This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Driving Neuroplasticity With Nerve Stimulation and Modified CIT (NCT02587234), a randomized phase 1, phase 2 study. The primary outcome is Change in Wolf Motor Function Test (WMFT), Timed Portion.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02587234 |
| Phase | Phase 1, Phase 2 |
| Condition | Stroke, Cerebrovascular Accident |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 21 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Kentucky |
| Results posted | Yes |
2. Clinical Question
Population
People with stroke or cerebrovascular accident. The registry record lists enrollment of 21 participants. It also notes that two participants in the Sham PNS group were lost to follow-up for the primary outcome.
Intervention
Active peripheral nerve stimulation paired with intensive task-oriented upper-extremity training: 2 hours of active stimulation alongside 4 hours of training.
Comparator
Sham peripheral nerve stimulation paired with the same stated training schedule: 2 hours of sham stimulation alongside 4 hours of intensive task-oriented upper-extremity training.
Primary question
How did the mean change in the timed portion of the Wolf Motor Function Test compare between active and sham stimulation, from baseline to post-intervention and from baseline to the 1-month follow-up? Numerical primary outcome results are not reported in the registry record.
The clinical question concerns whether pairing peripheral nerve stimulation with task-oriented training is associated with a different pattern of change in timed upper-extremity motor performance than pairing sham stimulation with the same training. Because the training schedule is described for both arms, the intended contrast is the addition of active rather than sham stimulation within this treatment context. It is not a comparison of stimulation against no training.
The registry record lists change in the Fugl Meyer Assessment Motor Score and change in the Action Research Arm Test as secondary outcomes. These measures address motor impairment and arm function, while the primary measure focuses on the time required to perform tasks. The record does not report numerical results for these outcomes, so the clinical question can be described but the size, direction, and precision of any between-group difference cannot be assessed from the information available.
3. Trial Design
The registry record describes a randomized, double-masked, parallel-group trial listed as Phase 1 and Phase 2. Enrollment was 21. The condition terms are Stroke and Cerebrovascular Accident, and the sponsor is the University of Kentucky. The record gives a start date of 2006-11, a primary completion date of 2010-02, and a status of COMPLETED.
Participants were assigned to active peripheral nerve stimulation or Sham PNS. Both arm descriptions include 4 hours of intensive task-oriented upper-extremity training. The active arm paired that training with 2 hours of active peripheral nerve stimulation; the sham arm paired it with 2 hours of sham peripheral nerve stimulation. Thus, the stated arm contrast is stimulation type against a shared training regimen.
Randomization is intended to make treatment groups comparable on average, while masking is intended to limit influences from knowledge of assigned treatment on participant experience, care, or outcome assessment. These are general purposes of the design; details of the randomization procedure and who was masked are not reported in the registry record. The record identifies a parallel model, meaning the arms are separate groups rather than a crossover in which participants receive both assignments.
The primary outcome is the mean change in the timed portion of the Wolf Motor Function Test, expressed in log(seconds). The stated assessment schedule includes baseline, post-intervention, and 1-month follow-up. Secondary outcomes are change in Fugl Meyer Assessment Motor Score and change in Action Research Arm Test score. The registry record lists three outcome measures, but gives no numerical outcome estimates in the registry record for this analysis. It therefore does not establish how the groups compared or how certain any comparison was.
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
| Stage | Active | Sham PNS |
|---|---|---|
| STARTED | 11 | 10 |
| COMPLETED | 10 | 7 |
| NOT COMPLETED | 1 | 3 |
Reasons for not completing this period:
| Reason | Active | Sham PNS |
|---|---|---|
| Withdrawal by Subject | 1 | 1 |
| Lost to Follow-up | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Two subjects in the Sham PNS group were lost to follow-up.
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.
| Characteristic | Unit | Active PNS | Sham PNS | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 10 | 21 | |
| Age, Continuous | years | 56.7 (SD 8.6) | 54.6 (SD 10.2) | 55.7 (SD 9.2) |
| Sex: Female, Male: Female | Participants | 7 | 3 | 10 |
| Sex: Female, Male: Male | Participants | 3 | 6 | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Wolf Motor Function Test (WMFT), Timed Portion, measured over baseline, post-intervention, 1-month follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | log(seconds) |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in the timed portion of the Wolf Motor Function Test, with results expressed in log(seconds). The test is identified in the registry record as a motor function measure. Its timed component captures task completion time, so it represents performance speed rather than a direct measure of strength or a broad quality-of-life outcome. The record describes changes from baseline to post-intervention and from baseline to the 1-month follow-up.
Taking the logarithm of time is a way of representing duration on a transformed scale. In general, transformation can be useful when time measurements are strongly skewed or when differences are more naturally interpreted on a multiplicative scale. That is a general statistical rationale, not a statement about the distribution observed in this trial; the registry record does not report the distribution of the endpoint or the reason for choosing the transformation.
