Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury (NCT00676182), a registered phase not stated study. The primary outcome is Craig Handicap Assessment and Reporting Technique (CHART).

2. Clinical Question

3. Trial Design

This completed registry study examined telerehabilitation for OIF/OEF returnees with combat-related traumatic brain injury. Enrollment was 81. The sponsor was the VA Office of Research and Development. The registry record gives a start date of 2008-07 and a primary completion date of 2015-04.

The intervention is named Telerehabilitation and is categorized as OTHER. The arm description identifies telerehabilitation. The record does not state allocation, and the comparison is not a randomized comparison; the arms are not a like-for-like control comparison. It would therefore be inappropriate to describe the study as a randomized trial or to interpret its arm entries as establishing a controlled causal contrast.

The scientific objective was to address rehabilitation needs among combat-wounded Veterans with mild to moderate TBI and assess physical health and outcomes including function and community participation. Other stated objectives included evaluating benefits and limitations from Veteran and caregiver perspectives and the impact on VA healthcare facility use. These objectives describe the program's aims; the record does not provide results for them.

The primary outcome was the Craig Handicap Assessment and Reporting Technique (CHART), measured at baseline, 6 Months, and 12 Months. It is a continuous measure reported as a mean with standard deviation. The record states that only participants with data at the specified time points were analyzed. It identifies 8 outcome measures overall and 0 analyses. The record does not report a detailed protocol, the allocation method, or a statistical analysis plan. Those features cannot be inferred from the study's completion status or stated aims.

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: 81 participants were enrolled, but some did not participate or dropped out, leaving 75 participants who participated enough to collect data.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Only participants with data at the specified time points are included in the 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.

6. Primary Endpoint

The registry lists the primary outcome as Craig Handicap Assessment and Reporting Technique (CHART), measured over Baseline, 6 Months, 12 Months.

The primary endpoint was the Craig Handicap Assessment and Reporting Technique (CHART), a continuous measure expressed in units on a scale. The registry record lists assessment at baseline, 6 Months, and 12 Months. It describes subscales for Physical Independence, Cognitive Independence, Mobility, Occupation, Social Integration, and Economic Self Sufficiency. Most listed ranges are 0 - 100; the Physical Independence range is 4 -100. For each subscale, a higher score means more independence, while a lower score means more assistance is needed.

CHART is relevant to the stated rehabilitation goals because it assesses areas of independence and participation rather than being limited to a clinical diagnosis. In general, repeated measurement can describe how these functional domains vary over time. The registry record, however, does not report numerical means, standard deviations, changes from baseline, or a comparison estimate for any time point. It therefore does not show the magnitude or precision of any change in CHART. The record also does not explain how the CHART subscales were combined or prioritized beyond identifying CHART as the primary outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies CHART as a continuous outcome and specifies a mean as the summary parameter, with standard deviation as the measure of dispersion. The record does not report numerical outcome estimates or analyses. The concepts below explain how these statistics are generally interpreted; they do not assert that a particular analysis was conducted in this study.

What does a mean describe?

In general, a mean is a summary of the observed scores in a group at a specified time. For a continuous measure such as CHART, it can provide a compact description of the group's average level on a subscale. A mean does not show every participant's score, nor does it show how scores are distributed around the average. It is also not itself a comparison between time points or between interventions. To estimate a difference, an analysis must define a contrast and report the relevant estimate.

For CHART, direction matters: the registry record says that higher scores on each subscale mean greater independence. A mean at one time point would need to be interpreted alongside the same subscale's scale and measurement time. If a study reports a change, its meaning depends on which time points are contrasted and how the change is calculated. The registry record does not report such a change or specify a contrast.

What does the standard deviation describe?

In general, a standard deviation describes the spread of individual observations around a mean. A relatively narrow spread indicates that observations are more concentrated around the mean, while a wider spread indicates more variation. It is not the same as the standard error, which describes uncertainty in an estimated mean. Standard deviation is useful for understanding participant-to-participant variation but does not alone establish how precisely a group mean or an intervention contrast has been estimated.

How should a confidence interval be read?

In general, a confidence interval gives a range of values compatible with an estimate under the statistical model and procedure used. Its width conveys precision: a narrower interval indicates greater precision than a wider one, all else equal. A confidence interval for a contrast can help show whether the data are compatible with a range of possible effects. No confidence interval for CHART is reported in the registry record, so the precision of its primary outcome findings cannot be assessed. A confidence interval is not a guarantee that the true value lies in the particular interval, nor does it remove concerns about study design or missing data.

