This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Assessment of the Stroke Rehabilitation Assessment of Movement as a Clinical Tool (NCT00635661), a registered phase not stated study. The primary outcome is Stroke Rehabilitation Assessment of Movement (STREAM).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00635661 |
| Phase | Phase not stated |
| Condition | Stroke |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 34 |
| Arms in the primary outcome | n/a |
| Lead sponsor | State University of New York - Upstate Medical University |
| Results posted | Yes |
2. Clinical Question
Population
People with stroke enrolled in a rehabilitation study. The registry records 34 participants enrolled; 4 were dropped, and 30 provided data for analysis.
Intervention
STREAM was used as a clinical assessment of movement impairment and mobility. It is a measurement tool, not a treatment assigned to participants.
Comparator
The study's stated comparison involved the Functional Independence Measure (FIM) and Stroke Impact Scale (SIS). The registry does not describe randomized comparison groups or an allocation procedure.
Primary question
Could STREAM quantify motor ability at discharge, and how would its assessment relate to function and disability measures?
The study focuses on whether STREAM can measure movement-related impairment and clinical change among stroke patients in acute rehabilitation in the USA. Its stated hypothesis concerns a statistically significant change in motor abilities from admission to discharge. A further aim is to compare STREAM with FIM and SIS, measures described in the study summary as accepted and widely used clinical measures of function and disability.
The registry identifies the primary outcome as the STREAM score at discharge, with a timeframe of 4 weeks. It does not report admission scores, a numerical change estimate, or results for FIM or SIS. Therefore, the study question can be described from the stated aims, but the registry record does not establish whether the hypothesized change occurred or how closely the measures were related in the analyzed participants.
3. Trial Design
This is a completed clinical study sponsored by State University of New York - Upstate Medical University. The registry records a start date of 2008-01 and primary completion in 2009-12. Enrollment was 34 participants with stroke. The record says that 4 participants were dropped and that 30 participants provided data for analysis.
The study's stated purpose was to assess STREAM as a clinical measurement tool, including its ability to measure impairment and clinical change among acute rehabilitation patients in the USA. It also aimed to compare STREAM with FIM and SIS. These aims concern measurement and relationships among clinical measures; the registry does not describe a treatment-versus-control question.
The record explicitly characterizes the study as not being a randomized comparison. Allocation is not stated, and the record cautions that any arms are not a like-for-like control comparison. It therefore would not be appropriate to interpret the study as a randomized trial of competing interventions or to attribute differences to a randomized assignment.
The registry lists one outcome measure, STREAM, with discharge as the assessment point and 4 weeks as the timeframe. The official title names FIM and SIS, but no outcome descriptions or numerical results for those measures are included in the recorded results. The registry lists no analyses. It also does not report the protocol details needed to explain how participants entered the study, why participants were dropped, or how measurements at different times were handled. Those details should not be inferred from the stated aims or the completed status.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Study Participants |
|---|---|
| STARTED | 34 |
| COMPLETED | 30 |
| NOT COMPLETED | 4 |
Reasons for not completing this period:
| Reason | Study Participants |
|---|---|
| Withdrawal by Subject | 4 |
Analysis population for the primary outcome, as defined in the registry: 34 participants were enrolled, 4 participants were dropped from the study resulting in 30 participants providing data for analysis.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Study Participants |
|---|---|---|
| Participants analysed | 34 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 14 |
| Age, Categorical: >=65 years | Participants | 20 |
| Age Continuous | years | 66.1 (SD 15.4) |
| Sex: Female, Male: Female | Participants | 17 |
| Sex: Female, Male: Male | Participants | 17 |
6. Primary Endpoint
The registry lists the primary outcome as Stroke Rehabilitation Assessment of Movement (STREAM), measured over 4 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Stroke Rehabilitation Assessment of Movement (STREAM) score at discharge, expressed as a mean with standard deviation. The measure covers quality of arm and leg movements and mobility during functional tasks, including walking 10 feet. It has 10 items for each of three assessments: arm, leg and mobility. Each item is rated from 0, meaning unable to perform, to 2 or 3, meaning normal movement.
The ratings on the 30 items are added and divided by the total number of items to produce a percentage score. The stated scale has a minimum of 0, a maximum of 100 and a range of 100. The study uses this measure because its stated purpose is to assess movement impairment and quantify motor ability in stroke rehabilitation. The brief summary also frames STREAM as a way to evaluate recovery of voluntary movement and basic mobility.
