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 rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke (NCT03441334), a non-randomized na study. The primary outcome is Change in Walking Speed.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03441334 |
| Phase | NA |
| Condition | Stroke |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Texas Woman's University |
| Results posted | Yes |
2. Clinical Question
The study asked whether high-frequency repetitive transcranial magnetic stimulation (rTMS), used with body weight supported treadmill training (BWSTT), could be examined for feasibility and efficacy after stroke. Its primary outcome concerned change in walking speed. The record also lists quality of life, motor function, cortical excitability, and walking endurance as secondary outcomes.
Population
Individuals after stroke. The record says one participant enrolled; that participant did not finish the protocol.
Intervention
High-frequency rTMS combined with BWSTT. The registry describes active rTMS and a sham rTMS device, but does not report that the enrolled participant completed the treatment protocol.
Comparator
A sham rTMS arm is listed. Allocation was non-randomized, so the arms are not a like-for-like control comparison.
Primary question
How did regular and fast walking speed change over 10 weeks? The participant had baseline data only, and change could not be calculated.
The clinical question therefore remains unanswered by comparative outcome data in this record. Although the study was intended to examine feasibility and efficacy, an efficacy comparison requires outcome information that was not available for the enrolled participant. In particular, the record reports no post-training walking-speed result and no calculated change from baseline. It also does not establish whether the planned combination could be delivered as intended or whether the study procedures were feasible beyond the experience of this single enrollee.
3. Trial Design
The registry lists a parallel study with non-randomized allocation and double masking. It identifies high-frequency rTMS and sham rTMS as the interventions. Because allocation was not randomized, the sham arm should not be treated as a balanced control group for estimating a causal treatment effect. The record does not report how participants were assigned to arms or which people were masked.
The brief summary says the study planned to enroll 5 individuals after stroke. Actual enrollment was 1, and the record states that this participant did not finish the protocol. The study status is terminated. The reason for termination is not reported in the registry record. Start and primary completion dates are recorded as 2018-11-12 and 2018-11-26, respectively.
The active intervention is described as high-frequency rTMS combined with BWSTT, while the sham device is described as producing auditory and cutaneous feedback without active stimulation. The registry does not establish that the enrolled participant received or completed either protocol. Details about the treadmill-training schedule, treatment adherence, and the allocation process are not reported in the registry record.
The record lists five outcome measures and no analyses. The primary outcome is change in walking speed; listed secondary outcomes concern quality of life, motor function, cortical excitability, and walking endurance. Outcome results beyond the note that baseline data were collected and post-training data were not collected are not reported. There is no numerical treatment comparison to interpret, and the non-randomized design would in any case limit direct causal comparison between arms.
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 | High Frequency rTMS | Sham rTMS |
|---|---|---|
| STARTED | 1 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 1 | 0 |
Reasons for not completing this period:
| Reason | High Frequency rTMS | Sham rTMS |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: We only enrolled 1 participant and the participant did not finish the protocol. We only collected baseline data but not post-training data. The changes in outcome could not be calculated.
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: No participants were enrolled for the Sham rTMS group
| Characteristic | Unit | High Frequency rTMS | Sham rTMS | Total |
|---|---|---|---|---|
| Participants analysed | 1 | 0 | 1 | |
| Age, Continuous | years | 58 (SD 0) | — | 58 (SD 0) |
| Sex: Female, Male: Female | Participants | 0 | — | 0 |
| Sex: Female, Male: Male | Participants | 1 | — | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | — | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | — | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | — | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | — | 0 |
| Race (NIH/OMB): White | Participants | 1 | — | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 | — | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | — | 0 |
| Region of Enrollment: United States | participants | 1 | — | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Walking Speed, measured over 10 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change in walking speed over 10 weeks. The registry describes measuring both regular and fast walking speeds in meters per second with GaitRite. It states that faster walking speed indicates better gait performance. A change endpoint would compare a participant’s post-training measurement with baseline, capturing movement over the specified follow-up period rather than only a single measurement.
As a general measurement principle, walking speed is a quantitative way to describe gait performance. Recording regular and fast speeds can characterize performance under two walking conditions. Repeated measurement can be useful when a study is interested in change during an intervention period. The endpoint definition alone, however, does not establish that a measured change is caused by treatment; interpretation depends on the design, available observations, and analysis.