What role does the study design play?

General statistical interpretation depends on the design that generated the data. Random allocation, when used and properly implemented, can support a causal comparison by balancing measured and unmeasured factors on average. Here the registry record does not state allocation and identifies the study as not a randomized comparison, with arms that are not a like-for-like control comparison. Thus, any within-group change, if reported, could reflect factors other than telerehabilitation. The record does not provide a controlled estimate that separates those explanations.

Repeated measurements can describe participants' outcomes over time, but they bring additional questions. The analysis may use only complete observations at each time, or it may apply a model that handles repeated measurements in another way. The registry record says that only participants with data at the specified time points were analyzed. It does not report the model, whether comparisons used paired observations, or how the analysis handled participants missing one or more assessments.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a statistical model expects. It matters particularly for count outcomes when a simple model assumes a level of variability that is too small: standard errors may then be understated and uncertainty may look smaller than it is. The primary outcome is described as continuous and summarized by a mean and standard deviation. The registry record does not report a model for CHART, a dispersion assessment, or a count-outcome analysis, so no claim about over-dispersion in this study is supported.

How should sample-size illustrations be treated?

The registry record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. For those illustrations, the effect to detect is expressed as a stated fraction of the observed effect. The record distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event outcomes. These are planning assumptions, not a description of the actual design, and any sample-size illustration is not observed power. The registry record does not report the study's own sample-size justification or the values needed to assess such illustrations.

The record lists 0 analyses. This means the registry information does not include a reported analysis result to interpret; it does not establish why results are absent or whether analyses were conducted outside the record. No particular model, adjustment strategy, interim analysis, or hypothesis-testing procedure is reported. Those methods should not be assumed.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 8 outcome measures, while the primary endpoint is identified as CHART. It reports 0 analyses. The record does not describe a multiplicity strategy, such as how statistical testing across multiple outcomes or subscales would be handled, and no family of hypotheses or adjustment procedure is reported. It would therefore be inappropriate to infer that multiplicity was controlled or to interpret unreported results as if a particular correction had been used.

Missing outcome data are relevant because the record states that only participants with data at the specified time points were analyzed. The assessment schedule is baseline, 6 Months, and 12 Months, but the registry record does not report the number with CHART data at each assessment, how many lacked data, or reasons for missingness. It also does not describe imputation, sensitivity analyses, or a model for incomplete repeated measurements. The enrollment of 81 should not be taken to mean that all participants contributed data at every time point.

The record does not define additional analysis populations, such as an intention-to-treat population, beyond its statement about participants with data at the specified time points. Allocation is not stated, and the comparison is not randomized or like-for-like. The statistical plan, treatment of protocol deviations, and handling of any other analysis populations are not reported in the registry record. These gaps limit assessment of both the risk of bias from missing data and the relationship between the stated endpoint and any analysis population.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: death (1.3%), hospitalization due to suicidal ideation (1.3%), hospitalization (1.3%).

The registry record reports the Telerehabilitation group with 75 at risk and 4 affected by serious adverse events. For other adverse events, it reports 75 at risk and 0 affected. The record's list of serious-event terms includes Death, Hospitalization due to suicidal ideation, and Hospitalization, each reported as 1.3%. These are descriptions of events in the recorded group, not estimates of comparative risk or evidence that an event was caused by the intervention.

The deaths field itself is not reported in the registry record, even though Death appears in the list of serious-event terms. Those entries should be kept distinct rather than treated as interchangeable. The record does not explain how event terms were counted, whether individuals could appear under more than one term, or the observation period for these safety counts. It also does not provide a control comparison suitable for attributing differences in events to telerehabilitation. The figures describe what the registry reports; they do not establish a causal safety effect.

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

The registry record documents a completed study of telerehabilitation for Veterans with combat-related TBI and identifies CHART as its primary outcome. It also describes the intended rehabilitation goals, the outcome's time points and direction, and a set of adverse-event counts. These details clarify what the study set out to examine and how the primary measure is defined.

