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 Muscle Fatigue and Scapular Sensorimotor System (NCT03066102), a na na study. The primary outcome is Change From Baseline in Scapular Proprioception.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03066102 |
| Phase | NA |
| Condition | Muscle; Fatigue |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Yang Ming Chiao Tung University |
| Results posted | Yes |
2. Clinical Question
Population
The registry record reports an enrollment of 30 participants. It does not report the eligibility criteria, participant characteristics, or whether the enrolled population was limited to a particular sex or clinical group.
Intervention
The intervention is described as muscle fatigue. The study aimed to examine scapular proprioception and neuromuscular performance around fatigue, including muscle strength, shoulder movement kinematics, muscle activity, and recruitment timing during arm elevation in the scapular plane.
Comparator
This is a single-group study with no randomized allocation and no separate control group identified in the registry record. The stated primary outcome is a change from baseline, so the comparison of interest is within participants across the fatigue intervention rather than between assigned groups.
Primary question
Does scapular proprioception, measured as the ability to actively reposition the scapula, change from baseline through completion of the fatigue intervention? The primary measure is reported in centimeters. Numerical baseline and follow-up results are not reported in the registry record.
The study title is “Muscle Fatigue and Scapular Sensorimotor System.” Its stated aims concern the effects of scapular muscle fatigue on scapular joint position sense and neuromuscular performance. The registry description hypothesizes that fatigue would increase scapular reposition error and affect neuromuscular performance during scaption, meaning arm elevation in the scapular plane. That hypothesis is a proposed expectation, not a reported finding.
The primary endpoint is change from baseline in scapular proprioception. The record also names changes in scapular muscle strength, shoulder kinematics, scapular muscle activity, and scapular muscle recruitment timing as secondary outcomes. These measures address related but distinct aspects of sensorimotor performance. The registry record does not report the actual results for these outcomes, so it cannot establish whether any of them changed or how precisely a change was estimated.
3. Trial Design
The registry describes a completed, single-group study with an enrollment of 30. The study began on 2017-07-01, and primary completion was recorded as 2017-08-11. The phase is listed as not applicable. Allocation is listed as not applicable, masking is none, and the model is single group. These features mean the record does not describe a randomized comparison or a masked assessment.
The intervention is named “muscle fatigue” and classified as “other.” The registry description focuses on scapular muscle fatigue and examines measures before and around the intervention. The primary outcome timeframe is described as through fatigue intervention completion, averaging 20 minutes in female subjects and 40 minutes in male subjects. Those are reported average timeframes; the record does not give the individual duration for each participant or explain why durations differed.
The primary outcome is change from baseline in scapular proprioception. The named secondary outcomes are change from baseline in scapular muscle strength, shoulder kinematics during shoulder elevation in the scapular plane, scapular muscle activity during that elevation, and scapular muscle recruitment timing during arm elevation in the scapular plane. The registry record reports six outcome measures overall, but the remaining measure or measures are not identified in the information available for this description.
A single-group, before-and-after design can describe within-participant changes over the study period. It does not provide a concurrent control group for separating changes associated with the fatigue intervention from changes due to measurement variability, repeated testing, time, or other influences. The record does not report the precise intervention protocol, how fatigue was induced or verified, the schedule of all measurements, or the analysis plan. These details are not reported in the registry record.
The sponsor is National Yang Ming Chiao Tung University, and the study status is completed. Completion and enrollment describe the study’s recorded conduct, not whether the planned outcomes support the hypothesis. Numerical outcome results and their uncertainty are not reported in the registry record, so the study’s direction and precision of effect cannot be assessed from those results.
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 | Fatigued Group |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
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 | Fatigued Group |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 23.5 (SD 1.8) |
| Sex: Female, Male: Female | Participants | 15 |
| Sex: Female, Male: Male | Participants | 15 |
| Race and Ethnicity Not Collected | Participants | — |
| height | centimeters | 167.57 (SD 8.29) |
| weight | kilograms | 59.30 (SD 8.53) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Scapular Proprioception, measured over through fatigue intervention completion, an average of 20 minutes in female subjects and 40 minutes in male subjects.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | centimeters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in scapular proprioception, measured in centimeters. The registry describes a test of the ability to actively reposition the scapula from neutral to 90% range of protraction and elevation. Proprioception refers generally to sensing the position and movement of a body part; in this study, the endpoint operationalizes that concept through an active repositioning task.
A change-from-baseline measure is used to focus on how a participant’s measurement differs across the study period. It can account for some stable differences between participants when the analysis compares each participant with their own baseline. However, it does not by itself establish that the intervention caused a change. Without a concurrent control group, other influences on measurements over time cannot be separated from the intervention effect.
