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 Clinic-Based AMES Treatment of Stroke (NCT00847704), a na phase 1, phase 2 study. The primary outcome is Fugl-Meyer Assessment of the Lower Extremity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00847704 |
| Phase | Phase 1, Phase 2 |
| Condition | Stroke, Cerebrovascular Accident |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 3 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Oregon Health and Science University |
| Results posted | Yes |
2. Clinical Question
Population
People with chronic stroke are the population named in the official title. The conditions listed are Stroke and Cerebrovascular Accident. Further eligibility details and participant characteristics are not reported in the registry record.
Intervention
The device intervention is called Assisted movement and enhanced sensation. The study description says it investigates assisted movement with biofeedback and muscle vibration applied to the lower limb.
Comparator
No comparator group is listed. The study is identified as a single-group study, and allocation is recorded as NA. Its treatment arm therefore does not provide a like-for-like control comparison.
Primary question
The primary question concerns lower-extremity motor impairment measured with the Fugl-Meyer Assessment of the Lower Extremity before training, after 30 training sessions (8-10 weeks), and at 3-Month Follow-up. The record gives no analyzed endpoint values, so it does not establish how scores changed over time.
The study also names gait, stroke impact, spasticity, strength, and active motion among its secondary outcomes. Its stated purpose is to investigate whether this treatment reduces impairment and improves gait. That purpose is a research question, not a finding: the registry record contains no analyses with which to judge changes in the primary measure or the other outcomes. The small enrollment and absence of a comparison group also limit what could be concluded even if within-group scores were available. Without a control group, observed changes could not by themselves distinguish treatment effects from other explanations, such as change over time or measurement variability.
3. Trial Design
The registry identifies NCT00847704 as a Phase 1 and Phase 2 study titled “Clinic-Based AMES Treatment of Stroke.” Its official title specifies treatment of the lower extremity in chronic stroke subjects. Oregon Health and Science University is listed as the sponsor. The study began in 2008-04, had a primary completion date of 2009-11, and is marked TERMINATED. The reason for termination is not reported in the registry record.
The design is listed as single group, with allocation recorded as NA and masking listed as NONE. One arm, “Test treatment group,” is described as receiving the device intervention Assisted movement and enhanced sensation. There is no separate control arm listed, so the design does not support a randomized between-group comparison. The registry records enrollment of 3.
The primary outcome is the Fugl-Meyer Assessment of the Lower Extremity, reported as a mean with standard deviation. The specified assessment times are pre-training, after 30 training sessions (8-10 weeks), and 3-Month Follow-up. Named secondary outcomes are the Timed 10-Meter Walk, Stroke Impact Scale, Spasticity (Modified Ashworth) Scale, Strength Test, and Active Motion Test. The record lists six outcome measures overall.
The registry record does not report the analysis population, a statistical analysis plan, or analyzed outcome results. It also does not state whether participants completed the training schedule or follow-up assessments. The status and dates describe the study record; they do not, on their own, explain why the study ended or what happened to individual participants.
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 | Test Group |
|---|---|
| STARTED | 3 |
| COMPLETED | 2 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Test Group |
|---|---|
| Withdrawal by Subject | 1 |
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.
Population: Stroke \>1 yr prior to enrollment Able to stand independently \<50% normal strength in affected leg Functioning proprioception in affected leg
| Characteristic | Unit | Test Group |
|---|---|---|
| Participants analysed | 2 | |
| Age, Continuous | years | 67 (SD 2.0) |
| Gender: Female | Participants | 1 |
| Gender: Male | Participants | 1 |
| Region of Enrollment: United States | participants | 2 |
| Time since stroke | Months | 113.5 (SD 85.5) |
6. Primary Endpoint
The registry lists the primary outcome as Fugl-Meyer Assessment of the Lower Extremity, measured over Pre-training, After 30 training sessions (8-10 weeks), 3-Month Follow-up.
| 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 Fugl-Meyer Assessment of the Lower Extremity. The registry describes it as a measure of motor impairment in people with stroke and identifies it as a gold standard. It assesses tone, range-of-motion, and synergies of the lower limb. The total score is formed by summing scores from 7 subscales. The stated scale range is 0-34, with higher scores referring to improved motor ability.
The record specifies the outcome as a mean in units on a scale, with standard deviation as the measure of dispersion. These summaries would describe the average score and the spread of scores at the specified assessments. The recorded timeframe is pre-training, after 30 training sessions (8-10 weeks), and 3-Month Follow-up. Comparing measurements across these times can describe a within-group trajectory, but a trajectory alone does not isolate the effect of treatment.
