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

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

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.

Study Overview

• Status: Completed
• Conditions: Motor Function; Nonhemorrhagic Ischemic Stroke
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
    • Edmonton, Alberta, Canada, T6G 2B7
    • Edmonton, Alberta, Canada, T6L 5X8
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
    • Montreal, Quebec, Canada, H2L 4M1
• United States
  • California
    • Newport Beach, California, United States, 92658
  • Colorado
    • Englewood, Colorado, United States, 80113
  • Georgia
    • Lawrenceville, Georgia, United States, 30045
  • Illinois
    • Chicago, Illinois, United States, 60612
  • Iowa
    • Des Moines, Iowa, United States, 50314
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
    • Springfield, Massachusetts, United States, 01199
    • Worcester, Massachusetts, United States, 01606
  • Michigan
    • Detroit, Michigan, United States, 48236
  • New Jersey
    • Edison, New Jersey, United States, 08818
  • New York
    • Bronx, New York, United States, 10467
    • Brooklyn, New York, United States, 11220
  • Oregon
    • Portland, Oregon, United States, 97239
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
    • Philadelphia, Pennsylvania, United States, 19104
    • Philadelphia, Pennsylvania, United States, 19107
  • South Carolina
    • Charleston, South Carolina, United States, 29402
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
    • Nashville, Tennessee, United States, 37232-2551
  • Virginia
    • Norfolk, Virginia, United States, 23507
    • Richmond, Virginia, United States, 23298
  • Washington
    • Seattle, Washington, United States, 98104

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants may be selected upon admission to an acute care emergency center, inpatient facility, or rehabilitation center.

Description

Inclusion Criteria:

• Male or female participants between 21 and 85 years, inclusive
• Participants had no prior history of stroke (unless the stroke was silent or not associated with a motor deficit) presented between 24 and 48 hours from onset with an acute stroke with clinical assessments and imaging studies (conducted as part of the standard of care procedures in stroke patients) indicating that the stroke was ischemic, with no secondary hemorrhage large enough to exert a mass effect that would contribute significantly to the neurological deficit (small punctate hemorrhages were permitted), in the vascular distribution of the middle cerebral artery and not classifiable as a lacunar stroke
• Participants understood and agreed to comply with the requirements of the study and they were willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study
• Participants were to have scored at least 16 on the Mini Mental Status Examination (MMSE) at screening. If the participant had an expressive aphasia and was unable to qualify based on the MMSE, the participant may have been evaluated with a language-modified form of the MMSE1 in conjunction with the investigator's clinical assessment that the participant was cognitively able to complete study procedures and stroke scales to determine eligibility. If the aphasia was too severe for the participant to complete the language-modified MMSE, the participant was excluded.
• Participants had to have a total score between 20 and 85, inclusive, 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; or other clinically significant diseases which, in the opinion of the investigator, would have jeopardized the safety of the participant or impacted the validity of the study results
• Development of hemodynamic instability following the stroke as manifested by a persistent post stroke systolic blood pressure less than 80 mm Hg (or was dependent on medications to maintain a systolic blood pressure greater than or equal to 80 mm Hg) or greater than 190 mm Hg at the time of screening
• Presence of significant global or receptive aphasia that would have interfered with the participant's ability to understand and comply with study procedures or complete stroke assessments
• Abnormal clinical laboratory values on routine clinical laboratory test values at screening including alanine transaminase or aspartate transaminase greater than or equal to 3 times the upper limit of normal, serum creatinine greater than or equal to 3.0 mg/dL, or hemoglobin less than or equal to 10 g/dL, or any other laboratory investigation deemed by the investigator to be indicative of a clinically significant illness that could have prevented the participant from complying with study procedures or impacted on the outcome of the stroke scales
• History of drug or alcohol abuse
• History of any surgery or presence of any medical condition that, in the judgment of the investigator, may have affected the validity of the study results
• Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of screening
• Unable to complete baseline S-STREAM and NIHSS assessments within 48 hours of stroke onset

