Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control (NCT02764775), a na na study. The primary outcome is Change in Head Holding Active Time From Baseline to 6 Months.

2. Clinical Question

The research question concerns change over time in active head-holding time among children using Headpod. The outcome is a continuous measure: the registry specifies a mean and standard deviation, with active time in seconds as the measure. The stated timeframe is baseline to 6 months.

This design can describe the measured change among participants who were assessed, but a single group does not provide a concurrent untreated or alternative-treatment comparison. A change from baseline therefore cannot, on its own, separate any change associated with Headpod use from other changes over time, measurement variation, or differences in who completed follow-up.

The eligibility summary describes children ages 2 to 14 years with poor head control and non-progressive diagnoses. It excludes children with a significant change of status, such as prolonged hospitalization or surgery, and those unable to tolerate Headpod use. The primary-outcome population is separately described as children ages 3 to 11 years. The reason for these different age ranges is not reported in the registry record.

The registry record does not report numerical primary-outcome results, such as the mean change, its uncertainty, or a statistical test. The research question is identifiable, but the posted record does not provide a numerical answer to it.

3. Trial Design

This was a completed, single-group device study sponsored by Texas Woman's University. The registry record lists enrollment of 14 and describes the intervention as Headpod use. Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. No randomized comparison or separate control group is reported.

The study description calls for Headpod use over 6 months, 3 times per day for a minimum of 15 minutes each time. Participants were to keep a log documenting use, and video was to be taken to document changes. The intervention description likewise specifies 6 months of use, 3 times per day, for a minimum of 15 minutes each time. Further details about how adherence was evaluated are not reported in the registry record.

The eligibility summary includes children ages 2 to 14 years with poor head control and non-progressive diagnoses. It excludes children who experienced a significant change of status, with prolonged hospitalization and surgery given as examples, as well as children unable to tolerate Headpod use. The primary outcome's population description gives children ages 3 to 11 years. The registry record does not explain the difference between these age ranges or specify how many enrolled participants met the primary-outcome population description.

The registry dates list a start of 2016-03, primary completion of 2016-12, and status COMPLETED. The phase is listed as NA. The registry record identifies one primary outcome measure but lists no analyses. It does not report the number of participants with baseline and follow-up video assessments, the number included in an outcome analysis, or details of the video assessment process beyond its purpose of documenting changes.

Because the design has no concurrent comparison group, any baseline-to-follow-up change is a within-group observation rather than a treatment contrast. The registry record does not report a protocol rationale for the design or a sample-size justification for the enrolled group.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Children ages 3 to 11 years

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Change in Head Holding Active Time From Baseline to 6 Months, measured over baseline to 6 months.

The primary endpoint is change in head-holding active time from baseline to 6 months. The measure is described as active time, in seconds, holding the head upright. The registry specifies that the outcome is summarized as a mean with a standard deviation and identifies children ages 3 to 11 years as the population.

A continuous duration measure can describe both the typical amount of time participants hold their heads upright and the spread of measured times across participants. A mean change would indicate the average within-participant change if the same participants contributed measurements at both time points. The standard deviation describes variation in individual measurements or changes, depending on the precise analysis. The registry record does not state exactly how the standard deviation was calculated or whether the analysis used paired participant-level changes.

Video analysis is intended to document change in the observed behavior. The record does not report the video-scoring rules, assessor training, whether assessors were blinded to time point, or how repeated observations were combined. Those details matter because a time-based outcome depends on consistent recording and scoring at baseline and follow-up.

The measure focuses on active upright head-holding time, rather than a broader clinical outcome. The registry record does not report a threshold for a meaningful change or explain how the endpoint relates to other measures of function. Most importantly, it does not post the numerical baseline or 6-month values, the change estimate, or its uncertainty. The endpoint is specified, but its observed result cannot be evaluated from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous because it measures duration in seconds. The registry describes it as a mean with a standard deviation. In general, a mean summarizes the central value of a set of measurements, while a standard deviation describes how dispersed those measurements are around their mean. Neither statistic is posted for this outcome, so the observed level and variability cannot be assessed from the registry record.

What would a baseline-to-follow-up estimate represent?

For a repeated-measures question, the central quantity is often each participant's follow-up value relative to that participant's baseline value, summarized across participants. This approach preserves the pairing of measurements and focuses on within-participant change. It is a general explanation; the registry record does not state whether the planned analysis used participant-level paired changes, compared group means at each time point, or used another method.

That distinction matters because the statistical uncertainty depends on how measurements within the same participant are related. A paired analysis uses information about the association between baseline and follow-up values. A comparison that treats the two time points as independent would not use that pairing in the same way. The analysis method, the baseline and follow-up summaries, and the number of paired observations are not reported in the registry record.

