This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Movement-based Infant Intervention (NCT03082313), a na na study. The primary outcome is Movement Rate.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03082313 |
| Phase | NA |
| Condition | Infant Development, Infant,Premature, Infant, Very Low Birth Weight |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Southern California |
| Results posted | Yes |
2. Clinical Question
Population
The study population was all infants enrolled in the study, described as infants at risk for developmental delay. The registry lists conditions including prematurity, very low birth weight, and small for gestational age. Enrollment was 12. The record does not report further details about participant characteristics or eligibility criteria.
Intervention
The intervention was behavioral and aimed to promote infant movement experience from 3 months to sitting onset. Its stated goal was to increase the amount and type of leg movement above 1200 movements per hour of awake time. The record describes this goal but does not report whether participants reached it.
Comparator
There was no control group listed. The study model is single group, and allocation is listed as NA. The record therefore does not provide a like-for-like comparison between infants receiving the intervention and infants receiving a different intervention or usual care.
Primary question
The primary outcome was median leg movements per hour awake, measured using wearable sensors after the intervention. The registry does not report the numerical outcome result. As a result, the record cannot establish how the measured movement rate compared with the stated goal or how movement changed over time.
In statistical terms, this is a pilot assessment of a movement-focused intervention with a sensor-measured outcome, not a randomized effectiveness comparison. A single-group result can describe outcomes among enrolled participants, if reported, but it cannot by itself separate an intervention-associated change from changes that might occur over time or for other reasons. The registry record does not report an outcome estimate or an analysis that would answer even that descriptive question.
3. Trial Design
The registry identifies Movement-based Infant Intervention as a completed study sponsored by the University of Southern California. Its official title describes an intervention intended to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. The study status is COMPLETED. The record lists a start date of 2017-09-01 and a primary completion date of 2019-12-17.
The trial model is single group, with enrollment of 12. Allocation is listed as NA, and masking is listed as NONE. Phase is also listed as NA. The record does not describe a randomized allocation procedure, a control arm, or blinding. Its own design information indicates that the arms are not a like-for-like control comparison; in this study, the intervention arm is the only group listed.
The behavioral intervention promoted movement experience from 3 months to sitting onset. The stated goal was to increase both the amount and type of infant leg movement experience above 1200 movements per hour of awake time. This is a target described in the intervention information, not a reported outcome. The record does not report adherence, the intervention delivered to each participant, or whether participants attained that target.
The primary outcome is Movement Rate, defined as median leg movements per hour awake. It was assessed using wearable sensors after the intervention, whose duration ranged from 2-6 months. The population for the measure is all infants enrolled in the study. Although the record lists one outcome measure, it lists zero analyses, and the numerical outcome is not reported in the registry record. Consequently, the design and measurement plan can be described, but the intervention's observed movement-rate result cannot be assessed 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
| Stage | Movement Intervention |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: all infants enrolled in the 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.
| Characteristic | Unit | Movement Intervention |
|---|---|---|
| Participants analysed | 12 | |
| Age, Categorical: <=18 years | Participants | 12 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 4 |
| Sex: Female, Male: Male | Participants | 8 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 9 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 4 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 6 |
| Region of Enrollment: United States | participants | 12 |
| leg movement rate | average leg movements per hour awake | 1294 (506 to 2105) |
6. Primary Endpoint
The registry lists the primary outcome as Movement Rate, measured over post intervention (intervention duration ranged from 2-6 months).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | average leg movements per hour awake |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint, Movement Rate, is the median number of leg movements per hour of awake time, assessed with wearable sensors after the intervention. The registry defines the measurement for all infants enrolled. The intervention description gives a goal of movement experience above 1200 movements per hour awake; that target is not itself an observed endpoint result.
Movement rate is a behavioral measure that directly reflects the movement experience the intervention was intended to promote. Wearable sensors offer a way to record leg movements during awake time, rather than relying only on a general impression of activity. The awake-time denominator matters: movement opportunity and sleep are not the same, so the endpoint expresses movement relative to awake time.
