Discrete Versus Rhythmic Gait Training: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Discrete Versus Rhythmic Gait Training (NCT02650440), a randomized na study. The primary outcome is Functional Ambulation Scale (FAC).

2. Clinical Question

The clinical question is whether the two training approaches are associated with different levels of independence during walking as assessed by the FAC. The registry's study description proposes that the novel protocol's progressive decrease in gait speed and guidance force may facilitate greater motor recovery than the standard protocol. That statement describes the study's hypothesis, not a conclusion established by the posted results.

The FAC is a six-level scale, with scores described from 0 to 5. The registry's descriptions range from inability to walk or needing help from two or more people at 0, through differing levels of support, to independent walking at 5. The score therefore gives a clinical interpretation to the comparison: the outcome concerns how much assistance is needed for gait, rather than a direct measure of walking speed or distance.

The record identifies additional walking and function outcomes, including the Six-minute Walking Test, Time Up and Go, Ten-meters Walking Test, Lower Limbs Fugl-Meyer, and Berg Scale. The central question for the primary outcome remains the comparison of FAC results between the novel and standard training groups.

3. Trial Design

The registry describes a completed, randomized, parallel-group study comparing two procedures: Novel Protocol and Standard Protocol. It lists triple masking. The record does not identify which participants, clinicians, assessors, or other roles were masked, so the meaning and implementation of that masking cannot be specified from the registry entry.

The planned contrast was between two robotic gait-training approaches after stroke. Both protocols began at 1.4 km/h and involved a decrease in guidance force. The protocols differed in their speed progression: the novel approach progressively decreased speed to 1.0 km/h, whereas the standard approach progressively increased speed to 1.9 km/h. The registry does not give further detail about session frequency, session duration, treatment duration, or how adherence was monitored.

The registry lists enrollment of 20. For the primary outcome summaries, it lists 10 participants in the Novel Protocol group and 8 in the Standard Protocol group. These group counts are the denominators attached to the posted outcome summaries; they do not establish why the counts differ from the enrollment figure. Reasons for unavailable outcome data or exclusions are not reported in the registry record.

The study is marked completed. The listed study start is 2014-11, and the listed primary completion is 2016-03. The registry does not report a phase designation beyond NA. It names Thais Amanda Rodrigues as sponsor. These administrative details identify the record but do not provide information about the conduct or quality of the trial beyond what is explicitly described.

The primary endpoint is the Functional Ambulation Scale, with the timeframe stated as baseline and 6 weeks. The record lists five secondary outcomes in addition to the primary outcome. It does not report a detailed statistical analysis plan, allocation method beyond randomization, sample-size justification, or prespecified handling of missing observations.

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

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 Functional Ambulation Scale (FAC), measured over Baseline and 6 weeks.

The Functional Ambulation Scale measures independence during gait. The registry describes it as a six-level scale, with scores from 0 through 5. At 0, a patient cannot walk or needs help from two or more people; the intermediate descriptions distinguish levels of physical support, balance assistance, and walking without physical contact; at 5, a patient can walk independently. The listed scale therefore represents an ordered progression in gait independence.

This endpoint is relevant to the study question because the intervention is intended to train walking with a robotic gait orthosis. The FAC focuses on the assistance a person needs while walking, rather than on distance, speed, or a broad measure of motor impairment. That makes it a direct way to describe the functional independence targeted by the training comparison, while not capturing every aspect of walking ability.

The registry gives the timeframe as baseline and 6 weeks and describes comparing gait independence between the two arms after intervention in relation to baseline. However, the posted arm summaries consist of one median and interquartile range for each group. The record does not make clear whether those summaries represent baseline scores, 6-week scores, changes from baseline, or another summary. This ambiguity limits the clinical interpretation of the displayed values.

The primary outcome is reported as a median with an interquartile range. The median describes the middle observation in an ordered set, while the interquartile range describes the spread across the central half of the observations. These summaries can describe an ordinal scale without assuming that each step on the scale represents an equal-sized change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the median describe?

