PRIORITI-MTF Study- Testing Patient Response to the IDEO: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PRIORITI-MTF Study- Testing Patient Response to the IDEO (NCT02158884), a na na study. The primary outcome is Four Square Step Test.

2. Clinical Question

3. Trial Design

PRIORITI-MTF is recorded as a completed, single-group study sponsored by the Major Extremity Trauma Research Consortium. Its enrollment was 91. The registry lists the study start as 2014-06 and primary completion as 2017-08-31. It describes the study as concerning leg injuries and trauma and identifies the IDEO brace as the intervention.

The brief summary frames the intervention more broadly: an IDEO brace used with Return to Run physical therapy. It says the initiative was designed to support broader use in military treatment facilities beyond the center where the program was developed. The intervention listing itself names the brace; further details about how the rehabilitation program was delivered are not reported in the registry record.

The study is designated single-group, allocation NA, and masking NONE. These entries describe a study without a listed randomized allocation or masked assessment. A concurrent control group is not reported in the registry record, so the design does not provide a like-for-like comparison with participants receiving another intervention or no intervention.

In the primary-measure population description, 91 people consented at 3 military treatment facilities and received an IDEO; 87 had complete baseline assessments and were included in the analysis. The record does not explain the status of participants without complete baseline assessments or describe a participant flow beyond those statements.

The registry lists 30 outcome measures and 0 analyses. The primary outcome is the Four Square Step Test at baseline. Follow-up schedules, treatment duration, eligibility criteria, and the detailed statistical analysis plan are not reported in the registry record. Consequently, the design information establishes who entered the study and what baseline measure was recorded, but does not establish a reported post-intervention analysis.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. This is not a randomized study, all consented participants were provided with an IDEO brace and the Return to Run Physical Therapy program. Participants who completed the PT program are included in each follow up period. Missing a follow up does not exclude the participant from the next follow up.

Baseline Assessment

Reasons for not completing this period:

Intervention: IDEO and PT Program

Reasons for not completing this period:

Post Intervention (~4 Weeks)

Reasons for not completing this period:

6 Month Assessment

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: 91 consented at 3 military treatment facilities and received an IDEO. 87 had complete baseline assessments and were included in analysis.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: 87 participants completed baseline assessments; 6 did not complete any of the RTR PT program and were excluded from analysis.

6. Primary Endpoint

The registry lists the primary outcome as Four Square Step Test, measured over Baseline.

The Four Square Step Test is an objective measure of agility. The registry records the outcome in seconds and states that lower values represent better outcomes. It describes the measure as having a range greater than zero to positive infinity. The measure is part of a broader “change in functional performance” composite, which the description says is calculated using the mean of participant scores across objective performance measures of agility, strength and power, speed, and postural stability.

Agility is relevant to the study’s stated interest in physical function. A timed task can provide a numerical description of performance, while the direction of interpretation is important: lower recorded times correspond to better performance for this measure. That direction should not be confused with evidence of improvement; an outcome value or change estimate is needed to describe what happened after intervention.

The primary outcome timeframe in the registry is baseline. The record does not report a later Four Square Step Test result, a change from baseline, or a composite result. It also does not report how any composite would be analyzed. Thus the endpoint description explains what was intended to be measured and how its values are oriented, but it does not provide an outcome finding.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a baseline mean describe?

For a continuous measure, a mean describes the average observed value in a group. A standard deviation describes how spread out individual values are around that mean. These are different quantities: a mean gives a measure of central location, while a standard deviation gives information about variability among participants. The registry identifies the primary outcome as a mean with standard deviation, but does not report either statistic for the Four Square Step Test.

For this test, the measurement unit is seconds and lower values are described as better. A mean would therefore summarize average completion time, while the standard deviation would help describe how much participants’ times varied. Neither statistic alone would measure a treatment effect. To assess change, a relevant post-intervention value or a change estimate would also be needed. Those results are not reported in the registry record.

What would a confidence interval add?

General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity. Its width reflects how precisely the estimate is determined under the analysis assumptions. A narrow interval indicates greater precision than a wide interval, while both the estimate and interval endpoints are needed to judge the range of values consistent with the data and method. The registry record does not report a confidence interval for the primary outcome.

A p-value, if reported, would address how compatible the observed data are with a specified statistical null model. It does not measure the size or practical importance of an effect, and it cannot replace an estimate with an interval. No primary-outcome p-value is reported. Since the design is single-group and the outcome timeframe is baseline, a p-value cannot be inferred from the information in the record.

Why does the design affect the analysis?

