Nonhemorrhagic Ischemic StrokeNCT01496885
Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke
An observational study of Nonhemorrhagic Ischemic Stroke and Motor Function, run by Daiichi Sankyo at 27 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Nonhemorrhagic Ischemic Stroke, Motor Function
- What is being tested?
- Observational study
- How many people
- 120 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 18 Jan 2012to 22 May 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants may be selected upon admission to an acute care emergency center, inpatient facility, or rehabilitation center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States22 sites
Study site
Boston, Massachusetts, 02114
Study site
Brooklyn, New York, 11220
Study site
Charleston, South Carolina, 29402
Study site
Chattanooga, Tennessee, 37403
Study site
Chicago, Illinois, 60612
Study site
Des Moines, Iowa, 50314
Study site
Detroit, Michigan, 48236
Study site
Edison, New Jersey, 08818
Study site
Englewood, Colorado, 80113
Study site
Hershey, Pennsylvania, 17033
Study site
Lawrenceville, Georgia, 30045
Study site
Nashville, Tennessee, 37232-2551
Study site
Newport Beach, California, 92658
Study site
Norfolk, Virginia, 23507
Study site
Philadelphia, Pennsylvania, 19104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Portland, Oregon, 97239
Study site
Richmond, Virginia, 23298
Study site
Seattle, Washington, 98104
Study site
Springfield, Massachusetts, 01199
Study site
The Bronx, New York, 10467
Study site
Worcester, Massachusetts, 01606
Canada5 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Edmonton, Alberta, T6G 2B7
Study site
Edmonton, Alberta, T6L 5X8
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Montreal, Quebec, H2L 4M1
About this study
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
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.
- Conditions
- Nonhemorrhagic Ischemic Stroke, Motor Function
- Being tested
- Observational study
- Keywords
- stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This was an observational study and no study drug was administered.
| Study group | Role | What they receive |
|---|---|---|
| Nonhemorrhagic Ischemic Stroke | Subjects obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study start18 Jan 2012
- Primary completion22 May 2013
- Study completion22 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonhemorrhagic Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496885
- Sponsor's protocol ID
- ASBI 801
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2011
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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/
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01496885
- Acronym / sponsor ID
- ASBI 801
- Conditions
- Nonhemorrhagic Ischemic Stroke, Motor Function
- Keywords
- stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2012 (actual)
- Primary completion
- 22 May 2013 (actual)
- Study completion
- 22 May 2013 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonhemorrhagic Ischemic Stroke | – | Other: Observational studySubjects obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants may be selected upon admission to an acute care emergency center, inpatient facility, or rehabilitation center.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis was an observational study and no study drug was administered. | Other | Nonhemorrhagic Ischemic Stroke |
Primary outcome
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
Time frame: Baseline up to Day 84 post 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.
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
Time frame: Baseline up to Day 84 post 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.
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
Time frame: Baseline up to Day 84 post non-hemorrhagic ischemic stroke
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.
3 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Baseline up to Day 84 post non-hemorrhagic ischemic stroke
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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/
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Leader study director
Daiichi Sankyo
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonhemorrhagic Ischemic Stroke and Motor Function, run by Daiichi Sankyo at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline up to Day 84 post non-hemorrhagic ischemic stroke). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.