However, the numerical CHART results are not reported in the registry record. There is no reported mean, standard deviation, change estimate, or confidence interval for the primary outcome. As a result, the record does not show whether scores changed, how large any change was, or how precise an estimate might be. This should not be interpreted as evidence that there was no change or that an effect was absent.

The design information also prevents a strong causal reading. The registry record does not state allocation and explicitly characterizes the comparison as non-randomized and not like-for-like. Without a suitable randomized comparison, a change over time cannot by itself be attributed to telerehabilitation. The record does not report an adjusted or unadjusted treatment-effect analysis for CHART.

The safety entries can be read as recorded counts and terms for the Telerehabilitation group. They cannot establish causation or a difference in safety relative to another treatment. More generally, the study's objectives include function, community participation, Veteran and caregiver perspectives, and VA facility use, but corresponding numerical findings are not reported in this record. The available registry information therefore supports a description of study aims and reporting, not a conclusion about treatment benefit or lack of benefit.

13. Why This Trial Matters Statistically

This study is statistically instructive because it distinguishes a clearly named clinical outcome from an interpretable numerical result. CHART is defined as a continuous measure, its direction is stated, and its measurement schedule is given. Yet without reported outcome estimates, readers cannot evaluate either the size of a change or its precision. Knowing the endpoint alone is not enough to judge what the study found.

The record also makes study design central to interpretation. It does not state allocation and says the comparison is not randomized or like-for-like. This matters because statistical analysis cannot, by itself, make a non-comparable group into a randomized control. Descriptive changes over time and causal effects are different quantities, and the record does not report a primary-outcome contrast that would support the latter.

Missingness and analysis-population details are another important part of the statistical reading. The record specifies that participants with data at each time point were analyzed, but gives no time-specific denominators or missing-data methods. Those omissions leave uncertainty about who contributes to each estimate and whether the observed participants represent the enrolled group.

Finally, the registry contains safety counts but does not provide a comparative framework for interpreting them. It lists serious-event terms and a deaths field that is not reported. Keeping event counts, causal attribution, and comparative inference separate is essential. Taken together, the record illustrates why endpoint definitions, study design, analysis populations, precision, and transparent reporting all matter alongside enrollment and completion status.

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 registry record does not report numerical results for the primary CHART outcome. It gives neither scores at baseline, 6 Months, and 12 Months nor estimates of change or precision. The record also does not explain whether the separate CHART subscales were analyzed individually or combined into another summary. Without these details, the primary outcome cannot be quantitatively interpreted.

Allocation is not stated, and the record explicitly says this is not a randomized comparison and that arms are not a like-for-like control comparison. The arm description identifies telerehabilitation, but a valid comparator for assessing its effect is not established by the record. The absence of a reported analysis further prevents evaluation of how the study addressed possible differences among participants or other sources of bias.

Although enrollment was 81, time-specific counts for the primary measure are not reported. The stated analysis population includes only participants with data at the specified time points, and no missing-data reasons or methods are described. The record also does not report the protocol, the study's sample-size justification, a detailed statistical plan, or any interim-analysis approach. These details are not reported in the registry record and should not be inferred.

The registry describes broader aims, including function, community participation, perspectives of Veterans and caregivers, and VA facility use, but does not report numerical findings for those aims in the information available. Safety reporting is limited to the counts and terms identified above; the record does not provide a comparative causal analysis or explain event coding. These limitations concern what can be learned from the registry record and do not establish what may or may not have been analyzed elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Telerehabilitation for OIF/OEF Returnees With Combat-Related Traumatic Brain Injury — NCT00676182.
• Registry record last updated 2016-03-25; status last verified 2016-03.
• Results first posted 2016-03-25.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

The registry record describes a completed study of telerehabilitation for OIF/OEF returnees with combat-related traumatic brain injury. Enrollment was 81, the sponsor was the VA Office of Research and Development, and the recorded start and primary completion dates were 2008-07 and 2015-04.

CHART was the primary continuous outcome, assessed at baseline, 6 Months, and 12 Months, with higher scores indicating greater independence. The record lists 8 outcome measures and 0 analyses. Numerical CHART results are not reported in the registry record. Allocation is not stated, and the record does not describe a randomized, like-for-like comparison. Safety reporting includes 4 participants with serious adverse events and 0 with other adverse events among 75 at risk in each category; the deaths field is not reported. These data support a description of the study and its registry reporting, but not an estimate of the primary outcome effect.