Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy (NCT06455930), a na na study. The primary outcome is Center of Pressure Sway Area, Standing.

2. Clinical Question

The broader research questions concern static balance, dynamic balance, and mobility function in children with cerebral palsy after use of the devices. The registry description also identifies a full biomechanical assessment, including kinematics, kinetics, muscle activity, and gait spatiotemporal characteristics. The primary endpoint is specifically the center of pressure sway area during standing; it is not a composite of all those assessments.

The before-and-after design can describe how measurements change over the intervention period in the enrolled group. It does not include a concurrent group assigned to another device, usual care, or no device. As a result, the clinical question is about observed within-group change, not a direct comparison of treatment strategies. Numerical pre-intervention and post-intervention values and a numerical estimate of change are not reported in the registry record, so the direction and size of any observed change cannot be established from the posted results.

3. Trial Design

This is a completed interventional study listed as a single-group study. Its title is “Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy,” and the official title describes the biomechanical changes underpinning these devices. The University of North Florida is listed as sponsor. The registry lists enrollment as 10 and the condition as cerebral palsy.

The study description concerns children ages 4-6 years old with cerebral palsy at GMFCS levels II and III. Participants received an individually adapted stand-on ride-on powered mobility device for home and community use over a three-month intervention period. Biomechanical assessments were planned before and after the intervention. The registry gives the primary outcome timeframe as pre-intervention, immediately before the intervention, and post-intervention, three months after the pre-intervention assessment.

The design is not randomized: allocation is listed as NA, and the study model is single group. Masking is listed as none. There is no parallel comparison arm in the record, so the before-and-after assessments are not a like-for-like comparison between separate groups. The phase is listed as NA.

The registry lists a study start date of 2024-06-01, a primary completion date of 2025-12-31, and status as completed. Completion status does not, by itself, provide outcome estimates or establish that every planned measurement was available for analysis. The number of participants completing each assessment, the analysis population, and the handling of any missing measurements are not reported in the registry record. A sample-size justification and the detailed statistical analysis plan are also 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.

Before assignment: Ten participants with cerebral palsy were enrolled in the study following eligibility screening. One participant did not return for post-intervention assessment, lost to follow-up.

Overall Study

Reasons for not completing this period:

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: Children with cerebral palsy received an individually adapted stand-on ride-on powered mobility device for home and community use over a three-month intervention period. Participants completed biomechanical assessments before and after the intervention.

6. Primary Endpoint

The registry lists the primary outcome as Center of Pressure Sway Area, Standing, measured over Pre (immediately before intervention), Post (3 months post Pre).

The primary endpoint is center of pressure sway area during quiet standing, measured in mm^2. It is described as the area of the 95% confidence ellipse derived from force plate measurements. In general, center of pressure describes the location of the net pressure applied to a support surface; its movement during standing is used to characterize postural sway. In this study's endpoint description, a larger sway area indicates greater postural sway and reduced standing balance stability.

The endpoint is relevant to the stated question about static balance because it quantifies the area covered by sway during a standing assessment. It is a biomechanical measurement rather than a direct report of everyday mobility or participation. The registry records absolute pre-intervention and post-intervention measurements, with the post assessment conducted three months after the pre assessment.

For participants completing multiple standing trials at an assessment, the participant-level median across trials was used. The group result was then defined as the median of those participant-level medians. This approach reduces the influence of unusually high or low trial values on the reported central summary. The registry identifies inter-quartile range as the dispersion measure, but numerical group medians and inter-quartile ranges are not reported in the registry record. The endpoint definition therefore explains what was intended to be measured, but does not show the measured results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a repeated assessment of one group: participants were assessed before the device intervention and again three months after the pre-intervention assessment. This is a within-group design. In general, a within-group comparison examines how measurements in the same study group differ across time. It can describe temporal change, but it does not provide the direct contrast that would come from a concurrent comparison group.

What does the median summarize?

The primary outcome is summarized using medians. A median is the central value after observations are ordered, and it is less affected by extreme observations than the arithmetic mean. The registry specifies two levels of summarizing: for participants with multiple standing trials at an assessment, the participant-level median across trials was used; the group value is the median across those participant-level medians. Thus the stated group summary is not a pooled median across every trial measurement.

The registry names inter-quartile range as the measure of dispersion. In general, the inter-quartile range describes the spread of the middle portion of a distribution, from its lower to its upper quartile. It gives context for how variable participant-level medians are around the group median. The registry does not report the numerical medians or inter-quartile ranges, so the actual central values and spread cannot be assessed.

What does the endpoint measure?

