Trial Outcomes & Findings for Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke (NCT NCT01496885)
NCT ID: NCT01496885
Last Updated: 2021-02-03
Results Overview
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.
COMPLETED
120 participants
Baseline up to Day 84 post non-hemorrhagic ischemic stroke
2021-02-03
Participant Flow
A total of 120 participants who met all inclusion and no exclusion criteria were enrolled in the study at 36 sites (30 sites in the United States and 6 sites in Canada).
All participants received standard of care based on investigator opinion and institutional policy.
Participant milestones
| Measure |
All Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
|
|---|---|
|
Overall Study
STARTED
|
120
|
|
Overall Study
COMPLETED
|
97
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
All Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Clinically significant change in subject status that prevented compliance or impacted stroke outcome
|
2
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Who Have Experienced a Nonhemorrhagic Ischemic Stroke
Baseline characteristics by cohort
| Measure |
All Participants
n=120 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
|
|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 13.3 • n=93 Participants
|
|
Age, Customized
|
67.0 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
35 participants
n=93 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 84 post non-hemorrhagic ischemic strokePopulation: Total Simplified-Stroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in the Primary Analysis population.
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.
Outcome measures
| Measure |
All Participants
n=120 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
|
|---|---|
|
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
Change from baseline to Day 7
|
8.9 score on a scale
Standard Deviation 13.39
|
|
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
Baseline
|
57.6 score on a scale
Standard Deviation 15.97
|
|
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
Day 3
|
60.9 score on a scale
Standard Deviation 19.77
|
|
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
Day 7
|
66.3 score on a scale
Standard Deviation 22.79
|
|
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
Day 28
|
77.4 score on a scale
Standard Deviation 22.57
|
|
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
Day 56
|
80.0 score on a scale
Standard Deviation 20.82
|
|
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
Day 84
|
83.0 score on a scale
Standard Deviation 19.35
|
|
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
Change from baseline to Day 3
|
4.2 score on a scale
Standard Deviation 9.59
|
|
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
Change from baseline to Day 28
|
19.5 score on a scale
Standard Deviation 16.50
|
|
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
Change from baseline to Day 56
|
22.7 score on a scale
Standard Deviation 17.05
|
|
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
Change from baseline to Day 84
|
24.8 score on a scale
Standard Deviation 16.39
|
PRIMARY outcome
Timeframe: Baseline up to Day 84 post non-hemorrhagic ischemic strokePopulation: Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in the Primary Analysis population.
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.
Outcome measures
| Measure |
All Participants
n=113 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic 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
Day 3
|
6.9 percent change
Standard Deviation 20.18
|
|
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
Day 7
|
15.0 percent change
Standard Deviation 26.92
|
|
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
Day 28
|
37.3 percent change
Standard Deviation 40.78
|
|
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
Day 56
|
45.6 percent change
Standard Deviation 43.40
|
|
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
Day 84
|
49.7 percent change
Standard Deviation 47.00
|
PRIMARY outcome
Timeframe: Baseline up to Day 84 post non-hemorrhagic ischemic strokePopulation: Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in the Primary Analysis population.
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.
Outcome measures
| Measure |
All Participants
n=120 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic 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
Day 7: 0 to <20 score
|
3 Participants
|
|
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
Day 56: 20 to <50 score
|
9 Participants
|
|
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
Baseline: 0 to <20 score
|
1 Participants
|
|
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
Baseline: 20 to <50 score
|
38 Participants
|
|
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
Baseline: 50 to <70 score
|
51 Participants
|
|
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
Baseline: ≥70 score
|
30 Participants
|
|
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
Day 3: 0 to <20 score
|
3 Participants
|
|
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
Day 3: 20 to <50 score
|
22 Participants
|
|
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
Day 3: 50 to <70 score
|
45 Participants
|
|
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
Day 3: ≥70 score
|
43 Participants
|
|
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
Day 7: 20 to <50 score
|
19 Participants
|
|
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
Day 7: 50 to <70 score
|
35 Participants
|
|
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
Day 7: ≥70 score
|
56 Participants
|
|
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
Day 28: 0 to <20 score
|
5 Participants
|
|
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
Day 28: 20 to <50 score
|
6 Participants
|
|
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
Day 28: 50 to <70 score
|
17 Participants
|
|
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
Day 28: ≥70 score
|
73 Participants
|
|
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
Day 56: 0 to <20 score
|
1 Participants
|
|
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
Day 56: 50 to <70 score
|
12 Participants
|
|
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
Day 56: ≥70 score
|
73 Participants
|
|
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
Day 84: 0 to <20 score
|
2 Participants
|
|
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
Day 84: 20 to <50 score
|
6 Participants
|
|
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
Day 84: 50 to <70 score
|
9 Participants
|
|
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
Day 84: ≥70 score
|
80 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 84 post non-hemorrhagic ischemic strokePopulation: Subgroup analysis of Total Simplified-STroke Rehabilitation Assessment of Movement (S-STREAM) score was assessed in patients with available data in the Primary Analysis population.