General statistical explanation: a randomized comparison can estimate a difference between assigned groups while supporting a causal interpretation under the design and analysis assumptions. A single-group study instead observes outcomes within participants receiving the intervention. A before-and-after analysis, if available, could quantify within-group change, but it would not by itself establish what would have happened over the same period without the intervention.

Here, no comparator is listed and no post-intervention primary measure is reported. As a result, neither a between-group treatment contrast nor a within-group change can be reconstructed from the registry record. A baseline mean, even if reported, would describe starting status rather than response to the program.

How should the composite description be understood?

The registry says the Four Square Step Test is part of a “change in functional performance” composite involving several objective performance measures. A composite can combine information from multiple measures into a broader summary, but interpretation depends on its components, scoring, and analysis definition. The record describes the component domains and says the composite uses the mean of participant scores across measures. Further details about standardization, weighting, handling of incomplete component data, and the composite’s analysis are not reported in the registry record. No composite result is reported.

What is over-dispersion?

General statistical explanation: over-dispersion arises when the observed variability in data exceeds what a chosen statistical model assumes. If ignored, uncertainty estimates can be too small, which can make confidence intervals overly narrow and p-values misleading. The registry identifies a continuous outcome summarized with a mean and standard deviation; it does not report an over-dispersion assessment or a model for the primary endpoint. No conclusion about over-dispersion can be drawn from the record.

What does a planning sample size mean?

General statistical explanation: a sample-size calculation is a planning exercise based on assumptions about the target effect, variability, significance level, allocation, and analysis. It is not an observed treatment result, and it is not observed power. The record describes a planning illustration based on a fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. It distinguishes participants per arm for most outcomes from total events for time-to-event outcomes. The numerical planning outputs and the underlying effect estimates are not reported in the registry record. Because this study is recorded as single-group, such a two-arm illustration should not be mistaken for the study’s actual allocation or an observed comparison.

Overall, the registry gives enough information to explain the endpoint’s scale and direction and to identify the study’s single-group structure. It does not give the outcome data or analysis details required to evaluate an estimated functional change, its uncertainty, or its statistical significance.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("IDEO Brace")
n   <- c(87)
m   <- c(8)
sp  <- c(2.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  IDEO Brace  87  8.000  2.900  7.382  8.618

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 30 outcome measures, while the primary measure is the Four Square Step Test at baseline. When a study assesses multiple outcomes, multiplicity can arise if several statistical tests are performed and interpreted together. General statistical explanation: the more tests that are considered, the greater the chance that at least one result may appear notable by chance under a set of null hypotheses. Prespecified priorities and suitable adjustment methods can help readers understand how multiple outcomes were handled.

The record does not describe a multiplicity strategy, a hierarchy of outcomes, or the statistical analysis for the 30 measures. It lists 0 analyses. Whether additional outcomes were analyzed, and how any such analyses were selected or reported, is not reported in the registry record. Without that information, the primary measure’s place among the other outcomes cannot be evaluated beyond its registry designation.

The primary measure’s analysis population is described as 87 participants with complete baseline assessments, among 91 who consented and received an IDEO. The reason for incomplete baseline assessments, any imputation, and the handling of missing data for other measures are not reported in the registry record. It is also not reported whether all enrolled participants were intended for each analysis or whether a separate analysis population was prespecified.

Missingness can affect interpretation if the participants with observed data differ from those without data. General statistical explanation: complete-case results describe those with the required measurements, and may not represent the full enrolled group when missingness is related to participant characteristics or outcomes. The registry does not provide information to assess that possibility. Since no post-intervention primary result is reported, there is no reported missing-data strategy for a change analysis to evaluate.

12. 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 an IDEO Brace group with 81 participants at risk for serious adverse events and 0 affected. It also lists 81 at risk for other adverse events and 0 affected, and reports 0 deaths. These are the adverse-event figures recorded for this group.

A count of 0 affected means no events are recorded in the corresponding category for the stated group and risk population. It does not, by itself, establish that an event could not occur or that the intervention has no safety risks. The record does not state a safety follow-up timeframe or describe how adverse events were collected and classified.

The safety population listed as at risk is not the same as the 91 participants who consented and received an IDEO or the 87 with complete baseline assessments included in the primary analysis. The reason for the different safety count is not reported in the registry record. The record does not list serious adverse-event terms. These figures should therefore be read as the counts recorded for the stated risk group, not as a complete account of safety beyond the information entered in the registry.

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

The registry establishes that PRIORITI-MTF was a completed single-group study involving an IDEO brace, with a stated broader objective of evaluating an integrated orthotic and rehabilitation initiative. It identifies the Four Square Step Test as the primary measure, explains that it is measured in seconds, and states that lower times represent better outcomes. It also documents that 87 participants had complete baseline assessments and were included in the primary analysis population.

