Movement Assessment for Concussion Management: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Movement Assessment for Concussion Management (NCT02776904), a randomized na study. The primary outcome is Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete.

2. Clinical Question

3. Trial Design

The registry record describes Movement Assessment for Concussion Management, sponsored by the University of Arkansas. Its official title is Comprehensive Dynamic Movement Assessment for Concussion Management. The study status is completed, and the listed enrollment is 327. The registry lists the phase as not applicable. The study start is recorded as 2016-06-01 and primary completion as 2019-05-01.

There is an important design-description mismatch. Allocation is recorded as randomized, masking as none, and the model as single-group. The record does not explain how these classifications fit together. It names healthy athletes and concussed athletes in the group descriptions, but the primary outcome is specifically described for a subset of healthy athletes, and the registry indicates fewer than two arms for that outcome. A randomized allocation label alone is not enough to establish what was randomized, what comparisons were intended, or whether the primary analysis was between groups.

The study summary describes a pilot assessment battery intended to add functional movement and dynamic postural-control measures to routine neuro-cognitive testing. Listed procedures are ImPACT, gait with single and dual task, Y-Balance testing, and the Psychomotor Vigilance Task. The summary states an interest in ImPACT stability among youth athletes and in using movement and balance assessments in concussion management. Those statements describe the study rationale and aims, not findings.

The registry record does not report the recruitment process in detail, the timing or frequency of all assessments beyond the primary-outcome timeframe, or the sample-size justification. It also does not report a protocol explanation for the design classifications. The outcome description names preseason, postseason, end of the school year, and pre-season year 2 for the primary measure, but does not establish that every participant contributed data at every assessment. No inference about completion or adherence can be made from the listed enrollment alone.

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

Analysis population for the primary outcome, as defined in the registry: subset from healthy athlete group

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.

6. Primary Endpoint

The registry lists the primary outcome as Impact ( Immediate Post-concussion Assessment and Cognitive Testing) Healthy Athlete, measured over preseason, postseason, end of the school year, pre-season year 2.

The primary outcome is titled as an ImPACT measure in healthy athletes and is described as a mean of a continuous score. The assessed population is a subset of the healthy-athlete group. The registry identifies a score on the Immediate Post-concussion Assessment and Cognitive Testing scale as the unit and lists preseason, postseason, the end of the school year, and pre-season year 2 as the timeframe.

The description covers verbal memory, visual memory, and visual motor speed. Verbal memory is described through correct responses on memory tasks; visual memory uses correct responses during a module; and visual motor speed reflects correct responses on specified modules. The registry says verbal and visual memory scores range from 70-99 and visual motor speed scores range from 27-39.8. For the listed measures, higher scores are described as better than lower scores.

ImPACT is included because the study aims to assess the stability of cognitive testing in youth athletes amid ongoing neurodevelopment. In general, repeated measurements can describe how scores vary over time, but their interpretation depends on the score definition, assessment schedule, and analysis method. The registry record does not report the observed means at the listed time points, how the component scores were combined or analyzed, or an estimate of change with its uncertainty. The endpoint description therefore identifies the intended measurement, not the result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a mean of a continuous measure and lists standard error as its dispersion statistic. The following explains those terms generally; it does not describe an analysis method confirmed to have been used in this study. The registry record does not report the specific statistical model, test, or estimation procedure used for the primary outcome.

What does a mean represent?

For a continuous measurement, a mean is the arithmetic average of the observed values in an analysis group. It gives a summary of the group’s central level on the measured scale. A mean does not show the full spread of individual observations, whether the observations cluster in subgroups, or whether a small number of unusually high or low values influence the summary. Those features may matter when interpreting cognitive or movement scores.

In a repeated-assessment setting, means can be presented separately by assessment time. A comparison of those means may describe a change in the observed group average, but interpretation depends on which participants contribute at each time, how missing observations are handled, and whether the analysis accounts for dependence between measurements from the same athlete. The listed primary-outcome time points do not by themselves establish which of these methods was used.

What does standard error describe?

In general, the standard error quantifies the sampling precision of an estimated statistic, such as a mean. It is not the same as the standard deviation, which describes variability among individual observations. A small standard error indicates greater precision for the estimate under the assumptions of the calculation; it does not mean that individual scores are tightly clustered. The registry names standard error but does not provide its numerical value for the primary outcome.

A confidence interval is a general way to express uncertainty around an estimate. Its width reflects both the variability in the data and the precision of estimation under the chosen method. A confidence interval for a mean or mean difference can help readers judge which values are compatible with the data and analysis assumptions. The registry record does not report a primary-outcome confidence interval. Without an estimate and its uncertainty, the size and precision of any observed pattern cannot be assessed.

How should repeated measurements be considered?

Repeated scores from the same athlete are generally related rather than independent, because the observations share the same person and may also share measurement conditions. General methods for repeated data account for this within-person relationship when estimating changes or comparing time points. Treating correlated observations as independent can make uncertainty estimates misleading. The record lists several assessment times but does not report whether a repeated-measures model, a paired comparison, or another approach was used.