For this trial, change could not be calculated. The record states that only one participant enrolled, that the participant did not finish the protocol, and that baseline data—but no post-training data—were collected. The endpoint therefore has no posted change estimate, uncertainty interval, or comparison between the active and sham arms. The record does not report the baseline walking-speed values. The endpoint description explains what the study intended to measure, but it cannot support a conclusion about change in walking speed in this trial.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary outcome is not estimable from the recorded measurements. The participant did not finish the protocol, and no post-training walking-speed data were collected. Without both baseline and follow-up measurements, the intended change in regular or fast walking speed could not be calculated. The registry explicitly says the changes in outcome could not be calculated.
Accordingly, there is no posted primary-outcome estimate to compare with zero or with a clinically meaningful threshold. No confidence interval, p-value, or treatment-effect estimate is reported. The absence of an estimate is not evidence that the intervention had no effect; it means that this record contains no post-training observation from which to estimate change. The baseline data alone cannot answer the change question, and their numeric values are not reported in the registry record.
The design also limits interpretation of the arms. Allocation was non-randomized, and the registry identifies the arms as high-frequency rTMS and sham rTMS. The record specifically cautions that these are not a like-for-like control comparison. In a non-randomized study, differences between groups can reflect factors other than the intervention. Here, the available record does not contain outcome changes with which to describe even an unadjusted arm contrast.
Feasibility was part of the stated study aim, but the record does not provide a detailed feasibility analysis. It reports planned enrollment of 5 and actual enrollment of 1, and notes that the enrolled participant did not complete the protocol. Reasons for non-completion, recruitment details, protocol adherence, and the reason for termination are not reported in the registry record. Those omissions prevent a fuller account of why recruitment or completion was limited.
The status is terminated, but this status does not supply an outcome result or an explanation for stopping. No formal statistical analyses are listed. The record therefore supports a description of study conduct and missing outcome measurement, not a claim about the magnitude, direction, or precision of a treatment effect. Any numerical planning illustration based on an observed effect would also lack an observed primary change estimate from this trial to use as its basis.
9. Statistical Methods Explained
The main statistical issue is not which test to use, but that the primary outcome change could not be computed. A change analysis needs measurements at the relevant time points. The registry describes baseline collection without post-training collection for the sole participant, so the planned 10-week change in walking speed is unavailable. No outcome analysis is listed in the record.
What would a change estimate represent?
As a general statistical explanation, a change estimate describes how a measured outcome differs between an initial assessment and a later assessment. For this study, the intended measurements were regular and fast walking speeds. A change estimate could describe the participant’s observed movement across the follow-up period, but would not by itself prove that treatment caused the change. That causal interpretation depends on the study design and the possibility of other explanations for the observed movement.
Here, follow-up measurements are absent, so neither a participant-level change nor an average change can be calculated from the record. The actual baseline values are not reported in the registry record. There is also no reported summary of variation across participants, which would be needed to characterize between-participant variability for a group estimate.
How should uncertainty be understood?
As a general statistical explanation, a confidence interval gives a range of values compatible with the data and analysis under stated assumptions. Its width reflects uncertainty: an interval can be wide when data are sparse or variable. A p-value, when reported, describes how compatible the data are with a specified null model; it is not a measure of clinical importance and does not replace an effect estimate. Neither a confidence interval nor a p-value for the primary outcome is reported in this record. Since no change estimate could be calculated, there is no trial-specific precision estimate to interpret.
A single enrollee would in any case provide very limited information about variability across people. However, the central limitation is more basic: the participant had no post-training measurement, so the primary change was not observed. It would be inappropriate to substitute a hypothetical outcome or infer the missing follow-up result from the baseline assessment.
What does the design imply for comparison?
Allocation is recorded as non-randomized. As a general statistical principle, random allocation helps balance known and unknown participant characteristics across study arms on average. Non-randomized allocation does not provide that protection. Differences between groups can be associated with participant characteristics, assignment procedures, or other factors as well as intervention exposure. The registry cautions that the arms are not a like-for-like control comparison. In this trial, no outcome data are available for a comparison in any event.
