Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke
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Lead
Daiichi Sankyo
Age
21–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke