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.
Outcome measures
| Measure |
All Participants
n=104 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic ischemic stroke.
|
|---|---|
|
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
Baseline: Unknown area of brain affected
|
60.6 score on a scale
Standard Deviation 14.10
|
|
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
Baseline: USA
|
58.7 score on a scale
Standard Deviation 14.80
|
|
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
Baseline: Canada
|
55.0 score on a scale
Standard Deviation 18.49
|
|
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
Day 84: USA
|
82.7 score on a scale
Standard Deviation 18.35
|
|
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
Day 84: Canada
|
83.7 score on a scale
Standard Deviation 21.63
|
|
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
Change from baseline: United States
|
23.1 score on a scale
Standard Deviation 16.04
|
|
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
Change from baseline: Canada
|
28.4 score on a scale
Standard Deviation 16.82
|
|
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
Baseline: <75 years
|
58.1 score on a scale
Standard Deviation 16.56
|
|
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
Baseline: ≥75 years
|
56.2 score on a scale
Standard Deviation 14.27
|
|
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
Day 84: <75 years
|
84.9 score on a scale
Standard Deviation 19.74
|
|
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
Day 84: ≥75 years
|
77.6 score on a scale
Standard Deviation 17.44
|
|
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
Change from baseline: <75 years
|
26.4 score on a scale
Standard Deviation 17.33
|
|
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
Change from baseline: ≥75 years
|
20.2 score on a scale
Standard Deviation 12.54
|
|
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
Baseline: Male
|
57.0 score on a scale
Standard Deviation 15.93
|
|
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
Baseline: Female
|
58.5 score on a scale
Standard Deviation 16.15
|
|
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
Day 84: Male
|
82.4 score on a scale
Standard Deviation 19.70
|
|
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
Day 84: Female
|
83.9 score on a scale
Standard Deviation 19.04
|
|
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
Change from baseline: Male
|
25.4 score on a scale
Standard Deviation 16.22
|
|
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
Change from baseline: Female
|
23.9 score on a scale
Standard Deviation 16.82
|
|
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
Baseline: Body mass index, <30 kg/mg^2
|
56.3 score on a scale
Standard Deviation 15.55
|
|
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
Baseline: Body mass index, ≥30 kg/mg^2
|
60.6 score on a scale
Standard Deviation 16.71
|
|
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
Day 84: Body mass index, <30 kg/mg^2
|
82.9 score on a scale
Standard Deviation 17.88
|
|
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
Day 84: Body mass index, ≥30 kg/mg^2
|
83.2 score on a scale
Standard Deviation 22.48
|
|
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
Change from baseline: Body mass index, <30 kg/mg^2
|
26.5 score on a scale
Standard Deviation 15.98
|
|
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
Change from baseline: Body mass index, ≥30 kg/mg^2
|
21.2 score on a scale
Standard Deviation 16.95
|
|
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
Baseline: Right handedness
|
57.6 score on a scale
Standard Deviation 16.01
|
|
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
Baseline: Left handedness
|
57.9 score on a scale
Standard Deviation 16.20
|
|
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
Day 84: Right handedness
|
82.3 score on a scale
Standard Deviation 18.57
|
|
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
Day 84: Left Handedness
|
88.2 score on a scale
Standard Deviation 24.51
|
|
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
Change from baseline: Right handedness
|
24.0 score on a scale
Standard Deviation 16.25
|
|
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
Change from baseline: Left handedness
|
30.4 score on a scale
Standard Deviation 17.07
|
|
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
Baseline: Left and right side of brain affected
|
50.1 score on a scale
|
|
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
Baseline: Left side of brain affected
|
59.4 score on a scale
Standard Deviation 15.47
|
|
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
Baseline: Right side of brain affected
|
54.8 score on a scale
Standard Deviation 17.19