In general, a standardized impairment measure can make the target of assessment more explicit than an informal judgment. It is also important to interpret a scale in light of its range and direction: the registry states that higher values refer to improved motor ability. The posted registry record contains no analyzed means or standard deviations for these time points, so the size, direction, and precision of any change cannot be assessed from it.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record lists enrollment of 3 and identifies a single treatment group, but it lists no outcome analyses. In particular, it gives no analyzed Fugl-Meyer scores at pre-training, after 30 training sessions (8-10 weeks), or at 3-Month Follow-up. It is therefore not possible to describe an observed average change, its variability, or whether scores were available at each time. The study objective should not be mistaken for a result: investigating whether impairment or gait improves does not show that either changed.
The design also matters for interpretation. With one group and no comparator, a before-and-after difference, if one were reported, would be a within-group observation. It would not separate a treatment-related change from changes that might occur over time, effects of other care, practice on a test, or measurement variation. The registry does not report random allocation or masking; masking is listed as NONE. These features leave no randomized, masked comparison described in the record.
The primary measure has a stated scale range of 0-34 and a stated direction in which higher scores refer to improved motor ability. Those details explain how an available score would be read, but the record does not provide the values needed to apply that interpretation. It also does not give confidence intervals or other uncertainty estimates for the primary endpoint. In general, a confidence interval expresses a range of values compatible with the data and analysis under its assumptions; without an analyzed estimate and interval, precision cannot be judged.
The registry lists five named secondary outcomes, but no analyses are listed for those measures either. Their presence indicates additional outcomes of interest, not evidence of a change in walking, stroke impact, spasticity, strength, or active motion. The record does not report outcome-specific results, missingness, or analysis populations.
Safety information is limited to the recorded adverse-event counts: zero serious events among 3 at risk and one other adverse event among 3 at risk. These counts are descriptive and do not establish the overall safety profile of the intervention. Deaths are not reported in the registry record. Taken together, the posted information describes the study's design, endpoints, and limited safety counts, but does not permit an estimate of treatment effect or its precision.
9. Statistical Methods Explained
The main design feature for statistical interpretation is that this is a single-group study. There is one listed test treatment group and no comparator group. Allocation is NA, and masking is NONE. Consequently, the primary endpoint is framed as a set of measurements over time within the treatment group, rather than as a contrast between randomized groups. The record reports no analysis results for those measurements.
What does a mean and standard deviation describe?
The primary outcome is specified as a mean with standard deviation. In general, the mean describes the central value of a set of measurements, while the standard deviation describes how dispersed those measurements are around that mean. They answer different questions: a mean is about the average level, while a standard deviation is about variation among observed values. A standard deviation is not itself an uncertainty interval for the mean. A standard error or confidence interval would address uncertainty in an estimated mean, under the assumptions of the chosen analysis.
The scale has a stated range of 0-34, and higher scores refer to improved motor ability. The registry specifies pre-training, after 30 training sessions (8-10 weeks), and 3-Month Follow-up as assessment times. A comparison of means across these times could describe average movement in the group. A within-person analysis would also need to account for the fact that repeated observations from the same participant are related. The registry record does not state what analysis was planned or used, whether all time points were observed, or whether measurements were analyzed as paired data.
Why does the absence of a control group matter?
In general, a treatment comparison is most informative when the groups are sufficiently comparable and outcome differences can be attributed to the intervention under the design assumptions. A single-group before-and-after comparison does not have a contemporaneous control group to represent what might have happened without the intervention. Changes can be described, but causal interpretation is limited because other influences and natural change are not separated from the intervention. No statistical adjustment can recreate a control group that the study did not include.
The registry lists no analyses, so there is no estimated change to interpret as either a point estimate or a treatment effect. It also reports no confidence interval or p-value for the primary endpoint. In general, a p-value addresses the compatibility of data with a specified null model under assumptions; it does not measure the size or practical importance of an effect. A confidence interval communicates uncertainty around an estimate, but its meaning depends on the design and analysis. Neither concept can supply evidence when the corresponding result is absent.
What do the planning assumptions mean?
The sample-size assumptions describe a planning illustration, not the study's own design or observed power. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. The assumptions are explicitly about a hypothetical two-arm planning exercise. They do not match the recorded single-group design, which has allocation NA and no listed comparator.
