Effects of Cholinergic Augmentation on Measures of Balance and Gait: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Cholinergic Augmentation on Measures of Balance and Gait (NCT02206620), a randomized phase 2 study. The primary outcome is Delta Medio-lateral Postural Sway Range (Foam).

2. Clinical Question

The trial was exploratory. Its registry description says it was intended to examine whether cholinergic manipulation might affect gait, balance, or attention, and whether a physiological measure of cholinergic activity or attention might relate to changes in gait and balance. These are related questions, but the posted primary outcome is specifically a balance measure: delta medio-lateral postural sway range on foam over six weeks. The record also lists short-latency afferent inhibition and the Attention Network Test as secondary outcomes. The primary comparison therefore addresses a defined measure under two treatment conditions, not every aspect of mobility or the broader proposed biological explanation.

3. Trial Design

This was a randomized, quadruple-masked, crossover Phase 2 trial sponsored by Oregon Health and Science University. The registry lists 49 participants, a July 2014 start, a July 2017 primary completion, and a completed status. In a crossover study, participants are assigned to sequences and receive more than one treatment condition over time. The listed sequences were donepezil followed by placebo, or placebo followed by donepezil. This allows a participant's measurements under different conditions to contribute to the comparison, although the registry's posted summary does not explain how within-participant dependence was handled in the analysis.

The listed donepezil and placebo regimens each began at 5 mg per day and could increase to 10 mg per day if tolerated. The schedule is described with different week ranges for the treatment sequence, and the adverse-event groups identify Phase I, washout, and Phase II periods. The registry record does not report further details about the duration or conduct of the washout, sequence generation, concealment, or how adherence and treatment-period completion were handled.

Quadruple masking indicates that the record labels the study as masked at four levels, but the identities of those levels are not reported in the registry record. The brief description calls the study double-blind; the registry's design field labels masking as quadruple. Those descriptions should not be taken to identify precisely who was masked without further documentation. The record identifies placebo as the comparator and describes donepezil as the intervention.

The trial's primary completion date is listed as July 2017, and its overall status is completed. Enrollment and outcome denominators should be read separately: 49 participants are listed for each treatment condition in the posted primary outcome, but the record does not explain the participant flow behind those denominators or whether all randomized participants contributed usable measurements to every endpoint.

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.

Phase I - First Intervention (6 Weeks)

Reasons for not completing this period:

Washout (6 Weeks)

Phase II - Second Intervention (6 Weeks)

Reasons for not completing this period:

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 Delta Medio-lateral Postural Sway Range (Foam), measured over Six weeks.

The primary endpoint is delta medio-lateral postural sway range while standing on a foam pad, measured over six weeks and reported in m/s^2. The registry describes increased body sway as a possible marker of increased fall risk in Parkinson's disease. It says that sway was measured using an inertial sensor attached to the waist. For each treatment phase, the reported value is the post-period measurement minus the pre-period measurement: post-donepezil minus pre-donepezil for the donepezil phase, and post-placebo minus pre-placebo for the placebo phase.

This outcome captures change in a particular direction of postural sway under a specified standing condition. It is not itself a direct count of falls or a comprehensive measure of daily mobility. The measure was selected as the primary endpoint within an exploratory study asking whether donepezil and placebo phases differ on a balance measure. The registry description explains why sway may be relevant to fall risk, but it does not report a threshold for a meaningful change or establish how a given change in this measure maps to an individual's experience.

The posted mean change was 0.007 m/s^2 in the donepezil phase and -0.004 m/s^2 in the placebo phase. The reported mean difference, donepezil minus placebo, was 0.011 m/s^2. These are descriptive results for the posted outcome; their interpretation depends on the precision of the comparison and on the analysis details available in the registry record.

7. Results Posted in the Registry

• Donepezil: mean 0.01 versus -0.00 on control; difference 0.01 (95% CI -0.00 to 0.03), standardized effect d = 0.29; z-test p = 0.146.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Short-latency Afferent Inhibition is a Marker of Cortical Cholinergic Activity

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Donepezil: mean 72.50 versus 74.30 on control; difference -1.80 (95% CI -11.86 to 8.26), standardized effect d = -0.07; z-test p = 0.726.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Donepezil and the control. The interval gives the range of effects that remain compatible with the data.

