Sensory Stimulation During CIMT: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sensory Stimulation During CIMT (NCT03558230), a randomized na study. The primary outcome is Feasibility (Total Number of Hours That Participants Wear the Device).

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group pilot trial. The registry reports quadruple masking, but does not identify which participants, staff, assessors, or other parties were masked. Enrollment was 13. The study is listed as completed, with a start date of 2018-07-16 and primary completion date of 2018-10-28. The phase is listed as not applicable.

Both groups received standardized constraint-induced movement therapy and wore a vibration device. The experimental group received wrist stimulation during CIMT; the control group wore the device with no vibration. The registry also lists placebo for vibration and standardized CIMT among the interventions. It describes the device as a generic, commercially available vibrator, not specifically designed for peripheral skin stimulation.

The study's long-term goal was to assess whether sensory stimulation could enhance outcomes of CIMT in children with cerebral palsy. However, the posted primary outcome is feasibility, operationalized as total hours of device wear through 5-day study completion. The registry reports one outcome measure and no secondary outcomes. It lists zero analyses. Details of random-sequence generation, allocation concealment, masking procedures, adherence instructions, and the protocol's sample-size justification are not reported in the registry record.

The arm summaries include 7 participants in the vibration group and 6 in the no-vibration group. The record presents group means and standard deviations for device-wearing hours. It does not post an inferential comparison between groups, such as an estimated contrast with a confidence interval or a test result. Consequently, the design and descriptive endpoint summaries are available, but the registry record does not provide a reported statistical conclusion from a between-group analysis.

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 Feasibility (Total Number of Hours That Participants Wear the Device), measured over through 5-day study completion..

The primary endpoint is the total number of hours participants wore the device through 5-day study completion. It is classified as a continuous measure, reported as a mean with standard deviation, and labeled as a feasibility outcome. Device-wearing time can indicate whether the device was used during the study period, which is relevant when evaluating whether a stimulation procedure can be implemented alongside CIMT.

Feasibility is distinct from clinical benefit. A record of device-wearing hours describes exposure to the device; on its own, it does not show whether vibration changed movement, function, or any other clinical outcome. The registry lists no secondary outcomes, and does not post a clinical endpoint for treatment effectiveness.

The reported means are 28.3 hours for vibration and 27.9 hours for no vibration. Their reported standard deviations are 0.3 and 1.0 hours, respectively. These summaries describe the recorded endpoint within each group. The registry does not specify how device wear was recorded, how missing or incomplete records were handled, or whether the endpoint was assessed by a blinded assessor. Those measurement and analysis details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The endpoint is continuous and is summarized using a mean and standard deviation. The mean describes the arithmetic center of the observed device-wearing times in an arm. The standard deviation describes how spread out the individual observations are around that arm's mean. These summaries provide different information: the mean describes a typical level, while the standard deviation describes within-group variability. The reported means are 28.3 hours for vibration and 27.9 hours for no vibration; the standard deviations are 0.3 hours and 1.0 hours, respectively.

What can descriptive summaries establish?

Descriptive statistics characterize the data recorded in the trial. They do not, by themselves, quantify the uncertainty in a difference between randomized groups. A confidence interval is a range of values compatible with the data and the statistical method used, and its width conveys precision. The registry does not post confidence intervals for this endpoint or an estimated group contrast. Without those results, the comparative precision cannot be read from the registry record. The observed means should not be treated as proof that the groups differ or as proof that they are equivalent.

In general, a standard deviation is not a standard error or confidence interval. It reflects the spread of participant-level observations, whereas uncertainty in a mean or contrast also depends on the amount of information and the analysis method. The registry provides the arm counts and standard deviations, but no inferential output. Recalculating an unadjusted test from summary statistics would be a separate analysis, not the sponsor's reported result; no such recalculation is included in the posted results.

Why does randomization matter?

In general, random assignment is intended to make treatment groups comparable in expectation, reducing systematic allocation differences. It does not guarantee balance in every small trial, and it does not eliminate uncertainty. This study is described as randomized and parallel-group. The registry does not report the sequence-generation method or allocation-concealment procedure, so those details cannot be assessed. The record states quadruple masking but does not specify who was masked or how masking was maintained.