The median is the central value after observations are ordered. It is useful for an outcome such as the FAC because the scale has ordered categories and because the median is less sensitive to unusually high or low observations than an arithmetic mean. It does not describe the full distribution. Two groups can share a median while differing in other ways, or have different medians while still having substantial overlap in individual scores. The reported medians are descriptive summaries, not a direct estimate of a treatment effect.

How should the interquartile range be read?

The interquartile range spans the central half of observed values. It gives information about variability around the median, but does not show every participant's result or the uncertainty in the median itself. The FAC summaries are reported as a median and interquartile range: 1.0 with 1.0 to 2.0 for Novel Protocol, and 0.0 with 0.0 to 1.5 for Standard Protocol. These ranges describe the spread of the posted observations, not a confidence interval for a difference between groups.

What would an inferential comparison add?

A comparative analysis would estimate how the groups differ on the outcome and quantify the uncertainty in that estimate. A confidence interval is a range of values compatible with the data under the assumptions of the analysis; its width conveys precision. A p-value addresses how compatible the observed data are with a specified null hypothesis under the chosen model. Neither is reported for the primary comparison in this registry record. Without them, readers cannot assess the inferential strength or precision of a between-group effect from the posted arm summaries alone.

The record lists 0 analyses. That does not erase the descriptive arm summaries, but it means the entry does not include a reported statistical test or model-based comparison. The registry also does not identify an analysis method for the primary outcome. It is therefore not possible to determine whether the investigators planned to compare final scores, changes from baseline, or scores adjusted for baseline, nor whether the analysis accounted for the ordered nature of FAC scores.

Why does the outcome's timing matter?

The stated timeframe is baseline and 6 weeks, and the outcome description refers to assessing gait independence after intervention relative to baseline. Yet the posted arm summaries do not separate measurements by time or identify a change score. This distinction is essential. A final value and a change from baseline answer different questions, while baseline values describe participants before the intervention. Without explicit labels, the summaries cannot be assigned reliably to one of those interpretations.

In a randomized study, baseline information can be used to describe whether the groups began at similar levels and can be incorporated in a prespecified comparison. A change score can describe within-participant movement between assessments, while a comparison of final scores asks how groups differ at the end of follow-up. These are general statistical concepts; the registry record does not say which approach was used for the posted FAC results.

What do the sample-size illustrations mean?

Sample-size calculations are planning tools that estimate how many participants would be needed to detect a specified effect under stated assumptions. They are not a measure of whether a completed trial found an effect, and they are not observed power. The registry describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also says the effect to detect is expressed as a stated fraction of the observed effect. No numerical illustration results are included in the record details, so no required participant counts can be reported.

Such calculations depend on assumptions about the outcome, variability, target effect, error rate, allocation, and statistical method. If the observed effect is imprecise or unstable, a planning illustration derived from it may also be unstable. The registry does not report a prospective sample-size justification for this trial; the described illustrations should not be mistaken for evidence that the completed study was adequately powered.

What can be inferred from the group counts?

The primary outcome summaries are based on 10 participants in the novel group and 8 in the standard group, whereas enrollment is listed as 20. The record does not explain this difference. The summaries alone cannot identify whether it reflects missing outcomes, withdrawals, exclusions, or another reason. The statistical consequences depend on why results are absent and how the analysis handled them. No missing-data method or analysis population is reported in the registry record.

General statistical methods can address missing outcomes in different ways, but each method relies on assumptions. Complete-case summaries describe participants with recorded outcome data, while other methods may use additional information to account for missingness. The registry does not say which approach applies. No assumption about the reason for the counts or the handling of absent observations can therefore be made.

Why can the ordinal scale affect analysis?

The FAC is ordered: higher scores indicate more independence, but the registry's descriptions do not establish that every step represents the same amount of change. Statistical methods for ordinal outcomes can preserve this ordering without treating the gaps as equal. Alternatively, some analyses treat scale scores numerically, but that makes assumptions about the score structure. The record does not report which approach was selected. Consequently, readers cannot evaluate whether the analysis model matched the outcome's measurement properties.

Overall, the available statistics support a descriptive account of the posted group summaries. They do not provide a stated model, treatment-effect estimate, confidence interval, or significance test for the primary comparison. Those omissions constrain both the strength of inference and the assessment of precision.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five secondary outcomes: the Six-minute Walking Test, Time Up and Go, Ten-meters Walking Test, Lower Limbs Fugl-Meyer, and Berg Scale. Along with the primary FAC outcome, the record lists 6 outcome measures. Examining multiple outcomes can raise a multiplicity issue: when many hypotheses are tested, the chance of at least one apparently notable result can increase. Common approaches include prespecifying a primary outcome, adjusting significance thresholds, or treating secondary analyses as exploratory. These are general statistical options; the registry record does not report a multiplicity strategy or indicate which secondary outcomes were analyzed.

The record lists 0 analyses, so it does not provide a set of reported inferential results across which an adjustment could be evaluated. The absence of a stated adjustment does not establish that none was conducted outside the registry, but it means the registry does not document one. The study description identifies FAC as primary and names the other outcomes as secondary, but does not explain how their results were to be interpreted together.

Missing-data information is also limited. Enrollment is listed as 20, while the primary outcome summaries are based on 10 participants for Novel Protocol and 8 for Standard Protocol. The registry does not report why the numbers differ, whether all randomized participants were included in the analysis, or how missing observations were handled. It does not identify withdrawals, exclusions, or an intention-to-treat population. Those details are not reported in the registry record.

These omissions matter because estimates based on observed outcomes may differ from estimates that account for participants without recorded outcomes, depending on the reasons for missingness and the methods used. No specific missing-data explanation or method can be inferred from the listed counts. The registry also does not report a prespecified statistical analysis plan, so the intended relationship among the primary endpoint, secondary endpoints, and analysis populations remains unclear.

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.

For the Novel Protocol group, the registry lists 10 participants at risk for serious adverse events, 0 affected, 10 at risk for other adverse events, and 0 affected. It lists 0 deaths. For the Standard Protocol group, it lists 8 participants at risk for serious adverse events, 0 affected, 8 at risk for other adverse events, and 0 affected, with 0 deaths.

These figures describe what the registry reports for the listed groups. They should not be read as proof that no adverse events occurred beyond the events captured and entered in this record. The entry does not provide event descriptions for either group, and no serious adverse-event terms are listed. It also does not describe the method or duration of adverse-event collection, or whether events were assessed for relatedness to the procedures.

Zero reported events in these summaries do not establish that the protocols have no safety risks. In a study with the listed group sizes, uncommon events may not appear in the observed record, and the registry's event counts alone cannot quantify the risk of future events. The figures are a description of the recorded safety results, not a comparative safety analysis. The record does not report a statistical comparison of adverse events between groups.

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

The posted primary outcome summaries indicate that the median FAC was 1.0 in the Novel Protocol group and 0.0 in the Standard Protocol group. Their reported interquartile ranges are 1.0 to 2.0 and 0.0 to 1.5, respectively. Since the FAC descriptions progress toward greater independence at higher levels, the numerical summaries can be described in that scale context. However, they do not establish that one protocol caused greater improvement or that the groups differed reliably.

The record's interpretation is constrained by the unclear timing and form of those values. Although the timeframe is baseline and 6 weeks and the description refers to comparing the post-intervention outcome with baseline, the arm summaries do not say whether they are baseline results, 6-week results, or changes. Without this information, the clinical meaning of the group medians is uncertain.

No confidence interval, p-value, or comparative effect estimate is reported, and the registry lists 0 analyses. The data therefore do not show how precisely any difference has been estimated or whether a statistical comparison supported the stated hypothesis. Descriptive summaries cannot substitute for an inferential comparison, and no conclusion about treatment effectiveness follows from the reported medians alone.

The record also does not explain why the primary outcome counts are 10 and 8 when enrollment is listed as 20. It does not report missing-data procedures, the analysis population, or an adjustment for baseline. These details could affect how a comparative result should be interpreted, but their absence does not permit an assumption about what happened.

Accordingly, the result should be understood as a limited record of group-level FAC summaries, not a definitive estimate of a treatment effect. It neither confirms the proposed advantage of the novel protocol nor demonstrates that the protocols are equivalent. The registry's stated hypothesis and its descriptive outcome values should be kept distinct from evidence of a statistically supported clinical difference.

