Examining the Effectiveness of My Scrivener on Handwriting Legibility: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Examining the Effectiveness of My Scrivener on Handwriting Legibility (NCT00693303), a na na study. The primary outcome is Evaluation Tool of Children's Handwriting.

2. Clinical Question

The underlying question concerns whether handwriting performance changes during training that incorporates the stylus. The study description says the device provided additional feedback and that this feedback was hypothesized to produce improvement. That is the study's rationale, not a reported finding. Because the design is single-group and no untreated or alternative-training group is described, any change over time cannot, from this record alone, be separated from changes that might occur for other reasons. The registry record also does not report enough detail to assess participant selection, adherence, or how the endpoint was analyzed.

3. Trial Design

The registry record lists this as a completed, single-group study with enrollment of 21. The condition is healthy children, and the intervention is categorized as behavioral. The record gives the study start as 2008-06 and primary completion as 2008-08. It lists phase and allocation as NA and masking as none. These entries describe the registry design fields; they do not provide a detailed account of recruitment, follow-up, or implementation.

The intervention is named Handwriting Training using My Scrivener. Its arm description says participants received 20 minutes of training per week, including writing letters and words with the My Scrivener device. The study summary describes handwriting training and says the stylus was intended to provide additional feedback. The record does not give the total number of training sessions, details of training beyond that description, or adherence information.

A single-group design can describe outcomes in the enrolled group over time, but it does not provide a concurrent control-group contrast. The registry record does not describe random assignment, and it does not identify a comparison arm. Consequently, the design information does not support a direct estimate of how outcomes would have differed under another intervention or no training.

The record lists one primary outcome measure and one analysis. It does not report the numerical outcome result, participant flow, analysis population, or a detailed statistical analysis plan. The status is completed, but that status alone does not establish which participants contributed data to the endpoint or how missing observations were handled. Those details are not reported in the registry record.

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 Evaluation Tool of Children's Handwriting, measured over 8 weeks from start of training.

The primary endpoint is the Evaluation Tool of Children's Handwriting, reported as a mean for percent of legible letters. The registry description says the criterion-referenced tool measures legibility and speed in grades one through six. Tasks include writing letters and words, writing numerals, near-point and far-point copying, writing to dictation, and composing a sentence. The listed timeframe is 8 weeks from the start of training.

A measure that samples several handwriting tasks can describe performance across more than a single writing activity. The registered endpoint focuses on legibility as a percentage of letters judged legible, while the instrument description also notes that the tool measures speed. The record does not report a separate speed result or explain how the different tasks contribute to the primary score. Scoring procedures, assessor training, and whether assessors knew participants' training status are not reported in the registry record.

In general, a continuous endpoint expressed as a mean describes the average score in the analyzed group; a standard deviation describes how dispersed individual scores are around that mean. The registry record identifies the endpoint's parameter as mean and its dispersion as standard deviation, but gives no numerical mean, standard deviation, baseline value, or follow-up value. The size and precision of any observed change therefore cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The endpoint is identified as a continuous measure summarized by a mean and standard deviation. General statistical concepts can clarify what those summaries would represent, but the registry record does not report their numerical values or the method used to analyze them.

What does a mean describe?

In general, a mean is the arithmetic average of the observed scores in the analysis group. For a handwriting endpoint expressed as percent of legible letters, it would describe the group's average measured legibility at the specified assessment. If measurements were available at more than one time, a difference between those means could describe change over time. The registry record does not give the scores needed to make that description or report a numerical change.

A mean can be informative, but it does not show whether participants had similar or widely varying scores. The standard deviation addresses that spread: in general, a larger standard deviation indicates more variation around the mean, while a smaller one indicates less. It is not a measure of uncertainty in the mean itself. The registry lists standard deviation as the endpoint's dispersion statistic but does not report its value.

How would uncertainty be assessed?

In general, a confidence interval gives a range of estimates compatible with the data under the method's assumptions. It can convey both the estimated effect and its precision. A narrow interval generally indicates greater precision than a wide interval, although the interpretation depends on the design and analysis. No confidence interval is reported in the registry record, so the precision of the primary result cannot be evaluated.

