Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke (NCT02199795), a randomized na study. The primary outcome is Change in Lower Extremity Fugl-Meyer Score at End of Treatment.

2. Clinical Question

The registry record describes the study as a small pilot randomized controlled trial. The primary objective was to compare motor impairment and functional mobility after six weeks of treatment. The primary posted outcome focuses on lower-limb motor impairment, measured as change in Lower Extremity Fugl-Meyer score. Higher scores on this measure are considered better.

The clinical question concerns the relative outcome in the two randomized groups, not whether either group changed from baseline in isolation. The posted group means describe average change in each arm, but the record does not provide an estimable two-arm comparison for this continuous endpoint. The reported means therefore need to be read as descriptive results rather than as a formal estimate of the treatment contrast.

3. Trial Design

The registry identifies NCT02199795 as a completed, randomized, single-masked, parallel-group study sponsored by MetroHealth Medical Center. The listed enrollment is 7. The study start is recorded as 2014-05, and primary completion as 2015-02. The phase is listed as NA. The registry record does not report further details about how randomization was generated or concealed, who was masked, or how masking was maintained.

The two listed arms are CCNMES and Cyclic NMES. In the CCNMES description, movement of the stronger ankle controls electrical stimulation intended to move the weaker ankle. Cyclic NMES is described as automatic, repetitive stimulation of the muscles to move the weaker ankle. The study description specifies six weeks of lower-extremity CCNMES in an anti-phase application; additional treatment-delivery details are not reported in the registry record.

The primary outcome is change in Lower Extremity Fugl-Meyer score from baseline to the end of treatment, defined as six weeks. The record also lists three secondary outcomes: change in the 10-Meter Walk Test, change in Ankle Movement Tracking Error at End of Treatment, and change in Modified Emory Functional Ambulation Profile at End of Treatment. Although these outcomes are listed, their numerical results are not reported in the registry record.

The posted primary outcome contains group summaries for 2 participants in the CCNMES arm and 3 participants in the Cyclic NMES arm. These arm-specific outcome counts are not the same as the listed overall enrollment of 7. The registry record does not explain the difference, so it should not be interpreted as evidence about exclusions, withdrawals, or missing measurements.

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:

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 Change in Lower Extremity Fugl-Meyer Score at End of Treatment, measured over Baseline and End of Treatment (6 weeks).

The Lower Extremity Fugl-Meyer Assessment measures lower-limb motor impairment. Participants attempt a list of isolated and simultaneous movements involving the hip, knee, and ankle. The tasks take account of synergy patterns, isolated strength, coordination, and hypertonia. Each movement attempt receives an ordinal score of 0, 1, or 2, corresponding to inability to perform, partial performance, or full performance. The subscores are summed, with a full scale range of 0-34.

Higher scores are considered better. The posted endpoint is not the final score alone: for each participant, the baseline score is subtracted from the score at the end of the six-week treatment, and each group’s change scores are averaged. A positive mean change therefore describes an average increase in score during the measured interval; it does not by itself establish that the groups differ.

This measure is used because the study’s primary objective includes motor impairment, and the assessment directly captures performance of lower-limb movements. As a general statistical point, a defined assessment can make change in a clinical construct more reproducible than an unstructured judgment. The record does not report measurement properties, a threshold for clinically important change, or a prespecified interpretation of a particular score change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For this continuous outcome, the registry reports a mean and standard deviation in each arm. A mean is the arithmetic average of the participant-level change scores within a group. Here, each change score is calculated by subtracting the baseline Lower Extremity Fugl-Meyer score from the end-of-treatment score. The group mean therefore describes average change, not the score of a typical participant and not the treatment contrast between arms.

A standard deviation describes how spread out individual values are around their group mean. A larger standard deviation indicates greater observed variability in change scores. It does not describe the precision of the mean in the same way as a confidence interval. Precision depends in part on the amount of information in the sample, and the reported group counts are small. The record gives standard deviations of 1.4 for CCNMES and 2.9 for Cyclic NMES. With few observations, a small number of individual values may strongly affect both a mean and a standard deviation.

A direct comparison would ordinarily estimate the difference in average change between randomized arms, with an uncertainty measure such as a confidence interval and, where appropriate, a test statistic or p-value. A confidence interval is a range of values compatible with the data under the assumptions of the analysis; its width communicates precision. A p-value, when reported, describes how compatible the observed data are with a specified null model. It does not measure the probability that a treatment works, and it does not communicate the size or clinical importance of an effect. Neither a confidence interval nor a p-value for the primary two-arm comparison is reported in the registry record.

