Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy (NCT03870893), a randomized na study. The primary outcome is Change of Clinical Global Improvement(CGI).

2. Clinical Question

The trial asks whether hippotherapy is associated with changes in clinical global impression among children with cerebral palsy, and whether it affects physical activity, cardiopulmonary fitness, attention, and other listed measures. The registered primary outcome is change in Clinical Global Improvement score at 16weeks. The registry record does not report the observed primary outcome values or a between-group comparison, so it does not establish the direction or size of any difference.

The registered secondary outcomes include attention, physical activity measured as a percentage and as steps, peak oxygen uptake, gross motor function, resting heart rate, respiratory exchange ratio, and heart rate recovery. The brief summary also mentions general health and quality of life as interests of the research, but their results are not reported in the registry record. The intervention and comparison define the trial question; they do not, on their own, show whether an outcome changed or whether any difference was attributable to the intervention.

3. Trial Design

The registry describes a randomized, single-masked, parallel-group trial. Participants were assigned to an intervention group receiving hippotherapy or to a control group receiving no intervention. Enrollment was 47, and the study status is completed. The registry record names Samsung Medical Center as sponsor and lists the condition as cerebral palsy, along with physical activity and attention disorder.

Random allocation is intended to make the groups comparable, on average, with respect to factors that could affect outcomes. It does not guarantee that every characteristic is balanced in a particular trial. The record does not describe the randomization procedure, allocation concealment, or baseline characteristics, so those aspects cannot be assessed from the registered information. The term single-masked is recorded, but the identity of the masked party is not reported in the registry record.

The registry lists the start date as 2017-07-05 and primary completion date as 2020-02-28. It records the phase as NA. These registration details describe the study but do not provide evidence about the results. The intervention is identified as hippotherapy, but the treatment protocol, including its schedule and implementation, is not reported in the registry record. The control arm is described as having no intervention; whether participants in either group received other care is not reported in the registry record.

The primary outcome is described as change in Clinical Global Improvement score at 16weeks. The registry lists 19 outcome measures, including the primary outcome and secondary outcomes. It reports zero analyses. That listing does not establish that all outcomes were measured, analyzed, or reported in a particular way. The record does not report a participant flow, exclusions from analysis, or the number contributing data to each outcome. Consequently, the trial’s design can be described, but its comparative findings and the completeness of outcome reporting cannot be evaluated from this 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 Change of Clinical Global Improvement(CGI), measured over Change in baseline CGI at 16weeks.

The registered primary endpoint is change in Clinical Global Improvement score, described as a score on a scale and assessed at 16weeks. The endpoint description discusses two instruments: the Clinical Global Impression - Severity scale (CGI-S) and the Clinical Global Impression - Improvement scale (CGI-I). CGI-S asks a clinician to rate illness severity relative to experience with patients with the same diagnosis. Its listed ratings range from normal, not at all ill, to among the most extremely ill patients, and the description says lower values represent a better outcome. CGI-I asks the clinician to judge change relative to the baseline state. Its listed ratings range from very much improved to very much worse, and the description says higher values represent a better outcome.

A clinician-rated global measure can offer a broad assessment that is not limited to one physical test or activity measure. It may therefore complement specific measures such as steps, peak oxygen uptake, or gross motor function. This is a general explanation of why clinical global measures are used; the registry record does not report why this trial selected its primary endpoint.

The record’s wording leaves uncertainty about which scale and direction define the primary score: the outcome title refers to Clinical Global Improvement, while the timeframe says change in baseline CGI and the description includes both CGI-S and CGI-I, whose stated directions differ. The actual scoring procedure and observed values are not reported in the registry record. Without those details, a score change cannot be interpreted as improvement or worsening with confidence.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods determine how observations are converted into estimates and how uncertainty is assessed. The registry identifies a randomized parallel-group design and describes the primary measure as a mean with standard deviation. However, it does not report the statistical analysis plan, the methods used for the registered outcomes, or any analysis results. The following concepts are general explanations, not claims about methods used in this trial.

What a group comparison estimates

In a randomized parallel-group study, a treatment contrast can be estimated by comparing the outcome distributions in the assigned groups. For a continuous measure, a mean summarizes the center of observed scores, while a standard deviation describes their spread among participants. These summaries do not by themselves indicate the uncertainty in the difference between groups. The registry describes the primary parameter as a mean and its dispersion as a standard deviation, but it does not report the actual group means, standard deviations, or a contrast.

For a change outcome, interpretation depends on how change is defined. It may refer to a score at follow-up relative to baseline, but the exact calculation and analysis model need to be specified to know how baseline values enter the estimate. The record names change from baseline at 16weeks but does not report the calculation or model. It also does not report whether baseline and follow-up observations were both available for each participant.

What uncertainty measures mean

A confidence interval is a range of estimates compatible with the observed data under the analysis assumptions. Its width reflects precision: narrower intervals indicate greater precision, while wider intervals indicate greater uncertainty. A confidence interval can help readers assess both the direction and the range of plausible effect sizes. No confidence intervals are reported for this trial’s outcomes. A p-value, when used, measures how incompatible the observed data are with a specified null hypothesis under the test assumptions; it is not the probability that the null hypothesis is true and does not quantify the size or importance of an effect. No p-values are reported in the registry record.

