Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. (NCT06385392), a registered phase not stated study. The primary outcome is To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial..

2. Clinical Question

The study focuses on in-community testing of a device system for people with Parkinson disease who experience freezing of gait. The proposed system combines an insole device with a haptic module and is intended to detect freezing events and trigger external cueing. The registry describes the overall Phase II study as also involving development of a production-ready system, a companion mobile app, and refinement of previously developed detection algorithms. The stated focus of this study is validation of the system and demonstration of efficacy through in-community testing.

The question is not framed as a comparison against a control group. The registry’s study description identifies a group using the experimental device, and its notes state that the study is not a randomized comparison and that the arms are not a like-for-like control comparison. The allocation method is not stated. Therefore, the primary question is descriptive: what change in freezing-event duration was recorded during the stated timeframe? A numerical answer, including an estimate of the change and its uncertainty, is not reported in the registry record.

3. Trial Design

The registry record identifies NCT06385392 as a completed study sponsored by HealthPartners Institute. The recorded study start date is 2024-09-11, and the primary completion date is 2025-04-28. Enrollment was 31. Parkinson disease is the listed condition, and the intervention is the haptic module and insole device.

The described evaluation concerns people with Parkinson disease and freezing of gait using the experimental device in an in-community setting. The intervention description presents the system as intended for daily use: it detects freezing-of-gait events and triggers external cueing stimuli. The record’s summary places this evaluation within an overall Phase II study that also aims to develop the system and its companion mobile app and refine detection algorithms. The stated focus of the study is validation and in-community testing.

The primary outcome timeframe is 5 weeks. The registry states that the study is not a randomized comparison, the allocation method is not stated, and the arms are not a like-for-like control comparison. It does not describe a comparator that would support a controlled estimate of the device’s effect relative to another treatment or condition. The available description therefore does not establish a randomized or controlled design.

The record lists one outcome measure and no analyses. It gives the primary measure as the mean duration of freezing-of-gait events in seconds, with standard deviation as the dispersion measure. It does not report numerical endpoint results, an analysis estimate, a confidence interval, or a p-value. The number of participants included in the endpoint analysis is also not reported in the registry record. Some withdrawn participants and those with device issues were excluded from that analysis because freezing events could not be calculated.

The registry record does not report the protocol’s sample-size justification, the intended analysis plan, or whether interim analyses were planned or conducted. Planning illustrations based on an observed effect, where shown in a statistical presentation, are not the trial’s design justification and do not represent observed power. They cannot fill the gap left by the absence of a reported endpoint estimate.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Some withdrawn participants and those with device issues were not included in the analysis as we were unable to calculate the freezing of gait (FOG) events.

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 To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial., measured over 5 weeks.

The primary endpoint is the change in duration of freezing-of-gait events, measured in seconds over a timeframe of 5 weeks. The registry specifies a mean as the measure of central tendency and standard deviation as the measure of dispersion. It states that decreased duration of freezing events indicates higher efficacy of the device system.

Event duration is a continuous measure: each event can have a duration, and the endpoint summarizes those durations as a mean. In general, a mean provides a summary of the measured values, while the standard deviation describes how spread out those values are around the mean. These summaries address different aspects of the data; a mean alone does not show how variable event durations were among the observations or participants.

The endpoint is relevant to the device’s stated purpose because the system is intended to detect freezing events and trigger cueing stimuli. However, a measure of event duration by itself does not describe every aspect of system performance. The registry’s primary outcome description does not provide numerical results for duration, the change from baseline or another reference point, or the variability estimate. It also does not report how many participants contributed usable event data.

Some withdrawn participants and participants with device issues were not included in the analysis because freezing-of-gait events could not be calculated. The number and details of these exclusions are not reported in the registry record. Without the endpoint estimate and a clear account of the analysis population, the direction and precision of the observed change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean summarize?

The endpoint is a mean duration of freezing-of-gait events, expressed in seconds. In general, the mean is an average that summarizes a set of observed measurements. It can be useful for describing the typical level of a continuous outcome, but it does not show whether individual measurements cluster closely or vary widely. The registry specifies standard deviation as the measure of dispersion. In general, standard deviation describes the spread of observed values around their mean.