The record explicitly indicates that values were missing or not estimable for a two-arm comparison of this continuous endpoint. The reason is not reported in the registry record. The group summaries remain descriptive, but they should not be treated as a substitute for an inferential comparison. No recalculated treatment contrast is available in the record, and the posted summaries should not be used to imply an unreported analysis.

Randomization is intended, in general, to make treatment groups comparable on average with respect to measured and unmeasured characteristics. In a pilot trial with small groups, randomization does not guarantee balance in the participants who happened to enroll. The record does not provide baseline characteristics by arm, so readers cannot assess balance from the registry record. The record also does not state whether the analysis adjusted for baseline score or other variables.

The Lower Extremity Fugl-Meyer score is formed by summing ordinal ratings for movement tasks. The registry reports the resulting score and analyzes change using means and standard deviations. As a general statistical consideration, treating a summed score as continuous can be useful for describing average change, but the interpretation depends on the scale and the distribution of scores. The record does not report diagnostic checks, distributional summaries, or details of any model used.

Over-dispersion is a general concern when observed variability is greater than a model allows for. If an analysis assumes less variability than the data contain, uncertainty can be understated. That concern cannot be assessed from the posted arm summaries alone, and no specific over-dispersion model or diagnostic is reported in the registry record. In this trial, the reported spread is descriptive; it does not establish that a particular statistical model was used.

The registry record does not report a prespecified statistical analysis plan, the method used to handle missing outcomes, or the population included in the primary analysis. It also does not report whether an interim analysis was planned or conducted, or a sample-size justification. These details should not be inferred from the fact that the study is described as a pilot.

General sample-size planning uses assumptions about the effect to detect, variability, significance level, power, and allocation. The registry record states that a separate planning illustration uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of the observed effect. Such an illustration is not the trial’s own design rationale and does not describe observed power. No numerical planning results are reported in the registry record. A post hoc power interpretation should not be substituted for the missing uncertainty estimate around the treatment comparison.

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("CCNMES", "Cyclic NMES")
n   <- c(2, 3)
m   <- c(1, 1.7)
sp  <- c(1.4, 2.9)
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  CCNMES  2  1.000  1.400  -11.579  13.579
CARM  Cyclic NMES  3  1.700  2.900  -5.504  8.904

11. Multiplicity, Missing Data and Analysis Populations

The primary outcome is change in Lower Extremity Fugl-Meyer score at the end of treatment. The registry also lists three secondary outcomes: change in the 10-Meter Walk Test, change in Ankle Movement Tracking Error at End of Treatment, and change in Modified Emory Functional Ambulation Profile at End of Treatment. The registry lists four outcome measures in total, but numerical results for the secondary outcomes are not reported in the registry record.

When an analysis considers multiple outcomes or multiple comparisons, the chance of at least one apparently notable finding can increase. Statistical methods can address multiplicity, but the registry record does not report whether any adjustment was planned or used. It also does not report a hierarchy among the primary and secondary outcomes beyond identifying the Lower Extremity Fugl-Meyer change as primary. No multiplicity-adjusted interpretation can therefore be made from the posted information.

The overall enrollment is 7, while the posted primary outcome summaries include 2 participants in CCNMES and 3 in Cyclic NMES. The registry record does not explain the difference. It does not report whether outcome data were unavailable, participants were excluded from a particular analysis, or another accounting approach was used. These possibilities should not be assumed.

The analysis population is not reported in the registry record. In particular, the record does not specify whether the primary outcome analysis followed all randomized participants, included only participants with an observed endpoint, or used another population definition. The approach to missing data, including any imputation or sensitivity analysis, is also not reported. These omissions limit assessment of how representative the posted summaries are of the randomized groups.

12. Safety Results

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

Other (non-serious) adverse events

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

The registry reports serious adverse events for 0 of 2 participants at risk in the CCNMES arm and 0 of 3 participants at risk in the Cyclic NMES arm. It also reports other adverse events for 0 of 2 participants at risk in the CCNMES arm and 0 of 3 participants at risk in the Cyclic NMES arm. No serious adverse-event terms are listed.

These counts describe events recorded among the participants identified as at risk in each arm. They do not show that the risk of an event is zero, nor do they establish that the treatments have equivalent safety. With such small at-risk groups, the absence of a recorded event provides limited information about uncommon events. The registry record does not report additional details about how adverse events were collected, their observation period, or the criteria used to classify them.

Deaths are not reported in the registry record. A blank or unreported death count should not be interpreted as a reported count of zero. The safety figures should therefore be read as a limited account of recorded adverse events in this small trial, not as a comprehensive estimate of safety.

