NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) (NCT06269367), a randomized na study. The primary outcome is Gait Speed.

2. Clinical Question

The study addressed short-term biomechanical performance and usability of NewGait in a stroke population, rather than a long-term clinical outcome. Each device condition included a baseline measure, a measure immediately during use, and a post-intervention measure after training. These measurements were obtained on the same day. The primary outcome timeframe was up to 2 hours. Because the numerical results and the number of analyzed participants are not reported in the registry record, the research question can be described, but the comparative result cannot be quantified from the record.

3. Trial Design

The registry record describes a randomized, unmasked crossover study sponsored by the University of Michigan. It lists an enrollment of 20 and a completed study status. The listed study dates are 2024-04-01 for the start and 2024-12-09 for primary completion. The phase is listed as NA. The study condition is stroke.

In a crossover design, participants receive more than one intervention condition, so each participant can contribute observations under both devices. This structure can support within-participant comparisons: differences between device conditions are evaluated while accounting for the fact that measurements come from the same person. General statistical explanation: paired observations are usually analyzed differently from observations in independent groups, because measurements from one person may be correlated. The specific statistical model and handling of that correlation are not reported in the registry record.

The listed conditions were NewGait and a control wearable limb orthotic device. Participants walked on a treadmill and overground in each condition; the arm descriptions also say that participants may have received gait biofeedback. The primary outcome procedures describe baseline, during-training, and post-intervention measures for each device. Participants trained with a device for about 15 minutes, then rested for 20-30 minutes before the process was repeated with the second device. All measures were obtained on the same day.

The registry record identifies the allocation as randomized and masking as none. The method used to generate the allocation sequence, how the order of device conditions was assigned, whether order effects were assessed, and whether any washout or other period-effect procedures were used are not reported in the registry record. The record lists six outcome measures and three analyses, but does not detail all analysis procedures. The actual number completing the study, the number included in each analysis, and reasons for any non-completion are not reported in the registry record.

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

Reasons for not completing this period:

Phase II

Analysis population for the primary outcome, as defined in the registry: Data was only analyzed on participants who completed the study.

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 Gait Speed, measured over Up to 2 hours.

The primary endpoint was change in gait speed from baseline, measured using the 10 Meter Walk Test. For this test, participants walked down a 14 meter walkway, and a stopwatch was used to time the intermediate 10 meter distance. The recorded speed was self-selected while walking overground in a hallway. The outcome is described as a mean, with standard error as its measure of dispersion, and the timeframe is up to 2 hours.

Gait speed is a continuous measure: it can take a range of values rather than placing a participant into a yes-or-no category. General explanation: a timed walking test can express walking performance as speed, making it possible to describe changes in the same measurement units across conditions. The study used baseline values to describe change during device use and after training, then compared the NewGait and control conditions.

The primary-outcome description specifies that baseline for the first device was recorded immediately before intervention, followed by an immediate during-training measure, about 15 minutes of training, and an immediate post-intervention measure. The same process was then repeated with the second device after a 20-30 minute rest. This sequence means that the recorded outcome concerns short-term responses on the testing day. It is not, by itself, a measure of sustained change over a longer follow-up period.

The registry record does not report the mean changes, standard errors, confidence intervals, or a statistical test for the primary outcome. It therefore does not allow the magnitude or precision of the device comparison to be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record characterizes the primary outcome as a mean of a continuous measure, with standard error as the stated dispersion statistic. It does not report the numerical outcome estimates or a specific inferential method. The concepts below explain how these quantities are generally used; they do not describe undocumented procedures as if they were used in this study.

What does a mean describe?

General explanation: the mean is an average that describes the central level of a continuous measurement in a group or condition. For gait speed, the mean would summarize participants' measured speeds or changes in speed under a condition. A mean alone does not reveal how similar or different individual participant values were. Individual measurements can vary widely even when their average is precisely estimated, or can cluster closely while the mean remains uncertain because relatively little information is available.

What does standard error describe?

General explanation: the standard error describes the sampling uncertainty of an estimated mean. It is not the same as the standard deviation, which describes variability among individual observations. A smaller standard error generally indicates a more precise estimate under the analysis assumptions, while a larger standard error indicates less precision. The registry record names standard error but does not report its value for the primary outcome. No estimate of precision can therefore be recovered from that label alone.

How should a confidence interval be read?

General explanation: a confidence interval presents a range of estimates that are compatible with the observed data and the assumptions of the statistical procedure. It conveys uncertainty around an estimate and is often more informative than a point estimate alone. A narrow interval indicates greater precision than a wide interval, all else equal. A confidence interval does not assign a probability to the true effect being inside that particular interval. No primary-outcome confidence interval is reported in the registry record.

Why does crossover structure affect analysis?