The assessment interval may also be relevant to interpretation. The primary outcome lists preseason, postseason, the end of the school year, and pre-season year 2. The record does not explain how the timing was operationalized for each athlete, whether all time points were available for each participant, or whether the analysis used all available observations. These details matter because the meaning of a time trend can depend on which observations are included and how incomplete follow-up is addressed.

What can allocation and masking tell readers?

Random allocation can support a fair comparison when the assigned groups, intervention, and analysis are clearly specified. Here, allocation is recorded as randomized, while the study model is recorded as single-group and the primary outcome has fewer than two arms. The record does not state what was randomized or reconcile these fields. The randomized label should therefore not be treated as evidence of a randomized primary-outcome comparison.

Masking is recorded as none. In general, masking can reduce the influence of expectations on some aspects of measurement, conduct, or assessment. Its relevance varies with the outcome and study procedures. The registry does not report further detail about who knew which information or how potential measurement influence was addressed. No particular bias can be concluded from the masking entry alone.

What is not described in the statistical plan?

The registry record does not report a statistical analysis plan for the primary outcome, a model specification, covariate adjustments, a handling rule for outliers, or a method for constructing confidence intervals. It does not report whether results were adjusted for baseline score or for differences in participant characteristics. These methods can affect both the estimated effect and its uncertainty, so their absence limits independent interpretation of any result that might otherwise be reported.

The record lists 10 outcome measures and 11 analyses. In general, when many outcomes or analyses are examined, the chance of finding at least one apparently notable result can increase if each is assessed without accounting for multiplicity. Approaches to multiplicity may include prespecifying a primary comparison, adjusting significance thresholds, or treating secondary findings as exploratory. The registry information does not describe a multiplicity strategy. The counts alone do not establish that the analyses were inappropriate, nor do they reveal which results were primary or confirmatory beyond the listed primary outcome.

Sample-size figures, when used as planning illustrations, answer a design question under specified assumptions; they do not describe the observed result or the probability that a completed study detected an effect. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The illustration is not described as the trial’s own design justification. The record does not report a sample-size justification in the protocol or actual planning target. Such calculations should not be read as observed power.

For a continuous outcome, general methods may also need to address the distribution of scores and the possibility that variability differs across groups or times. The registry does not report diagnostic checks or a distributional model. Over-dispersion is a concern chiefly for data whose variance exceeds what a chosen model expects, often count data; it is not a reason to assume that a continuous-score model was over-dispersed. The record does not identify a model for which that concern was evaluated.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and 11 analyses. It does not describe a multiplicity strategy, such as an adjustment for testing several outcomes or a prespecified hierarchy that distinguishes confirmatory from exploratory analyses. In general, evaluating many outcomes can increase the chance that at least one result appears noteworthy by chance when each is assessed separately. Whether that concern applies to a particular result depends on the analysis plan and the role assigned to each outcome. The listed counts do not reveal the plan or establish how any result should be classified.

The primary outcome is described as a mean ImPACT score in a subset of healthy athletes, but the record does not report the analysis population in operational detail. It does not say how athletes were selected for the subset, which participants were included at each time, or how exclusions were handled. The listed enrollment is not necessarily the analysis population for every measure or time point.

Missing-data methods are not reported in the registry record. It does not state how incomplete assessments were handled, whether the analysis used available observations, or whether any assumptions about missingness were made. In general, missingness can affect both the composition of the analyzed group and the interpretation of repeated measurements. Without the extent and handling of missing data, the robustness of any time-based result cannot be assessed.

The registry also does not report the analysis populations for the other outcomes, an intention-to-treat approach, or a per-protocol approach. These omissions do not establish that such methods were not used; they mean they are not documented in the registry record. The allocation and model classifications are not reconciled, adding uncertainty about which participants or groups were intended for the primary analysis.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists healthy athletes with 281 at risk for serious events and 0 affected, and 281 at risk for other events and 0 affected. For concussed athletes, it lists 46 at risk for serious events and 0 affected, and 46 at risk for other events and 0 affected. Deaths are listed as 0 in each group. No serious adverse-event terms are listed.

These entries indicate that the registry reports no events in the listed categories for the stated groups. They do not establish that no event of any kind occurred outside the categories or reporting period captured by the registry. They also do not show how events were monitored, defined, collected, or verified. The record does not report further details about safety surveillance or the timing of adverse-event collection.

In general, a zero count is a description of the observed report, not proof that the underlying risk is zero. The size and composition of the population at risk, the event definitions, and completeness of reporting all affect what can be inferred. These safety entries should be read separately from the primary ImPACT outcome: they do not measure score stability, cognitive performance, or the effectiveness of an assessment strategy.

12. What the Result Does, and Does Not, Mean

The record establishes that the study was completed and describes an assessment program involving ImPACT, gait with single and dual task, Y-Balance testing, and the Psychomotor Vigilance Task. It identifies a primary continuous outcome based on mean ImPACT scores in a subset of healthy athletes and lists the assessment timeframe. These details clarify what the study set out to assess, but they do not supply the numerical primary result.

