The Effects of Neurodevelopmental Therapy on Feeding and Swallowing.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Effects of Neurodevelopmental Therapy on Feeding and Swallowing. (NCT04403113), a randomized na study. The primary outcome is Gross Motor Function Classification System (GMFCS).

2. Clinical Question

3. Trial Design

The registry describes a randomized, triple-masked, parallel-group study that is now marked completed. It reports enrollment of 40 and dates the study start to 2018-04-30 and primary completion to 2019-05-31. The registry lists the phase as NA. The sponsor is Marmara University.

The groups differ in the addition of structured neck and trunk stabilization exercises. Both groups are described as receiving feeding and oral motor intervention strategies and caregiver training related to feeding. The Study Group also received the structured exercises; the Control Group did not. The registry reports 20 participants in each group. It does not describe the randomization sequence, allocation concealment, or the roles of the people who were masked. The meaning of triple masking for this study is therefore not reported in the registry record.

A parallel-group design assigns participants to a group and compares outcomes across the groups, rather than describing a planned sequence in which each participant receives both conditions. Randomization is intended, in general, to reduce systematic differences between groups at assignment. It does not guarantee that groups will be identical, especially in a study of this size; nor does the design description alone establish how allocation was carried out.

The registry lists seven outcome measures but reports zero analyses. Its primary outcome is a GMFCS classification assessed before intervention, in the first session, only one time. That timing is important: the listed primary measure is a baseline classification, not a reported change or post-intervention comparison. The registry does not report the intervention schedule, duration, follow-up procedures, or detailed operational methods for administering the interventions.

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 Gross Motor Function Classification System (GMFCS), measured over Immediately before the intervention, the evaluation was performed in the first session (only one time)..

The registered primary endpoint is the Gross Motor Function Classification System (GMFCS), recorded as a count of participants. The GMFCS is described in the registry as a five-level classification of gross motor function in children with cerebral palsy. Its levels reflect abilities ranging from unlimited walking at level I to severe limitations in head and trunk control, extensive use of assistive technology and physical assistance, and wheelchair use at level V. Higher levels indicate more severe limitations, while lower levels indicate better motor function.

A classification system can describe functional status in a standardized way. In general, a baseline classification may help characterize the participants and the functional range represented in a study. It does not, by itself, show whether an intervention changed function. The registry states that this assessment took place immediately before the intervention, at the first session, and only one time. It does not provide the distribution of participants across GMFCS levels, a later assessment, or a between-group comparison of change.

The study’s stated aim concerns feeding and swallowing activity, while its registered primary outcome is a gross motor classification. These are different measurement domains. The registry record does not explain how the primary measure was intended to address the feeding and swallowing aim, nor does it report results for the primary measure. Accordingly, the endpoint description supports an account of what was classified and when, but not a conclusion about effects on function, feeding, or swallowing.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The following statistical concepts are general explanations, not a description of methods confirmed for this study. The registry identifies the allocation as randomized, the masking as triple, and the model as parallel. It does not report the detailed statistical analysis plan or the methods used to analyze the outcomes.

What does randomization contribute?

In general, randomization uses an allocation process based on chance to assign participants to study groups. Its purpose is to reduce the risk that group assignment systematically favors participants with particular measured or unmeasured characteristics. Randomization does not ensure that groups will be alike in every respect, and it does not prevent problems such as incomplete outcome measurement or departures from assigned treatment. The registry does not report how the random sequence was generated, whether allocation was concealed, or how assignment was implemented.

The trial is described as parallel-group. In general, a parallel design compares groups assigned to different study conditions over the study period. The registered contrast is between a group receiving feeding and oral motor intervention strategies plus caregiver training and structured neck and trunk stabilization exercises, and a group receiving feeding and oral motor intervention strategies plus caregiver training. The record does not report enough detail to establish treatment adherence, differences in intervention delivery, or the timing and duration of exposure.

What does masking mean in this record?

The registry labels the study triple-masked. Masking is intended, in general, to limit the influence of knowledge about assignment on care, assessment, or interpretation. The label alone does not reveal which people were masked, whether masking was successful, or whether outcome assessors could infer group assignment. Those details are not reported in the registry record. The design label should therefore be reported as registered, without assuming which roles it covers.

How should the GMFCS outcome be understood?

The GMFCS is described as a five-level classification, with higher levels representing more severe gross motor limitations. A count of participants is a way to report how many people occupy each category, rather than a continuous measurement such as a length or time. Categories have an order, but the gaps between successive categories should not automatically be treated as equal. In general, analysis of an ordered categorical outcome should respect its category structure and should make clear whether it compares distributions, category probabilities, or another defined summary.

The registry says the GMFCS assessment was performed immediately before intervention and only one time. The record does not provide category counts or describe a repeated assessment. It therefore does not support an analysis of change over time. Nor does the count-based outcome description identify a statistical model or test. The analysis method, handling of the ordered categories, and any adjustment for baseline characteristics are not reported in the registry record.

