Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy (NCT03858335), a randomized na study. The primary outcome is Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test.

2. Clinical Question

In statistical terms, the central comparison would concern whether the groups differed in change on the PMAL over the stated assessment period. The registry identifies the study as randomized, single-masked, and parallel-group, but does not explain how the random sequence was generated, who was masked, or how the PMAL components were combined for the primary score. Those details matter when judging the strength and meaning of a group comparison. The registry record also does not report a numerical estimate of the treatment contrast, its uncertainty, or a significance test. The research question is therefore clear in broad terms, while the posted record does not permit a quantitative answer about the observed difference.

3. Trial Design

The study is listed as a randomized, single-masked, parallel-group trial, with an enrollment of 32. It is marked completed. The registry lists Samsung Medical Center as the sponsor and identifies cerebral palsy spastic hemiplegic as the condition. The record gives a study start of 2015-09-14 and a primary completion date of 2019-09-28. These dates describe the registry entry and do not, by themselves, explain recruitment or follow-up procedures.

Participants assigned to the CIMT group were described as wearing a forearm splint on the unaffected arm for 24 hours for 3 weeks and receiving 15 mCIMT sessions, with a 30-hour dosage. The control group was described as receiving only traditional rehabilitation therapies and not wearing a splint. The record does not specify the content, frequency, or duration of the traditional rehabilitation therapies. It also does not describe whether other care was standardized across groups.

The primary outcome is change from baseline in PMAL score at post-test, with the timeframe stated as baseline and 4 weeks. Secondary outcomes include changes in Pediatric Evaluation of Disability Inventory, Peabody Developmental Motor Scales-2, Gross Motor Function Measure, and accelerometer measures of moderate to vigorous physical activity and use ratio. The registry record does not provide a complete schedule of assessments for these outcomes.

Although the design is identified as single-masked, the masked party or parties are not reported in the registry record. The randomization method, allocation concealment, eligibility criteria, treatment adherence, withdrawals, and analysis population are also not reported. The safety counts list 12 participants at risk in each group; those counts should not be taken as an account of how the enrollment of 32 was distributed or analyzed.

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 From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test, measured over baseline and 4 weeks.

The primary endpoint is change from baseline in the Pediatric Motor Activity Log score at post-test, with assessment described at baseline and 4 weeks. The PMAL is a parental assessment intended to measure use of the child’s affected upper extremity in everyday activities. Its description identifies 22 arm-hand tasks typical for children aged 7 months to 8 years, including taking off socks or shoes and holding a cup.

The registry describes two PMAL components: how often the child uses the affected arm-hand and how well the child uses it. Parents rate how often on a 6-point scale from 0, not at all, to 5, all the time. The how-well component uses a 6-point scale from 0, does not use, to 5, same as the unaffected arm. These ratings aim to capture everyday function as observed by parents, rather than performance on a single clinic task.

As general measurement context, a repeated assessment can describe whether reported function changes over time, while a comparison between randomized groups can help distinguish the groups’ average changes. The registry specifies a mean and standard deviation as the outcome summary format. It does not explain whether the two PMAL components are analyzed separately or combined into one score, nor does it report the observed scores, changes, or group contrast. The PMAL description cites test-retest reliability of r=0.94; P < 0.01, and internal consistency of Cronbach’s α=0.88 to 0.95. Those instrument characteristics are not trial outcome results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a randomized, single-masked, parallel-group design and describes a continuous primary outcome summarized by a mean and standard deviation. It does not report the trial’s detailed statistical analysis plan. The explanations below are general statistical context, not a description of analyses confirmed to have been used in this trial.

What randomization contributes

In general, random assignment is intended to make treatment groups comparable at the start of a study, including with respect to factors that are measured and factors that are not measured. It does not guarantee that groups will be identical, especially in a trial with a limited enrollment. It also does not prevent bias caused by departures from assigned treatment, missing outcome data, or differences in assessment. The registry record does not describe the random-sequence method or allocation concealment, so those features cannot be evaluated from the entry.

What a group contrast would represent

For a baseline and post-test measure, an analysis might compare each group’s change over time or compare post-test values while accounting for baseline values. These approaches answer related but not identical statistical questions and rely on different modeling choices. A between-group estimate would express the contrast on the PMAL scale. The record does not say which approach was prespecified or used, and it does not report a numerical estimate. It would therefore be misleading to imply that a particular model or adjustment was used.

As general context, a mean is an average value and a standard deviation describes the spread of individual observations around that average. The standard deviation is not the uncertainty of the estimated group mean. Uncertainty in a group contrast is commonly conveyed with a confidence interval, which gives a range of values compatible with the data and analysis assumptions at a stated confidence level. No confidence interval for the primary contrast is reported in the registry record.