A significance test, when used, addresses compatibility between the data and a specified null hypothesis under a statistical model. A p-value is not the probability that a hypothesis is true, and it does not measure the size or practical importance of an effect. The registry record does not report a p-value or describe a test for the primary endpoint. It would therefore be inappropriate to claim statistical significance or nonsignificance.

What does the single-group design imply?

General interpretation of a single-group study separates description from causal attribution. A change in the participants' scores over time can be described if both measurements and the analysis are available. Without a concurrent comparison group, that change cannot by itself show what part is attributable to the training, the stylus, practice with the assessment, or other influences. This is a design limitation, not a judgment about whether a change occurred.

The registry lists the study as single-group and does not describe a control condition. Its allocation field is NA and masking is listed as none. The record does not explain how outcome assessment was conducted or whether the measure's scorers were aware of the training. Those details matter because knowledge of study participation or repeated exposure to a task can affect measurement in some settings, but their role cannot be assessed for this study from the registry record.

How should planning illustrations be understood?

General sample-size calculations use assumptions about the effect to detect, variability, significance level, allocation, and statistical model. The record describes planning illustrations based on fractions of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It specifies that participant counts are per arm for outcomes other than time-to-event outcomes. These are planning assumptions, not the study's own design justification. The record does not report the numerical illustrations or a sample-size justification for this trial.

Planning calculations do not show the probability that a completed study detected an effect. In particular, a calculation using an observed effect is not observed power, and a planning illustration does not repair the absence of a comparison arm. Since the numerical outcome is not reported, the effect on which such illustrations depend cannot be reviewed from the registry record.

For continuous outcomes, general analysis may use methods that compare means, but the appropriate method depends on the design, distribution, repeated-measure structure, and analysis plan. The registry record does not identify a statistical test, model, covariate adjustment, or method for repeated observations. No specific analytic procedure should be inferred from the endpoint's mean-and-standard-deviation format.

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("My Scrivener Training")
n   <- c(21)
m   <- c(96)
sp  <- c(6.9)
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  My Scrivener Training  21  96.000  6.900  92.859  99.141

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one outcome measure and one analysis. It does not report a detailed analysis plan, so it is not possible to determine whether other outcomes, time points, tasks, or analytic choices were considered. Nor does the record describe any multiplicity adjustment. With only the listed count, it would be unwarranted to conclude that no other analyses were performed or that multiplicity was not a concern.

In general, multiplicity arises when several hypotheses or comparisons are assessed; repeated testing can increase the chance of a result appearing notable by chance. The record does not describe a testing strategy or identify the number of comparisons underlying the analysis. Because no endpoint result or test statistic is reported, the impact of multiplicity cannot be evaluated.

Missing-data methods are also not reported in the registry record. The enrollment is listed as 21, but the record does not say how many participants completed the endpoint assessment, whether any observations were missing, or whether data were imputed or otherwise handled. Completion status refers to the study status and does not establish complete follow-up for every participant.

The analysis population is not described. The record does not say whether the analysis included all enrolled participants, only participants with observed outcome data, or another defined group. It also does not explain exclusions or deviations from the training schedule. These omissions limit assessment of potential bias and reproducibility. The posted information supports no claim about the direction or extent of any missing-data bias.

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 1% reporting threshold.

The registry lists one group, My Scrivener Training. For serious adverse events, the group has 21 participants at risk and 0 affected. For other adverse events, it also lists 21 at risk and 0 affected. No serious adverse event terms are listed. Deaths are not reported in the registry record.

These entries describe the counts recorded for the listed group; they do not establish that no adverse events of any kind occurred. The registry record does not provide further information about event collection, monitoring, reporting periods, or the definitions applied. It also does not give detail on events outside the categories and counts shown.

In general, a recorded count of zero means that no affected participants are listed in that category in the record. It does not prove that an event is impossible, and it does not establish the safety of an intervention. Here, the safety information should be read narrowly as the registry's reported serious and other adverse-event counts, not as a complete account of all experiences during the study.

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

This record documents a completed study of handwriting training that included the My Scrivener stylus, with a stated focus on change in handwriting performance. It identifies the primary measure, the population description, the training schedule, and the assessment timeframe. Those details show what the study set out to examine; they do not supply the result.