In general, a sample-size calculation asks what study size might be needed to detect an effect under specified assumptions. It is not a measure of how likely the completed study was to find an effect, and it does not turn an absent result into evidence. Here the registry record gives no analyzed observed effect to connect to such an illustration. Any planning values should therefore be read only as hypothetical planning scenarios, not as observed power, confirmation of the trial's design, or evidence about the intervention.
Why can small samples make estimates unstable?
In general, estimates from a small number of observations can vary substantially depending on which observations are included. Confidence intervals, when calculated under an appropriate model, can convey some of this uncertainty. Small samples can also make distributional assumptions difficult to check. The enrollment recorded for this study is 3, but no outcome values or uncertainty estimates are reported, so the extent of variability in the endpoint cannot be evaluated. It would be inappropriate to infer a precise treatment effect from the study description alone.
For continuous outcomes, investigators may also need to consider whether the chosen analysis assumptions fit the data, whether repeated measurements are handled correctly, and how missing observations are treated. Those are general statistical considerations, not documented methods for this study. The registry record does not report a statistical analysis plan, an estimation method, or model diagnostics. Accordingly, no claim about adjustment, distributional assumptions, or robustness can be made from the posted information.
10. Multiplicity, Missing Data and Analysis Populations
The registry names the Fugl-Meyer Assessment of the Lower Extremity as the primary outcome and lists secondary measures of walking, stroke impact, spasticity, strength, and active motion. It does not report how these outcomes were prioritized statistically, whether any multiplicity adjustment was planned, or whether a hierarchy of confirmatory tests was specified. Such details are not reported in the registry record. Because no analyses are listed, there are no outcome-specific estimates or tests to interpret, adjusted or otherwise.
In general, evaluating multiple outcomes can increase the chance that at least one result appears notable by chance if each is tested separately. A prespecified hierarchy or multiplicity adjustment can address that issue, depending on the study's goals. Those approaches cannot be attributed to this study without a reported analysis plan. The registry's designation of one primary outcome identifies the main endpoint, but it does not establish what statistical procedures were used.
Information about missing data is also not reported in the registry record. It does not state whether any assessments were missed, whether participants withdrew from particular assessments, or how missing measurements were handled. The analysis population is not reported either. These omissions matter because the measurements available for each time point and the rules for including them affect interpretation of means and changes.
In general, a complete-case analysis uses only records with the needed measurements, while other methods may use assumptions to address missing values. No such method can be assumed. The registry status is TERMINATED, but the reason for termination and its relationship, if any, to outcome availability are not reported. The absence of results does not establish that data were missing; it means the record does not describe their availability or analysis.
11. 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 |
|---|---|---|---|
| Test Treatment Group | 0 | 3 | 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 |
|---|---|
| Test Treatment Group | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Test Treatment Group |
|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | 1 of 3 |
The registry reports serious adverse events for the Test Treatment Group as zero affected among 3 at risk. For other adverse events, it reports one affected among 3 at risk. These are counts within the recorded group, not estimates of comparative risk, because no control group is listed. The record does not list any serious adverse-event terms. Deaths are not reported in the registry record.
These figures should be read as the safety information recorded in this registry entry, not as proof that serious events could not occur or that the intervention is safe. The enrolled group is small, and the record does not provide event descriptions, timing, severity details for the other event, or a narrative account of how events were collected. It also does not report a comparison with another treatment or an untreated group.
In general, an adverse-event count is descriptive. A zero count in a study does not establish that the underlying risk is zero, particularly when the amount of safety observation is limited or incompletely described. The registry record does not state the duration of safety follow-up or whether all participants completed it. The counts therefore support only a narrow statement about what was recorded: no serious events are listed among those at risk, and one other adverse event is listed among those at risk.
12. What the Result Does, and Does Not, Mean
The record describes a study of assisted movement and enhanced sensation applied to the lower limb in chronic stroke subjects. It identifies a motor-impairment endpoint, specifies assessment times, and records limited adverse-event counts. It also documents enrollment of 3, a single-group design, and a TERMINATED status. Those details characterize the study, but they do not provide an estimate of the intervention's effect.
No analyzed values are listed for the Fugl-Meyer Assessment of the Lower Extremity. As a result, the record does not show whether the average score rose, fell, or remained similar between pre-training and later assessments. It does not show the variability of scores, the precision of any change, or whether results were available for all specified times. The same absence of analyses applies to the named secondary outcomes.