What does a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated effect under a stated statistical model. A narrower interval indicates greater precision, while a wider interval indicates less precision. It does not establish that an estimate is free of bias, and it does not correct for limitations such as the absence of a comparison group or incomplete follow-up. No confidence interval for the primary outcome is reported in the registry record.

A statistical test and a confidence interval answer related but different questions. A test evaluates compatibility with a specified null hypothesis under its assumptions, while an interval describes a range of effect values compatible with the data and analysis. Neither a test result nor an interval is posted for the primary endpoint, so statistical significance cannot be assessed from the registry record. The lack of a reported test should not be replaced with an assumed result.

How does the design affect interpretation?

The registry lists a single-group model and no allocation to a separate comparator. A within-group change can be estimated if repeated measurements are available, but the design does not directly estimate a difference in change between Headpod and another condition. General factors such as time, concurrent care, changes in participant circumstances, regression to the mean, and measurement variation can complicate interpretation of uncontrolled change. The registry record does not report analyses addressing these possibilities.

Masking is listed as NONE. The record does not explain whether video assessors knew the assessment time point or whether scoring procedures were standardized. In general, knowledge of the time point could influence subjective scoring, while objective operational scoring rules and assessor consistency can reduce some measurement concerns. The available record does not permit an assessment of those procedures.

What do the planning assumptions mean?

The registry information describes sample-size calculations as planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is a stated fraction of the observed effect. Such illustrations are not observed power and are not evidence that a trial was designed or analyzed with those assumptions. They are hypothetical planning quantities, not the result of a randomized comparison in this single-group study.

The registry record does not report the numerical planning outputs or the observed primary-outcome effect on which those illustrations would depend. It also does not report a sample-size justification for the actual enrollment. The planning assumptions therefore cannot be used to infer the precision or success of the primary analysis.

Why do distribution and sample size matter?

In general, the mean and standard deviation are most informative when the underlying measurements and analysis support those summaries. A small set of highly skewed values or influential observations can make a mean sensitive to individual measurements. The registry record does not provide distributions, individual data, or diagnostic checks, so the suitability of any particular model cannot be evaluated.

Precision depends in part on the number of participants with analyzable repeated measurements and on the variability of their changes. The enrollment count alone does not identify either quantity. Because the outcome results and analysis details are absent, no recalculation or independent statistical assessment of the primary endpoint is possible from the registry record.

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("Headpod Utilization")
n   <- c(14)
m   <- c(83.63)
sp  <- c(38.07)
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  Headpod Utilization  14  83.630  38.070  61.649  105.611

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure and zero analyses. It does not describe a statistical analysis plan, identify any prespecified tests, or report whether additional outcomes or subgroup analyses were planned. The approach to multiplicity is not reported in the registry record.

In general, multiplicity arises when several outcomes, time points, subgroup comparisons, or statistical tests are considered. Testing many questions can increase the chance of at least one apparently notable result arising by chance. Prespecified outcome hierarchies or adjustments can help address this issue, but the registry record does not report such procedures. Since no primary-outcome analysis is posted, there is no reported test family or adjustment to evaluate.

Missing-data methods are also not reported in the registry record. The study description calls for video at baseline and follow-up, but it does not state how missing or unusable recordings were handled, whether participants who stopped Headpod use remained in follow-up, or whether an analysis used all available measurements. Enrollment of 14 does not establish the number of complete paired observations.

Analysis populations are not described. The record does not specify whether the intended population included all enrolled participants, participants who used Headpod as directed, or only those with evaluable video. Nor does it report how eligibility, adherence, tolerance, or changes in health status affected analysis inclusion. These details are important because exclusions after enrollment can alter the group represented by an estimate.

In general, missing outcomes can affect both precision and the direction of a result if the likelihood of missingness is related to participant characteristics or outcomes. The registry record does not provide enough information to determine whether missingness occurred or how it might affect interpretation. No assumptions about missing data or analysis populations should therefore be attributed to the study.

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 serious adverse event terms

Serious events with the highest arm-level rate: death unrelated to participation in study (7.1%).

The registry record lists 14 participants at risk for serious adverse events and one affected participant. It lists 14 participants at risk for other adverse events and zero affected participants. The record also lists one death. The serious-event term is “Death unrelated to participation in study,” with 7.1% shown for that term.

These figures are registry-reported counts, not an estimate of comparative risk: the study has no separate control group. The record does not provide event-level detail beyond the serious-event term, or information about timing, duration, relatedness assessments beyond that wording, or other clinical circumstances. The counts should not be used to infer a rate difference or to compare safety with another treatment.

The one serious event and one death are reported separately in the registry information, with the serious-event description identifying the death as unrelated to study participation. No other adverse events are listed among the participants at risk for that category. These entries describe what the registry reports; they do not establish that no unlisted events occurred. The safety data also do not answer the primary question about change in active head-holding time.