The primary outcome is described as mean percent of legible letters on the Evaluation Tool of Children's Handwriting at 8 weeks from the start of training. Yet the numerical outcome is not reported in the registry record. There is no basis in the posted information to state whether average legibility increased, decreased, or remained unchanged, or to quantify the precision of any estimate.

The study's single-group design also limits what a change could mean. In general, a before-and-after observation in one group does not provide a direct comparison with another condition. The record therefore does not establish that any observed change would be caused by the stylus, by handwriting training, or by a particular component of the intervention. The stated hypothesis about additional feedback should not be mistaken for a finding.

The result does not support a conclusion about effects in children outside the population described in the record. Participant characteristics beyond the broad description are not reported in the registry record. The information also does not establish how consistently training was completed or how the outcome was scored.

The narrow conclusion is that the registry records a completed single-group study and its intended handwriting-legibility measure, but does not report the endpoint result needed to judge observed change. The lack of a concurrent comparator further limits causal interpretation. These are limits on what can be concluded from the registry record, not evidence for or against an effect.

14. Why This Trial Matters Statistically

This study is statistically instructive because it brings together a clearly described continuous endpoint and a design with no listed concurrent comparator. The endpoint is expressed as mean percent of legible letters, with standard deviation identified as the measure of dispersion. Those summaries can be useful for describing a group's scores, but they cannot answer a causal question without an appropriate comparison and a reported result.

The distinction between a study's rationale and its evidence is especially important. The registry summary describes additional feedback from the stylus as a proposed reason for improvement. That statement gives context for the research question; it does not indicate that improvement was measured or observed. The primary result is not reported in the registry record, so even a descriptive estimate is unavailable.

The record also illustrates why endpoint definitions matter. The named instrument includes several types of writing and copying tasks, while the primary unit focuses on percent of legible letters. Understanding how a broad instrument yields its primary score would help readers interpret the construct being measured, but scoring details are not reported in the registry record.

Finally, registry design fields, enrollment, and completion status do not replace outcome reporting. Readers need numerical estimates, uncertainty, analysis methods, and information about missing observations to assess a result. Here, those details are not reported. The study is therefore useful as an example of how a defined question and endpoint can coexist with substantial limits on statistical interpretation when outcome estimates and analytic details are unavailable.

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 most consequential limitation for interpretation is that the primary endpoint result is not reported in the registry record. Without numerical scores or an estimated change, the direction, size, and precision of the finding cannot be assessed. The record also does not report a confidence interval or test result.

The design is listed as single-group, with no concurrent comparator described. Any change over time, if one were documented elsewhere, could not be interpreted as a controlled contrast on the basis of this record. The registry does not report random assignment, and allocation is listed as NA. Masking is listed as none, while details about outcome scoring and assessor awareness are not reported in the registry record.

Participant information is limited. The record lists healthy children and enrollment of 21, but further characteristics and participant flow are not reported. It is not possible to determine the number contributing endpoint data, whether observations were missing, or how missingness was handled. Adherence and the total amount of training completed are also not reported.

The endpoint description names a tool and its tasks, but does not explain the scoring process or how legibility and speed relate to the primary score. The record lists one outcome and one analysis but does not provide the analysis method, analysis population, or a detailed statistical plan. These gaps prevent a full assessment of reproducibility, precision, and potential analytic choices.

These limitations concern the information available in the registry record. They do not establish that the study lacked procedures or analyses that are not recorded there.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Examining the Effectiveness of My Scrivener on Handwriting Legibility — NCT00693303.
• Registry record last updated 2017-12-15; status last verified 2017-06.
• Results first posted 2009-08-25.
• 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

The registry record describes a completed single-group study of handwriting training using the My Scrivener stylus in healthy children. Enrollment is listed as 21, with 20 minutes of training per week that included writing letters and words using the device. The primary endpoint is mean percent of legible letters on the Evaluation Tool of Children's Handwriting, assessed at 8 weeks from the start of training.

The record lists one outcome measure and one analysis but does not report the endpoint result, its uncertainty, or the analysis method. No concurrent comparison group is described. The serious and other adverse-event entries each list 0 affected participants among 21 at risk; deaths are not reported in the registry record. The record supports a description of the study question and design, but not an estimate of handwriting change or a causal conclusion.