Statistical significance and practical importance are different questions. A small estimated difference can be statistically distinguishable from zero yet have limited practical importance; an imprecise estimate may also leave meaningful effects unresolved. Interpretation generally considers the outcome’s scale, the clinical context, the estimate, and its uncertainty together. The registry does not report an effect estimate or a threshold for an important change, and the description’s ambiguity about CGI-S versus CGI-I further limits interpretation of any score direction.

Why outcome distributions matter

The primary outcome is described as a score on a scale, and the registry characterizes the outcome type as continuous with a mean summary. General statistical practice considers whether a mean and the analysis model adequately represent the observed measurements. If a measure has a limited set of ordered response categories, the spacing between categories may not carry the same meaning as for a continuous physical measurement. An analysis might account for that structure, but the registry does not report whether the trial did so. No particular model should be inferred from the outcome description alone.

Other outcomes also have different measurement properties. Steps and physical activity percentage, for example, are not interchangeable with a clinician-rated global score or a cardiopulmonary measure. General method selection depends on how each measure is recorded, its distribution, the estimand of interest, and the design. The registry lists secondary outcomes but does not specify their analysis methods or results.

Randomization and analysis populations

Randomization supports inference by balancing prognostic factors in expectation, but valid interpretation also depends on retaining the original assignment in the analysis or clearly describing any alternative. An intention-to-treat approach generally compares participants according to their randomized groups, regardless of adherence, while a per-protocol approach focuses on participants who met specified adherence criteria. These are general distinctions; the registry does not report which analysis population was used. It also does not report adherence, exclusions, or reasons for missing data.

Missing observations can affect estimates if the participants with observed outcomes differ systematically from those without them. General approaches include describing missingness, making explicit assumptions, and testing whether conclusions depend on those assumptions. The registry record does not report missing-data counts, reasons, or methods. It is therefore not possible to assess whether missingness could have influenced the outcomes.

Multiplicity and planning

When a trial assesses several outcomes or makes several comparisons, the chance of at least one false-positive finding can increase if each test is interpreted separately. General strategies include identifying a primary endpoint in advance, adjusting for multiple testing, or treating secondary outcomes as exploratory. The registry identifies a primary outcome and lists 19 outcome measures, but the analysis plan, multiplicity approach, and hierarchy among secondary outcomes are not reported. No conclusion about adjustment can be made.

Sample-size planning is distinct from observed results. A planning calculation depends on assumptions about the effect to detect, variability, significance level, power, allocation, and analysis method. Planning estimates do not establish the power actually achieved, and they cannot replace an outcome estimate or confidence interval. The registry record does not report the trial’s own sample-size justification. No numeric planning result is reported in the record’s outcome information, and no observed effect is available from which to interpret one.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and 19 outcome measures, with secondary outcomes spanning attention, physical activity, cardiopulmonary fitness, heart rate, and gross motor function. When many outcomes are tested, interpreting each result as an independent confirmatory test can increase the chance of a false-positive finding. General approaches include prespecifying a primary endpoint, defining a hierarchy for secondary outcomes, adjusting for multiple comparisons, or treating secondary findings as exploratory. The registry does not report a multiplicity strategy, the order of testing, or which outcomes were analyzed.

The record describes the primary endpoint as change in CGI at 16weeks, but it does not clarify whether the measure is CGI-S, CGI-I, or a specified combination. It also does not report an analysis plan that would establish how the endpoint was scored or compared. Without that information and the outcome estimates, the registered primary designation cannot be translated into a reported confirmatory result.

Missing-data methods and analysis populations are not reported in the registry record. The number enrolled does not reveal how many participants completed each assessment or contributed to each analysis. The adverse-event listing gives group-specific numbers at risk, but those entries do not substitute for an outcome-specific participant flow. The record does not give reasons for missing observations, exclusions, adherence information, or whether participants were analyzed according to randomized assignment.

These omissions matter because analyses can be sensitive to who is included and to assumptions about absent measurements. This is a general statistical concern, not evidence that missing data or selective analysis occurred in this trial. The registry record does not report whether sensitivity analyses were conducted, whether all prespecified outcomes were reported, or how missing outcomes were handled. With zero analyses listed, readers cannot evaluate the robustness of results or compare the reported findings with a prespecified statistical plan.

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 lists adverse-event information for the intervention and control groups. In each group, 23 participants are listed as at risk for serious adverse events and 23 as at risk for other adverse events. The record lists zero serious adverse events, zero other adverse events, and zero deaths in each group. No serious adverse-event terms are listed.

These entries describe what the registry reports, not proof that no events occurred outside the reporting process or that every possible event was captured. The record does not provide further details about event collection, definitions, follow-up, or whether participants had complete safety monitoring. It also does not describe event severity beyond the serious-versus-other categories or provide a comparative safety analysis.

Counts should be read in the context of the recorded groups and participants at risk. They do not establish that the groups had identical risks, and zero reported events do not establish absence of risk. The registry record provides no statistical comparison or uncertainty estimate for safety outcomes. These figures therefore support only a narrow statement: the posted record reports no serious adverse events, other adverse events, or deaths in either group.

