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 Acute Neurobehavioral Program for Improving Functional Status After TBI (NCT01166386), a randomized na study. The primary outcome is Functional Independence Measure Scores.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01166386 |
| Phase | NA |
| Condition | Traumatic Brain Injury |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 165 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Wake Forest University Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
Adults with moderate to severe traumatic brain injury receiving care in an acute brain injury rehabilitation unit. The brief summary describes eligibility as including English speakers, a stay of at least 5 days in the unit, age 18 years or older, and a Glasgow Outcome Scale-Extended score of at least 79. It also refers to time to following commands as an injury-severity criterion.
Intervention
The First Steps treatment intervention, described as a brief, manualized acute neurobehavioral program delivered individually. Its listed components include injury-related education, increasing awareness of deficits related to traumatic brain injury, and coping and cognitive skills training.
Comparator
Standard rehabilitation care. The description says control participants spent 10 one-half hours with a therapist watching videos selected from a menu. The therapist interacted naturally and sometimes related the video to brain injury rehabilitation.
Primary question
Does assignment to the intervention, compared with standard rehabilitation care, relate to functional status measured with the Functional Independence Measure before treatment, at the end of treatment, and at six-month follow-up? The registry record identifies the measure and its time points, but does not report an arm comparison or a treatment-effect estimate.
This is a question about functional status following treatment in a rehabilitation setting. The proposed study also describes broader aims involving emotional and behavioral functioning, productive activity in the community, injury severity, cognitive status, and treatment characteristics. Those aims provide context for the trial, but they do not substitute for a reported primary-outcome analysis. The record names several secondary measures, while the posted outcome information does not contain numerical outcome results for interpreting the primary question.
3. Trial Design
The registry describes a randomized, parallel-group trial with an enrollment of 165. It lists the study as completed and identifies Wake Forest University Health Sciences as the sponsor. The recorded start is 2008-03, and the primary completion is 2014-01. The phase is listed as NA, which is consistent with the record describing a behavioral intervention rather than a drug phase.
Participants were assigned to the First Steps treatment intervention or standard rehabilitation care. The intervention description presents an individually delivered, manualized neurobehavioral program, while the comparator description presents therapist-supported video viewing. Both arms therefore involved therapist contact, but the registry does not report enough detail to compare the amount or nature of contact beyond the descriptions posted. It also does not state whether other aspects of rehabilitation were standardized between groups.
There is an inconsistency in the blinding description. The structured design information lists masking as double, whereas the brief summary calls the trial single-blind. The registry record does not clarify which people were masked or reconcile the two descriptions. Blinding should therefore not be characterized more specifically on the basis of this record.
The brief summary says the investigators planned to enroll 150 participants, with 75 in each group, while the registered enrollment is 165. These figures describe planned and recorded enrollment, respectively; the record does not explain the difference or state how many participants were analyzed for the primary outcome. The outcome section also notes that several people terminated the intervention project and that some files were not transferred when an investigator changed institutions. These statements signal potential gaps in the available outcome data, but do not describe the analysis population or how missing observations were handled.
The registry lists the Functional Independence Measure as the primary outcome and names several secondary measures. It does not include numerical outcome results or a statistical comparison, so this page can describe the design and outcome definitions but cannot assess the observed treatment effect.
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 | First Steps Treatment Intervention | Standard Rehabilitation Care |
|---|---|---|
| STARTED | 82 | 83 |
| COMPLETED | 79 | 78 |
| NOT COMPLETED | 3 | 5 |
Reasons for not completing this period:
| Reason | First Steps Treatment Intervention | Standard Rehabilitation Care |
|---|---|---|
| Withdrawal by Subject | 3 | 5 |
Analysis population for the primary outcome, as defined in the registry: Several persons terminated the intervention project, some files did not get transferred from one of the PIs institutions to another when she changed jobs.
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 | First Steps Treatment Intervention | Standard Rehabilitation Care | Total |
|---|---|---|---|---|
| Participants analysed | 82 | 83 | 165 | |
| Age, Continuous | years | 39.62 (SD 16.75) | 42.21 (SD 18.95) | 41.07 (SD 18.13) |
| Sex: Female, Male: Female | Participants | 23 | 25 | 48 |
| Sex: Female, Male: Male | Participants | 59 | 58 | 117 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 1 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 79 | 79 | 158 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 24 | 21 | 45 |
| Race (NIH/OMB): White | Participants | 52 | 57 | 109 |
| Race (NIH/OMB): More than one race | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 3 | 4 |
| Region of Enrollment: United States | participants | 82 | 83 | 165 |
6. Primary Endpoint
The registry lists the primary outcome as Functional Independence Measure Scores, measured over Pre, at end of treatment up to one week, six-month follow up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is Functional Independence Measure (FIM) scores, reported as a mean with standard deviation. The record describes the scale as ranging from a minimum score of 18 to a maximum possible score of 126. Its direction is toward independence: lower scores indicate greater dependence on another person to complete a task or activity.