The listed statistical summary type for the primary outcome is a mean, with standard deviation as the measure of dispersion. In general, a mean describes the average measurement in a group, while a standard deviation describes how spread out individual measurements are around that average. The registry record does not report the baseline mean, the mean change, the standard deviation, a confidence interval, or a test result for this endpoint. It also does not give more detail about how repositioning error is calculated or whether the endpoint combines protraction and elevation measurements. The stated unit and task are available, but the numerical findings and additional operational details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the study as completed and reports an enrollment of 30, but it does not report numerical results for the primary outcome. In particular, baseline and follow-up values, mean change, standard deviation, confidence interval, and inferential test results are not reported in the registry record. As a result, the direction, magnitude, and precision of any change in scapular proprioception cannot be described from the posted outcome information.
The same limitation applies to the named secondary outcomes. The record lists changes in scapular muscle strength, shoulder kinematics, muscle activity, and recruitment timing, but numerical results for those measures are not reported in the registry record. The stated hypothesis that fatigue would increase scapular reposition error and affect neuromuscular performance therefore remains a hypothesis in the available record; it should not be treated as a finding.
The design matters when interpreting any within-person change that might be reported elsewhere. In general, a single-group design can show that measurements differ from baseline after an intervention period, but it cannot by itself distinguish an intervention-related change from other explanations, including practice with the task, ordinary measurement variability, or changes over time. This is a general design limitation, not evidence that any such influence occurred in this study. The absence of a randomized comparator in the registry record also means there is no between-group contrast to interpret.
Precision would ordinarily be judged using the spread of measurements and an interval estimate around the effect. A confidence interval gives a range of values compatible with the data under the assumptions of the analysis; a narrower interval generally indicates greater precision than a wider one. Neither an interval nor the summary values needed to assess it are reported in the registry record. A p-value or other test result is also not reported, so statistical evidence against a null hypothesis cannot be assessed from the posted results.
The registry lists 50 analyses, but the details and results of those analyses are not reported in the registry record. The count alone does not indicate which analyses were prespecified, which outcomes or time points they address, or whether any multiplicity adjustment was used. It also does not establish that all listed analyses produced results. Without those details and the estimates themselves, readers cannot assess whether findings were consistent across analytic choices.
Consequently, the posted record supports description of the study’s aim, design, outcome definitions, enrollment, and recorded safety counts. It does not support a numerical conclusion about the size or direction of the primary or secondary outcome changes. This distinction is important: a completed study and an articulated hypothesis do not substitute for posted results, and the absence of reported results is not evidence that no change occurred.
9. Statistical Methods Explained
The registry identifies the primary outcome as a continuous measure summarized by a mean and standard deviation. In general, a continuous outcome can take values along a numerical scale, such as the centimeters specified for scapular proprioception. The mean gives a central summary, while the standard deviation describes variability among measurements. These summaries would help readers understand both the typical observed change and how much participants differed from one another. The registry record does not report the actual mean or standard deviation for the primary endpoint.
What does a change-from-baseline endpoint represent?
In general, a change score expresses how a measurement differs from a participant’s baseline measurement. A within-person approach can be useful when participants begin at different levels, because each participant’s later measurement is interpreted relative to their own starting point. The group mean change then summarizes average within-person change. It does not show whether all participants changed in the same direction, and it does not replace a description of the distribution of individual changes.
Change scores also depend on how baseline and follow-up measurements are obtained. Repeated measurement can introduce variability, and familiarity with a test can affect performance. These are general considerations for repeated-measures studies, not reported events in this study. The registry record does not describe the full measurement schedule, the method used to calculate repositioning error, or whether multiple directions of movement were combined into one endpoint.
What would a standard deviation and confidence interval add?
In general, a standard deviation describes the spread of observed values around the group mean. It is about participant-to-participant variability, not by itself the uncertainty in the estimated mean. A confidence interval expresses uncertainty around an estimate under the statistical model used. Readers would use the estimate and interval together to assess both the size of a change and the precision with which it was measured. Neither the primary outcome estimate nor its standard deviation or confidence interval is reported in the registry record.
A confidence interval should not be read as a guarantee that the true value lies within the interval. Rather, it is a statistical summary whose interpretation depends on the sampling and analysis assumptions. If an interval is wide, estimates compatible with the data may span a broad range; if it is narrow, the estimate is more precise under those assumptions. The posted record does not contain an interval for the primary or named secondary outcomes, so this kind of precision assessment is not possible.
Why does the single-group design affect interpretation?
In general, a single-group before-and-after design measures participants at more than one point without a separate concurrent control group. Such a design can describe the course of measured outcomes in the enrolled group. However, a change over time is not automatically attributable to the intervention. Repeated-test familiarity, measurement variability, and other changes during the study period are possible alternative explanations in general. The record does not report evidence that any particular alternative explanation occurred.