General explanation: in a crossover study, measurements from the same participant are usually related. An analysis that treats those measurements as independent can misrepresent uncertainty because it ignores the pairing. A paired analysis can use each participant's measurements under both conditions, but the appropriate method depends on the outcome structure and study design. The registry record identifies a crossover model, but the statistical method used to analyze the primary outcome is not reported in the registry record.

The testing description includes baseline, during-training, and post-intervention values for each device. These repeated measurements add another layer of dependence: multiple values from the same participant are not necessarily independent observations. General explanation: repeated-measures methods can account for such dependence and distinguish changes over time or across conditions, but the precise method should be specified in the analysis plan or results. Whether the study used such a method, and how the multiple time points were handled, are not reported in the registry record.

What is over-dispersion?

General explanation: over-dispersion arises when observed variability is greater than a statistical model assumes. It is especially discussed for count outcomes, where a basic model may underestimate variability if counts are more heterogeneous than expected. The primary outcome in this study is continuous gait speed, not a count outcome, and the registry record does not report an over-dispersion assessment. This concept is included only as a general statistical distinction; it should not be read as a method applied to this trial.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial was designed using those assumptions. The record does not report the trial's own sample-size justification, and the numerical planning outputs are not reported in the registry record. Such sample-size calculations are illustrations of participant counts under stated assumptions; they are not observed power and do not show the probability that the study detected an effect.

The planning description refers to participants per arm for outcomes other than time-to-event outcomes. That framing does not change the registry's description of the actual study as a randomized crossover. The specific relationship between the planning illustration and the crossover design is not reported in the registry record. The illustration should therefore not be mistaken for the study's actual allocation, analysis population, or achieved precision.

What can be inferred from an unreported test?

General explanation: a p-value, when reported, measures how incompatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of an effect. A p-value also does not replace an estimate and interval. The registry record does not report a primary-outcome p-value or the test used. It is not appropriate to infer statistical significance from the study's completed status, its enrollment, or the fact that analyses are listed.

Because the estimate, uncertainty, analysis method, and analyzed sample size are not reported, the most defensible statistical reading is descriptive: the record establishes what was measured and how the comparison was organized, but it does not provide enough information to quantify the comparative result.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists six outcome measures and three analyses. It identifies changes in paretic leg propulsive force as a secondary outcome, while gait speed is designated as the primary outcome. The record does not describe how the outcomes or analyses were prioritized beyond those labels, whether any multiplicity adjustment was planned, or how multiple time points and device comparisons were handled. Those details are not reported in the registry record.

General explanation: when several outcomes, time points, or statistical comparisons are examined, the chance of obtaining at least one apparently unusual result can increase. Prespecified outcome hierarchies, adjustment procedures, or a clearly exploratory interpretation can help readers understand that context. No specific multiplicity procedure or interim analysis is reported in the registry record. The absence of a stated procedure does not establish that none was used; it means the record does not report one.

The primary-outcome population is described as participants who completed the study. The number of completers and the number analyzed are not reported in the registry record, nor are reasons for missing or excluded data. The method used to handle missing measurements, including whether any imputation or sensitivity analysis was used, is not reported in the registry record.

General explanation: restricting an analysis to completers can be difficult to interpret if completion is related to participant characteristics or outcomes. Missing-data methods rely on assumptions, and different assumptions can produce different estimates. Since the registry record gives no analysis counts or missing-data procedure, it is not possible to assess how incomplete observations affected the primary comparison. The enrollment of 20 should not be substituted for the unknown number analyzed.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 20 participants at risk in each device group. For NewGait, it records 0 serious adverse events affecting participants and 0 deaths, alongside 14 participants listed as affected by other adverse events. For the control device, it likewise records 0 serious adverse events affecting participants and 0 deaths, alongside 14 participants listed as affected by other adverse events. No serious adverse event terms are listed.

These figures should be read as the adverse-event counts recorded for the listed device groups, not as a randomized comparison of separate groups: the study is described as a crossover, so participants experienced both device conditions. The record does not report event types for the other adverse events, their timing, severity, relationship to the devices, or whether the same people were affected in both conditions. It is therefore not possible to tell whether the counts refer to overlapping participants or to compare risks as if each device had been tested in an independent group.

General explanation: zero recorded serious events in a study does not establish that a device has no serious risk; it describes what was recorded in the study population and follow-up. The adverse-event figures do not substitute for the missing numerical primary-outcome results.

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

The registry record describes a randomized crossover comparison of NewGait and a control wearable limb orthotic device in a short-term gait study involving people with stroke. The primary question concerns changes in self-selected gait speed measured using the 10 Meter Walk Test. The measurement procedure and the study's completed status are reported, but numerical primary-outcome results are not reported in the registry record.