Why the scale and components matter

The PMAL description includes ratings for how often and how well the affected arm-hand is used. Those are related but distinct aspects of reported function. A combined score, separate component scores, or a prespecified selection among measures could lead to different interpretations. The registry record explains the rating scales but does not report how the named primary PMAL score was constructed or whether the two components were evaluated separately. Its reference to instrument reliability describes measurement properties, not the precision of a treatment-effect estimate in this trial.

How to read significance tests

In general, a p-value is calculated relative to a statistical model and a null hypothesis. A small p-value can indicate that the observed data would be unusual under that model if the null hypothesis were true, but it does not measure the probability that a treatment is effective, nor does it quantify the size or importance of a difference. A confidence interval and the estimated contrast are needed to understand magnitude and uncertainty. The registry record does not report a primary-outcome p-value or confidence interval.

Sample-size planning and observed effects

The planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. They also state that the effect to detect is a specified fraction of the observed effect. Such calculations are conditional planning illustrations: they depend on the chosen effect and assumptions and are not observed power. They do not demonstrate that the study was adequately powered for its actual primary question. No numerical observed effect or planning count is reported in the registry record, so no such value can be interpreted from this entry.

As general context, planning calculations can help describe the enrollment that would be needed to detect a chosen effect under stated assumptions. If the estimated effect used as a starting point is imprecise, the resulting illustration inherits that uncertainty. Equal allocation and a normal approximation are assumptions of the calculation, not evidence about actual enrollment, adherence, or analysis. The registry record does not report the original sample-size justification or explain how the study’s enrollment target was selected.

What remains undocumented

The registry record does not describe model diagnostics, treatment of baseline values, handling of repeated observations, missing-data methods, or sensitivity analyses. For continuous outcomes, model assumptions may concern the distribution of residuals, the form of the relationship between variables, and the independence or correlation structure of observations. General methods should be matched to the design and measurement process; no particular method can be attributed to this trial without a report of its analysis.

The record also does not report whether the analysis followed randomized assignment, included only participants who completed treatment, or used another population definition. Those choices can affect interpretation. The registry lists no statistical analyses, and no numerical results are available to check against the stated outcome plan. The information supports describing the design and outcome definitions, but not reconstructing the trial’s analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary PMAL outcome and secondary measures covering disability, motor development, gross motor function, physical activity, and use ratio. Testing several outcomes can increase the chance of obtaining at least one apparently notable result by chance. As general statistical context, a trial can address this issue by prespecifying a hierarchy of outcomes, adjusting tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy or explain how the primary and secondary outcomes were prioritized in the analysis.

The primary outcome itself is described through how-often and how-well components, but the record does not state whether each component was analyzed separately, how they were combined, or which comparison was designated as primary for statistical testing. It also does not report results for the outcomes or an analysis plan. Thus, the multiplicity of tests actually performed cannot be assessed from this entry.

Missing-data procedures and analysis populations are not reported in the registry record. It does not state how many participants had primary outcome measurements at each assessment, how withdrawals were handled, or whether any imputation or sensitivity analysis was used. These details are important because complete-case results can be biased if outcome availability is related to participant characteristics or outcomes. This is a general concern, not evidence that missingness occurred in this trial.

The record does not identify an intention-to-treat, per-protocol, or other analysis population. Nor does it describe adherence to the splint and session regimen. Without those details and outcome results, the effect of missing observations, treatment adherence, and analysis choices cannot be evaluated.

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 safety record lists 12 participants at risk in the CIMT group and 12 in the control group. In each group, zero serious adverse events, zero other adverse events, and zero deaths are recorded. No serious adverse-event terms are listed.

These are counts, not estimates of comparative risk. They describe the events recorded for the listed participants at risk and do not show how safety events were defined, collected, or reviewed. The registry does not report the duration or completeness of safety surveillance, nor does it explain why the at-risk counts differ from the overall enrollment of 32. The counts should not be used to infer an unreported safety analysis population.

As general statistical context, observing no events does not establish that an event cannot occur. Rare events may not appear in a study, and the amount of information available depends on how many people were observed and for how long. The registry does not provide follow-up detail or a comparative safety estimate with uncertainty. The appropriate interpretation is limited to the posted counts: none of the listed participants at risk had a recorded serious adverse event, other adverse event, or death.

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

The registry record establishes that a randomized, parallel-group comparison of CIMT and traditional rehabilitation therapies was registered for young children with hemiplegic cerebral palsy. It describes a regimen involving a forearm splint and mCIMT sessions, and identifies change in PMAL score at post-test as the primary outcome. It also lists functional and activity-related secondary outcomes.