Both groups received standardized CIMT and wore the device, while vibration was present in one group and absent in the other. This structure makes the intended contrast the addition of vibration within the CIMT setting. Because the primary measure is device-wearing hours, however, the posted endpoint does not evaluate whether vibration affects a clinical outcome. The registry's long-term project goal and its posted primary endpoint should therefore be kept distinct.

How should variability be considered?

Variability matters because individual participants need not wear the device for identical periods. The reported standard deviations indicate less observed spread in the vibration group than in the no-vibration group, but the small arm counts make both summaries specific to a limited set of observations. In general, when data show greater variability than an analysis model expects, standard errors and tests based on that model can be unreliable; analysts may need methods that accommodate over-dispersion or other features of the data. The registry does not report a model, distributional assessment, or analysis of over-dispersion, and the posted summaries do not establish that such a problem occurred.

What is known about planning and analysis?

The registry does not report the protocol's sample-size justification, a target enrollment rationale, or a prospective power calculation. A planning illustration based on an observed effect is not the same as the trial's original design justification and is not observed power. The registry's planning note describes a two-sided significance level of 0.05, equal allocation, and a normal approximation for such illustrations, with the effect to detect expressed as a stated fraction of the observed effect. It does not identify a prospective effect assumption for this pilot. No numerical planning results are reported in the registry record.

The endpoint is reported as a mean and standard deviation, but the registry does not post a test, confidence interval, adjusted model, or analysis population. It lists zero analyses. Thus, the available statistical evidence is descriptive rather than a reported inferential comparison. General statistical principles can explain what a mean, standard deviation, or confidence interval represents, but they cannot fill in analysis details that the registry does not report.

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("Vibration", "No Vibration")
n   <- c(7, 6)
m   <- c(28.3, 27.9)
sp  <- c(0.3, 1)
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  Vibration  7  28.300  0.300  28.023  28.577
CARM  No Vibration  6  27.900  1.000  26.851  28.949

11. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several outcomes, time points, or planned comparisons are tested, because repeated testing can increase the chance of a misleading positive result. The registry lists one outcome measure and zero secondary outcomes. It does not report an analysis plan, a hierarchy of endpoints, or a multiplicity adjustment. The record therefore does not establish whether additional outcomes or analyses were planned outside the posted results. The protocol's full multiplicity strategy is not reported in the registry record.

The registry does not describe missing outcome data, withdrawals, exclusions after randomization, or reasons for incomplete device-wear records. Although arm counts and endpoint summaries are posted, those summaries alone do not establish that every enrolled participant contributed a complete observation. The method used to handle missing data is not reported in the registry record.

Similarly, the record does not define an intention-to-treat, per-protocol, or other analysis population. It gives enrollment and arm-level counts, but does not explain whether those counts correspond to all randomized participants, all participants with observed endpoint data, or another analysis set. The analysis population and any exclusions are not reported in the registry record.

These omissions limit evaluation of the statistical process. They do not show that missingness, multiplicity, or exclusions caused bias; rather, the posted record does not contain the information needed to assess those possibilities. No assumptions about the handling of missing data or the scope of planned testing can be made from the available registry entries.

12. 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.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for participants at risk in each group. In the vibration group, 0 of 7 participants had a serious adverse event; in the no-vibration group, 0 of 6 did. The death count is 0 in each group. These are counts recorded during the trial, not estimates of risk beyond the study participants.

The record also lists other adverse events: 2 among 7 participants in the vibration group and 1 among 6 in the no-vibration group. It does not provide descriptions of these events or indicate their severity, timing, or relationship to study procedures. No serious adverse-event terms are listed. The registry does not report a statistical comparison of adverse events between groups.

Zero observed serious events does not demonstrate that serious events are impossible or that the groups have identical safety profiles. The trial enrolled 13 participants, so the safety counts are limited observations. The registry record supports only a description of the events it lists; it does not support a broader safety conclusion.

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

The record describes a completed pilot trial comparing wrist vibration with no vibration during standardized CIMT. Its posted primary outcome is device-wearing time through 5-day study completion. Mean wear time is reported as 28.3 hours in the vibration group and 27.9 hours in the no-vibration group. The standard deviations are 0.3 hours and 1.0 hours, respectively. These figures describe the observed endpoint in the two groups.