That absence sets a firm limit on interpretation. There is no reported estimate of the difference between conditions, no confidence interval or standard error value for the comparison, and no reported primary-outcome test. It is not possible to say from the registry record whether the observed gait-speed change favored either device, how large any difference was, or how precisely it was estimated. An unreported result is not a finding of no difference.

The outcome was measured on the same day, with immediate measurements during and after training. It therefore concerns short-term performance under the test conditions, not durability of an effect over longer follow-up. The registry record does not report a longer-term endpoint. It also does not report a numerical usability result, despite the study summary's interest in usability and functionality.

The crossover design permits a comparison within participants in principle, but the record does not give the order assignment details, the model used, or the way repeated observations were handled. The number completing the study and the number included in the primary analysis are also not reported in the registry record. Those gaps prevent a full assessment of analysis quality and precision.

The adverse-event entries record 0 serious adverse events affecting participants and 0 deaths in each listed device group, with 14 listed as affected by other adverse events in each. Event details and participant overlap are not reported, and the crossover design means those figures should not be treated as a simple comparison of independent groups. Taken together, the record documents the intended short-term comparison and some safety counts, but does not provide enough outcome detail to establish the comparative gait-speed result.

13. Why This Trial Matters Statistically

This study is statistically notable for the way its design links measurements from the same participant. A randomized crossover allows participants to experience both NewGait and the control device, which can make within-person comparisons informative. General explanation: when stable characteristics differ between people, comparing each participant with themselves can reduce the influence of those stable differences. That advantage depends on an analysis that respects the paired structure and considers the sequence of conditions.

The primary measurement also includes multiple observations within each condition: baseline, during-training, and post-intervention. These values may describe different stages of a short training session, but they are repeated observations from the same people. Careful interpretation depends on knowing which contrast was primary and how the measurements were modeled. Those analysis details are not reported in the registry record.

The record is also a useful reminder that a completed trial description is not the same as a complete results account. It specifies the outcome definition, timing, and dispersion measure, yet does not report the primary estimates or their uncertainty. Without those statistics, readers cannot distinguish a small, precise difference from a larger but uncertain one, or determine whether the estimates are compatible with a range of effects.

Finally, the record distinguishes a planning illustration from the actual study design. The stated planning assumptions do not establish the study's sample-size justification or achieved power. General explanation: planning calculations depend on assumptions about the effect to detect and variability, while observed uncertainty depends on the data and analysis. Treating an illustrative calculation as proof of adequate power would overstate what the record reports. The main statistical contribution available from the registry is therefore the design and measurement description, not a quantified comparative finding.

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 primary limitation for interpreting this trial from the registry record is the absence of numerical gait-speed results. Means, standard errors, confidence intervals, and a primary comparison test are not reported in the registry record. The magnitude, direction, and precision of the primary result therefore cannot be assessed.

The record says the primary analysis included participants who completed the study, but does not report the number of completers or the number analyzed. It does not describe missing measurements, reasons for non-completion, or missing-data handling. The enrollment of 20 does not establish how many contributed to the endpoint analysis.

Although the design is identified as randomized and crossover, the randomization procedure, condition order, analysis of order or period effects, and treatment of repeated measures are not reported in the registry record. The primary outcome description contains multiple measurement occasions for each device, but the planned contrast among these occasions is not specified in the record. The statistical model and its assumptions are not reported.

The study measured gait speed on the same day, with a timeframe of up to 2 hours. This limits the outcome described in the record to short-term testing; longer-term results are not reported. The record also does not provide numerical usability or functionality results. It lists six outcome measures and three analyses but does not report multiplicity procedures or interim analyses.

Safety reporting is limited to group-level counts. Other adverse-event terms, timing, severity, relationship to the devices, and overlap of affected participants across the crossover conditions are not reported in the registry record. These limits mean that neither the primary comparison nor the broader benefit-risk profile can be fully evaluated from the registry information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) — NCT06269367.
• Registry record last updated 2025-12-23; status last verified 2025-12.
• Results first posted 2025-12-23.
• 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

The registry record describes NCT06269367, titled NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations), sponsored by the University of Michigan. It lists a randomized, unmasked crossover study with enrollment of 20 and completed status. The listed start date is 2024-04-01 and primary completion date is 2024-12-09.

The study compared NewGait with a control wearable limb orthotic device. Its primary outcome was change in gait speed, measured using the 10 Meter Walk Test, with mean and standard error specified and a timeframe of up to 2 hours. Participants were described as walking with each device and potentially receiving biofeedback. The primary-outcome population was restricted to participants who completed the study.

The registry record lists six outcome measures and three analyses, but does not report numerical primary-outcome results, the number analyzed, the statistical model, or missing-data procedures. It records 0 serious adverse events and 0 deaths in each device group, and 14 affected by other adverse events in each. The comparative gait-speed result cannot be quantified from the registry record.