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Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01496885
First Posted: December 21, 2011
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
  Purpose
The purpose of this study is to evaluate the utility of the S-STREAM as an instrument to assess motor function in subjects who have experienced a nonhemorrhagic ischemic stroke.

Condition
Nonhemorrhagic Ischemic Stroke Motor Function

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Multicenter Observational Study to Evaluate the Simplified STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Obtained Between 24 and 48 Hours of a Nonhemorrhagic Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo, Inc.:

Primary Outcome Measures:
  • Evaluate the Simplified STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Obtained Between 24 and 48 Hours of a Nonhemorrhagic Ischemic Stroke [ Time Frame: Up to 84 days ]

Enrollment: 120
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Nonhemorrhagic Ischemic Stroke
Subjects obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects may be selected upon admission to an acute care emergency center, inpatient facility, or rehabilitation center.
Criteria

Inclusion Criteria:

  • Male or female subjects between 21 and 85 years, inclusive
  • Subjects obtained between 24 and 48 hours of a nonhemorrhagic ischemic stroke
  • Total score between 20 and 85 on the S-STREAM administered between 24 and 48 hours after stroke onset

Exclusion Criteria:

  • History of previous stroke; uncontrolled severe hypertension; dementia; advanced Parkinson disease or other significant movement disorders
  • Development of hemodynamic instability following the stroke
  • Abnormal clinical laboratory values on routine clinical laboratory testing
  • History of drug or alcohol abuse
  • Current participation in another clinical study involving study drug
  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): NCT01496885


  Show 27 Study Locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
  More Information

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01496885     History of Changes
Other Study ID Numbers: ASBI 801
First Submitted: December 19, 2011
First Posted: December 21, 2011
Last Update Posted: October 20, 2015
Last Verified: October 2015

Keywords provided by Daiichi Sankyo, Inc.:
stroke

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