The record does not show the observed score means, their changes across the listed times, or uncertainty estimates. It therefore cannot establish whether the scores were stable, whether they changed, or how precisely any pattern was estimated. The stated ranges and direction of score interpretation describe the measures; they are not evidence of the participants’ actual scores.

The study summary discusses potential roles for dynamic balance and gait assessment in concussion management and in anticipating musculoskeletal injury. The record does not report evidence that these measures predicted injuries, guided return-to-play decisions, changed rehabilitation, or improved clinical outcomes. Those applications remain motivations in the study description rather than conclusions supported by the primary endpoint information.

The healthy and concussed athlete descriptions do not, on their own, support a comparison between those groups. The primary outcome is listed for a healthy-athlete subset, and the registry marks it as having fewer than two arms. The randomized allocation entry is not reconciled with the single-group model. Without a clearly reported comparison and analysis, a difference between groups cannot be inferred.

More generally, an assessment study can address whether a measurement is feasible, how scores behave over time, or whether a measure is associated with another outcome. Those are distinct questions and require different analyses. The registry’s stated aims span several possible questions, but the posted primary-outcome details do not report results for those questions. The record supports a description of the study and its measurement plan, not a claim of clinical benefit or lack of benefit.

13. Why This Trial Matters Statistically

This study is statistically relevant because it brings together cognitive testing and functional movement assessments in young athletes, while identifying repeated ImPACT measurement as its primary outcome. The record’s aim of examining score stability raises a measurement question: whether scores collected at different times provide a consistent picture in a developing population. That question is distinct from asking whether a test identifies concussion or predicts a later injury.

The design information also illustrates why registry classifications need to be read together. Randomized allocation, a single-group model, and a primary outcome with fewer than two arms appear in the same record. Without an explanation of the relationship among those entries, readers should not assume that the primary outcome was evaluated through a randomized group comparison. Clear reporting of the analyzed population, estimand, and model would be needed to interpret such a comparison.

Repeated scores also make the analysis structure important. Measurements from the same athlete are generally related, and the way that relationship is handled affects estimates of change and their uncertainty. The timeframe is named, but the analysis method and participant contribution at each time are not reported. This leaves an important part of the statistical interpretation unresolved.

Finally, the record lists 10 outcome measures and 11 analyses, but does not describe multiplicity handling or distinguish confirmatory analyses from exploratory ones. Transparent reporting of prespecified outcomes, missing-data methods, and uncertainty would help readers judge how much weight to place on observed patterns. Since the numerical primary results are not reported in the available record, the statistical importance of the study lies chiefly in its measurement aims and the reporting questions it leaves open.

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 main limitation for interpreting the primary outcome is that the registry record does not report its numerical results. Mean scores, changes across assessment times, standard errors, confidence intervals, and statistical tests are not included in the outcome details. Without these, the magnitude, direction, and precision of the score pattern cannot be evaluated.

The endpoint applies to a subset of healthy athletes, but the record does not describe how that subset was defined or selected. It also does not report how many participants contributed to each assessment, whether each athlete completed every listed time point, or how incomplete data were handled. This makes it difficult to judge the population represented by any repeated-score estimate.

Study design fields are not fully aligned: allocation is listed as randomized, the model as single-group, and the primary outcome as having fewer than two arms. The record does not explain the discrepancy or identify what was randomized. It also does not provide the analysis model, covariate strategy, or detailed statistical plan. These omissions limit assessment of how the intended question was translated into an analysis.

The registry lists multiple outcomes and analyses but does not report a multiplicity plan. It does not provide details on the measurement procedures beyond the endpoint descriptions, nor does it report the study’s sample-size justification. The listed planning assumptions are described as illustrations rather than the trial’s own design plan. As a pilot study, its stated purpose is exploratory, but the registry does not document a formal distinction between exploratory and confirmatory findings.

The study summary names potential uses in injury prediction and concussion management, but the available outcome description does not report predictive performance or clinical decision outcomes. Those aims cannot be evaluated from the primary ImPACT measure alone. These limitations concern what can be concluded from the registry record; they do not establish that additional analyses or details were absent from other study materials.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Movement Assessment for Concussion Management — NCT02776904.
• Registry record last updated 2020-02-26; status last verified 2020-02.
• Results first posted 2020-02-26.
• 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.

18. Record Summary

Movement Assessment for Concussion Management is a completed study sponsored by the University of Arkansas, with listed enrollment of 327. The registry describes healthy athletes and concussed athletes aged 14-18 and lists ImPACT, gait with single and dual task, Y-Balance testing, and the Psychomotor Vigilance Task as assessments.

The primary outcome is mean ImPACT score in a subset of healthy athletes at preseason, postseason, the end of the school year, and pre-season year 2. The measure description covers verbal memory, visual memory, and visual motor speed. Numerical primary-outcome results and their uncertainty are not reported in the registry record.

Allocation is listed as randomized, while the model is single-group and the primary outcome has fewer than two arms; the record does not reconcile these classifications. It lists no serious events, other events, or deaths in the adverse-event entries. The study aims and assessment descriptions can be summarized, but the available record does not establish score stability, group differences, or clinical effects.