A randomized control comparison is often used to estimate how outcomes differ between intervention and comparison conditions while reducing the influence of systematic group differences. This study is recorded as single group, with allocation not applicable and no masking. Therefore, the registry record does not offer a randomized, between-group treatment contrast. Any interpretation of a within-group change would need to reflect that design limitation.
What can be inferred from analysis counts?
The registry reports 50 analyses. In general, multiple analyses may reflect different outcomes, time points, populations, or statistical approaches, but the count does not reveal which of these applies. The analysis methods, definitions, and numerical findings are not reported in the registry record. It is therefore not possible to determine from the count whether analyses were planned in advance, whether they were exploratory, or how their results relate to one another.
When many statistical questions are tested, multiplicity can increase the chance that some results appear statistically notable by chance. This is a general statistical concern, not a claim about the study’s findings. Whether an adjustment was used, or whether multiplicity was addressed through a prespecified hierarchy or another approach, is not reported in the registry record. The analysis count alone cannot establish that an adjustment was needed or absent.
Why is a p-value not enough?
In general, a p-value measures how incompatible the observed data are with a specified null model, assuming the model and analysis are appropriate. It does not measure the size or importance of an effect, nor does it give the probability that the null hypothesis is true. Estimates and confidence intervals are needed to describe magnitude and precision. The registry record does not report a p-value, effect estimate, or confidence interval for the primary outcome, so neither statistical significance nor effect size can be assessed.
These explanations describe general statistical concepts, not methods confirmed for this study. The registry record does not report the statistical test, model, covariates, handling of repeated observations, missing-data method, analysis population, or prespecified analysis plan. Those details should not be inferred from the outcome labels or the number of analyses.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures and reports 50 analyses. It names the primary outcome as change from baseline in scapular proprioception and identifies secondary outcomes involving strength, shoulder kinematics, muscle activity, and recruitment timing. The specific definitions and results for every analysis are not reported in the registry record. The number of analyses does not disclose whether each corresponds to a distinct outcome, time point, subgroup, or statistical model.
Multiplicity is a general concern when several hypotheses are tested: the chance of at least one apparently unusual result can increase as the number of tests grows. Approaches can include prespecifying a primary hypothesis, adjusting significance thresholds, or treating secondary analyses as exploratory. The registry record does not report whether any such approach was planned or applied. Without analysis details and results, the relevance of multiplicity to the reported findings cannot be assessed.
Missing-data handling is also not reported in the registry record. The record does not state whether all enrolled participants contributed primary outcome measurements, how incomplete measurements were handled, or whether any values were excluded. It does not identify an analysis population, such as all enrolled participants or only those with complete measurements. Enrollment of 30 is not enough to determine the number included in an analysis.
The record also does not report a statistical analysis plan, the methods used for confidence intervals or hypothesis tests, or any interim analysis. Those details should not be inferred. Their absence limits assessment of how prespecified the analyses were and how missing observations or multiple comparisons may have affected interpretation.
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 |
|---|---|---|---|
| Fatigued Group | 0 | 30 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Fatigued Group | 0 of 30 |
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 |
|---|---|
| Fatigued Group | 0 of 30 |
The registry reports one group, titled “Fatigued Group,” with 30 participants at risk for serious adverse events and 0 affected. It also reports 30 at risk for other adverse events and 0 affected. Deaths are recorded as 0. These are the posted safety counts for this group.
“At risk” is the registry’s denominator for the listed category; “affected” is the count recorded with an event in that category. These figures indicate that no serious adverse events, other adverse events, or deaths are recorded among the participants at risk in the posted results. They do not establish that every possible symptom or event was actively assessed or that no unrecorded event occurred. The registry record does not provide a list of non-serious event types, details of safety monitoring, or further information about event collection.
Safety counts should also be read separately from outcome measurements. They do not show whether scapular proprioception or neuromuscular measures changed, and they do not resolve the absence of a control group. The counts describe what the registry records for the study group, not a comparison of event rates between conditions.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, single-group study enrolled 30 participants and was designed to examine scapular proprioception and related neuromuscular measures around a muscle-fatigue intervention. It identifies the primary endpoint, its unit, the repositioning task, and several secondary outcomes. It also records 0 serious adverse events, 0 other adverse events, and 0 deaths among 30 participants at risk in the corresponding categories.
What the record does not establish is the direction or magnitude of change in the primary endpoint. Numerical outcome results are not reported in the registry record. Therefore, the stated hypothesis about increased reposition error and altered neuromuscular performance cannot be evaluated from the posted results. The same applies to the named secondary outcomes. A study’s aim or hypothesis is not a result, and completion status does not indicate whether the findings agreed with that hypothesis.