The registry record does not provide the mean, standard deviation, or numerical change for the primary endpoint. These measure types identify how the outcome was intended to be summarized; they are not results. Without the numerical summaries, the record does not show the observed level of event duration, the direction of change, or the variability in the measurements.

What would a change estimate mean?

A change estimate would express how the mean duration differed between the measurements used for comparison. The outcome description identifies a decrease in duration as indicating higher efficacy. The registry record does not state the numerical change or provide the underlying values, so no direction or magnitude can be stated. In general, an estimate is most informative when accompanied by an uncertainty interval and a clear explanation of the comparison and analysis population.

A confidence interval is a statistical range constructed by a method that, under its assumptions, captures the underlying parameter at a stated rate across repeated applications. In general, it communicates uncertainty about an estimate; it is not a range containing a fixed proportion of individual participant measurements. No confidence interval for the primary endpoint is reported in the registry record. Its absence means that precision cannot be evaluated using this record.

What can a p-value establish?

In general, a p-value measures how incompatible observed data are with a specified null model, under the assumptions of the analysis. It does not measure the probability that a treatment works, the size of an effect, or the probability that the null hypothesis is true. A p-value is also not a substitute for an effect estimate and its uncertainty. No p-value or analysis result for the primary endpoint is reported in the registry record, so statistical significance cannot be assessed from this entry.

Why does the comparison matter?

The registry states that the study is not a randomized comparison, allocation is not stated, and the arms are not a like-for-like control comparison. In general, random allocation can help create groups that are comparable in expectation, while a suitable control can help distinguish changes associated with an intervention from changes that could occur for other reasons. These principles do not establish which design was used beyond what the record states. The available description does not support a controlled estimate of the system’s effect.

If an analysis compared measurements over time in users of the device, that would describe change in the analyzed group. Without information about a concurrent, comparable control condition, such a change alone would not establish that the device caused it. The registry record does not report the detailed analysis method, the reference measurement for the stated change, or a numerical estimate.

Why does missing outcome information matter?

The endpoint description says some withdrawn participants and participants with device issues were not included because freezing events could not be calculated. In general, excluding participants with unavailable measurements can affect how well an analysis represents everyone enrolled, particularly when missingness is related to the experience being studied. The direction or size of any such effect cannot be determined without information about who was excluded, why data were unavailable, and how missingness was handled.

The record does not report the number included in the endpoint analysis, the number with missing measurements, or a detailed approach to missing data. It also does not describe whether the analysis followed an intention-to-treat principle or another analysis-population definition. Those methods are therefore not reported in the registry record; they should not be inferred from the stated enrollment total or the description of exclusions.

How should planning illustrations be understood?

Planning illustrations based on an observed effect are hypothetical calculations about sample sizes under specified assumptions. The stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. These assumptions describe an illustration, not necessarily the study’s own design or analysis. The protocol’s sample-size justification is not reported in the registry record.

Such illustrations are not observed power. In general, observed power calculated from an observed effect does not add a separate measure of evidence beyond the estimate and its uncertainty. A planning calculation also cannot replace a reported endpoint result. The record provides no numerical primary outcome estimate on which to base an independent recalculation, and the planning assumptions should not be mistaken for evidence of an observed effect.

What does over-dispersion mean in general?

Over-dispersion is a general concern when the variability in data exceeds what a statistical model assumes. If a model underestimates variability, its uncertainty estimates can be too narrow and inferential conclusions can be misleading. The registry identifies a continuous mean endpoint with standard deviation as dispersion; it does not report an over-dispersion analysis or indicate that one was needed. This concept should not be read as a finding about the study.

In summary, the registry identifies the outcome type and some planning assumptions but does not report a primary endpoint estimate or a detailed analysis method. Statistical concepts can clarify what those items would mean, but they cannot supply the missing numerical result or determine the analysis actually used.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("On-Cue Phase", "Off-Cue Phase")
n   <- c(24, 24)
m   <- c(4.4, 5.69)
sp  <- c(6.135, 7.458)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  On-Cue Phase  24  4.400  6.135  1.809  6.991
CARM  Off-Cue Phase  24  5.690  7.458  2.541  8.839

11. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and no analyses. It does not report a statistical analysis plan, a hierarchy of outcomes, or whether multiple comparisons were planned. The presence of one listed outcome does not establish that only one analysis was conducted. Whether multiplicity adjustments were needed or used is not reported in the registry record.