What is needed to interpret an effect estimate?

In general, an effect estimate summarizes the contrast between groups for a defined outcome and time point. Its meaning depends on the outcome scale, the comparison being made, and the analysis population. An uncertainty interval conveys how imprecisely the effect is estimated; narrower intervals generally indicate greater precision under the model. A test result alone would not describe the magnitude or practical meaning of an effect. In this record, no primary effect estimate, confidence interval, or test result is reported, so these aspects cannot be evaluated.

The registry describes seven outcome measures and zero analyses. It does not identify which outcomes were treated as primary or secondary beyond the listed GMFCS primary outcome, explain how outcomes were scored, or state whether models were adjusted. It also does not report assumptions about data distributions, how repeated observations would be handled, or how the analysis would account for clustering or other dependencies. These are not details that can be inferred from the randomized, parallel design.

What do the planning illustrations represent?

In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability or event frequency, significance level, power, and allocation. The registry’s description says its planning illustrations use a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. It also distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event calculations. The record explicitly describes these as planning illustrations computed from an observed effect, not as the trial’s own design.

A planning illustration does not establish the actual power of a completed study. In particular, observed effects can be uncertain, and calculations based on them do not replace a prespecified design rationale. No sample-size justification for the trial itself is reported in the registry record. The record also does not report an interim analysis plan or the assumptions used for a trial-specific calculation. No planning value can be interpreted as a result of the randomized comparison.

Over-dispersion is a general concern when observed variation is greater than a model assumes. If a model assumes less variation than the data contain, its uncertainty estimates may be too small and tests may appear more decisive than warranted. This concept may matter for some count outcomes, but the registry does not report a fitted count model or any analysis of the primary outcome. It cannot be said that over-dispersion was assessed or that a particular model was used.

Finally, inference depends on how missing observations, protocol deviations, and analysis populations are handled. The registry does not report these methods. Without the analysis plan and outcome data, the statistical properties of the reported design cannot be assessed beyond the registry entries stated in the record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures and identifies GMFCS as the primary outcome, but reports zero analyses. It does not provide analyzed results for the primary outcome or the other listed measures. A multiplicity strategy—such as prioritizing outcomes, adjusting tests, or defining a hierarchical testing sequence—is not reported in the registry record.

Multiplicity matters in general when a study evaluates several outcomes or makes several statistical comparisons. When many tests are conducted, the chance of at least one apparently notable result can increase if no strategy accounts for the number of tests. This does not establish that the study conducted unreported tests; the record reports no analyses. It means that the approach to multiple outcomes and comparisons cannot be evaluated from this record.

The registry does not report how missing outcome data were handled, whether participants withdrew, or whether any outcome observations were unavailable. It also does not state the analysis population—for example, whether the intended analysis included participants according to randomized assignment, treatment received, or another rule. These are not details that can be inferred from the enrollment and group descriptions.

The record does not report a prespecified statistical analysis plan, rules for protocol deviations, an interim analysis plan, or a missing-data sensitivity analysis. These omissions limit assessment of how analyses would have been selected and how robust results might be to incomplete data. Since no outcome analysis is posted, there are no estimates for which the effects of multiplicity or missing data can be examined.

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 reports zero serious adverse events and zero other adverse events in the Study Group, with 20 participants at risk for each count. It reports the same counts and number at risk for the Control Group. Deaths are recorded as zero in each group. These are event counts as entered in the registry; they are not a statistical comparison between groups.

A zero count means that no events of the recorded type appear in these posted figures. It does not establish that risk is zero, that every event was detected, or that the groups have the same safety profile. In general, safety interpretation depends on event definitions, monitoring procedures, reporting completeness, and the duration of observation. The registry record does not report these details or a safety analysis method.

The record also does not report how adverse events were collected, whether events were actively solicited, or how severity and relatedness were assessed. The counts should therefore be read narrowly as the posted serious-event, other-event, and death figures, not as proof of absence of harm.

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

The record describes a randomized comparison of feeding and oral motor intervention strategies with caregiver training, with structured neck and trunk stabilization exercises added in the Study Group. It also describes a GMFCS assessment taken before intervention. These details establish the intended study contrast and the nature and timing of the registered primary measure.

They do not establish what happened to participants’ feeding, swallowing, or gross motor function after treatment. The registry reports zero analyses and does not give GMFCS category counts, post-intervention values, group contrasts, or uncertainty estimates. No conclusion about the direction, size, or precision of an intervention effect can be drawn from the posted outcome information. The absence of a reported result should not be interpreted as evidence of no effect or as evidence that the groups were equivalent.