Center of pressure sway area is defined as the 95% confidence ellipse area from force plate measurements during quiet standing. In general, an ellipse area summarizes the spatial extent of measured sway. The confidence ellipse in this measurement definition is a geometric summary of force plate observations; it should not be confused with a confidence interval around a treatment effect. The registry explicitly states that larger sway areas indicate greater postural sway and reduced standing balance stability. This is the measure's stated interpretation, not a reported finding about the participants.

The assessment is a biomechanical measure of static balance. It is distinct from the listed secondary outcomes and from the wider set of assessments described in the study summary, including dynamic balance, mobility function, kinematics, kinetics, muscle activity, and gait spatiotemporal characteristics. The record does not provide numerical results for these other domains in the material describing outcomes.

What analysis was reported?

The registry lists 0 analyses. It does not report a statistical test, a model for the pre/post comparison, an adjustment strategy, a confidence interval for change, or a p-value. A median and inter-quartile range are named as descriptive summaries for the primary endpoint, but the record does not state how inferential comparisons were performed. It is therefore not possible to reconstruct or evaluate an inferential analysis from the registry record.

In general, a confidence interval for a change estimate would convey uncertainty about the magnitude of change, while a p-value would quantify the compatibility of data with a specified null model under the assumptions of a test. Neither measure substitutes for the estimated change itself, and neither can be interpreted without knowing the analysis method. Here, numerical estimates and inferential methods are not reported in the registry record.

How should the planning assumptions be read?

The registry describes a sample-size planning illustration based on the observed effect, rather than the trial's own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. Such illustrations are hypothetical planning calculations. They are not an observed trial outcome and do not represent observed power. The record does not report a sample-size justification for this single-group study or numerical planning results in the information describing the trial.

The planning description refers to two-arm equal allocation even though the registered study is single group. That distinction matters: planning calculations under a two-arm comparison do not describe the design actually registered. Any figures attached to such an illustration should be understood as planning quantities under its stated assumptions, not as a feature of the trial's observed design or results.

General statistical interpretation also depends on the distribution and completeness of the measurements. Medians and inter-quartile ranges provide a distribution-robust descriptive summary, but no dispersion values or participant-level data are reported. The record does not state whether measurements were missing, how missingness was handled, or whether any observations were excluded. These details cannot be inferred from the endpoint definition or completed study status.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome of Center of Pressure Sway Area, Standing and two secondary outcomes: Center of Pressure Sway Area, Sit-to-stand and Trunk-pelvis Coupling. It also describes broader assessments of static balance, dynamic balance, mobility function, kinematics, kinetics, muscle activity, and gait spatiotemporal characteristics. The number of outcome measures is listed as 3. The presence of several outcomes raises a general multiplicity question: when many outcomes are tested, the chance of at least one apparently unusual result can increase unless the analysis plan addresses that issue.

A multiplicity adjustment or a prespecified hierarchy of outcomes is not reported in the registry record. The record also does not state whether additional time points, subgroups, or outcome components were tested. Without a reported analysis plan and numerical results, it is not possible to determine how multiplicity was handled or how it affects interpretation.

Missing-data handling is not reported in the registry record. The enrollment entry is 10, but the record does not state the number with observed primary endpoint measurements at either assessment, the number completing the intervention, or how incomplete assessments were treated. It does not report whether an analysis included all enrolled participants or a subset. The analysis population is therefore not described.

These are reporting limitations, not evidence that data were missing or that a particular method was used. In general, the handling of missing measurements can affect a before-and-after estimate, especially if the availability of measurements is related to participants' outcomes. Because the record does not provide analysis-population details, the extent of that concern cannot be assessed for this study.

11. 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.

The registry's adverse-event entry lists 0 serious adverse events among 10 participants at risk in the intervention group. It also lists 0 other adverse events among 10 at risk and 0 deaths. No top serious adverse-event terms are listed.

These are the figures recorded for this study; they should be read as registry counts, not as proof that risk is absent. In general, a zero count in a study does not establish that an event could never occur, and the ability to characterize uncommon harms depends on the amount and duration of safety observation. The registry record does not describe the safety surveillance procedures or provide additional details about the period over which events were collected.

The record identifies a three-month intervention period, but it does not state whether adverse-event monitoring was limited to that period or included other follow-up. It also does not report event definitions or a more detailed account of ascertainment. The safety figures therefore describe the entries in the registry, while the context and completeness of adverse-event collection are not reported in the registry record.

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

The study addresses a biomechanical question about children with cerebral palsy using individually adapted stand-on ride-on power mobility devices. Its primary endpoint is a force-plate measure of center of pressure sway area during quiet standing, assessed before and after a three-month intervention period. The endpoint description explains how the measure is defined and how larger values are interpreted.