Double masking is recorded, but the people who were masked and the masking procedures are not reported in the registry record. Masking can reduce some forms of expectation or assessment bias, but it cannot address missing follow-up measurements or eliminate all sources of bias. The masking label should therefore not be interpreted as evidence that every potential source of bias was controlled.
What do the planning assumptions mean?
The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with an effect specified as a fraction of the observed effect. These are planning assumptions, not trial outcome findings. No numerical planning requirement is reported in the registry record. Because the primary change could not be calculated, a planning exercise based on the observed effect cannot be grounded in an observed primary-outcome effect from this trial. Any sample-size illustration is a planning scenario, not observed power and not evidence that the trial had a particular probability of detecting an effect.
As a general statistical point, sample-size planning depends on assumptions about the effect to detect, variability, allocation, and the chosen error rate. Changing those assumptions changes the resulting planning estimate. A calculation using a fraction of an observed effect is especially dependent on the credibility of that effect estimate. In this case, the lack of a calculated primary outcome change means the record does not furnish an observed effect estimate for interpreting such a planning scenario.
Are model or distribution choices reported?
The registry does not report an analysis model, an outcome distribution, an adjustment strategy, or an approach to repeated measurements. It also does not report an interim analysis or a statistical analysis plan. These details should not be inferred from the general design labels or from the endpoint definition. With no completed primary outcome measurement and no analyses listed, there is no fitted model or statistical test to explain as a trial result.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary walking-speed outcome and secondary outcomes concerning quality of life, motor function, cortical excitability, and walking endurance. It records five outcome measures and no analyses. Results for the secondary outcomes are not reported in the registry record. Without reported analyses, there is no set of outcome-specific estimates or tests to assess for multiplicity.
As a general statistical explanation, multiplicity arises when a study evaluates multiple outcomes, time points, subgroups, or comparisons. If many statistical tests are considered, the chance of at least one apparently unusual result can increase. Analysis plans may address this by identifying a primary outcome, setting an order for testing, or adjusting inference. The registry does not report a multiplicity strategy, a testing hierarchy, or which outcomes, if any, were analyzed.
Missing data are central to interpretation. The only participant did not finish the protocol, and the record says baseline data were collected but post-training data were not. Thus the primary change could not be calculated. The reason for non-completion, any imputation method, and any other missing-data handling are not reported in the registry record.
The analysis population is also not described beyond the statement that one participant enrolled. Whether any modified or per-protocol population was defined, and what rules would govern inclusion in an analysis, are not reported in the registry record. There are no listed analyses, so there is no basis for determining whether the stated endpoint or secondary measures were analyzed in a particular population. No missing-data method should be presumed.
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 |
|---|---|---|---|
| High Frequency rTMS | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| High Frequency rTMS | 0 of 1 |
| Sham rTMS | 0 of 0 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| High Frequency rTMS | 0 of 1 |
| Sham rTMS | 0 of 0 |
The adverse-event figures are counts within the risk groups recorded for each arm. For high-frequency rTMS, 1 participant was recorded as at risk for serious adverse events and 0 had a serious adverse event. For other adverse events, 1 participant was recorded as at risk and 0 had an event. Deaths are recorded as 0. The sham rTMS arm has 0 participants recorded as at risk for these event summaries, with 0 events and 0 deaths.
The sham-arm zeros should not be read as evidence of no safety events among exposed participants: the recorded number at risk is 0. The risk groups are small, and the enrolled participant did not finish the protocol. The registry does not provide detailed event descriptions, exposure duration, or additional safety analyses. No serious adverse-event terms are listed.
As a general statistical explanation, a zero event count in a small group does not establish that an event cannot occur or precisely quantify its frequency. These figures describe only what was recorded in this trial and should not be interpreted as a comparative safety estimate between arms. The absence of recorded events is not a measure of safety beyond the limited observation captured in the registry record.
12. What the Result Does, and Does Not, Mean
This record documents a planned pilot study of high-frequency rTMS combined with BWSTT after stroke, with walking-speed change designated as the primary outcome. The registry reports actual enrollment of 1, a participant who did not complete the protocol, and baseline data without post-training data. As a result, the primary change could not be calculated. The study status is terminated.