Functional status is relevant to this trial because the intervention is intended to address functioning after traumatic brain injury during rehabilitation. A measure of independence can summarize the assistance a person needs in daily tasks, providing an outcome that is directly connected to the stated aim of improving functional status. The registry lists assessment before treatment, at the end of treatment up to one week, and at six-month follow-up. These time points are intended to describe status across the treatment period and later follow-up; the record does not report how the investigators planned to combine or compare measurements across time.
Interpretation depends on the scale direction. A higher FIM score represents greater independence relative to a lower score, according to the registry description. The record does not provide a threshold for a clinically meaningful change, an expected variability, or the observed group means and standard deviations. It is therefore not possible to judge the size or precision of any difference from the posted outcome information. Naming the measure and its range explains what was intended to be assessed, not what the trial found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and defines a primary functional-status outcome, but it does not report a primary-outcome result. In particular, it provides no group means, standard deviations, between-group estimate, confidence interval, or statistical test for the FIM. There is consequently no posted numerical estimate to interpret, and no basis for describing the direction, magnitude, or precision of a treatment contrast.
The outcome is listed at several time points: before treatment, at the end of treatment up to one week, and at six-month follow-up. The registry's skip note says the primary outcome has several categories or time points and was not reduced to one comparison. That means the record does not offer a single primary contrast for this page to discuss. It also does not say whether investigators compared change from baseline, endpoint values, trajectories across time, or another formulation. Those approaches answer related but not identical questions, so one should not infer which was used.
The outcome section notes that several people terminated the intervention project and that some files were not transferred between institutions. This describes a potential source of incomplete data, but it does not quantify missing FIM observations or identify which study visits were affected. The record does not state whether analyses included all randomized participants, only participants with available measurements, or another population. It also does not report methods for handling missing data.
The registry lists the Neurobehavioral Rating Scale as a secondary outcome and the brief summary mentions other measures, including the Disability Rating Scale, Glasgow Outcome Scale-Extended, Rehabilitation Intensity of Therapy Scale, and Frontal Systems Behavior Scale. However, the posted results section does not provide numerical findings for these outcomes either. Their inclusion in the study description should not be treated as evidence of a particular result.
Safety information is recorded separately from functional outcomes. The serious adverse event counts are 1 in the First Steps group and 0 in standard rehabilitation care, with participants at risk listed as 82 and 83, respectively. The record also lists no non-serious adverse events in either group and leaves deaths unreported. These descriptive counts do not establish a causal safety difference, and they do not answer the primary functional-status question.
Overall, the posted information supports a description of the trial's structure, intended outcome, and some safety counts. It does not support a conclusion about the comparative FIM outcome. A numerical estimate accompanied by uncertainty would be necessary to assess how compatible the data are with different possible treatment effects.
9. Statistical Methods Explained
The methods information in the registry is limited. The trial is described as randomized and parallel group, with participants assigned to the First Steps treatment intervention or standard rehabilitation care. Random assignment is generally used to make treatment groups comparable, on average, with respect to factors that could affect outcomes. This is a general explanation of randomization; the registry record does not describe the sequence-generation method, allocation concealment, or the procedures used to implement assignment.
The structured masking entry says double, while the brief summary says single-blind. In general, masking can reduce the influence of expectations on treatment delivery, outcome assessment, or reporting. Which protections apply depends on who was masked. The record does not identify masked parties or resolve the difference between its descriptions, so the precise role of masking cannot be evaluated.
The primary outcome is continuous: FIM scores are summarized in the registry using a mean and standard deviation. In general, a mean describes the center of a set of scores, while a standard deviation describes their spread. These summaries can help readers understand both average function and how variable participants' scores are. The registry does not post the outcome means or standard deviations for either group, so those summaries cannot be compared.
A treatment-effect estimate would describe the contrast between groups for a clearly specified outcome and time point, or for a defined pattern across time. A confidence interval gives a range of values compatible with the data and the statistical model at the stated confidence level. It conveys precision as well as direction: a wide interval indicates greater uncertainty than a narrow one. Neither an effect estimate nor a confidence interval for the FIM is reported in the registry record. The tables or plots should therefore be read as displays of the posted information, not as evidence of an unreported primary comparison.
The primary outcome includes measurements at more than one time point. In general, repeated measurements from the same participant are related, rather than independent observations. An analysis of repeated measurements needs to account for that relationship, and its interpretation depends on the chosen outcome contrast and model. The registry does not report the statistical model, whether baseline FIM was used as an adjustment variable, how the time points were handled, or which time point was designated as the main inferential comparison. It would be inappropriate to infer any of those choices from the listed assessment schedule alone.