The registry specifies a median and full range rather than a mean and a measure of standard deviation. In general, a median describes the middle of the observed values and is less affected by unusually high or low values than a mean. A full range describes the extent from the smallest to the largest recorded value, but does not show how values are distributed between those endpoints. Neither summary alone describes the measurement precision for the median.
The numerical median and full range are not reported in the registry record. Thus, the endpoint's definition is available, but its observed value and variability are not. It is not possible to judge from this record whether measured movement was near, below, or above the stated intervention goal.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the intervention, its intended movement target, and the planned primary measure. It does not give the numerical result for Movement Rate. That absence is central to interpretation: no observed median or full range is available to characterize leg movement among enrolled infants after the intervention.
The intervention goal was above 1200 movements per hour of awake time. This is a stated goal, not evidence that participants achieved it. Without a reported movement-rate result, the registry record cannot show how the observed values related to that target. It also cannot describe the spread of participant outcomes, despite specifying full range as the dispersion measure.
The study is single group and has no listed control comparison. Even if a pre- and post-intervention change had been reported, a single-group design would not establish that the intervention caused the change. General developmental change over time, differences in exposure, measurement variability, and other influences could also contribute. The record does not report a comparison group or a causal analysis to distinguish among such explanations.
The registry lists enrollment of 12, one outcome measure, and zero analyses. The enrollment figure describes the study record, not the number with an available primary outcome; the number with outcome data is not reported in the registry record. A lack of an analysis entry does not establish that no analysis was conducted outside the registry, but it means that the registry does not provide an analysis result for interpretation.
Precision cannot be assessed because there is no reported effect estimate, interval estimate, or other uncertainty summary for the primary outcome. In general, an interval estimate expresses the range of values compatible with the data under the method's assumptions; narrower intervals indicate greater statistical precision, while wider intervals indicate more uncertainty. No such interval is reported for this endpoint.
The posted registry information therefore supports a description of the study question and measurement approach, not a conclusion about the size or direction of the outcome. It also does not establish whether the intervention promoted neurodevelopmental outcomes: the listed primary outcome is movement rate, and no developmental outcome result is reported. These limitations are about what this registry record reports and should not be converted into a claim that the intervention did or did not have an effect.
9. Statistical Methods Explained
The registry specifies a median and full range for the primary outcome, but does not report the numerical result or an analysis. The statistical concepts below explain how those methods are generally interpreted; they are not claims about analyses conducted in this study.
What does a median describe?
In general, the median is the central value after observations are ordered. It is useful when data are skewed or include unusually large or small values, because extreme observations have less influence on it than they do on the mean. For an outcome such as movements per hour, the median can summarize a typical observed value without requiring the data to be symmetrically distributed.
A median does not reveal all features of the distribution. Different sets of observations can have the same median but differ in spread, clustering, or shape. The registry's choice to report a full range would add the lowest and highest observed values, but the range alone cannot show whether most observations lie close together or are widely dispersed. The actual median and range are not reported in the registry record.
What does a full range show?
In general, a full range identifies the extremes in the observed data. It is straightforward to interpret, but it can be sensitive to a single unusual measurement. It also does not convey how uncertain the median is. For that, an analysis would ordinarily need to report an uncertainty measure, with its method and assumptions. No uncertainty interval for Movement Rate is reported in the registry record.
Why does the study design matter?
A single-group study can describe what was measured in the enrolled group, provided the measurements and analysis are reported. It does not provide a concurrent control group to show what would have happened over the same period without the intervention. In general, this makes it difficult to attribute a change to the intervention rather than to time, maturation, differences in exposure, or other influences. The registry lists no randomized comparison and explicitly indicates that the arms are not a like-for-like control comparison.
Masking is listed as NONE. In general, masking can reduce the influence of expectations on some aspects of treatment delivery, assessment, or interpretation. Its relevance depends on the measurement and study procedures. The registry does not describe sensor processing, assessor procedures, or whether outcome data were reviewed without knowledge of intervention exposure, so those details are not reported in the registry record.