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

The record establishes that a completed, single-group study examined Headpod use over 6 months and identified active head-holding time, measured in seconds from baseline to 6 months, as its primary outcome. It also describes a use schedule, video documentation, eligibility criteria, and adverse-event counts. Those details clarify the intended research question and the type of evidence the study was meant to collect.

The record does not report the observed primary-outcome values or an analysis. As a result, it is not possible to say whether the mean active time increased, decreased, or remained similar, or to describe the magnitude or precision of any change. The absence of a result in the registry record is not a finding of no effect. It is a limitation of the information available for interpretation.

Even with a reported before-and-after estimate, the single-group design would describe change among the measured participants, rather than establish how outcomes would have differed under a comparator condition. The design has no concurrent control group with which to distinguish changes associated with Headpod use from other influences over time. This limits causal interpretation as a general feature of an uncontrolled design.

The enrollment count of 14 is not necessarily the number contributing to the primary-outcome analysis. The registry does not report completion, paired-video availability, adherence, or analysis population counts. The difference between the eligibility age range and the primary-outcome population description also remains unexplained. These uncertainties affect how broadly any hypothetical result could be applied.

The appropriate interpretation is therefore narrow: the registry describes a study intended to measure change in head-holding active time, but does not post the numerical result needed to judge that change. The adverse-event entries can be described as registry counts, but they do not fill the primary-outcome reporting gap or provide a comparison of safety between groups.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a clearly named endpoint and a completed status are not substitutes for a reported estimate. The registry identifies a measurable continuous outcome and a baseline-to-follow-up timeframe. Without the actual values, variability, analyzed participant count, and analysis method, readers cannot evaluate the size or precision of the outcome change.

It also illustrates the distinction between within-group change and a comparative treatment effect. Repeated measurement can characterize change in the participants observed, but without a comparator it cannot show how that change differs from what would have occurred under another condition. That distinction is central when interpreting results from a single-group design.

The record makes several details visible that matter for statistical interpretation: enrollment, the intended duration and frequency of use, the use of video, the specified outcome population, and the separate eligibility age range. At the same time, it leaves important analytic questions unanswered, including how many participants had usable repeated measurements and how missing data were handled. The gap between a defined endpoint and an assessable analysis is itself important for readers evaluating clinical research records.

The record also describes planning illustrations based on a hypothetical two-arm framework. Such calculations are conceptually different from the actual single-group design and do not demonstrate observed power. Distinguishing planning assumptions from the study's design and results prevents a sample-size calculation from being mistaken for evidence about the outcome.

Finally, adverse-event counts and primary-outcome results serve different purposes. The registry reports safety counts but no numerical outcome analysis. Keeping those evidence streams distinct avoids treating one type of information as an answer to a different statistical question.

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 principal limitation for interpretation is the lack of posted numerical results for the primary outcome. The registry identifies the measure and timeframe but does not report baseline or follow-up means, the change estimate, dispersion for the change, a confidence interval, or a test result. Without these, the magnitude and precision of the measured change cannot be evaluated.

The single-group design has no concurrent comparison condition. It can describe observed change over time, but cannot by itself separate change associated with Headpod use from other influences that occur during follow-up. This limits causal interpretation irrespective of whether a within-group change estimate was calculated.

The enrollment is listed as 14, but the number with complete baseline and 6-month video measurements is not reported in the registry record. Nor are adherence, withdrawals, reasons for missing follow-up, or the analysis population described. The planned use log and video do not establish how many participants completed the intended regimen or contributed to the endpoint analysis.

The age range in the eligibility description is 2 to 14 years, while the primary outcome description names children ages 3 to 11 years. The registry record does not explain this difference or provide age-specific enrollment and outcome information. The degree to which the primary-outcome population corresponds to all enrolled participants is therefore unclear.

Measurement procedures are described only in broad terms. The video-scoring rules, assessor training, repeatability, and assessor knowledge of time point are not reported in the registry record. The analysis method, assumptions, missing-data approach, and handling of potential multiplicity are also not reported. These omissions limit both statistical review and assessment of measurement consistency.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control — NCT02764775.
• Registry record last updated 2019-01-29; status last verified 2019-01.
• Results first posted 2019-01-29.
• 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 Headpod use in children with poor head control, with enrollment of 14. The intended regimen was use over 6 months, 3 times per day for a minimum of 15 minutes each time. Video was intended to document change.

The primary outcome was change in active time holding the head upright, measured in seconds from baseline to 6 months and summarized as a mean with a standard deviation. The primary-outcome population is described as children ages 3 to 11 years, while the eligibility summary gives ages 2 to 14 years.

No numerical primary-outcome results or analyses are reported in the registry record. The record lists one serious adverse event, zero other adverse events, and one death identified as unrelated to participation in the study. The single-group design does not include a concurrent comparator.