Those details do not establish whether participants’ function changed after the program. The primary measure is listed at baseline, and no later result, change estimate, or statistical uncertainty is reported in the registry record. The study objective and the endpoint’s intended relevance cannot substitute for observed outcome data.

The design also constrains what conclusions could be drawn from a change result, even if one were available. A single-group study without a listed comparator can describe outcomes in participants who received the intervention, but does not supply a randomized comparison against another group. A within-group change would not, on its own, distinguish the program’s effect from other influences over time.

The record’s safety counts are limited to the stated risk group and adverse-event categories. They should not be generalized beyond that recorded information, particularly because the safety follow-up period and the reason for the risk population size are not reported.

Accordingly, the registry supports a description of the study population, intervention framing, design, and baseline functional measure. It does not support a conclusion about the direction, magnitude, or precision of a post-intervention effect, or a comparative treatment effect. Absence of a reported outcome is not evidence that there was no change.

14. Why This Trial Matters Statistically

This study illustrates why a clearly defined endpoint and a reported endpoint result are both needed for statistical interpretation. The registry describes a functional performance measure, its unit, and the direction in which better performance is represented. Those details help establish what a future estimate would mean. Without the outcome values or an estimated change, however, there is no basis for quantifying response or its uncertainty.

The single-group design is also central to interpretation. The study’s objective concerns an integrated brace and rehabilitation initiative, but the registry lists no comparator. This distinction matters because an observed change within a group and a difference between groups answer different questions. The first describes change over time among observed participants; the second can compare outcomes across groups. The registry record reports neither a post-intervention change nor a comparative estimate.

The participant counts show why analysis populations should be stated explicitly. The study records 91 people who consented and received an IDEO, 87 with complete baseline assessments included in the primary analysis population, and 81 at risk in the safety record. These figures refer to different recorded populations and should not be treated as interchangeable. The reasons for the differences are not reported.

Finally, the registry lists multiple outcome measures but no analyses. Without a reported analysis plan or results, readers cannot assess how outcomes were prioritized, how missing data were handled, or how multiplicity was considered. These are not merely reporting details: they affect what can be inferred from a study and how precisely its findings can be interpreted. The record is therefore informative about study structure, but limited as evidence about outcome change.

15. 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 principal limitation for statistical interpretation is that the registry identifies the primary outcome at baseline but does not report its numerical result or a post-intervention assessment. No mean, standard deviation, change estimate, confidence interval, or p-value is reported for this endpoint. The magnitude and precision of functional change therefore cannot be assessed from the registry record.

The study is listed as single-group, with allocation NA and masking NONE. No comparator is described, so the record does not support a randomized between-group estimate. The brief summary describes a brace used with Return to Run physical therapy, while the intervention listing names the IDEO brace; details about delivery, adherence, and the rehabilitation regimen are not reported in the registry record.

The record states that 91 participants consented at 3 military treatment facilities and received an IDEO, and that 87 had complete baseline assessments and were included in the primary analysis. It does not explain why baseline assessments were incomplete for some participants. Safety figures are reported for 81 participants at risk, but the reason for that population size and the safety follow-up period are not reported.

Although 30 outcome measures are listed, the registry lists 0 analyses. The statistical plan, multiplicity handling, missing-data methods, outcome timing beyond the primary baseline entry, and analysis populations for other outcomes are not reported in the registry record. The composite’s detailed scoring and analysis are also not described. These reporting gaps limit assessment of both the intended analytic approach and any outcome claims.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: PRIORITI-MTF Study- Testing Patient Response to the IDEO — NCT02158884.
• Registry record last updated 2026-07-02; status last verified 2016-12.
• Results first posted 2019-10-14.
• 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.

19. Record Summary

PRIORITI-MTF is recorded as a completed, single-group study sponsored by the Major Extremity Trauma Research Consortium. Enrollment was 91, and the study concerned leg injuries and trauma. The intervention listing names the IDEO brace; the brief summary describes the broader objective as evaluating the brace with the Return to Run physical therapy regimen.

The primary measure is the Four Square Step Test in seconds at baseline, with lower values representing better outcomes. The record says 87 participants had complete baseline assessments and were included in the analysis. It lists 30 outcome measures and 0 analyses. No numerical primary outcome result or post-intervention change is reported in the registry record.

The safety record lists 81 at risk for serious adverse events and 0 affected, 81 at risk for other adverse events and 0 affected, and 0 deaths. The registry’s design and baseline measure can be described, but its recorded results do not quantify functional change or establish a comparative effect.