Attention Network Test

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Donepezil: mean -19.50 versus -5.10 on control; difference -14.40 (95% CI -19.25 to -9.55), standardized effect d = -1.17; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Donepezil than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The two posted secondary outcomes address different aspects of the study's exploratory rationale. Short-latency afferent inhibition is presented as a marker of cortical cholinergic activity, while the Attention Network Test assesses attention. Along with the primary balance measure, they span physiological, cognitive, and postural domains. The registry's stated rationale proposes examining whether gait and balance deficits relate to cholinergic function and whether changes in gait and balance might be mediated by attention.

The secondary results do not create a single consistent account that can be reduced to the primary endpoint. The outcomes use different units and measure different constructs. Their relationship to sway is conceptually relevant to the study's hypotheses, but the registry does not report analyses testing whether changes in either secondary outcome are associated with changes in the primary outcome, or whether attention mediates any treatment-related change. Separate endpoint comparisons cannot establish those relationships.

The registry lists no reported analyses for the secondary outcomes, and the posted comparisons are labeled unadjusted. When several outcomes are examined, an unadjusted result does not account for the increased chance of seeing an apparently notable finding among multiple comparisons. The record does not report a multiplicity adjustment or identify a confirmatory hierarchy for the secondary measures. Their results should therefore carry less weight than a prespecified, multiplicity-aware analysis would, and should be treated as exploratory rather than as independent confirmation of a treatment effect.

These endpoints may help motivate future, more focused questions, as the study description itself anticipates. But the registry does not establish a link among cholinergic activity, attention, and balance through the posted comparisons alone. They are best read as separate measurements within a broader exploratory investigation, not as proof of a mechanism or as substitutes for the primary outcome.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Short-latency Afferent Inhibition is a Marker of Cortical Cholinergic Activity
• Attention Network Test

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is a continuous measure, and the registry reports the mean and standard deviation for each treatment condition. A mean is the arithmetic average of the observed values; a standard deviation describes how spread out participant measurements are around that average. These summaries communicate the center and variability of the posted changes, but they do not show the full distribution or identify outliers.

The condition means are 0.007 m/s^2 for donepezil and -0.004 m/s^2 for placebo. The comparison is expressed as a mean difference, defined in the posted result as donepezil minus placebo. Its estimate is 0.011 m/s^2. A positive value means the posted average change is numerically higher in the donepezil condition under that subtraction order. It does not, by itself, determine whether that difference is important in practice or whether it is attributable to treatment rather than other features of the trial.

A confidence interval gives a range of values compatible with the observed data and the assumptions of the calculation. The 95% interval for the primary mean difference runs from -0.004 to 0.026 m/s^2. Because it includes zero, the data do not rule out no mean difference under the calculation used. The interval also includes positive values, so it should not be summarized as showing that the conditions are identical. A confidence interval is not a range containing 95% of individual participant measurements, and it is not a guarantee that the true effect lies within its endpoints.

The unadjusted p-value is 0.146. A p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that null hypothesis and the test assumptions held. It is not the probability that the null hypothesis is true, nor a measure of the probability that the result will replicate. The registry labels this value unadjusted. The record does not report an adjustment for multiple outcomes or an analysis plan specifying which comparisons were confirmatory.

The listed standard deviations for the primary outcome are 0.045 m/s^2 in the donepezil condition and 0.028 m/s^2 in the placebo condition. The posted comparison also includes a pooled standard deviation of 0.037 m/s^2 and a standardized effect estimate of 0.293. Standardizing expresses the difference relative to a measure of variability, which can help describe scale-free magnitude. It does not replace the original measurement units, and interpretation still depends on the design, precision, and clinical context. The record does not give a clinical threshold for the standardized or unstandardized effect.

A crossover trial differs from a parallel-group trial because participants receive treatment conditions in sequence. Measurements from the same participant are generally related rather than independent. A statistical analysis may need to account for that dependence, as well as period and sequence effects. The registry posts the numbers of participants and the condition-specific summaries, but does not report the model, test, or variance calculation used for the primary comparison. It is therefore not possible to confirm from the registry record whether the posted comparison accounts for within-participant correlation or other crossover features.