The record identifies the score as a discharge measure, not as a reported admission-to-discharge change. Although the study hypothesis concerns change between admission and discharge, the registry gives no numerical discharge mean, standard deviation, admission score or change estimate. Thus the endpoint's definition is available, but its observed value and the precision of that value are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies STREAM discharge score as the primary outcome and describes how it is constructed, but it contains no numerical outcome result. In particular, it gives no mean discharge score or standard deviation for the 30 participants whose data were analyzed. The record therefore does not show the observed level of movement ability on the scale or the degree of variation among participants. It also reports no confidence interval, test statistic or p-value for the primary outcome.
The stated hypothesis concerns a statistically significant change in motor abilities from admission to discharge. That claim requires results describing change, such as measurements at both assessment times and an analysis comparing them. The registry record does not report admission measurements, a change estimate or an analysis of change. A discharge score alone would describe status at discharge; it would not, by itself, quantify how much participants changed during rehabilitation. Since no discharge summary values are reported either, even the endpoint's observed distribution cannot be evaluated from this registry entry.
The study also aimed to compare STREAM with FIM and SIS. The official title names those measures, and the summary explains the rationale for relating movement deficits to function and disability. However, the registry does not provide numerical results for FIM or SIS, correlations, comparisons, or other estimates of association. It is consequently not possible to determine from the registry record how closely the measures corresponded or whether one measure tracked clinical change more closely than another.
The enrollment and analysis population are described: 34 participants were enrolled, 4 were dropped, and 30 provided data for analysis. These counts give context for the reported study population but do not substitute for outcome data. No reasons for dropping participants or details about missing measurements are reported. The record's status is COMPLETED, but completion does not imply that a particular result was statistically significant, clinically important or precise.
Statistical significance and measurement usefulness are also distinct questions. A statistically significant result, if one were reported, would address compatibility with a specified statistical model and null hypothesis; it would not automatically establish that the measurement is useful in practice. Conversely, an absent p-value is not evidence of no change. Here, because the registry supplies no numerical results or analyses, neither statistical significance nor the size and precision of change can be assessed. Interpretation should remain limited to the study aims, endpoint definition and participant accounting actually recorded.
9. Statistical Methods Explained
The methods needed to interpret a clinical measurement study include the definition of the outcome, the population measured, the timing of assessments and the analysis used to answer the study question. The registry provides the endpoint definition and the stated timeframe, but it does not report a statistical analysis. The following points explain what the recorded information means and what remains unavailable.
What does a mean and standard deviation describe?
The primary outcome is continuous: STREAM scores lie on a stated percentage scale with a minimum of 0 and maximum of 100. The registry says the discharge score is reported as a mean with standard deviation. In general, the mean describes the average score in the analyzed group, while the standard deviation describes how dispersed individual scores are around that average. The standard deviation is not a confidence interval and does not by itself express the precision of the estimated mean.
The registry record does not include either the mean or the standard deviation. It therefore does not permit a reader to assess the average discharge score or how much scores varied among the participants analyzed. It also does not give a confidence interval. In general, a confidence interval expresses uncertainty around an estimate under a statistical procedure; its width depends on the data and method. No such interval or method is reported for this outcome.
What would be needed to assess change?
The summary describes a hypothesis about change from admission to discharge, whereas the primary outcome description specifies the discharge score. To estimate change, measurements at both times and a defined comparison are needed. In general, when the same participants are measured repeatedly, an analysis should account for the relationship between each participant's measurements. A comparison of separate group means may not represent that within-participant relationship. This is a general statistical point, not a description of an analysis used in this study.
The registry does not report admission scores, paired changes, a model, a test or an estimate of change. It also does not state whether the stated 4-week timeframe was the sole assessment occasion or how that timeframe relates to admission and discharge. Consequently, the proposed admission-to-discharge hypothesis cannot be evaluated using the registered results. No particular statistical test should be attributed to the study.
How should comparisons among measures be understood?
The study aimed to compare STREAM with FIM and SIS. In general, agreement, association and responsiveness are different measurement questions. Association asks whether scores tend to vary together; agreement asks whether measures give sufficiently similar values, where their scales permit that comparison; responsiveness concerns whether a measure captures change over time. These questions require different summaries and interpretations. The study summary explains a rationale for linking movement deficits to function and disability, but the registry provides no estimates or methods for these comparisons.
The three STREAM components assess arm, leg and mobility, and their item ratings contribute to a total score. Component-level results could describe different aspects of the assessment, but the registry's primary outcome description specifies the total score and does not report component results. No additional component analysis should be assumed.
What can be said about precision and statistical significance?
A point estimate describes an estimated quantity, while a confidence interval gives information about its sampling uncertainty under the stated method. A p-value, if used, summarizes how compatible observed data are with a specified null model; it does not measure the probability that a hypothesis is true or the clinical importance of an effect. These are general interpretations. The registry lists no analyses and reports no estimate, confidence interval, p-value or statistical model, so none of these can be interpreted for the primary outcome.
The record does not state a statistical plan, sample-size justification or interim analysis plan. These items are not reported in the registry record, and they should not be reconstructed from the enrollment count or study aims. A planning calculation is not an observed trial result and cannot replace reported outcome data. No inference about power can be made from the participant counts alone.
What does the participant accounting contribute?
The registry states that 34 participants were enrolled, 4 were dropped, and 30 provided data for analysis. This identifies the analysis count but does not explain the reasons for dropping participants, whether all planned outcomes were available for each analyzed participant, or how missing observations were treated. In general, missing-data methods can affect an estimate when the availability of measurements relates to participant characteristics or outcomes. The registry does not describe such methods, and no assumption about the missing observations is justified.
Overall, the record supports a clear description of the intended measure and the group contributing data, but not a reconstruction of the analysis. Statistical conclusions about change, relationships among measures, uncertainty or significance would require results and methods that are not reported in the registry record.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| Study Participants | 30 | 73.100 | 26.100 | 63.354 to 82.846 |
R code and output
arm <- c("Study Participants")
n <- c(30)
m <- c(73.1)
sp <- c(26.1)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM Study Participants 30 73.100 26.100 63.354 82.84611. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, STREAM, and no analyses. The study's aims also mention comparison with FIM and SIS, but the registry does not list numerical results or analysis details for either measure. It is therefore unclear which comparisons were conducted, whether the named aims corresponded to prespecified outcomes, or whether any multiplicity procedure was planned. These details are not reported in the registry record.
Multiplicity refers, in general, to the increased chance of at least one false-positive finding when multiple hypotheses are tested. Whether an adjustment is appropriate depends on the planned family of comparisons and the inferential goals. The record does not provide enough information to identify such a family or determine whether any adjustment was used. No conclusion about multiplicity control can be drawn.
For participant accounting, the record states that 34 participants were enrolled, 4 were dropped and 30 provided data for analysis. It does not explain why participants were dropped or whether their measurements were unavailable, incomplete or excluded for another reason. It also does not state whether the analysis used all available observations, a prespecified analysis population, imputation, or another missing-data approach. Those points are not reported in the registry record.
The 30 participants are identified as providing data for analysis, but the record does not say whether that group was defined before analysis or whether all participants with data were included for every measure. There is no reported intention-to-treat population or other detailed analysis-population definition. Accordingly, the reader can describe the recorded participant flow, but cannot assess the effect of missing data or exclusions on the results. Since numerical results are also absent, the extent to which any analysis might be sensitive to these decisions cannot be evaluated.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Study Participants | 0 | 30 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Study Participants | 0 of 30 |
The registry's safety entry lists 30 participants at risk for serious adverse events and 0 affected. It also lists 30 at risk for other adverse events and 0 affected. These are participant counts, not a numerical summary of the STREAM outcome. They indicate that the registry records no participants affected in either reported category for this entry.
No serious adverse event terms are listed. The deaths field is null, which means death information is not reported in the registry record; it should not be interpreted as a reported count of zero deaths. The record also does not provide descriptions, timing, severity, or adjudication details for adverse events.
Safety counts should be read in the context of the reported study and its recorded follow-up, not as a broad estimate of risk. The registry identifies a 4-week timeframe for the primary STREAM endpoint, but does not specify the safety surveillance period in the adverse-event entry. The zero affected counts are the posted figures, while the missing death information and absent event details limit what can be concluded about safety monitoring or completeness. These data do not establish that no unrecorded events occurred.
13. What the Result Does, and Does Not, Mean
The registry record establishes that this completed study evaluated STREAM as a measure of movement and mobility in people with stroke, and that 30 participants provided data for analysis after 4 of the 34 enrolled participants were dropped. It also defines the primary outcome as the STREAM discharge score and describes the scoring scale. These details explain what was intended to be measured and identify the group contributing data.
The record does not report the actual discharge mean or standard deviation, admission scores, a change estimate, or inferential analyses. It therefore does not show whether motor abilities changed from admission to discharge, how large any change was, or how precise an estimate might be. The study's stated hypothesis is not itself evidence that the hypothesized result occurred. Completion status likewise does not establish a positive, negative or statistically significant finding.