|
|
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
Day 84: Left and right side of brain affected
|
79.3 score on a scale
|
|
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
Day 84: Left side of brain affected
|
84.2 score on a scale
Standard Deviation 19.65
|
|
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
Day 84: Right side of brain affected
|
82.2 score on a scale
Standard Deviation 22.98
|
|
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
Day 84: Unknown area of brain affected
|
83.2 score on a scale
Standard Deviation 11.18
|
|
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
Change from baseline: Left and right side of brain affected
|
29.2 score on a scale
|
|
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
Change from baseline: Left side of brain affected
|
24.6 score on a scale
Standard Deviation 17.17
|
|
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
Change from baseline: Right side of brain affected
|
26.7 score on a scale
Standard Deviation 17.04
|
|
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
Change from baseline: Unknown area of brain affected
|
21.4 score on a scale
Standard Deviation 14.58
|
|
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
Baseline: tPA use at baseline, yes
|
51.8 score on a scale
Standard Deviation 15.69
|
|
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
Baseline: tPA use at baseline, no
|
58.7 score on a scale
Standard Deviation 15.85
|
|
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
Day 84: tPA use at baseline, yes
|
85.8 score on a scale
Standard Deviation 18.36
|
|
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
Day 84: tPA use at baseline, no
|
82.5 score on a scale
Standard Deviation 19.60
|
|
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
Change from baseline: tPA use at baseline, yes
|
32.0 score on a scale
Standard Deviation 14.16
|
|
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
Change from baseline: tPA use at baseline, no
|
23.4 score on a scale
Standard Deviation 16.51
|
SECONDARY outcome
Timeframe: Baseline up to Day 84 post non-hemorrhagic ischemic strokePopulation: National Institutes of Health Stroke Scale (NIHSS) Score was assessed in the Primary Analysis population.
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.
Outcome measures
| Measure |
All Participants
n=118 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic 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
Change from baseline: Day 84
|
-4.3 score on a scale
Standard Deviation 3.09
|
|
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
Baseline
|
6.2 score on a scale
Standard Deviation 3.64
|
|
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
Day 3
|
5.4 score on a scale
Standard Deviation 3.81
|
|
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
Day 7
|
4.6 score on a scale
Standard Deviation 3.88
|
|
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
Day 28
|
3.1 score on a scale
Standard Deviation 3.57
|
|
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
Day 56
|
2.5 score on a scale
Standard Deviation 2.97
|
|
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
Day 84
|
2.1 score on a scale
Standard Deviation 2.85
|
|
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
Change from baseline: Day 3
|
-0.9 score on a scale
Standard Deviation 1.77
|
|
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
Change from baseline: Day 7
|
-1.6 score on a scale
Standard Deviation 2.49
|
|
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
Change from baseline: Day 28
|
-3.1 score on a scale
Standard Deviation 3.56
|
|
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
Change from baseline: Day 56
|
-3.8 score on a scale
Standard Deviation 3.42
|
SECONDARY outcome
Timeframe: Baseline up to Day 84 post non-hemorrhagic ischemic strokePopulation: National Institutes of Health Stroke Scale (NIHSS) Score was assessed in the Primary Analysis population.
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.
Outcome measures
| Measure |
All Participants
n=113 Participants
Participants who were obtained within 24 to 48 hours of a nonhemorrhagic 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
Day 3
|
-16.8 percent change
Standard Deviation 30.94
|
|
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
Day 7
|
-30.3 percent change
Standard Deviation 40.33
|
|
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
Day 28
|
-52.6 percent change
Standard Deviation 57.21
|
|
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
Day 56
|
-63.0 percent change
Standard Deviation 43.60
|
|
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
Day 84
|
-73.3 percent change
Standard Deviation 30.66
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place