Even if a before-and-after change were available, a single-group design would not establish that the intervention caused it. A change over time could have explanations other than treatment, and the registry lists no comparator with which to assess those alternatives. The record also does not report randomization or masking; masking is listed as NONE.
The safety counts do not resolve the effectiveness question. Zero serious adverse events and one other adverse event are descriptive observations in the recorded group, not comparative measures and not a complete characterization of risk. The reason for termination, participant-level follow-up, and analysis population are not reported in the registry record.
Thus the appropriate interpretation is limited: the registry documents the study's stated purpose, design, outcomes, status, and recorded safety counts, but does not report outcome analyses. It cannot support a conclusion about the direction or size of motor changes, gait changes, statistical significance, or treatment benefit. The absence of results in the record should not be recast as evidence that no change occurred.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of why design and reporting determine what can be learned from an outcome measure. The registry identifies a clear primary construct: lower-extremity motor impairment measured with the Fugl-Meyer Assessment. It also gives the scale direction and the planned assessment times. That information helps define what an eventual analysis would need to describe.
At the same time, the single-group design places a firm limit on causal interpretation. Measurements at multiple times can describe a trajectory within the treatment group, but without a comparator they cannot show how that trajectory differs from what would otherwise have occurred. This distinction between describing change and estimating a treatment effect is central to interpreting clinical evidence.
The record also illustrates the importance of complete results reporting. It lists the primary and secondary outcomes but no analyses. Without outcome values, dispersion estimates, or uncertainty intervals, readers cannot assess magnitude, direction, or precision. A sample-size planning illustration cannot replace those results; its assumptions concern a hypothetical two-arm design rather than the recorded single-group design.
Finally, safety counts should be interpreted in context. The recorded serious and other adverse-event counts are useful descriptive details, but they are not comparative evidence and do not define the full safety profile. The enrollment of 3 further limits how broadly the recorded experience can be interpreted.
These features make the record a useful reminder that a named endpoint and a stated research objective are not findings. Design, analysis, and transparent reporting all shape whether an outcome can answer a clinical question.
14. 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.
Several limitations specific to this record restrict interpretation. The study is single group, with allocation recorded as NA and no comparator arm. Masking is listed as NONE. These design features do not support a randomized comparison, and any within-group score change, if reported, would not by itself establish a treatment effect. In this record, no analyzed primary or secondary outcome values are listed at all.
Enrollment is recorded as 3. The registry does not provide participant characteristics, baseline endpoint values, or a description of who contributed measurements at each assessment. It does not report whether participants completed training or follow-up. The primary endpoint timeframe specifies pre-training, after 30 training sessions (8-10 weeks), and 3-Month Follow-up, but completion of those assessments is not documented in the information recorded.
The study status is TERMINATED, but the reason for termination is not reported in the registry record. The record also does not report a statistical analysis plan, analysis population, methods for repeated measurements, handling of missing data, or multiplicity procedures. These omissions make it impossible to assess the intended analysis or determine whether it was carried out as planned.
Safety information is limited to group counts. The record does not describe the other adverse event, report deaths, or state the duration of safety observation. Further eligibility criteria and details of the intervention schedule are not reported in the registry record. Together, these gaps mean the posted information is insufficient for evaluating endpoint change, precision, or the completeness of safety follow-up.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinic-Based AMES Treatment of Stroke — NCT00847704.
- Registry record last updated 2017-01-23; status last verified 2016-11.
- Results first posted 2017-01-23.
- 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.
18. Record Summary
NCT00847704 is a Phase 1 and Phase 2, single-group study of device-based Assisted movement and enhanced sensation for the lower limb in chronic stroke subjects. Oregon Health and Science University is the sponsor. Enrollment is listed as 3; the study began in 2008-04, reached primary completion in 2009-11, and is marked TERMINATED.
The primary outcome is the Fugl-Meyer Assessment of the Lower Extremity, with assessments specified before training, after 30 training sessions (8-10 weeks), and at 3-Month Follow-up. Named secondary outcomes include walking, stroke impact, spasticity, strength, and active motion measures. No outcome analyses are listed in the registry record, and the reason for termination is not reported.
The recorded safety counts are zero serious adverse events among 3 at risk and one other adverse event among 3 at risk. Deaths are not reported in the registry record. The information documents the study structure and limited safety counts, but does not provide analyzed results for estimating outcome change or its precision.