Those design details do not establish what the trial found. The registry record does not report numerical outcome values, a group contrast, or uncertainty around a treatment estimate. It is therefore not possible to state from this entry whether the observed PMAL scores differed between groups, in which direction any difference went, or how precisely it was estimated. The same limitation applies to the listed secondary outcomes.

As general statistical context, an estimate should be interpreted alongside its uncertainty, the outcome scale, and the analysis population. A statistically detectable difference is not automatically important to children or families, and an imprecise estimate may remain compatible with a range of effects. Conversely, a missing result in a registry record is not evidence of no difference. No conclusion about benefit, lack of benefit, or comparative clinical value follows from the absence of posted estimates.

The safety counts offer a narrow description of recorded events among the participants listed at risk. They do not resolve the outcome question or establish the absence of risk. The record does not provide enough detail to assess the completeness of surveillance or the precision of a comparative safety estimate.

The most defensible conclusion is about reporting: the record describes a trial design and outcome framework, but does not supply the numerical results needed to estimate effects. Readers seeking an effect estimate, its confidence interval, or details of the analysis would need a results report not contained in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a registered research question and a reported result are different things. The record specifies a randomized comparison, identifies the intervention and control conditions, and names an outcome focused on everyday use of the affected arm. These details allow the broad question to be understood. They do not replace the data summary and analysis needed to answer it quantitatively.

The endpoint also illustrates that outcome definition matters. The PMAL description separates frequency of use from how well the arm is used, with parental ratings on specified scales. Clear reporting of how those components form the primary score would help readers understand what a treatment contrast represents. That scoring detail is not reported in the registry record.

Several functional and activity-related outcomes are listed. When trials assess multiple outcomes, prespecified priorities and a multiplicity strategy help readers distinguish confirmatory questions from exploratory findings. The record does not describe such a strategy, and it contains no numerical outcome results from which to assess the pattern of findings.

Finally, the registry lists an enrollment of 32 while the safety counts identify 12 participants at risk in each group. These figures serve different registry fields, and the record does not explain their relationship. They should not be combined into a reconstructed analysis population. Clear reporting of participant flow, outcome availability, analysis populations, effect estimates, and uncertainty would be needed to evaluate the evidence more fully.

The statistical importance of the record lies in the boundary between design information and outcome evidence. A well-described comparison can frame a useful question, but only the reported analysis can show the observed contrast and its precision. Those numerical results are not reported in this entry.

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.

Several trial-specific details needed to assess internal validity are not reported in the registry record. Although the study is labeled randomized and single-masked, the sequence-generation method, allocation concealment, and identity of the masked party are not described. The record also does not give eligibility criteria, participant ages, recruitment details, or baseline characteristics. These omissions prevent assessment of how participants were selected and how similar the groups were at study entry.

The intervention description gives the splint schedule and mCIMT dosage, but details of treatment delivery, adherence, and fidelity are not reported. The control condition is described only as traditional rehabilitation therapies without a splint; the content and amount of that care are not specified. The registry also does not explain whether co-interventions were monitored or balanced.

Outcome reporting is a central limitation: numerical PMAL results, secondary outcome results, and analysis estimates are not reported. The record does not define the analysis population, describe missing-data handling, or report participant flow by assessment. It does not explain the scoring or aggregation of the two PMAL components, or state how multiple outcomes were handled statistically.

The safety record gives counts for participants at risk but does not describe surveillance duration or methods. The relationship between those counts and the overall enrollment is not explained. These limitations concern what can be evaluated from the registry entry; they do not establish that the trial lacked the relevant procedures or that any particular bias occurred.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy — NCT03858335.
• Registry record last updated 2020-07-28; status last verified 2020-07.
• Results first posted 2020-07-28.
• 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 identifies NCT03858335 as a completed, randomized, single-masked, parallel-group study sponsored by Samsung Medical Center. The recorded enrollment is 32, and the condition is cerebral palsy spastic hemiplegic. The study compares constraint-induced movement therapy with a control condition described as traditional rehabilitation therapies without splint use.

The CIMT description specifies a forearm splint on the unaffected arm for 24 hours for 3 weeks and 15 mCIMT sessions, described as a 30-hour dosage. The primary outcome is change from baseline in Pediatric Motor Activity Log score at post-test, with the timeframe stated as baseline and 4 weeks. Secondary outcomes address disability, motor development, gross motor function, physical activity, and use ratio.

The registry record does not report numerical outcome results, a primary comparison estimate, or its uncertainty. Safety counts list no serious adverse events, other adverse events, or deaths among 12 participants at risk in each group. Details of allocation, masking, missing data, analysis populations, and statistical methods are not reported.