The study description also identifies several secondary outcomes and additional aims. When multiple outcomes or comparisons are examined, the chance of obtaining an apparently notable result by chance can increase. General statistical approaches to this issue include prespecifying a primary comparison, adjusting for a family of tests, or interpreting secondary findings as exploratory. The record does not report a multiplicity strategy, a hierarchy of hypotheses, or a complete analysis plan. The stated primary outcome can be identified, but the treatment of additional measures and comparisons cannot.
The sample-size section accompanying the page is a planning illustration, not a report of observed power. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between arms, a normal approximation, and an effect defined as a fraction of the observed effect. In general, such calculations describe how many participants per arm might be needed under stated assumptions to detect a specified effect. They do not show the probability that this completed trial found an effect, and they are sensitive to the assumed effect size and variability. The registry does not report its own sample-size justification or design assumptions. Because no observed primary-effect estimate is posted in the record, a numerical interpretation of planning rows based on that effect is not available.
Over-dispersion is a general concern when a model assumes less variability than the data contain. If it is present and ignored, standard errors can be too small and uncertainty can be understated. This concept is more directly relevant to some count outcomes than to the FIM's registered mean-and-standard-deviation description. The record does not say that over-dispersion was assessed or that a model requiring such an assessment was used. It should not be inferred to have affected this trial.
In general, an analysis plan would identify the target population, endpoint, time point or contrast, model, handling of missing data, and approach to multiplicity. Here, the registry identifies the primary measure and schedule but leaves these analysis details unreported. The absence of those details limits reproducibility and makes it difficult to judge whether a particular table or plot corresponds to the intended primary analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry describes a primary FIM outcome assessed before treatment, at the end of treatment up to one week, and at six-month follow-up. It also names additional outcomes and broader study aims. Examining several outcomes or time points creates a multiplicity question: results can vary across comparisons, and the chance of an apparently unusual result can rise when many tests are considered. The registry record does not report a prespecified hierarchy, a correction method, or another strategy for interpreting multiple comparisons. It therefore does not establish how any secondary or time-specific finding should be distinguished from the primary question.
The primary outcome section notes that several people terminated the intervention project and that some files were not transferred between institutions. It does not state how many FIM observations were missing, when the missingness occurred, or whether missingness differed by treatment group. It also does not report an imputation method, a sensitivity analysis, or a rule for excluding participants with incomplete measurements. The effect of missing data on an outcome estimate cannot be assessed from the record alone.
The enrollment is recorded as 165, while the brief summary describes a plan to enroll 150 participants, with 75 per group. These figures do not identify the number randomized or analyzed at each assessment. The record does not report an intention-to-treat population, a per-protocol population, or another analysis population. Thus, neither the treatment effect population nor the handling of participants who discontinued can be established from the posted information.
In general, clear reporting of analysis populations, missing-data methods, and multiplicity plans helps readers distinguish prespecified confirmatory analyses from exploratory ones. Those details are not reported in the registry record.
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 |
|---|---|---|---|
| First Steps Treatment Intervention | 1 | 82 | 1.2% |
| Standard Rehabilitation Care | 0 | 83 | 0.0% |
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 |
|---|---|
| First Steps Treatment Intervention | 0 of 82 |
| Standard Rehabilitation Care | 0 of 83 |
Most frequent serious adverse event terms
| Event term | Organ system | First Steps Treatment Intervention | Standard Rehabilitation Care |
|---|---|---|---|
| stroke | Nervous system disorders | 1 of 82 | 0 of 83 |
Serious events with the highest arm-level rate: stroke (1.2%).
The registry lists 82 participants at risk for serious adverse events in the First Steps treatment group and 83 in standard rehabilitation care. The corresponding serious adverse event counts are 1 and 0. For non-serious adverse events, the counts are 0 in both groups. Deaths are not reported in the registry record.
These are descriptive counts, not a complete safety analysis. The record does not give event dates, duration of follow-up for safety, participant-level details, or an analysis comparing the groups. It lists stroke at 1.2% among the top serious adverse event terms. The registry does not provide enough detail to determine the event's timing, relationship to the intervention, or clinical context.
A count of serious events should not be interpreted on its own as proof that an intervention caused an event or changed risk. Group sizes, follow-up, definitions, and event ascertainment all matter. The listed at-risk counts describe the denominator for these registry entries; they do not establish that all participants had identical safety observation. The available entries should therefore be read as the safety figures reported by the registry, not as a definitive comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
This trial was designed to compare an acute neurobehavioral intervention with standard rehabilitation care in people with traumatic brain injury, using functional status as the primary outcome. The registry provides the broad design, intervention descriptions, FIM scale direction and range, and intended assessment schedule. Those details clarify the clinical question and the type of outcome the investigators intended to study.