What can an effect estimate and interval tell a reader?
In general, an effect estimate gives the direction and size of a measured contrast or change, while a confidence interval communicates statistical uncertainty around that estimate under a specified model. An interval is not a guarantee that the true value lies within it; its interpretation depends on the method and assumptions used. Here, the registry gives neither an outcome estimate nor an interval, so neither magnitude nor precision can be evaluated.
There is also no reported pre-intervention value or change estimate. Therefore, the post-intervention endpoint definition cannot be treated as evidence of improvement or decline. The record does not report whether each infant contributed a sensor measurement, how repeated sensor observations were processed, or how missing measurements were handled.
What do the planning assumptions mean?
The registry includes generic sample-size planning assumptions based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It describes the effect to detect as a stated fraction of an observed effect. Such sample-size calculations are planning illustrations, not observed power and not outcomes of this single-group study. The registry does not report the observed effect used for those illustrations or numerical planning results. The two-arm assumption does not describe the listed single-group design.
Recalculated estimates, if available, would be unadjusted calculations from posted summary statistics and would not supersede a sponsor's own analysis when a discrepancy is identified. No outcome summaries or analyses are reported from which to assess a recalculation. General principles about estimation and planning should not be mistaken for evidence of an intervention effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, Movement Rate, and zero analyses. It does not report an analysis plan describing which outcomes or contrasts were designated primary for statistical testing, or whether any additional analyses were planned. The title and stated purpose mention neurodevelopmental outcomes, but the listed primary measure is movement rate. A result for a separate developmental endpoint is not reported in the registry record.
Multiplicity arises in general when several hypotheses or outcomes are tested: the chance of at least one apparently notable result can increase as more tests are considered. Statistical plans can address this by identifying a primary analysis in advance or by adjusting inference across tests. The registry record does not report a multiplicity strategy. With no analysis results reported, it is not possible to determine whether multiple testing was relevant to the analyses actually conducted.
The registry defines the primary outcome population as all infants enrolled, but does not report the number with usable sensor data or the analysis population. It does not describe missing outcome data, withdrawals, exclusions, or reasons that a measurement might be unavailable. Missing-data handling, including any assumptions or sensitivity analyses, is not reported in the registry record.
These omissions matter because the group included in an analysis can differ from the group initially enrolled, and missing measurements can affect both the estimate and its uncertainty. The record does not support a judgment about the extent or direction of any such effect. The defined population should therefore not be read as confirmation that outcome data were available for every enrolled infant.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Movement Intervention | 0 | 12 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Movement Intervention | 0 of 12 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Movement Intervention | 0 of 12 |
The registry lists a Movement Intervention group with 12 at risk for serious adverse events and 0 affected. It separately lists 12 at risk for other adverse events and 0 affected. Deaths are recorded as 0. No top serious-event terms are listed.
These are registry counts for the reported group and categories. They do not show how safety events were collected, how long participants were followed for safety, or what event definitions and reporting procedures were used. Those details are not reported in the registry record. The zero counts should therefore be read as no events recorded in these fields, not as proof that no events occurred or that the intervention has no safety risks.
Because the study has no listed control group, these counts do not permit a comparative estimate of adverse-event risk. The record also does not provide detail about the severity or nature of non-serious events; the other adverse-event count is 0. Safety interpretation should remain limited to the entries recorded in the registry.
12. What the Result Does, and Does Not, Mean
The record establishes what the study set out to evaluate: a behavioral intervention to promote movement experience in infants at risk for developmental delay, with leg movements per hour awake as the primary endpoint. It also describes a target above 1200 movements per hour awake and measurement using wearable sensors after the intervention. These details define the question and measurement, but do not provide the observed answer.
The primary outcome value, its full range, and a statistical analysis are not reported in the registry record. As a result, the posted information cannot show whether measured movement met the stated target, how much values varied, or how precisely any intervention-associated outcome was estimated. No conclusion about the size or direction of the primary outcome follows from the endpoint definition alone.