Those details do not show that the intervention improved or worsened walking speed. They also do not establish that there was no effect. There is no post-training measurement from which to estimate the direction or size of change, and no confidence interval or other precision estimate is reported. Similarly, no efficacy conclusion can be drawn from the listed outcomes because no outcome analyses are reported.
The record does not establish whether the intervention was feasible, whether the planned treatment was completed, or why the study stopped. Although feasibility and efficacy were stated aims, the information about enrollment and protocol completion is too limited to explain the barriers or judge feasibility comprehensively. The reason for termination is not reported in the registry record.
The non-randomized allocation also means the listed arms cannot be regarded as a balanced comparison. Even if outcome values had been available, group differences would require cautious interpretation, because allocation may relate to other factors. In this record, the absence of post-training outcome data prevents an outcome comparison altogether.
The appropriate reading is therefore descriptive: the study enrolled one participant, did not obtain the planned post-training primary outcome, and reports no analyses. The posted information cannot establish benefit, lack of benefit, or a comparative safety profile. It identifies an important evidence gap rather than resolving the study’s clinical question.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the distinction between a study’s intended question and the information needed to answer it. The protocol designated change in walking speed over 10 weeks as the primary endpoint, but the participant did not complete the protocol and had no post-training assessment. Without that follow-up measurement, the planned change estimate is unavailable, regardless of which statistical method might otherwise have been chosen.
The record also makes clear why enrollment and completion are part of interpreting a pilot study. The brief summary describes a plan to enroll 5 individuals, while the record reports enrollment of 1 and non-completion by that participant. These details are relevant to feasibility, but they do not explain why enrollment or completion fell short. Recruitment processes, reasons for withdrawal, and the reason for termination are not reported in the registry record.
It also demonstrates why design labels should be read alongside allocation details. Double masking is recorded, but allocation was non-randomized and the arms are not a like-for-like control comparison. Masking and randomization address different concerns; one does not replace the other. Neither can create outcome data that were not collected.
Finally, a planning calculation is not a substitute for a trial estimate. Planning illustrations rely on assumptions about the effect and other design features. Since the primary change could not be calculated, no observed primary effect from this trial is available to anchor an effect-based planning scenario. The distinction between planned, observed, and missing information is essential to avoid giving an incomplete study more statistical certainty than its record supports.
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.
The most direct limitation is the absence of post-training outcome data. The participant did not finish the protocol, and the registry states that only baseline data were collected. The primary endpoint therefore has no calculated change. The actual baseline measurements are not reported in the registry record, so even baseline walking performance cannot be described numerically.
Enrollment was 1, compared with a planned enrollment of 5 in the brief summary. A single enrollee who did not complete the protocol cannot provide a usable group estimate of change or between-person variability. The reason for non-completion and the reason the study was terminated are not reported in the registry record. No detailed account of recruitment, treatment delivery, adherence, or completion is available.
The allocation was non-randomized, and the registry warns that the arms are not a like-for-like control comparison. The record does not report how assignment occurred or which parties were masked. These details limit assessment of potential bias even apart from the lack of outcomes. The intervention and sham descriptions do not establish which protocol, if any, the enrolled participant completed.
No analyses are listed. The record does not report an analysis plan, missing-data approach, endpoint-specific estimates, or statistical tests. Secondary outcome results are not reported in the registry record. Together, these limitations mean the record can describe study status and missing outcome collection, but cannot support an estimate of treatment effect or a detailed assessment of feasibility.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: rTMS Combined With BWSTT in Stroke With Body Weight Supported Treadmill Training (BWSTT) After Stroke — NCT03441334.
- Registry record last updated 2023-05-06; status last verified 2023-05.
- Results first posted 2023-05-06.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a pilot study of high-frequency rTMS combined with BWSTT after stroke. It lists a parallel design, non-randomized allocation, double masking, and active and sham rTMS arms. The stated primary outcome is change in regular and fast walking speed over 10 weeks, measured with GaitRite.
The brief summary says the study planned to enroll 5 individuals. Actual enrollment was 1. The participant did not finish the protocol, and only baseline data were collected; post-training walking-speed data were not available, so change could not be calculated. The record lists secondary outcomes in quality of life, motor function, cortical excitability, and walking endurance, but reports no analyses. The study status is terminated. The reason for termination and the reason for non-completion are not reported in the registry record.