The registry record specifies the endpoint summary as a mean and its dispersion as a 95% confidence interval. In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis. It is not an interval containing a fixed proportion of individual participants' results. No mean changes or confidence interval limits are reported in the registry record, so neither the estimated change nor its precision can be described from these registry entries.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of active versus sham peripheral nerve stimulation, with both groups receiving intensive task-oriented upper-extremity training. Its primary endpoint is change in the timed portion of the Wolf Motor Function Test, measured at post-intervention and 1-month follow-up relative to baseline. This defines what the trial set out to assess, but does not establish what the results were.
No numerical primary endpoint estimates are reported in the registry record details available for this analysis. The record therefore does not support a statement about which arm had a larger mean change, the magnitude of any between-arm difference, or whether the result was precise or uncertain. Although a mean and 95% confidence interval are specified as the endpoint summary, their values are not reported in the registry record. A confidence interval cannot be interpreted without its estimate and limits.
The registry record notes that two participants in the Sham PNS group were lost to follow-up. This is relevant to interpretation because missing outcome data can affect the number of observations contributing to an analysis and can introduce bias if missingness is related to outcome or treatment. The record does not explain why the participants were lost, whether their post-baseline observations were available, or how missing data were handled. Consequently, the effect of the losses on the primary analysis cannot be determined.
The registry record lists three outcome measures and zero analyses. The absence of reported analyses means there is no posted numerical analysis to interpret in the registry record. It does not by itself establish that no analysis was conducted outside the registry record. The analysis population, statistical model, handling of repeated assessments, and any adjustment for multiple outcomes or time points are not reported in the registry record.
The adverse-event information lists no serious adverse events in either arm, with 11 at risk in Active PNS and 10 at risk in Sham PNS. Other adverse events are listed for 1 of 11 participants in Active PNS and 0 of 10 in Sham PNS. These are descriptive counts; no comparative safety analysis is reported. Death counts are not reported in the registry record. The small group counts and lack of further detail limit what can be inferred from these figures.
In short, the record describes a clinical question, design, endpoint, and selected safety counts, but it does not contain the numerical efficacy results needed to estimate the treatment contrast. No conclusion about the direction, size, or statistical uncertainty of the primary outcome difference can be drawn from the registry record information available.
9. Statistical Methods Explained
The registry record names a continuous primary outcome summarized by a mean and a 95% confidence interval. It also gives a transformed measurement scale, log(seconds), and specifies changes from baseline at post-intervention and at 1-month follow-up. These details identify the type of quantity that an analysis would estimate. They do not reveal the actual estimates or the method used to calculate them.
What does a mean describe?
In general, a mean is an average that combines participant-level measurements into a single summary. For a change outcome, each participant's value depends on the difference between a follow-up measurement and that participant's baseline measurement, according to the specified definition. A group mean change summarizes those individual changes. A contrast between group means can then describe how average change differs between assigned arms. The registry record does not report group means or a between-group contrast, so none can be interpreted for this trial.
The endpoint is stated in log(seconds), not seconds. In general, logarithms change the scale on which differences are represented and may make a skewed time measure more suitable for analysis. A mean on a log scale is not simply an arithmetic mean of untransformed times. Interpretation of a transformed estimate depends on the analysis and any back-transformation used. The registry record does not describe a back-transformation or give estimates that would permit interpretation in seconds.
What does a confidence interval express?
In general, a confidence interval gives a range of values compatible with an estimated effect under the model and assumptions used to construct it. Its width reflects uncertainty: narrower intervals indicate greater precision, while wider intervals indicate less precision. A confidence interval is not a guarantee that the true value lies in the particular reported interval, and it does not describe the spread of individual participant responses. Here, the registry record specifies 95% confidence intervals but does not report the interval limits or the associated mean changes. Precision therefore cannot be judged.
Interpreting an interval for a treatment contrast also requires knowing what quantity it covers. It could describe a mean within an arm or a difference between arms. The registry record identifies the primary summary as a mean with 95% confidence interval, but the registry entries available do not specify a numerical between-arm estimate. Whether the reported interval is arm-specific or comparative is not reported in the registry record.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model expects. When a model understates variability, standard errors can be too small and confidence intervals too narrow, giving an overly precise impression. This concept is especially relevant to count outcomes, where assumptions about the relationship between the mean and variance may not fit the data. The primary endpoint in this trial is described as a continuous timed measure, and the registry record does not report an over-dispersion assessment or a model for that endpoint. No conclusion about over-dispersion in this trial is warranted from the registry entries.
How should repeated assessment times be considered?
The primary outcome description includes baseline, post-intervention, and 1-month follow-up, with changes defined from baseline to each of the two later assessments. In general, repeated measurements on the same participant are correlated rather than independent. An analysis can account for this dependence through an appropriate repeated-measures model or by analyzing specified change scores at each assessment. The choice affects the estimand, uncertainty, and handling of incomplete observations. The registry record does not state which approach was used, whether each assessment was analyzed separately, or whether a common model used both follow-up times.
Because more than one assessment time is named, interpretation also depends on which comparison is treated as primary and how results across times are handled. The registry record indicates that the primary outcome has several categories or time points and is not reduced to one comparison in the analysis information available. It does not report a designated primary time-point contrast or an adjustment for examining multiple times.
What do the planning assumptions mean?
The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It also describes planning for stated fractions of the observed effect. In general, such calculations show what sample size might be needed under specified assumptions to detect an effect. They are planning illustrations, not observed power and not evidence that a treatment effect was established. Their interpretation depends on the effect estimate and assumptions used. Numerical planning results and the observed effect are not reported in the registry record details.
The record states that its planning illustration is not the trial's own design calculation. The trial's sample-size justification is not reported in the registry record. The illustration therefore should not be treated as documentation of the rationale for enrollment or as a retrospective measure of the trial's success.
What can be said about analysis choices?
The record identifies randomized allocation and a double-masked parallel model, but does not give the statistical analysis plan. The exact randomization method, model specification, covariate adjustments, analysis population, missing-data method, and any sensitivity analyses are not reported in the registry record. These omissions matter because analysis choices determine how estimates and uncertainty are obtained. With no numerical outcome results, no recalculated estimate can be made and no comparison between a sponsor analysis and a recalculation is available.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome includes two post-baseline comparisons: change from baseline to post-intervention and change from baseline to 1-month follow-up. The record also lists two secondary outcomes, change in Fugl Meyer Assessment Motor Score and change in Action Research Arm Test. Considering multiple outcomes or time points can increase the chance of a nominally notable result occurring by chance if each is tested separately. In general, multiplicity procedures can control that risk, or a prespecified hierarchy can identify which comparisons carry confirmatory emphasis. The registry record does not report a multiplicity strategy, a hierarchy among outcomes, or which time-point comparison was designated as the main contrast.
The primary outcome population description says that two participants in the Sham PNS group were lost to follow-up. The record does not state whether this loss occurred before post-intervention, before the 1-month follow-up, or at both assessments. It also does not report reasons for loss, whether any measurements remained available, or how the missing outcomes were treated. In general, complete-case analysis, imputation, and model-based approaches rely on different assumptions about missingness. Without the analysis method and relevant data, it is not possible to evaluate the likely influence of missing observations.
The analysis population is not reported in the registry record. It is therefore unclear whether results, if analyzed, were based on all randomized participants, participants with observed endpoint data, or another defined group. The registry record lists zero analyses, so no analysis population or missing-data procedure is described in the registry record. These reporting gaps limit reproducibility and make it harder to judge whether the primary comparison reflects the randomized assignment.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Active PNS | 0 | 11 | 0.0% |
| Sham PNS | 0 | 10 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Active PNS | 1 of 11 |
| Sham PNS | 0 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Active PNS | Sham PNS |
|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | 1 of 11 | 0 of 10 |
The registry record lists serious adverse events for 0 of 11 participants at risk in Active PNS and 0 of 10 participants at risk in Sham PNS. It lists other adverse events for 1 of 11 participants at risk in Active PNS and 0 of 10 participants at risk in Sham PNS. These are counts of participants with events as presented in the registry record; they are not a statistical comparison between arms.
No serious adverse event terms are listed. Death counts are not reported in the registry record. The other adverse event information does not include event descriptions, severity details, timing, or attribution in the registry record, so those characteristics cannot be assessed. The record also does not explain whether participants could experience more than one event, and the participant counts should not be read as event totals.
In general, adverse-event counts describe what was recorded during the specified monitoring and reporting period. Small group counts provide limited information about uncommon events, and a zero count does not establish that an event is impossible or that risks are identical. The registry record does not report a formal safety analysis, exposure-adjusted rates, or uncertainty intervals. These figures should therefore be read as descriptive registry counts, not as a definitive assessment of comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare active with sham peripheral nerve stimulation when each was paired with intensive task-oriented upper-extremity training. It identifies a randomized, double-masked, parallel-group design and a primary measure focused on timed motor task performance. It also specifies assessments after intervention and at 1-month follow-up. These registry entries describe the research question and intended comparison.
The record does not report numerical primary outcome results. Therefore, it does not show the direction or magnitude of mean change in either group, the difference between groups, or the precision of an estimated effect. The specified 95% confidence interval cannot be evaluated without its limits. No claim that active stimulation improved, worsened, or made no difference to the measured outcome is supported by the numerical information available.
The listed secondary outcomes broaden the kinds of motor function and arm activity considered, but their results are not reported in the registry record details. Similarly, the safety counts describe a small number of participants and do not supply a comparative statistical assessment. They should not be used to infer a general safety profile.
The trial's completed status and its enrollment of 21 participants do not substitute for outcome estimates. Nor does a planning illustration based on an observed effect establish that the effect was statistically or clinically meaningful. Planning calculations concern sample sizes under assumptions; they are not observed power and cannot fill the gap left by unreported results.
The most defensible conclusion is limited: the registry record documents the design, intervention schedule, endpoint definition, follow-up timing, two Sham PNS losses to follow-up, and descriptive adverse-event counts. It does not provide enough numerical outcome information to estimate efficacy or judge the certainty of a treatment contrast. The absence of results in the registry record is a limitation of the record, not proof that no results exist elsewhere.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a clearly described intervention contrast and endpoint are not enough to interpret a study without reported estimates. The registry record specifies active versus sham peripheral nerve stimulation, a shared training regimen, a randomized parallel design, and a timed motor-function outcome. Those details clarify what the comparison was intended to address. Yet without numerical group changes, a between-group estimate, and uncertainty intervals, the central statistical question remains unanswered in the available record.
The endpoint involves repeated assessments and a transformed time measure. In general, both features require careful reporting: the analysis should make clear how repeated observations are handled and how results on the log(seconds) scale are interpreted. The registry record identifies the assessment schedule but does not report the analysis model or a back-transformation approach. This illustrates the importance of reporting not only the outcome label, but also the estimand, model, and interpretation of the scale.
The reported loss of two Sham PNS participants raises a further issue. Missing observations can affect both the analysis population and the assumptions underpinning an estimate. The registry record does not explain how the missing data were handled. Transparent reporting of the timing and reasons for missingness, along with the analysis approach and sensitivity checks, would help readers assess the robustness of a result.
Finally, the record names multiple outcomes and time points, but does not report how inferential emphasis or multiplicity was handled. This matters because selective emphasis among several possible comparisons can complicate interpretation. The statistical significance of any contrast cannot be judged without results, and even a reported p-value would need to be considered alongside effect size, confidence interval, and analysis choices. The available information supports a description of the design, not a conclusion about treatment effect.
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 main limitation for interpretation is that numerical primary outcome results are not reported in the registry record details available for this analysis. There is no reported mean change, between-group estimate, confidence interval limit, or p-value to assess. Although the primary outcome summary is described as a mean with a 95% confidence interval, the values themselves are absent. As a result, neither the size nor precision of the primary comparison can be evaluated.
Two participants in the Sham PNS group were lost to follow-up, but the registry record does not report when this occurred, why it occurred, or how missing outcomes were handled. The analysis population and statistical model are not reported in the registry record. Without this information, it is not possible to judge whether the available observations were analyzed in a way that preserves the randomized comparison or to assess sensitivity to missing-data assumptions.
The endpoint description includes changes at post-intervention and 1-month follow-up, but the record does not specify how these correlated measurements were analyzed or which contrast was the principal inferential target. The record also lists secondary motor outcomes, yet does not report a multiplicity plan. These omissions prevent assessment of how the analysis addressed repeated time points and multiple outcomes.
The record describes a double-masked randomized trial, but details of sequence generation, allocation concealment, masking roles, and outcome assessor masking are not reported in the registry record. The training regimen and stimulation duration are stated, but further details about adherence, treatment delivery, and the monitoring period for adverse events are not reported. These limitations concern the information available in the record and should not be mistaken for proof that the underlying study lacked these procedures.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Driving Neuroplasticity With Nerve Stimulation and Modified CIT — NCT02587234.
- Registry record last updated 2023-09-13; status last verified 2023-09.
- Results first posted 2017-07-14.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT02587234, titled Driving Neuroplasticity With Nerve Stimulation and Modified CIT. It lists a completed randomized, double-masked, parallel-group Phase 1 and Phase 2 trial with enrollment of 21, sponsored by the University of Kentucky. The study concerns stroke or cerebrovascular accident.
The active arm paired 2 hours of active peripheral nerve stimulation with 4 hours of intensive task-oriented upper-extremity training. The Sham PNS arm paired 2 hours of sham stimulation with the same stated training duration. The primary outcome was change in the timed portion of the Wolf Motor Function Test, expressed in log(seconds), assessed after intervention and at 1-month follow-up relative to baseline. Secondary outcomes were change in Fugl Meyer Assessment Motor Score and change in Action Research Arm Test.
Two Sham PNS participants were lost to follow-up for the primary outcome. Numerical primary and secondary outcome results, the statistical analysis plan, and missing-data methods are not reported in the registry record. The record lists no serious adverse events in either arm and one participant with another adverse event in Active PNS; death counts are not reported.