In general, over-dispersion means that observed variability is greater than a model assumes. When a model underestimates variability, standard errors may be too small and intervals too narrow; when it accommodates the actual variability, inference can be more appropriately calibrated. That general concern is relevant whenever a statistical model is used, but the record does not report a model or an over-dispersion assessment for this outcome. The posted standard deviations show variation in the observed measures, not whether a particular model adequately represented it.

The sample-size illustrations use a normal approximation, two-sided significance level 0.05, and equal allocation between two arms, with the effect to detect set to the stated fraction of the observed effect. These are planning assumptions for the illustrations, not reported assumptions from the trial's original protocol. In general, smaller target effects require more participants to detect with a chosen power under otherwise unchanged assumptions. The trial's own sample-size justification and original design assumptions are not reported in the registry record.

The registry lists 49 participants for each condition in the posted primary result, but does not give a participant-flow account or explain whether all observations were complete. It also does not report the approach to missing measurements, exclusions, analysis populations, or sensitivity analyses. These omissions matter because the handling of incomplete data can affect both the estimate and its precision, particularly in a study with multiple treatment periods.

What is not reported about the analysis?

The registry's analysis listing reports zero analyses. The posted outcome comparisons therefore do not come with a documented model specification, adjustment strategy, diagnostic checks, or prespecified hierarchy of hypotheses. The record also does not state whether the reported p-values and intervals come from a paired test, a crossover model, or another procedure. General statistical interpretations of means, confidence intervals, and p-values remain useful, but the analysis details needed to evaluate model fit and design-specific assumptions are not reported in the registry record.

11. Confidence Intervals and Precision

The primary mean difference is 0.011 m/s^2, and its 95% confidence interval ranges from -0.004 to 0.026 m/s^2. The interval includes zero, so the posted data do not distinguish clearly between no average difference and a difference in either direction within the interval. Its width indicates that the estimate is not highly precise relative to the range of values compatible with the calculation. The unadjusted p-value of 0.146 is consistent with that uncertainty; neither the p-value nor the interval establishes equivalence.

Precision concerns the uncertainty in an estimated group-level difference, not whether individual participants had similar responses. The posted standard deviations, 0.045 m/s^2 for donepezil and 0.028 m/s^2 for placebo, describe spread among the phase-specific values. They are distinct from the uncertainty around the mean difference. The registry does not provide participant-level distributions, so the extent of skew, outliers, or variation in individual treatment responses cannot be assessed from these summaries.

Interpretation is also limited by missing analysis details. Because the study is a crossover trial, a precision calculation may depend on the relationship between a participant's values in different periods. The registry does not report that within-participant correlation or the method used to calculate the interval. The interval remains the posted summary, but readers cannot independently evaluate its design-specific assumptions using the registry record alone.

No clinical-importance threshold is reported for the primary measure. Thus, the confidence interval cannot be classified from the registry record as excluding or including a particular clinically important difference. It expresses statistical precision in the measure's units, not a judgment about importance.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial's original design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect equal to the stated fraction of the observed effect. The original trial's own sample-size assumptions and justification are not reported in the registry record.

For continuous outcomes, the figures are participants per arm, not total participants. The accompanying planning curve should be read under the same assumptions and effect-size choices. The 80% power column describes the number of participants per arm that the illustration estimates would be needed to have an 80% chance of detecting the target effect if the assumptions hold. The 90% power column uses a higher chance of detecting that effect and therefore generally calls for more participants per arm. These are design-planning quantities, not counts of participants observed in this trial.

The rows represent planning for 100%, 75%, and 50% of the observed effect. For the primary outcome, planning for 100% of the observed effect gives 183 participants per arm for 80% power and 244 participants per arm for 90% power. Planning for 75% gives 324 and 434 participants per arm, respectively; planning for 50% gives 729 and 976. The pattern illustrates that smaller effects require more participants to detect under the same assumptions.