Multiplicity refers, in general, to the increased chance of a false-positive finding when many hypotheses are tested. Methods such as a prespecified testing hierarchy or adjustment of significance thresholds can address that issue, depending on the design and aims. No adjustment method is described in the registry record. Since no endpoint p-value or analysis result is reported, the effect of multiplicity on any conclusion cannot be evaluated.

Missing outcome data are explicitly relevant: some withdrawn participants and participants with device issues were excluded from the primary analysis because freezing-of-gait events could not be calculated. The number of participants affected, the number analyzed, and the reasons for withdrawal or device issues are not reported in the registry record. Nor does the entry describe imputation, sensitivity analyses, or another method for addressing unavailable measurements.

In general, a missing-data method relies on assumptions about why values are unavailable. Those assumptions can matter when participants with missing outcomes differ from those with measured outcomes. Without counts and an analysis description, it is not possible to determine whether the reported analysis, if any, accounted for those differences. The record does not specify an intention-to-treat population or another formal analysis population; that information is not reported in the registry record.

These gaps limit assessment of both robustness and generalizability. They do not show that a particular bias occurred, but they prevent readers from judging how the exclusions may have influenced an endpoint estimate. In this case, the endpoint estimate itself is also not reported.

12. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia (3.2%).

The safety figures describe the group of people with Parkinson disease and freezing of gait using the experimental insole and haptic module. The record lists 31 people at risk for serious adverse events, with 1 affected; it lists 31 at risk for other adverse events, with 8 affected. Deaths are recorded as 0. Pneumonia is listed among the serious adverse-event terms at 3.2%.

These are counts and a listed term, not a comparison between randomized groups. The study description does not provide a like-for-like control comparison, and the allocation method is not stated. The figures therefore should be read as events recorded in the described group, not as estimates of the excess or reduced risk attributable to the device. The registry record does not establish that an event was caused by the device.

In general, adverse-event counts depend on how events were defined, collected, and attributed, as well as the number of participants observed and the duration of observation. The registry entries cited do not provide further information about event timing, severity grading beyond the serious and other categories, or causal assessment. The count of participants affected is not the same as a count of all event occurrences; the record does not give a full event-level account.

These safety figures do not resolve the missing primary efficacy result. They should be interpreted alongside the study’s design and reporting limitations, without treating the observed counts as a controlled safety comparison.

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

The registry record establishes that a completed in-community evaluation was conducted for a haptic module and insole device intended to detect freezing of gait and trigger external cueing. It reports enrollment of 31, identifies Parkinson disease as the condition, and specifies a primary endpoint based on change in freezing-event duration over 5 weeks. It also reports that some withdrawn participants and participants with device issues were excluded from endpoint analysis because events could not be calculated.

The record does not report the numerical primary endpoint result. It therefore does not show whether event duration decreased, increased, or stayed similar, nor does it show the magnitude or precision of any change. The endpoint description’s statement that a decrease indicates higher efficacy is an interpretation rule for a possible result, not a reported finding.

The record also does not provide a randomized, like-for-like control comparison. It states that this was not a randomized comparison, that allocation was not stated, and that the arms are not a like-for-like control comparison. In general, observations in a group using a device cannot, without an appropriate comparison and suitable methods, isolate a causal effect from other explanations for change. This is a design consideration, not a claim about what caused any particular observation in the study.

The findings cannot be extended beyond the information documented in the registry. The number contributing to the endpoint analysis, handling of missing measurements, detailed analysis methods, and numerical uncertainty are not reported in the registry record. These omissions prevent assessment of how representative the analyzed participants were of those enrolled or how stable an endpoint estimate might be.

The safety figures are also descriptive. They report affected participants and a serious-event term, but do not provide a controlled safety contrast or establish causation. Together, the available information describes the study’s aims, setting, outcome definition, exclusions, and recorded safety counts. It does not support a numerical conclusion about the device’s effect on freezing-event duration or a causal conclusion about efficacy or safety.