The study's single-group design also limits causal interpretation. Without a control group, an observed outcome, even if one were reported, would not by itself distinguish intervention effects from other changes over time or differences among participants. The registry does not provide a randomized comparison, an analysis of change, or another basis for attributing an outcome to the intervention.
The title and purpose refer to positive neurodevelopmental outcomes, but the listed primary measure is movement rate. A movement measure may be relevant to the intervention's focus, yet it is not interchangeable with a demonstrated developmental outcome. The record does not report a developmental result or a statistical relationship between movement rate and development.
The safety entries show 0 serious adverse events, 0 other adverse events, and 0 deaths recorded for the listed group. Those counts are limited to the registry fields and do not constitute a comparative safety assessment. Overall, this record is informative about the pilot's design and endpoint, but its lack of reported outcome results prevents conclusions about observed movement or neurodevelopment.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a clearly described research question and an interpretable outcome result. The registry identifies a population, behavioral intervention, stated movement target, sensor-based endpoint, and single-group design. Yet the numerical primary outcome and its analysis are not reported. A well-defined measure is necessary for interpretation, but definition alone cannot establish an observed result.
The study also illustrates why design determines the kinds of conclusions that data can support. A single-group pilot can be useful for describing the intervention context and collecting outcome measurements. Without a concurrent control comparison, however, it cannot isolate intervention effects from other explanations for an observed outcome. That distinction is especially important when an intervention is intended to influence development over time.
Reporting the median and full range would help readers understand the measured movement distribution, while an uncertainty estimate would help assess precision. The registry specifies these summary types but does not report their values. This makes transparent outcome reporting essential: readers need both the outcome estimate and enough information to understand variability, missing measurements, and the analysis population.
The study's importance statistically is therefore not that the registry demonstrates success or failure. Rather, it highlights how design, outcome reporting, and analysis reporting shape what can be concluded. The record supports describing the pilot's intent and measurement plan, while leaving the primary empirical question unanswered in the registry.
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 in the registry record is the absence of the numerical primary outcome. Although Movement Rate is defined as a median with a full range, neither summary is reported. There is also no analysis result or uncertainty estimate. Consequently, the endpoint cannot be interpreted for magnitude, spread, or precision.
The single-group design has no listed control arm, and the registry identifies the arms as not a like-for-like control comparison. This design cannot establish that any measured outcome was caused by the intervention. The record does not describe a baseline movement-rate measure or a reported change analysis.
Enrollment is listed as 12, but the number contributing sensor data is not reported in the registry record. Information about measurement availability, withdrawals, exclusions, adherence, and missing-data handling is also not reported. The outcome population is described as all infants enrolled, but this does not confirm that every enrolled infant had an analyzed outcome.
The intervention's stated movement goal is not an outcome finding. The registry also does not report a numerical developmental outcome, despite the intervention's neurodevelopmental aim. Finally, the safety entries lack detail about event definitions, ascertainment, and follow-up. These limitations restrict what can be learned from the registry record; they do not establish what occurred outside the information recorded there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Movement-based Infant Intervention — NCT03082313.
- Registry record last updated 2022-04-05; status last verified 2022-02.
- Results first posted 2022-04-05.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes a completed, single-group behavioral pilot sponsored by the University of Southern California, with enrollment of 12. The intervention promoted infant movement experience from 3 months to sitting onset, with a stated goal above 1200 movements per hour of awake time. The primary endpoint was median leg movements per hour awake, measured using wearable sensors after an intervention lasting 2-6 months.
No numerical primary outcome or analysis is reported in the registry record. Therefore, the measured movement rate, its variability, and its precision cannot be evaluated. The single-group design provides no like-for-like control comparison, limiting causal interpretation. The registry records 0 serious adverse events, 0 other adverse events, and 0 deaths for the listed group; further safety-collection details are not reported.