke rehabilitation content in specialized clinics in seven&#xD;
      countries: procedures for admission to rehabilitation, services available and provided to&#xD;
      patients, as well as duration of the stay and discharge routines. An observational study of&#xD;
      changes in regard to the physical function, quality of life and psycho-social factors in&#xD;
      stroke patients before and after specialized rehabilitation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The descriptive study is two folded:&#xD;
&#xD;
      1) Description of the rehabilitation centers and the content the respective clinic presents&#xD;
      as specialized rehabilitation.&#xD;
&#xD;
      A description of the expected change this input will result in in form of patients change in&#xD;
      ADL and life satisfaction, with repeated measurements:&#xD;
&#xD;
      2a) reports of change in activities of daily living from baseline, to one fixed time (18-22&#xD;
      days in rehab),at discharge (which will vary),6 and 12 months post discharge (relatively&#xD;
      fixed time) .&#xD;
&#xD;
      2b) reports of possible change in life satisfaction at baseline, discharge, 6 and 12 months&#xD;
      after discharge.&#xD;
&#xD;
      Since the times for admission is expected to vary, which will be described under 1),we also&#xD;
      want to measure if and how this difference might influence results. Therefore a fixed measure&#xD;
      is inserted between admission and discharge. we have added a &quot;relatively&quot; fixed date at 6&#xD;
      months post stroke in order to see if change of function from specialized rehabilitation will&#xD;
      differ in a longitudinal perspective, and if possible to see if the difference in time to&#xD;
      admission (time from debut till admission in specialized rehabilitation)might influence&#xD;
      results.&#xD;
&#xD;
      3) description of psycho- social factors at 6 and 12 months post discharge&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>activities of daily living</measure>
    <time_frame>patients will be followed 6 months from baseline testing</time_frame>
    <description>Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Life Satisfaction checklist (LiSat-11)</measure>
    <time_frame>patients will be followed 6 months from baseline testing</time_frame>
    <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</description>
  </secondary_outcome>
  <other_outcome>
    <measure>National Institutes of health stroke scale (NIHSS)</measure>
    <time_frame>patients will be tested baseline and at discharge</time_frame>
    <description>NIHSS is a clinical stroke assessment tool to evaluate and document neurological status in acute stroke patients.&#xD;
The timeframe for discharge will vary with the different clinics since this is one of the differences expected.&#xD;
Length of stay is one of the outcomes</description>
  </other_outcome>
  <other_outcome>
    <measure>Modified Rankin Scale</measure>
    <time_frame>patients will be followed 6 months from baseline testing</time_frame>
    <description>it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke</description>
  </other_outcome>
  <other_outcome>
    <measure>Description of the psycho- social situation</measure>
    <time_frame>6 months after discharge</time_frame>
    <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.</description>
  </other_outcome>
  <other_outcome>
    <measure>description of institution</measure>
    <time_frame>baseline</time_frame>
    <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</description>
  </other_outcome>
  <other_outcome>
    <measure>registration data</measure>
    <time_frame>baseline</time_frame>
    <description>questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">230</enrollment>
  <condition>Cerebral Stroke</condition>
  <arm_group>
    <arm_group_label>stroke patients</arm_group_label>
    <description>specialized rehabilitation in a multidisciplinary team, Sunnaas International Network</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>rehabilitation</intervention_name>
    <description>Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge</description>
    <arm_group_label>stroke patients</arm_group_label>
    <other_name>multidisciplinary specialised rehabilitation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        stroke patients in need of specialised comprehensive rehabilitation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary diagnosis of stroke, in need of specialized comprehensive rehabilitation,&#xD;
             voluntary participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sub-arachnoid hæmorrhage, tumor or other severe medical condition in combination with&#xD;
             stroke that will influence outcomes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan K Stanghelle, PhD, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sunnaas rehabilitation hospital, University of Oslo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rusk Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sichuan 81 rehabilitation center</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Research rehabilitation center</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba medical center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnaas rehabilitation Hospital</name>
      <address>
        <city>Nesoddtangen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Betlehem arab society rehabilitation</name>
      <address>
        <city>Betlehem</city>
        <state>Palestine</state>
        <country>Palestinian Territory, occupied</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>El Wafa rehabilitation center</name>
      <address>
        <city>Gaza</city>
        <country>Palestinian Territory, occupied</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petrozavodsk</name>
      <address>
        <city>Petrozavodsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska university hospital</name>
      <address>
        <city>Gothenburgh</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Israel</country>
    <country>Norway</country>
    <country>Palestinian Territory, occupied</country>
    <country>Russian Federation</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Palestinian Territories, Occupied</country>
  </removed_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>April 24, 2017</last_update_submitted>
  <last_update_submitted_qc>April 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnaas Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Birgitta Langhammer</investigator_full_name>
    <investigator_title>Associate professor/ project manager</investigator_title>
  </responsible_party>
  <keyword>stroke, rehabilitation, multidisciplinary, description</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732679
org study id: SINs stroke study
nct id: NCT01732679
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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
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
observational model: Cohort
time perspective: Prospective
measure: activities of daily living
time frame: patients will be followed 6 months from baseline testing
description: Changes in Activities of daily living are monitored as an indirect evaluation of how the specialized rehabilitation may influence patients' outcomes.
measure: The Life Satisfaction checklist (LiSat-11)
time frame: patients will be followed 6 months from baseline testing
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: National Institutes of health stroke scale (NIHSS)
time frame: patients will be tested baseline and at discharge
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: Modified Rankin Scale
time frame: patients will be followed 6 months from baseline testing
description: it is an evaluation of the degree of disability or dependence in the daily activities of people who have suffered a stroke
measure: Description of the psycho- social situation
time frame: 6 months after discharge
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 institution
time frame: baseline
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: registration data
time frame: baseline
description: questionnaire regarding demographic data; age, gender, civil status, comorbidity, medication
arm group label: stroke patients
description: specialized rehabilitation in a multidisciplinary team, Sunnaas International Network
intervention type: Other
intervention name: rehabilitation
description: Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge
arm group label: stroke patients
other name: multidisciplinary specialised rehabilitation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Johan K Stanghelle, PhD, MD
role: Study Director
affiliation: Sunnaas rehabilitation hospital, University of Oslo
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Israel
country: Norway
country: Palestinian Territory, occupied
country: Russian Federation
country: Sweden
country: United States
country: Palestinian Territories, Occupied
responsible party type: Principal Investigator
investigator affiliation: Sunnaas Rehabilitation Hospital
investigator full name: Birgitta Langhammer
investigator title: Associate professor/ project manager
mesh term: Stroke