14. Why This Trial Matters Statistically

This trial is statistically notable because its intended primary outcome is a continuous measure tied closely to the system’s purpose: duration of freezing-of-gait events. The registry specifies a mean and standard deviation, which signal that both the average duration and variation in observed durations are relevant to understanding the endpoint. Yet the registry record does not report either the numerical change or the uncertainty around it. The contrast between a clearly stated endpoint and an absent result is important for transparent interpretation.

The in-community setting is also central to the question. The proposed system is intended for daily in-community use, and the study’s stated focus is validating operation and demonstrating efficacy through such testing. Real-world measurement brings practical issues into the analysis: the device must function, events must be detected, and outcomes must be calculable. The registry explicitly notes that device issues prevented calculation of freezing events for some participants. That makes reporting the analysis population and missing outcomes especially important.

The design description further shapes the statistical question. The registry states that this is not a randomized comparison and not a like-for-like control comparison. Accordingly, a change within the group using the device would not, on its own, provide the same inference as a controlled comparison. The record does not report a numerical change in any case, so neither a descriptive estimate nor a comparative effect can be assessed.

Finally, the distinction between planning illustrations and observed results matters. A sample-size illustration based on an observed effect can explain hypothetical planning assumptions, but it is not the trial’s reported outcome and is not observed power. Without a reported endpoint estimate, planning calculations cannot answer the clinical or statistical question. The main lesson is the need to keep the intended measure, observed result, design, and analysis population distinct.

15. 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 efficacy is that the registry record does not report a numerical result for its primary endpoint. There is no stated mean change, standard deviation, confidence interval, or p-value. The intended direction of interpretation is described, but the actual direction and size of any change cannot be determined.

The analysis population is incompletely described. Some withdrawn participants and participants with device issues were not included because freezing-of-gait events could not be calculated, but the number excluded and the number analyzed are not reported in the registry record. The reasons for withdrawal and the details of device issues are also not reported. Missing-data methods and sensitivity analyses are not described.

The design limits causal interpretation: the registry states that this is not a randomized comparison, the allocation method is not stated, and the arms are not a like-for-like control comparison. The record does not describe a suitable control condition. Any within-group observation, if available elsewhere, would therefore need to be interpreted with attention to alternative explanations rather than as an isolated causal estimate.

Further methodological details are not reported in the registry record, including a statistical analysis plan, a sample-size justification, and any interim-analysis plan. The record lists no analyses, so it does not expose an analysis method or its assumptions. The enrolled total of 31 should not be mistaken for the primary analysis size, because some participants were excluded from that analysis and the included number is not stated.

Safety interpretation is limited as well. The record gives affected-participant counts and a serious-event term, but does not provide a controlled safety comparison or establish causation. These limitations identify what the registry entry does not allow readers to assess; they do not establish that the study was conducted improperly or that a particular bias occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. — NCT06385392.
• Registry record last updated 2026-05-28; status last verified 2026-05.
• Results first posted 2026-05-28.
• 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.

19. Record Summary

NCT06385392 is a completed study sponsored by HealthPartners Institute, with a recorded start date of 2024-09-11 and primary completion date of 2025-04-28. Enrollment was 31. The study concerns people with Parkinson disease and freezing of gait using an experimental haptic module and insole device intended to detect freezing events and trigger external cueing during in-community use.

The primary measure is change in mean freezing-event duration in seconds over 5 weeks, with standard deviation as the specified dispersion measure. The registry says decreased duration indicates higher device-system efficacy, but the numerical endpoint result is not reported. Some withdrawn participants and those with device issues were excluded from the endpoint analysis because events could not be calculated; the number excluded is not reported in the registry record.

The record states that the study is not a randomized comparison, allocation is not stated, and the arms are not a like-for-like control comparison. It lists no analyses. Safety entries report 1 participant with a serious adverse event, 8 with other adverse events, 0 deaths, and pneumonia as a serious-event term at 3.2%. The available record describes the study and its intended outcome but does not provide a numerical efficacy estimate or controlled comparison.