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:
Information provided by (Responsible Party):
Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01496885
First received: December 19, 2011
Last updated: June 6, 2013
Last verified: June 2013
  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 Asubio Pharmaceuticals, 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
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
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: NCT01496885

  Show 27 Study Locations
Sponsors and Collaborators
Asubio Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Asubio Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01496885     History of Changes
Other Study ID Numbers: ASBI 801
Study First Received: December 19, 2011
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board
Canada: Research Ethics Board

Keywords provided by Asubio Pharmaceuticals, Inc.:
stroke

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
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 16, 2014