These figures are not observed power. They do not show the probability that the completed trial's result is true, and they do not determine whether its estimate is important. They are hypothetical planning illustrations calculated using the observed effect and stated assumptions. Crossover design features are not specified among those assumptions, so the illustrations should not be read as a reconstruction of the trial's original sample-size calculation.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.011; pooled standard deviation σ = 0.037.
2. n = 2 × (1.96 + 0.842)² × 0.037² / 0.011² = 182.2, rounded up to 183 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.011                      # observed difference in means
sigma <- 0.037476659402887                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2206620)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 183 (80% power), 244 (90% power)
 75% of observed effect: n per arm = 324 (80% power), 434 (90% power)
 50% of observed effect: n per arm = 729 (80% power), 976 (90% power)
power.t.test: 183.2 
Simulated power at n = 183 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures in total and posts one primary outcome and two secondary outcomes in the available results. It does not report a prespecified statistical analysis plan, a hierarchy among outcomes, or a multiplicity adjustment. The posted p-values are identified as unadjusted. When several outcomes or comparisons are considered, repeated testing can increase the chance of at least one result appearing statistically notable by chance. Without a stated strategy for controlling that issue, secondary findings need cautious interpretation.

The registry's analysis listing reports zero analyses. It therefore does not document which analysis was designated primary before results were examined, whether all planned outcomes are posted, or whether additional analyses were conducted but not included in the record. The registry does not report interim analyses, stopping rules, or a prespecified approach to subgroup analyses. These details should not be inferred from the completed status or from the posted estimates.

Missing-data methods and analysis populations are also not reported in the registry record. Although 49 participants are listed in each primary treatment condition, the record does not explain whether those are all randomized participants, all participants with data at the relevant visit, or another analysis set. It does not provide participant flow by sequence or period, reasons for missingness, imputation methods, or sensitivity analyses. In a crossover design, incomplete periods can affect which participants contribute within-person comparisons, so these details are important for understanding the estimate.

The record also does not explain the statistical model used to account for repeated measurements, treatment sequence, treatment period, or possible carryover. The study's masking and randomization labels describe design features, but they do not fill in these analysis details. Readers can interpret the posted summaries as reported, while recognizing that the registry record does not permit a full audit of multiplicity handling, missing-data decisions, or analysis-population definitions.

15. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pulmonary embolus (3.8%).

The registry reports adverse events by treatment sequence and study period: Phase I, washout, and Phase II. These are period-specific group counts, not necessarily counts of unique participants across the entire trial. For the six listed groups, the number at risk ranges from 21 to 27. Serious adverse events are listed as zero in every group except the placebo-then-donepezil washout group, where one is listed. The registry lists zero deaths in all six groups.

Other adverse events are reported separately from serious adverse events, with counts shown for each group. Because participants could contribute to more than one treatment period, these group counts should not be added to produce a unique-participant total. The registry identifies Pulmonary Embolus as a top serious-event term and gives 3.8%; it does not provide further context for that percentage in the record. These descriptive figures do not by themselves establish whether an event was caused by a treatment, and the listed group sizes and periods should be kept in view when interpreting them.

The adverse-event summary does not provide detailed event narratives, timing relative to treatment, severity grading beyond the serious-versus-other classification, or a comparative statistical analysis. Those details are not reported in the registry record.

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

The primary finding is a posted mean difference of 0.011 m/s^2 in change in medio-lateral postural sway on foam, comparing donepezil with placebo. Its 95% confidence interval includes zero, and the unadjusted p-value is 0.146. These data do not establish a statistically clear difference in the average primary outcome under the reported comparison. They also do not establish that the conditions are equivalent or that any difference is absent.

The result concerns a specific sensor-based balance measure over a six-week period. It does not directly measure falls, the ability to perform daily activities, or every aspect of gait and balance. The registry gives a rationale for using sway as a marker related to fall risk, but does not report a clinically meaningful threshold or a validated interpretation of the observed difference for an individual. No conclusion about clinical benefit or harm should be drawn from this single continuous outcome alone.

The trial's exploratory purpose and its secondary measures provide context for why this outcome was studied, but the registry does not report analyses establishing a mechanism linking cholinergic activity, attention, and balance. Nor does the posted primary comparison establish how the result generalizes beyond the participants and conditions studied. Enrollment was 49, and the record does not provide enough analysis detail to assess the full effect of missing measurements or how the crossover structure was modeled.