The study aim focuses on feeding and swallowing activity, while the registered primary outcome is GMFCS. The record does not report a primary outcome result or analyzed findings for the listed outcomes. Consequently, it cannot establish whether the additional stabilization exercises changed feeding or swallowing activity, nor whether any observed difference, if one existed, was attributable to the exercises.

The safety counts are also limited in meaning. Zero recorded events in each group describe the figures in the registry, but do not establish that risk was absent or that monitoring captured every event. Information on definitions, observation time, and ascertainment is not reported.

Overall, the registry record supports a description of the study design, group interventions, baseline outcome timing, and posted adverse-event counts. It does not provide the analyzed clinical results needed to judge efficacy, precision, or comparative safety. Any stronger interpretation would go beyond what the registry record reports.

13. Why This Trial Matters Statistically

This trial is statistically notable for the distinction between the study’s stated clinical aim and its registered primary measure. The aim concerns feeding and swallowing activity, while the primary measure is GMFCS, a classification of gross motor function. The registry places that assessment immediately before intervention and describes it as occurring only one time. This makes endpoint timing central to interpretation: the registered primary measure characterizes baseline status, but the record does not report a post-intervention comparison.

The design also poses a clear contrast on paper. Feeding and oral motor strategies and caregiver training are described for both groups, while structured neck and trunk stabilization exercises are added for the Study Group. A comparison of analyzed outcomes could address the added contribution of those exercises, provided the outcome, timing, and analysis were defined appropriately. The registry does not report such an analysis, so the intended contrast should not be mistaken for an estimated effect.

For biostatisticians and clinical researchers, the record illustrates why design labels are not substitutes for analysis details. Randomized allocation and triple masking are reported, but the sequence-generation and masking procedures are not. The number of outcome measures is reported, but the record gives no multiplicity strategy, missing-data methods, or analysis population. These details matter when evaluating the credibility and scope of an estimate.

The record further distinguishes trial-specific design decisions from planning illustrations. The described sample-size illustrations are not the trial’s own design calculation and should not be read as observed power. No trial-specific sample-size justification or outcome analysis is reported. This prevents assessment of whether the completed study was designed around a prespecified clinically meaningful effect or whether its estimates would have been sufficiently precise.

Finally, the posted safety counts are all zero, but interpretation still depends on how events were defined and collected. Since those procedures are not reported, the counts are descriptive rather than a basis for comparative safety inference. Together, these features show how registry completeness and outcome timing shape what can responsibly be concluded from a trial record.

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 primary limitation for interpreting this study is that the registry record reports zero analyses and does not provide primary outcome values or effect estimates. The GMFCS measure was assessed before intervention, only one time, and no later assessment is reported. The record therefore does not show a change or between-group outcome comparison. It also does not report analyzed results for the feeding and swallowing outcomes named in the study aim.

The registry lists seven outcome measures but gives no results for them. It does not explain the multiplicity strategy, the missing-data approach, or the analysis population. The statistical analysis plan, model choice, adjustment procedures, and treatment of protocol deviations are not reported in the registry record. These omissions prevent evaluation of the analysis choices that would be needed to interpret an effect estimate.

Important design and implementation details are also absent. Although randomization and triple masking are registered, the method of sequence generation, allocation concealment, and masking roles are not described. The intervention schedule, duration, adherence, follow-up arrangements, and outcome-assessment procedures are not reported. Eligibility details beyond children with cerebral palsy are also not given in the record.

The safety figures do not resolve these uncertainties. The record reports zero serious and other adverse events and zero deaths in each group, but does not specify event definitions, ascertainment, or observation time. Thus, the counts are not sufficient to characterize comparative safety.

Finally, the stated primary measure is a baseline motor classification, whereas the study aim concerns feeding and swallowing. The record does not explain this relationship or provide outcome analyses that connect the two. These limitations concern what is reported in the registry; they do not establish that additional study information does not exist elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: The Effects of Neurodevelopmental Therapy on Feeding and Swallowing. — NCT04403113.
• Registry record last updated 2020-12-08; status last verified 2020-11.
• Results first posted 2020-12-08.
• 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.

18. Record Summary

The registry record describes NCT04403113, titled “The Effects of Neurodevelopmental Therapy on Feeding and Swallowing,” as a completed randomized, triple-masked, parallel-group study sponsored by Marmara University. It lists cerebral palsy as the condition, enrollment of 40, a start date of 2018-04-30, and primary completion on 2019-05-31. The phase is listed as NA.

The Study Group received feeding and oral motor intervention strategies, caregiver training related to feeding, and structured neck and trunk stabilization exercises. The Control Group received feeding and oral motor intervention strategies and caregiver training. The registry reports 20 participants in each group.

GMFCS is the primary outcome, assessed immediately before intervention in the first session, only one time. The registry lists seven outcome measures and zero analyses. It reports zero serious adverse events, zero other adverse events, and zero deaths in each group. Outcome results and further analysis details are not reported in the registry record.