The study's additional aim was to compare STREAM with FIM and SIS, but no numerical comparisons or associations are reported. The record cannot establish whether STREAM scores corresponded with either measure, whether the measures captured similar constructs, or whether one was more responsive to change. The conceptual rationale described in the summary is not a substitute for observed comparative results.
Nor can the registry establish the clinical importance of a score or change. That interpretation would require result values and an appropriate context for what differences matter, neither of which is stated. A measurement scale and a study hypothesis identify what investigators sought to assess; they do not show measurement validity, responsiveness or practical usefulness on their own.
The most defensible reading is therefore descriptive: the study had a measurement-focused aim, a defined STREAM endpoint, and a recorded analysis population. The reported record is insufficient to judge the outcome of the hypothesis or to draw conclusions about changes in motor ability. It should not be used to claim that a treatment worked or failed; the registry describes an assessment study rather than a randomized treatment comparison.
14. Why This Trial Matters Statistically
This study raises a central statistical issue in rehabilitation research: a measurement tool must be evaluated not only by what it scores, but also by whether the score can describe meaningful clinical status or change. STREAM is described as covering arm movement, leg movement and mobility, with item ratings combined into a percentage score. The study's aims connect those movement assessments with broader measures of function and disability.
The design question is especially relevant because the stated hypothesis is about change from admission to discharge, while the primary endpoint is described as the discharge score. In general, endpoint level and change are not interchangeable. A discharge score can characterize status at that time; estimating change requires relevant measurements at multiple times and an analysis that accounts for their relationship. This distinction is important when interpreting clinical measurement research.
The study also illustrates why registry aims and posted results must be distinguished. A planned comparison with FIM and SIS can motivate an investigation, but without estimates and analysis details it cannot establish the strength or nature of a relationship among the measures. Likewise, stating a hypothesis about statistical significance does not provide evidence that the threshold was met.
The record is statistically informative about the intended construct, scoring approach, timing and participant accounting. At the same time, its lack of numerical results leaves the key empirical questions unanswered. This contrast matters for readers assessing evidence: a clearly specified instrument and rationale can explain what the study sought to learn, while results and uncertainty estimates are necessary to judge what it found. The registry entry therefore offers context for a measurement question, but not enough outcome information to evaluate the answer.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most consequential limitation of the registry record for interpreting this study is the absence of numerical outcome results. Although it describes the STREAM endpoint and says the discharge score is summarized as a mean with standard deviation, neither statistic is reported. No admission value, change estimate, confidence interval, test result or p-value appears in the record. The principal hypothesis about change therefore cannot be assessed from the posted information.
The registry lists FIM and SIS as comparison measures in the study title and summary, but does not report their outcome values, any associations with STREAM, or methods for comparing them. It is not possible to tell from this record whether these aims were analyzed or what the results were. The record lists one outcome measure and no analyses, leaving the relation between the broad study aims and the registered results unclear.
The participant accounting is limited to enrollment, dropped participants and the number providing data for analysis. Reasons for dropping participants, completeness of measurements, and missing-data handling are not reported. This restricts assessment of whether the analyzed group may differ from those not included and whether the analysis population corresponds to the intended population.
The study is explicitly not a randomized comparison, and allocation is not stated. Any arms should not be treated as like-for-like control groups. In addition, the record does not report a statistical plan, sample-size justification, interim analyses, or detailed assessment and follow-up procedures beyond the stated endpoint timeframe. The safety entry gives affected counts but no event terms and does not report deaths. These limitations are specific to what the registry record documents; they do not establish that details were absent from all study materials, only that they are not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Assessment of the Stroke Rehabilitation Assessment of Movement as a Clinical Tool — NCT00635661.
- Registry record last updated 2012-03-02; status last verified 2012-01.
- Results first posted 2012-03-02.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
The registry record describes a completed study of STREAM as a clinical measurement tool for stroke rehabilitation. Its aims included assessing movement and mobility and comparing STREAM with FIM and SIS. The primary outcome is the STREAM discharge score, reported by design as a mean with standard deviation on a percentage scale, with a stated timeframe of 4 weeks.
Enrollment was 34 participants. The record says 4 participants were dropped and 30 provided data for analysis. It lists one outcome measure and no analyses. Numerical outcome results, including the discharge mean and standard deviation, are not reported in the registry record. Admission-to-discharge results and comparisons with FIM or SIS are also not reported. The study is not a randomized comparison, and allocation is not stated. Safety entries record 0 affected participants for serious and other adverse events; death information is not reported in the registry record.