They do not establish that vibration improved or worsened a clinical outcome. The primary measure concerns device use, not movement, function, or another clinical outcome. Although the project's long-term goal was to assess enhancement of CIMT outcomes, the registry lists no secondary outcomes. No comparative effect estimate, confidence interval, or hypothesis-test result is posted for the primary endpoint.

The trial's randomized design is relevant to the intended comparison, but randomization does not remove uncertainty, particularly in a pilot with enrollment of 13. The registry does not report enough detail to evaluate the allocation process, missing observations, analysis population, or inferential analysis. These are limits on what can be concluded from the posted results, not evidence that any particular design or analysis problem occurred.

The adverse-event record reports no serious adverse events or deaths in either group and lists other adverse events in both groups. Those counts are descriptive and do not establish comparative safety. Taken together, the results document device-wearing summaries and limited adverse-event counts in this pilot. They do not demonstrate clinical benefit, absence of benefit, equivalence between groups, or a definitive safety difference.

14. Why This Trial Matters Statistically

This trial is statistically instructive because its stated long-term objective and its posted primary endpoint address different questions. The project aims to assess whether sensory stimulation can enhance CIMT outcomes in children with cerebral palsy, while the primary measure records total hours of device wear. A feasibility measure can inform whether a study procedure was used, but it cannot substitute for a clinical outcome when the question concerns function or treatment benefit.

The record also illustrates the distinction between descriptive and inferential evidence. Arm means and standard deviations convey observed levels and variability, while a comparative estimate and confidence interval would address the size and precision of a group contrast. The registry does not post those inferential results. Without them, the group summaries should not be turned into a claim that vibration changes device use, much less a clinical outcome.

A small pilot can be useful for assessing procedures and generating information for later research, but limited enrollment also means that the posted summaries describe relatively few participants. The record's lack of a reported sample-size justification or analysis plan further constrains interpretation of how the study was designed to answer its questions. A planning illustration based on an observed effect, if considered, is not evidence of the trial's original power or an observed treatment effect.

Finally, reporting details matter. Information on missing data, analysis populations, measurement procedures, and who was masked would help readers assess potential sources of uncertainty. Their absence from the registry record does not invalidate the descriptive results, but it narrows the claims those results can support.

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.

This pilot enrolled 13 participants, with 7 in the vibration group and 6 in the no-vibration group. The limited enrollment means the arm summaries should be interpreted as describing this study rather than as precise population estimates. The registry does not post confidence intervals or a statistical comparison for the primary endpoint, so the uncertainty around any group contrast is not available.

The outcome is device-wearing time, a measure of feasibility, rather than a direct clinical outcome. The registry lists no secondary outcomes, despite describing a longer-term goal of assessing whether sensory stimulation enhances CIMT outcomes. As a result, the posted outcome does not answer that clinical-effectiveness question.

Several methodological details are not reported in the registry record: the method of random-sequence generation, allocation concealment, the identities of those included in quadruple masking, how device use was measured, the handling of missing observations, the analysis population, and the inferential analysis plan. The record also does not report the protocol's sample-size justification. These gaps limit assessment of bias, precision, and reproducibility, but do not establish that any specific flaw occurred.

The safety data consist of event counts without event descriptions or comparative analysis. The registry reports no serious adverse events and no deaths, but the small number of participants and absence of event details limit what can be inferred from those observations. The record is therefore best read as a limited feasibility report rather than a definitive assessment of clinical outcomes or safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Sensory Stimulation During CIMT — NCT03558230.
• Registry record last updated 2019-03-08; status last verified 2018-11.
• Results first posted 2019-03-08.
• 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

NCT03558230, titled Sensory Stimulation During CIMT, is a completed randomized parallel-group pilot sponsored by the Medical University of South Carolina. The registry lists cerebral palsy as the condition, enrollment of 13, quadruple masking, and a phase of not applicable. The start date is 2018-07-16, and primary completion is 2018-10-28.

The trial compared wrist vibration with no vibration during standardized CIMT. The primary feasibility outcome was total device-wearing hours through 5-day study completion, summarized by arm as a mean and standard deviation. The registry lists one outcome measure, no secondary outcomes, and zero analyses. It does not post an inferential comparison, confidence interval, or clinical outcome result.

Serious adverse events and deaths are listed as 0 in each group; other adverse events are listed as 2 in the vibration group and 1 in the no-vibration group. Event descriptions are not reported in the registry record.