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

The registry record is useful for understanding what the trial set out to compare: hippotherapy against no intervention in children with cerebral palsy, with a clinician-rated global outcome and several secondary measures. It also identifies a randomized, single-masked, parallel-group design and records the study as completed. Those details describe the research question and structure, not its findings.

The record does not report the primary outcome values, secondary outcome results, effect estimates, confidence intervals, or statistical tests. It therefore cannot show whether the groups differed, the size of any difference, or how precise an estimate might be. The listed zero analyses reinforce that no comparative result is available in the registry record. The study status and enrollment do not fill that gap.

The endpoint description also needs clarification before score direction can be interpreted. CGI-S and CGI-I are both described, but their stated directions differ: lower values are better for CGI-S, while higher values are better for CGI-I. The record does not identify unambiguously which scale constitutes the primary score. Without this and the outcome data, even a hypothetical score change cannot be characterized reliably as improvement or worsening.

More generally, a trial result would need to be considered alongside the analysis population, missing data, outcome measurement, uncertainty, and prespecified plan. Those details are not reported in the registry record. Nor does the record provide enough information to assess whether the intervention was delivered as intended or whether the groups received other care.

The appropriate conclusion is limited: a randomized trial of hippotherapy versus no intervention was registered and completed, with the listed outcomes and safety entries. The registry record does not report evidence establishing benefit, no effect, harm, or equivalence for the measured outcomes. This is an absence of posted results, not a result showing that an effect is absent.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it combines a randomized comparison with outcomes from several domains. A global clinician rating, physical activity measures, cardiopulmonary fitness measures, attention, and motor function address different aspects of health and function. Their inclusion raises a general question about how a study should distinguish a primary confirmatory question from secondary or exploratory questions. The registry names a primary outcome and lists 19 outcome measures, but does not report the analysis hierarchy or multiplicity approach.

The primary endpoint also illustrates why precise outcome definitions matter. CGI-S and CGI-I are both described, yet the record states opposite directions for better outcomes. Specifying the instrument, score construction, and intended direction is essential for interpreting a change estimate. Because the registry does not resolve this ambiguity and does not post results, readers cannot determine what a primary score change would represent.

The record also highlights the difference between trial completion and reporting of evidence. Enrollment and a completed status describe study conduct at a high level, while an effect estimate and its uncertainty are needed to understand comparative outcomes. Without analyses, confidence intervals, participant flow, or missing-data methods, readers cannot judge precision, robustness, or the potential influence of incomplete outcome data.

These are general statistical lessons rather than claims about how the trial was conducted. The registered design can frame the question, but it cannot substitute for transparent outcome reporting. The record’s available details identify what would need clarification for a rigorous assessment: the exact primary scale, analysis plan, outcome-specific analysis populations, handling of missing data, and results with measures of uncertainty.

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 of the registry record is that it does not report outcome results or analyses. There are no posted group-level primary or secondary outcome values, effect estimates, confidence intervals, or statistical tests. Consequently, neither the direction nor the precision of a comparative effect can be assessed.

The primary outcome definition is not fully clear. The registered title refers to Clinical Global Improvement, while the description explains both CGI-S and CGI-I. The timeframe refers to change in baseline CGI at 16weeks, but the record does not specify which scale was scored as the primary outcome. Because the description assigns different favorable directions to the two scales, the ambiguity prevents a clear interpretation of the intended score change.

Important design and analysis details are also not reported in the registry record. These include eligibility criteria, participant characteristics, the randomization and allocation-concealment procedures, the identity of the masked party, intervention delivery and adherence, other care received, and the statistical analysis plan. The record does not describe participant flow, outcome-specific analysis counts, exclusions, missingness, or analysis populations. It also does not report a multiplicity strategy despite listing 19 outcome measures.

The safety entries list zero events in each group, but the record does not describe event ascertainment or follow-up completeness. The control group is described as receiving no intervention, without further information about care. These limitations restrict assessment of trial conduct and interpretation; they do not establish that a particular bias or problem occurred. The registry record supports description of the registered design, but not a complete appraisal of its comparative findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy — NCT03870893.
• Registry record last updated 2020-08-05; status last verified 2020-07.
• Results first posted 2020-08-05.
• 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

NCT03870893 is a completed randomized, single-masked, parallel-group trial sponsored by Samsung Medical Center. It enrolled 47 participants and compared hippotherapy with no intervention in children with cerebral palsy. The registered primary outcome is change in Clinical Global Improvement score at 16weeks. The record lists 19 outcome measures, including secondary measures of attention, physical activity, fitness, heart rate, and gross motor function.

The endpoint description includes both CGI-S and CGI-I but does not clearly identify which defines the primary score. Outcome values, comparative analyses, confidence intervals, statistical tests, missing-data methods, analysis populations, and the trial’s own sample-size justification are not reported in the registry record. The record lists zero analyses. It reports zero serious adverse events, zero other adverse events, and zero deaths in each group, with 23 participants at risk in each group. The available record therefore describes the trial design and registered measures but does not provide comparative efficacy results.