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

The primary endpoint summaries show average score changes of 1.0 units on a scale for CCNMES and 1.7 units on a scale for Cyclic NMES. The posted standard deviations are 1.4 and 2.9, respectively. These values describe the observed participants in each arm and the variation in their change scores. Because the primary two-arm comparison is not estimable in the registry record, the summaries do not provide a precise estimate of the difference between treatments.

The trial was a small pilot study with listed enrollment of 7. The small arm-specific outcome counts make the descriptive results especially sensitive to individual observations. No confidence interval or p-value for the primary comparison is reported. The record therefore does not establish whether a between-arm difference is distinguishable from chance variation, nor does it communicate how precisely such a difference could be estimated.

The registry identifies the Lower Extremity Fugl-Meyer Assessment as a motor-impairment measure and states that higher scores are better. It does not report a threshold for clinically important change. As a result, the mean changes cannot be classified from the record as clinically important or unimportant. The secondary outcomes are named, but their numerical results are not reported.

These results do not establish that either intervention works or does not work. They describe the posted observations and highlight the limits of the available comparison. The study may inform questions for future research, but the registry record does not report a larger confirmatory trial, a protocol-based sample-size rationale, or a statistical plan that would support broader claims.

14. Why This Trial Matters Statistically

This trial is statistically instructive because it separates a descriptive result from an inferential comparison. The registry reports mean change and standard deviation in each arm, but also indicates that a two-arm comparison was not estimable. The presence of numbers for both groups does not by itself mean that the effect of one treatment relative to the other has been estimated with adequate precision.

The study also illustrates how small samples constrain interpretation. With 2 participants in one outcome group and 3 in the other, group averages can be strongly influenced by individual scores. Standard deviations convey observed variation, but they do not replace confidence intervals for the treatment contrast. Readers should distinguish what is directly described from what would require an analysis that the record does not report.

Another statistical issue is the difference between overall enrollment and the outcome counts. The registry lists enrollment of 7, while the primary summaries identify 2 participants in CCNMES and 3 in Cyclic NMES. Without an account of that difference, readers cannot determine how the posted summaries relate to the enrolled or randomized population. This makes transparent reporting of analysis populations and missing-data handling important.

Finally, the record lists multiple outcomes but does not report results for the secondary measures or how multiplicity was handled. The example underscores why outcome definitions, analysis plans, participant accounting, uncertainty estimates, and safety follow-up all matter when interpreting a randomized pilot study. These are general statistical reporting considerations; the record’s omissions do not establish what procedures were or were not followed outside the registry entry.

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 main trial-specific limitation is the small enrollment: 7 participants are listed. The primary outcome summaries are based on 2 participants in CCNMES and 3 in Cyclic NMES. The registry record does not explain how the outcome counts relate to overall enrollment, so the reasons for the difference and its implications for analysis cannot be assessed.

The registry reports arm-specific means and standard deviations but no estimable two-arm comparison for the continuous primary outcome. A confidence interval and p-value are not reported. This prevents assessment of the precision of the between-arm contrast using the registry record. Individual participant data and baseline outcome summaries are also not reported, limiting assessment of score distributions and baseline comparability.

The statistical analysis plan, analysis population, and methods for handling missing data are not reported in the registry record. It is also not reported whether the analysis adjusted for baseline values, whether any interim analyses were conducted, or how multiplicity was addressed. These details cannot be reconstructed from the arm summaries.

The record names three secondary outcomes but does not report their numerical results. It does not report a threshold for clinically important change on the primary measure. Safety counts are available for small at-risk groups, but further details about event collection and follow-up are not reported. These limitations concern interpretation of the registry record; they do not establish whether additional information exists outside it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke — NCT02199795.
• Registry record last updated 2017-11-08; status last verified 2017-10.
• Results first posted 2017-11-08.
• 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

NCT02199795 is a completed randomized, single-masked, parallel-group pilot trial sponsored by MetroHealth Medical Center. The listed enrollment is 7. The study compares six weeks of lower-extremity CCNMES with Cyclic NMES in stroke survivors with ankle dorsiflexion weakness.

The primary outcome is change in Lower Extremity Fugl-Meyer score from baseline to the end of treatment. The posted mean changes are 1.0 units on a scale for CCNMES and 1.7 units on a scale for Cyclic NMES. The corresponding standard deviations are 1.4 and 2.9, based on 2 and 3 participants, respectively. A two-arm comparison is not estimable in the registry record.

Three secondary outcomes are listed, but their numerical results are not reported in the registry record. Serious and other adverse-event counts are zero in the reported at-risk groups; deaths are not reported in the registry record.