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nonhemorrhagic Ischemic Stroke; Subjects obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke	Other: Observational study; This was an observational study and no study drug was administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke	The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM fit the requirements of the Rasch model. The raw scores were Rasch transformed to achieve logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean change from baseline in S-STREAM Rasch-transformed score is being reported; higher S-STREAM scores indicate better outcomes.	Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Mean Percent Change From Baseline in Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke	The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM has been shown to fit the requirements of the Rasch model. The raw scores were Rasch transformed to get the logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean percent change from baseline in S-STREAM Rasch transformed score is being reported; higher S-STREAM scores indicate better outcomes.	Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Number of Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke With Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) Score, by Category	The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). The S-STREAM assessments are conducted in the order of the following positions: supine, sitting, and standing. Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). Based on the point scales described, the maximum score for upper limb movements is 10, for lower limb movements is 10, and for mobility is 15; the maximum aggregate S-STREAM raw score is therefore 35. Higher S-STREAM scores indicated better outcome. Total S-STREAM scores were generated using Rasch transformations and subsequently scaled to scores between 0 and 100 for purposes of analysis with higher total S-STREAM scores indicating a better outcome.	Baseline up to Day 84 post non-hemorrhagic ischemic stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subgroup Analysis of Total S-STREAM Score and Mean Change From Baseline to Day 84 in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke	The S-STREAM is composed of 5 items each across 3 components (upper limb movements, lower limb movements, and mobility). Limb movements are scored on a 3-point integer scale ranging from 0 (unable to perform) to 2 (able to complete the movement comparable to the unaffected side). Basic mobility items are scored on a 4-point integer scale ranging from 0 (unable to perform) to 3 (able to complete the activity). All S-STREAM scores were transformed to a range of 0 to 100 via Rasch transformation since the S-STREAM has been shown to fit the requirements of the Rasch model. The raw scores were Rasch transformed to get the logits scores and then remapped from the logit score to a 0 to 100 scale, where 0 indicates worst outcome and 100 indicate best outcome. The mean change from baseline in S-STREAM Rasch-transformed score is being reported; higher S-STREAM scores indicate better outcomes.	Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Mean Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke	The NIHSS is a stroke deficit assessment scale composed of 11 components, where a score of 0 is defined as normal while higher scores indicate increasing severity of impairment for each component. Components include level of consciousness (3 evaluations, 2 of which are scored 0 to 2 and 1 of which is scored 0 to 3), best gaze (scored 0 to 2), visual (scored 0 to 3), facial palsy (scored 0 to 3), motor arm (scored 0 to 4 in both arms), motor leg (scored 0 to 4 in both legs), limb ataxia (scored 0 to 2), sensory (scored 0 to 2), best language (scored 0 to 3), dysarthria (scored 0 to 2), and extinction and inattention (scored 0 to 2). The total NIHSS score is calculated by summing individual scores. The maximum total score on the NIHSS is 42 and the level of stroke severity ranges from 0 (normal, no stroke) to 42 (severe stroke). Higher NIHSS scores indicate worse outcome. The mean change from baseline is also being reported; the greater the negative value, the better the outcome.	Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Mean Percent Change From Baseline in National Institutes of Health Stroke Scale Score in Participants Obtained Between 24 and 48 Hours of a Non-hemorrhagic Ischemic Stroke	The NIHSS is a stroke deficit assessment scale composed of 11 components, where a score of 0 is defined as normal while higher scores indicate increasing severity of impairment for each component. Components include level of consciousness (3 evaluations, 2 of which are scored 0 to 2 and 1 of which is scored 0 to 3), best gaze (scored 0 to 2), visual (scored 0 to 3), facial palsy (scored 0 to 3), motor arm (scored 0 to 4 in both arms), motor leg (scored 0 to 4 in both legs), limb ataxia (scored 0 to 2), sensory (scored 0 to 2), best language (scored 0 to 3), dysarthria (scored 0 to 2), and extinction and inattention (scored 0 to 2). The total NIHSS score is calculated by summing individual component scores. The max total score on NIHSS is 42 and the level of stroke severity as measured by the overall NIHSS score ranges from 0 (normal, no stroke) to 42 (severe stroke). The mean percent change from baseline is being reported; the greater the negative value, the better the outcome.	Baseline up to Day 84 post non-hemorrhagic ischemic stroke

Collaborators and Investigators

• Sponsor: Daiichi Sankyo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2012
• Primary Completion (Actual): May 22, 2013
• Study Completion (Actual): May 22, 2013

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 20, 2011
• First Posted (Estimate): December 21, 2011

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: ASBI 801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR