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 Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury (NCT00387673), a randomized na study. The primary outcome is Conduct pre-and Post-training Assessments of Behavioral Outcomes Using Wolf Motor Function Test and Jebsen Taylor Hand Function Test to Measure Upper Extremity Function, Hand-held Dynamometry to Measure Pinch Grip Strength, and Semmes-Weinstein Monofilam.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00387673 |
| Phase | NA |
| Condition | Spinal Cord Injury |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
Population
People with spinal cord injury. The registry record gives an enrollment of 11 and describes upper-extremity function, hand function, pinch grip strength, and sensory assessment as areas of interest. It does not report further eligibility details or characteristics of the enrolled participants.
Intervention
One arm is described as 6 weeks of upper-extremity training for 3 sessions/week, including 2 hours/session of somatosensory stimulation of the median, ulnar, and radial nerves at the wrist. Another arm received 2 hours of somatosensory stimulation of the hand without training during a 6-week period.
Comparator
A third arm received sham somatosensory stimulation of the hand for 2 hours, followed by 1 hour of activity-based training during a 6-week period. The record does not state which comparisons were planned as primary comparisons, or how participants were allocated among the arms.
Primary question
The study aimed to investigate whether electrical stimulation alone, or stimulation followed by activity-based training, produces gains in pinch strength and upper-extremity function in people with spinal cord injury. The registry lists several behavioral and sensory assessments over multiple time points, but reports no outcome results. The direction or size of any difference between arms is therefore not known from the registry record.
3. Trial Design
The registry identifies this as a randomized, single-masked, parallel study. It reports an enrollment of 11, a completed status, and a study start of 2006-10 with primary completion in 2009-10. The phase is recorded as NA. The registry does not report who was masked, the allocation ratio, the randomization procedure, or details of how allocation was concealed.
Three arm descriptions are present. One describes 6 weeks of upper-extremity training for 3 sessions/week, including stimulation of the median, ulnar, and radial nerves at the wrist for 2 hours/session. A second describes 2 hours of somatosensory stimulation of the hand without training during a 6-week period. A third describes 2 hours of sham somatosensory stimulation followed by 1 hour of activity-based training during a 6-week period. These descriptions identify the planned activities; they do not establish adherence, exposure actually received, or whether the regimens were delivered as planned.
In a parallel design, participants are assigned to a study arm and the arms are compared rather than each participant necessarily receiving every study condition. Randomization is intended to support fair comparisons by reducing systematic differences between groups, but the record does not provide details to assess how well that process worked. Single masking means that masking was planned for one party, but the masked party is not reported. The record does not report the protocol, eligibility criteria, recruitment setting, or additional design details needed to evaluate implementation.
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 | Arm 1 | Arm 2 | Arm 3 |
|---|---|---|---|
| STARTED | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Project has officially closed. PI for this project has left VA without forwarding information.
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.
Population: Project has officially closed. PI for this project has left VA without forwarding information.
| Characteristic | Unit | Effect of Prolonged Electrical Stimulation on Neural Plastici |
|---|---|---|
| Participants analysed | 0 | |
| Age, Categorical: <=18 years | — | |
| Age, Categorical: Between 18 and 65 years | — | |
| Age, Categorical: >=65 years | — | |
| Sex: Female, Male: Female | 0 | |
| Sex: Female, Male: Male | 0 | |
| Region of Enrollment: United States | participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Conduct pre-and Post-training Assessments of Behavioral Outcomes Using Wolf Motor Function Test and Jebsen Taylor Hand Function Test to Measure Upper Extremity Function, Hand-held Dynamometry to Measure Pinch Grip Strength, and Semmes-Weinstein Monofilam, measured over Outcome measures: baseline, 6 weeks after baseline, post testing, 6 weeks post testing.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The registry's primary outcome title describes behavioral assessments of upper-extremity function using the Wolf Motor Function Test and Jebsen Taylor Hand Function Test, pinch grip strength measured with hand-held dynamometry, and a sensory assessment identified as Semmes-Weinstein Monofilam. The title is truncated at that final term, so the record does not give the complete sensory measure name. It does not specify a unit, summary parameter, or dispersion measure.
The stated assessment schedule is baseline, 6 weeks after baseline, post testing, and 6 weeks post testing. The record does not clarify how these time points relate to one another, or identify a single time point or single outcome as the primary comparison. It also does not report endpoint values or an analysis that combines or distinguishes the listed measures and assessment times.
In general, functional tests characterize performance on specified tasks, dynamometry quantifies force, and sensory testing assesses responses to sensory stimuli. Multiple measures can describe different aspects of function, but they do not automatically answer the same statistical question. Interpreting an endpoint requires knowing how it was scored, which time point and comparison were prioritized, and how changes were analyzed; these details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a study intended to examine stimulation and activity-based hand training, but it contains no reported outcome results. There is no reported estimate of change in pinch strength, upper-extremity function, hand function, or sensory performance, and no reported comparison among the arms. Consequently, the record does not establish whether the measured outcomes changed or whether the arms differed.
The primary outcome entry contains several assessment types and time points. The registry marks the outcome as not reduced to one comparison, and it reports no analyses. This means there is no single posted estimate to interpret as the main treatment contrast. Without estimates, the magnitude and direction of any possible difference cannot be described. There are also no reported confidence intervals or p-values with which to assess uncertainty or statistical compatibility with a null difference.
In general, an effect estimate describes the size and direction of a contrast, while a confidence interval conveys the precision of that estimate and the range of values compatible with the analysis. A p-value, when reported, addresses compatibility with a specified null hypothesis under the statistical model; it does not measure clinical importance. None of these quantities is reported for the outcome in this record, so no such interpretation can be made for this study.
The enrollment of 11 is a registry-level study count, not an outcome result and not evidence of the precision of an unreported comparison. The record does not give arm-specific enrollment, missingness, outcome distributions, or the number of participants included in any analysis. Without these details, the adequacy of the data for estimating differences cannot be assessed from the registry entry.
The record also lists a closed project in its adverse-event information, with zero at risk and zero affected for serious and other events. Those values do not establish that no adverse events occurred during the study: the record does not report an evaluable at-risk population or a detailed adverse-event analysis. The trial's status is completed, but completion alone does not supply results. The appropriate statistical conclusion is limited to what is documented: the planned study question and assessments are described, while comparative outcome findings are not reported in the registry record.
9. Statistical Methods Explained
What does randomization contribute? In general, randomization assigns participants to study arms using a chance-based process. Its purpose is to reduce systematic differences in prognostic factors between arms, supporting an interpretable comparison. It does not guarantee that groups will be alike in every respect, especially in a small study. The registry identifies the allocation as randomized but does not report the randomization method, concealment procedures, or arm-specific participant characteristics. The actual balance of groups therefore cannot be assessed from the record.
What does a parallel design mean? In general, a parallel design compares outcomes across assigned arms, with each arm following its assigned regimen. The record describes three different regimens involving stimulation, sham stimulation, and training. However, it does not specify the planned primary contrast among those arms. A statistical interpretation depends on the comparison that was prespecified: for example, whether the question concerns stimulation versus sham, training added to stimulation, or another contrast. The registry does not report that choice.
What can masking tell readers? Masking is intended to limit the influence of expectations or knowledge of assignment on care, behavior, measurement, or analysis. The record labels the study single-masked, but does not identify who was masked or how masking was maintained. The label alone is not enough to judge whether outcome assessment was protected from knowledge of treatment assignment. This matters in studies that include performance-based assessments, because measurement procedures and participant effort can affect observed scores.
Why are endpoint definitions important? An outcome analysis needs a clearly defined measure, scoring rule, time point, and contrast. The registry lists the Wolf Motor Function Test, Jebsen Taylor Hand Function Test, hand-held dynamometry, and a sensory measure whose name is truncated. It gives an assessment schedule but no units, scoring details, summary parameters, or selected primary comparison. In general, distinct measures can represent different constructs and have different scales. Combining their results into a single claim without a stated analysis would not be justified.
How should repeated time points be handled? In general, repeated assessments from the same participant are related rather than independent observations. An analysis can account for that relationship, but the appropriate approach depends on the endpoint, timing, and planned estimand. This record lists baseline, 6 weeks after baseline, post testing, and 6 weeks post testing, without clarifying their relation or reporting an analysis. No model, change score, or between-arm contrast should be inferred from the schedule alone.
What do confidence intervals and p-values normally contribute? In general, a confidence interval expresses uncertainty around an effect estimate, while a p-value assesses the data's compatibility with a specified null hypothesis under assumptions. Both require an analysis and reported numerical results. Neither is present for the primary outcome in the registry record. There is therefore no basis to judge the precision or statistical evidence for an effect. A nonreported result should not be treated as a null result or as evidence that the arms were equivalent.
What is the role of the planning illustration? The registry's planning note describes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the target effect is a stated fraction of the observed effect. These are planning assumptions, not a report of the trial's design rationale or observed power. The record provides no observed effect estimate to anchor such an illustration, and the outcome entry is not reduced to one comparison. No sample-size adequacy conclusion can be drawn from those assumptions alone.
Why can over-dispersion matter in general? For outcomes analyzed with a count model, over-dispersion means that variation exceeds what the chosen model expects; ignoring it can make uncertainty appear too small. This is a general statistical consideration, not a description of this study's analysis. The registry does not report a count outcome model or any analysis model. The listed functional, strength, and sensory assessments cannot be assumed to have been analyzed with a particular distribution or method.
Overall, the registry supports a description of the randomized design and intended assessments, but it does not document an analysis plan or results. The statistical details needed to assess effect size, precision, assumptions, and robustness are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The outcome entry covers multiple assessment types and multiple time points. When a study tests several outcomes or comparisons, the chance of at least one apparently notable result can increase unless the analysis plan addresses multiplicity. In general, prespecifying a primary endpoint and comparison, or using an appropriate adjustment strategy, helps readers distinguish the main confirmatory question from secondary or exploratory findings.
The registry does not report a single reduced comparison, a hierarchy of outcomes, a multiplicity adjustment, or an analysis plan. It also does not report whether any outcomes or time points were added, removed, or selected after data collection. Because there are no posted outcome analyses, it is not possible to determine how multiple measures or repeated assessments were handled.
Missing-data methods and analysis populations are also not reported in the registry record. There is no account of outcome completeness, withdrawals, exclusions, adherence, or the population included in an analysis. In general, missing data can affect estimates when the reasons for missingness are associated with participant characteristics or outcomes. Readers need counts and methods to judge that risk; they are absent. The project-closed adverse-event entry does not provide information about missing outcome data or analysis populations.
These omissions prevent assessment of whether reported estimates, if any, would reflect all randomized participants or a selected subset. They also prevent evaluation of family-wise error, selective reporting, and sensitivity to missingness. No inference about the direction of any such bias is supported by the registry record.
11. What the Result Does, and Does Not, Mean
The record identifies a randomized study of somatosensory stimulation and activity-based hand training for people with spinal cord injury. It describes three arm regimens and planned assessments of function, pinch grip strength, and sensory performance over several time points. These details define the intended research question, but they are not evidence of an observed effect.
No outcome results, arm comparisons, effect estimates, confidence intervals, or p-values are reported in the registry record. It is therefore not possible to say whether any measure improved, worsened, or differed between study arms. Nor is it possible to evaluate the size, clinical relevance, or precision of a potential difference. The absence of posted results is not evidence that the interventions had no effect, and it does not establish equivalence among the regimens.
The enrollment of 11 does not, on its own, indicate whether the study was adequately powered or whether an estimate would be precise. The registry does not report an analysis population, arm-specific sample sizes, or outcome completeness. Its planning note gives assumptions for a sample-size illustration, but an illustration is not an observed result or an assessment of actual power.
The completed status indicates the registry lists the project as completed; it does not substitute for results. The entry also says the project had officially closed and that the principal investigator had left the VA without forwarding information. That administrative note helps explain the limited record but does not supply clinical or statistical findings. Conclusions about outcomes require reported data and analyses that are not present in the registry record.
12. Why This Trial Matters Statistically
Statistically, this study illustrates why a trial description and a trial result are different kinds of evidence. The registry identifies randomization, masking, a parallel design, intervention regimens, and a set of intended outcome assessments. Those details help define what the researchers set out to compare, but they do not reveal what the data showed.
The record also illustrates the importance of specifying a primary comparison when a study includes several measures and time points. Pinch strength, upper-extremity function, hand function, and sensory assessment are related to the study's broad aim but are not interchangeable endpoints. Without a stated priority and analysis, readers cannot tell which contrast was intended to carry the main inference or how results across assessments were to be interpreted.
For biostatisticians and clinical researchers, the missing outcome estimates and analysis details are consequential. Without them, effect magnitude, precision, multiplicity, missingness, and model assumptions cannot be evaluated. The enrollment figure cannot replace an effect estimate or uncertainty interval, and a planning illustration cannot establish the achieved informativeness of the data.
The record's limited reporting is itself a useful reminder: registration status and outcome reporting are separate. A completed study entry can document the question and planned measurements while leaving the comparative evidence unavailable. Transparent outcome reporting is necessary for readers to distinguish a result that is uncertain from a result that was never reported in the registry.
13. 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 most important limitation for statistical interpretation is that the registry contains no reported outcome findings or analyses. The primary outcome entry is not reduced to a single comparison, and the registry lists no analyses. Effect estimates, uncertainty measures, and between-arm results cannot be evaluated.
The outcome description is broad and partly truncated. It names several assessment instruments and indicates multiple assessment times, but does not provide complete scoring definitions, units, a selected primary time point, or an explicit estimand. The relationship among baseline, 6 weeks after baseline, post testing, and 6 weeks post testing is not clarified. The record also does not identify the planned comparison among the three described arms.
Important design and analysis information is absent, including eligibility criteria, randomization procedures, who was masked, arm-specific enrollment, participant flow, adherence, outcome completeness, missing-data handling, and analysis populations. The registry does not report the statistical model, covariate adjustment, multiplicity strategy, or prespecified analysis plan. These gaps limit assessment of bias and precision even apart from the lack of results.
The adverse-event entry is marked Project Closed and lists zero at risk and zero affected for serious and other events. With no reported evaluable population or detailed event assessment, those entries should not be read as a complete safety finding. The registry also notes that the project had officially closed and the principal investigator had left the VA without forwarding information, underscoring the limits of the available record.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury — NCT00387673.
- Registry record last updated 2017-06-16; status last verified 2017-05.
- Results first posted 2017-06-16.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
17. Record Summary
The registry describes NCT00387673, titled “Effect of Prolonged Electrical Stimulation on Neural Plasticity in Spinal Cord Injury.” It lists a randomized, single-masked, parallel study with enrollment of 11 and completed status. The sponsor is the VA Office of Research and Development. The recorded study start is 2006-10 and primary completion is 2009-10.
Three arm descriptions involve somatosensory stimulation, sham stimulation, and activity-based training. The primary outcome entry lists behavioral, strength, and sensory assessments at multiple time points, but does not identify one comparison. No outcome results or analyses are reported in the registry record. The record states that the project had officially closed and that the principal investigator had left VA without forwarding information.