The most defensible reading is therefore limited: the registry reports a small positive difference in the displayed mean-change comparison, with uncertainty that includes no difference, and without a documented clinically important threshold or complete statistical analysis plan. The finding is one piece of evidence about this measure in this trial, rather than a definitive answer to the broader questions about cholinergic manipulation, gait, balance, or attention.

17. Why This Trial Matters Statistically

This trial is statistically interesting because it combines a crossover design with several outcome domains. In principle, a crossover allows treatment conditions to be compared within the same participants, which can make a design informative when measurements under different periods are related. At the same time, analysis must respect that dependence and consider the order and timing of treatment periods. The registry does not report enough methodological detail to determine how those features were handled, making the distinction between design strengths and analysis documentation especially important.

The primary outcome is a continuous sensor-based measure rather than a binary event. That makes the mean difference and its uncertainty central to interpretation. The result illustrates why a point estimate alone is not enough: the confidence interval includes zero and spans a range on both sides of it. A non-significant unadjusted p-value does not demonstrate equivalence, while the absence of a clinical-importance threshold makes it difficult to translate the estimated difference into a practical judgment.

The study also puts a primary balance measure alongside physiological and cognitive outcomes. That breadth reflects exploratory questions, but it raises the need for clear prespecification and multiplicity methods when results are interpreted across outcomes. The registry does not report those methods or a documented analysis plan. This limits how strongly separate secondary findings can support a unified explanation.

Finally, the planning illustrations make visible how sample-size requirements depend on the effect one aims to detect. Smaller target effects require more participants under the stated planning assumptions. They are not a substitute for the trial's original sample-size justification, which is not reported. Taken together, the record is a useful example of why design labels, effect estimates, uncertainty, multiplicity, and analysis transparency all matter when reading a clinical trial result.

18. 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 registry record affect interpretation. The trial is described as a crossover study, but the statistical model used for the posted treatment comparison is not reported. In particular, the record does not explain whether within-participant correlation, treatment period, sequence, or possible carryover was considered. The reported summary comparison therefore cannot be independently assessed against the design structure using registry information alone.

The record gives 49 participants in each primary condition but does not include a participant-flow account by treatment sequence or period. It does not report how many participants completed both periods, how missing measurements were handled, whether observations were excluded, or which analysis population was used. Those omissions leave uncertainty about the data contributing to the condition summaries and comparison.

The primary endpoint measures change in postural sway on a foam pad. The record provides a rationale relating sway to fall risk, but does not report a clinically important threshold or a direct fall outcome for this primary comparison. As a result, the practical importance of the mean difference cannot be determined from the posted numbers alone. The result also does not represent all gait or balance domains.

The study is described as exploratory, and the registry does not report a statistical analysis plan, multiplicity strategy, or hierarchy for the secondary outcomes. The analysis listing contains no reported analyses. This limits assessment of prespecification and the strength of secondary evidence. Finally, the registry's description of masking differs in wording between the design label and brief description; the specific masked roles are not reported. These are limitations of the available record, not evidence that the trial did or did not follow procedures that are not documented there.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Effects of Cholinergic Augmentation on Measures of Balance and Gait — NCT02206620.
• Registry record last updated 2019-11-14; status last verified 2019-11.
• Results first posted 2019-11-14.
• 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.

22. Record Summary

NCT02206620 is a completed randomized, quadruple-masked, crossover Phase 2 trial sponsored by Oregon Health and Science University. It enrolled 49 participants with Parkinson's disease and compared donepezil with placebo across treatment periods. The primary endpoint was six-week change in medio-lateral postural sway range on foam, measured with a waist-worn inertial sensor.

The posted primary mean difference was 0.011 m/s^2, with a 95% confidence interval from -0.004 to 0.026 and an unadjusted p-value of 0.146. The confidence interval includes zero. The registry also posts short-latency afferent inhibition and Attention Network Test outcomes. It does not report formal analyses for these outcomes in its analysis listing, a statistical analysis plan, or details of the crossover model, missing-data handling, or multiplicity approach.