The record does not report an outcome comparison for FIM. Without group-level results and an estimate of the between-group contrast, it is not possible to say whether the posted data favor either group, how large a difference might be, or how precise an estimate would be. The completed status of a trial does not by itself mean that numerical results are available in this registry entry.
The record also does not establish whether changes, follow-up scores, or a repeated-measures contrast formed the primary analysis. It reports some participants terminated the project and some files were not transferred, but gives no account of how those missing observations were handled. These omissions limit interpretation independently of the study's randomized design.
General statistical interpretation separates the observed estimate from its uncertainty and from its clinical meaning. A point estimate describes a contrast in the observed data; an interval estimate describes its precision under a model. Whether an effect is important to patients or rehabilitation practice requires a meaningful threshold and relevant context. Neither a numerical FIM contrast nor such a threshold is reported.
Accordingly, this page can explain what the study set out to assess and how to read the outcome definition, but it cannot determine whether the intervention changed functional status. Nor can the small set of safety counts replace the missing efficacy analysis or support a broad safety conclusion. The appropriate interpretation is limited to what the registry actually records.
13. Why This Trial Matters Statistically
The trial raises statistical issues that are common in rehabilitation research. Functional outcomes may be measured repeatedly, and a study can include both a primary measure and a range of secondary outcomes. Specifying which contrast is primary, how time points are handled, and how additional comparisons are interpreted is essential for understanding what a result means. The registry names the outcome schedule and other measures, but does not report these analysis details.
The posted record also illustrates why a completed study and an interpretable result are not the same thing. The design and endpoint can be described, but without group summaries and a comparative estimate, readers cannot assess the direction or precision of the outcome. Missing files and participant discontinuation are noted, which makes transparent reporting of the analysis population and missing-data approach particularly important.
Differences between planned and recorded enrollment, as well as the conflicting masking descriptions, are examples of details that should be reconciled in a complete report. These points do not establish bias or invalidate the study. They identify information needed to evaluate how the trial was conducted and analyzed.
For statisticians and clinical researchers, the central lesson is to separate design information from outcome evidence. Randomization is an important design feature, but it cannot replace reporting the endpoint results, the prespecified comparison, uncertainty, multiplicity handling, and analysis population. A registry entry can document a study's aims and procedures while still leaving the main statistical question unanswered.
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 limitations specific to this record constrain interpretation. Most importantly, it contains no numerical primary FIM results or between-group estimate. It therefore does not permit an assessment of treatment effect, precision, or the pattern of outcomes across the listed assessment times.
The outcome information notes that several participants terminated the intervention project and that some files were not transferred when an investigator changed institutions. It does not quantify the missing data, identify affected visits or groups, or describe how incomplete records were handled. This leaves the completeness and composition of the outcome data unclear.
The registry gives two different masking descriptions: double in the structured design information and single-blind in the brief summary. It does not explain who was masked or resolve the discrepancy. The record also gives a planned enrollment of 150 in the summary and a recorded enrollment of 165 in the enrollment field, without explaining the difference or reporting the analyzed sample at each time point.
The primary outcome has multiple assessment times, and the record does not specify the analysis contrast or statistical model. It also does not report a sample-size justification, analysis plan, multiplicity approach, or defined analysis population. The absence of these details means readers cannot determine which comparisons were prespecified or how the investigators intended to address multiple measurements.
Finally, the intervention descriptions are abbreviated, and the record does not explain whether other rehabilitation services were balanced or standardized. These limitations concern what can be concluded from this registry entry; they do not establish that the study was conducted improperly.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Acute Neurobehavioral Program for Improving Functional Status After TBI — NCT01166386.
- Registry record last updated 2022-04-22; status last verified 2018-03.
- Results first posted 2021-10-05.
- 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
This completed, randomized, parallel-group trial evaluated the First Steps acute neurobehavioral intervention against standard rehabilitation care for people with traumatic brain injury. The recorded enrollment is 165. The registry identifies the Functional Independence Measure as the primary outcome, summarized by mean and standard deviation, with assessment before treatment, at the end of treatment up to one week, and at six-month follow-up.
The FIM is described as ranging from 18 to 126, with higher scores indicating greater independence. The registry record does not report a primary-outcome comparison, group means, or an effect estimate. It notes participant discontinuations and missing transferred files, but does not explain the analysis population or missing-data methods. Serious adverse event counts are 1 in the intervention group and 0 in standard rehabilitation care; deaths are not reported. The posted information supports a description of the trial and its measures, but not a conclusion about the comparative functional outcome.