What the registry record does not provide is the numerical primary outcome result. There is no reported pre-intervention or post-intervention median, inter-quartile range, change estimate, confidence interval, or p-value. Numerical findings for the listed secondary outcomes are also not reported in the registry record. Thus the record does not support a conclusion about the direction or magnitude of observed change, or the precision of any change.

The design is single group, with no concurrent control group. In general, a pre/post difference in a single group can describe change across the study period, but it cannot by itself separate intervention-related change from other changes over time. This limitation is relevant even when numerical results are available; in this record, the absence of numerical estimates prevents even the descriptive change from being assessed.

The record lists enrollment as 10 and status as completed. Neither entry provides the number with complete outcome data or the analysis population. Completion status indicates the registry's status entry; it should not be taken as a substitute for reported estimates or a detailed analysis.

Accordingly, the result that can be described from the registry is the measurement plan and the stated direction of interpretation for the primary endpoint, not a demonstrated effect on balance or mobility. The record does not establish that the device improved, worsened, or had no effect on the measured outcomes. Those conclusions would require outcome data and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable for connecting a clinically framed question about balance and mobility with a defined biomechanical endpoint. Center of pressure sway area during quiet standing is described using a force plate, and the registry specifies the participant-level and group-level median summaries. Clear definitions of the measure and summary method help readers understand what an eventual reported estimate would represent.

The design also illustrates why the comparison structure matters. This is a single-group before-and-after study, not a randomized or concurrent-control comparison. If outcome estimates were reported, they could describe change over time among the assessed participants. The absence of a control group would still limit attribution of that change to the device alone. Statistical significance, even if reported, would not resolve that design limitation.

At present, the principal statistical issue is that numerical outcome findings and analysis details are not reported in the registry record. The record lists a primary outcome, secondary outcomes, an enrollment entry, and completed status, but not estimates of the outcomes. Without those estimates, readers cannot assess effect magnitude, variability, precision, or inferential evidence. This distinction between a defined endpoint and a reported result is important when interpreting trial registries.

The study also draws attention to reporting needs in small, specialized clinical investigations. Knowing who was analyzed, which assessments were available, how missing observations were handled, and what comparisons were prespecified would help readers evaluate the reliability and scope of findings. Those details are not reported in the registry record. This does not invalidate the study; it limits what can be concluded from its posted statistical information.

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 trial-specific limitation for statistical interpretation is the absence of numerical primary and secondary outcome results in the registry record. Although the primary endpoint and its summary method are defined, the pre-intervention and post-intervention medians, inter-quartile ranges, and an estimate of change are not reported. A reader therefore cannot determine the observed direction or magnitude of change, or its precision.

The study has a single-group before-and-after design, with allocation listed as NA and masking listed as none. There is no concurrent control group. As a general design consideration, observed changes over time cannot be attributed solely to the intervention from a single-group comparison. The registry's description of a three-month intervention and assessments before and after it establishes the timing, but does not resolve this limitation.

The registry lists enrollment as 10, but does not report the number of participants with complete primary endpoint data, the number completing assessments, or the analysis population. Missing-data methods and exclusions are not reported in the registry record. The record lists 0 analyses, and does not describe inferential methods, adjustment for multiple outcomes, or a statistical analysis plan.

The primary endpoint captures quiet-standing sway area. It is one biomechanical measure and does not, by itself, represent all aspects of dynamic balance, mobility function, daily device use, or participation. The study summary describes broader biomechanical assessments, but numerical results for those domains are not reported in the registry record. The safety entry likewise provides event counts without detailed information about ascertainment or observation procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Stand-on Ride-on Power Mobility Devices for Children With Cerebral Palsy — NCT06455930.
• Registry record last updated 2026-09-24; status last verified 2026-08.
• Results first posted 2026-08-28.
• 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.

18. Record Summary

The registry record describes a completed, single-group interventional study sponsored by the University of North Florida, with enrollment listed as 10. It concerns children ages 4-6 years old with cerebral palsy at GMFCS levels II and III, using individually adapted stand-on ride-on power mobility devices for home and community use over a three-month period.

The primary outcome is center of pressure sway area during quiet standing, measured before and three months after the pre-intervention assessment. The stated summary is the group median of participant-level medians, with inter-quartile range as dispersion. The registry lists two secondary outcomes and 3 outcome measures overall.

Numerical outcome estimates, inferential analyses, missing-data handling, and the analysis population are not reported in the registry record. The registry lists 0 analyses. Adverse-event entries are 0 serious adverse events, 0 other adverse events, and 0 deaths in the intervention group. The record's completed status does not supply the missing outcome estimates.