Even if a within-group change estimate were available, the single-group design would limit causal interpretation. In general, a difference from baseline may reflect the intervention, but it may also reflect measurement variability, repeated testing, or other changes during the study period. A separate randomized comparison is not described in the registry record. This does not mean the study is uninformative; it means that the design answers a narrower descriptive question than a controlled trial could answer.
Precision also cannot be judged without the numerical estimate and its uncertainty. The registry record does not report a confidence interval or the summary statistics needed to assess how closely the result was estimated. The analysis count is not a substitute for those results, and the safety counts do not fill this outcome-reporting gap.
The most defensible reading is therefore limited: the registry describes what investigators intended to measure and how the study was structured, but the posted outcome information does not permit an estimate of the primary effect or a statistical conclusion about the hypothesis. This interpretation neither claims that the intervention changed the measures nor claims that it did not.
13. Why This Trial Matters Statistically
This study is statistically relevant because it illustrates the distinction between a research question and a result. The registry gives a clear primary question about change from baseline in scapular proprioception and describes a task intended to measure active repositioning. It also names related measures of strength, kinematics, muscle activity, and recruitment timing. Yet the numerical outcome results are not reported in the registry record. Without estimates and measures of uncertainty, readers cannot assess direction, magnitude, or precision.
The single-group structure is another important statistical feature. A within-participant comparison can be useful for describing change across a study period, particularly when the same people are measured more than once. But without a concurrent control group, such change cannot be separated from other possible influences using the design alone. Recognizing that limitation helps keep conclusions aligned with what the comparison can support.
The record’s six outcome measures and 50 analyses also make transparent reporting important. In general, multiple outcomes and analyses can create interpretive challenges if analysis choices are not described. Reporting which measures were primary, which analyses were prespecified, how missing data were handled, and whether multiplicity was addressed helps readers distinguish confirmatory from exploratory evidence. Those details are not reported in the registry record.
The safety counts provide a separate example of careful interpretation. Zero events are recorded in the listed categories among participants at risk, but those counts do not describe unlisted outcomes or establish the completeness of event ascertainment. Each statistic answers a particular question; it should not be extended beyond its recorded scope.
For biostatisticians and clinical researchers, the central lesson is that a registry entry can document design, endpoints, enrollment, and safety counts while still leaving the principal efficacy question unresolved. Clear outcome estimates, uncertainty measures, and analysis details are essential for evaluating what a completed study contributes.
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 principal limitation for interpreting the posted record is that numerical results for the primary and secondary outcomes are not reported in the registry record. There are no posted baseline or follow-up summaries, change estimates, measures of dispersion, confidence intervals, or hypothesis-test results for the outcomes described. Consequently, the size and precision of any change cannot be assessed.
The study is recorded as single group, with no randomized allocation and no masking. A within-group comparison can describe changes over time but cannot isolate the intervention’s contribution from other influences using a concurrent control contrast. This is a limitation of the recorded design, not a claim about whether any such influence affected the measurements.
Important procedural details are not reported in the registry record. These include how fatigue was induced and verified, how the repositioning task was scored, the full measurement schedule, and how the reported average intervention-completion time relates to individual measurements. Eligibility criteria and participant characteristics are also not reported, limiting assessment of the population to which any findings might apply.
The record lists six outcome measures and 50 analyses, but does not describe all analysis definitions or methods. Statistical models, handling of repeated measurements, missing-data procedures, analysis populations, and any multiplicity approach are not reported in the registry record. Without those details, the robustness and prespecification of analyses cannot be evaluated.
Finally, the safety figures are limited to the recorded categories and counts. The registry record does not provide additional event descriptions or details about safety ascertainment. These reporting limitations mean that the available record is informative about study structure but insufficient for a full assessment of outcome evidence, precision, or analytic conduct.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Muscle Fatigue and Scapular Sensorimotor System — NCT03066102.
- Registry record last updated 2019-07-29; status last verified 2019-07.
- Results first posted 2019-07-15.
- 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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18. Record Summary
NCT03066102 is a completed, single-group study titled “Muscle Fatigue and Scapular Sensorimotor System,” sponsored by National Yang Ming Chiao Tung University. Enrollment was 30. The study began on 2017-07-01, and primary completion was recorded as 2017-08-11. Masking is listed as none, and allocation is listed as not applicable.
The primary outcome is change from baseline in scapular proprioception, measured in centimeters through an active scapular repositioning task. Secondary outcomes concern changes in scapular muscle strength, shoulder kinematics, muscle activity, and recruitment timing. The registry record describes the aim and hypothesis but does not report numerical results for the primary or secondary outcomes.
The safety record lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 30 participants at risk in the corresponding categories. The analysis details, missing-data methods, analysis populations, and multiplicity approach are not reported in the registry record. The posted information therefore describes the study’s design and recorded safety counts but does not permit assessment of the magnitude or precision of outcome changes.