13. Why This Trial Matters Statistically

This trial is statistically notable because it compares two clearly described versions of robotic gait training while using a function-focused primary endpoint. The Novel Protocol decreases both speed and guidance force over the intervention, whereas the Standard Protocol increases speed and decreases guidance force. The primary outcome, the FAC, represents levels of gait independence and is directly related to the study's stated question about walking function.

The entry also illustrates why descriptive statistics and treatment comparisons are not interchangeable. Medians and interquartile ranges help characterize the observed group results, particularly for an ordered scale. But they do not quantify an adjusted between-group effect, its uncertainty, or the compatibility of the data with a null hypothesis. Those inferential details are absent from the registry record, which lists 0 analyses.

Clarity about outcome timing is important for any trial that refers to both baseline and follow-up. A value at one timepoint, a change from baseline, and a baseline-adjusted comparison have distinct interpretations. Because the posted FAC summaries are not explicitly assigned to baseline, 6 weeks, or change, readers cannot confidently connect them to the stated comparison.

The study also brings attention to the distinction between enrollment and outcome-specific counts. Enrollment is listed as 20, while primary outcome summaries include 10 and 8 participants in the respective groups. Without an account of the difference and the missing-data approach, the completeness and analysis population cannot be assessed from this record.

These points make the registry entry useful for understanding the design, endpoint, and descriptive results, while also showing why transparent reporting of analysis methods and data availability matters. The record supports a careful description of what was posted, but not a strong comparative conclusion about the training protocols.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation in interpreting this trial record is that the primary outcome summaries are not explicitly linked to a particular timepoint or change measure. The registry states baseline and 6 weeks as the timeframe, and describes comparing post-intervention gait independence with baseline, but the group entries provide only one median and interquartile range each. This makes the target contrast unclear.

No comparative statistical result is reported. There is no listed treatment-effect estimate, confidence interval, p-value, test statistic, or model description, and the record lists 0 analyses. The posted medians therefore cannot answer how uncertain a between-group difference is or whether a prespecified inferential test supported the study hypothesis.

There is also an unexplained difference between the listed enrollment of 20 and the outcome-summary counts of 10 and 8. The registry does not report participant flow, reasons for missing outcome values, the analysis population, or a method for handling missing data. This prevents assessment of whether the summaries represent all randomized participants or only those with recorded outcomes.

The entry does not state a prospective sample-size justification or detailed statistical analysis plan. Although it describes planning illustrations based on the observed effect, those illustrations are not numerical in the record details and should not be confused with the trial's original design justification. The handling of multiple outcomes is not described, despite five listed secondary outcomes in addition to FAC.

Finally, the registry does not specify which roles were masked, how the masking was maintained, or further details of training delivery and adherence. These omissions limit evaluation of implementation and possible sources of bias. They do not prove that study procedures were inadequate; they identify information not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Discrete Versus Rhythmic Gait Training — NCT02650440.
• Registry record last updated 2017-09-18; status last verified 2017-05.
• Results first posted 2017-09-18.
• 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 a completed, randomized, parallel-group trial comparing Novel Protocol with Standard Protocol for robot-assisted locomotor training after stroke. It lists triple masking and enrollment of 20. The primary endpoint is the Functional Ambulation Scale, with a stated timeframe of baseline and 6 weeks.

The posted primary outcome summaries give a median FAC of 1.0, with an interquartile range of 1.0 to 2.0, for 10 participants in the Novel Protocol group. The Standard Protocol summary gives a median of 0.0, with an interquartile range of 0.0 to 1.5, for 8 participants. The registry lists 0 analyses and does not report a comparative effect estimate or uncertainty interval. It does not clarify whether the summaries represent baseline, 6-week results, or change from baseline.

Five secondary outcomes are listed. Serious adverse events, other adverse events, and deaths are recorded as 0 in both groups. Reasons for the outcome counts, missing-data methods, analysis populations, sample-size justification, and multiplicity approach are not reported in the registry record. The posted statistics support a descriptive account but do not establish a comparative treatment effect.