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 Using the Xbox Kinect for Chronic TBI (NCT02889289), a na na study. The primary outcome is Dynamic Gait Index (DGI).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02889289 |
| Phase | NA |
| Condition | Traumatic Brain Injury |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Washington D.C. Veterans Affairs Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns one individual with a history of traumatic brain injury. The record describes the condition as traumatic brain injury and the study as addressing chronic TBI. It does not report further participant characteristics, such as age, injury details, or baseline clinical status.
Intervention
The participant was to engage in supervised physical therapy using Xbox One Kinect gaming. The intervention description specifies 15 sessions and two commercially available Xbox One Kinect games. The study aimed to assess balance and cardiovascular fitness during this approach.
Comparator
There is no separate comparator group. The registry identifies a single-group model and allocation as NA. The study therefore does not make a like-for-like comparison between gaming and another treatment, usual care, or no intervention.
Primary question
The primary outcome is the Dynamic Gait Index (DGI), a measure of dynamic balance and coordination during activities such as walking while turning the head, changing speed, or navigating obstacles. The record describes repeated assessments across baseline, intervention, and retention periods, but does not report the observed DGI values or their changes.
3. Trial Design
This is a completed, single-group study registered as NCT02889289, titled “Using the Xbox Kinect for Chronic TBI.” The official title is “Balance and Endurance Outcomes for Chronic TBI Using the Xbox Kinect.” The sponsor is the Washington D.C. Veterans Affairs Medical Center. The recorded start is 2015-05 and the primary completion is 2015-12.
The registry lists an enrollment of 1 and describes a single individual with a history of traumatic brain injury. The intervention, Xbox One Kinect Gaming, is classified as “OTHER.” Its description specifies 15 sessions of supervised physical therapy using two commercially available Xbox One Kinect games. The registry lists masking as NONE, phase as NA, and allocation as NA. The study is not a randomized comparison, and there is no control arm for a treatment contrast.
The primary outcome is the Dynamic Gait Index. The stated assessment schedule includes baseline weeks 1, 2, 3, 4, 6, 13, and 14; intervention weeks 1, 3, 4, 6, and 8; and retention weeks 1, 2, 3, 4, and 5. Secondary outcomes include Limits of Stability directional control and heart rate at the beginning and end of a mini-game. The registry lists six outcome measures in total.
The study description states that it would evaluate potential balance improvement and the viability of improving cardiovascular fitness, and records hypotheses about those aims. Those statements describe the study’s objectives, not findings. The registry lists zero analyses, and outcome values are not reported in the registry record. Thus, its design and aims can be described, but the primary outcome cannot be interpreted as an observed treatment response from the posted results.
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 | Xbox One Kinect Gaming |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
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 | Xbox One Kinect Gaming |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 37 (SD 0) |
| Sex: Female, Male: Female | Participants | 0 |
| Sex: Female, Male: Male | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Dynamic Gait Index (DGI), measured over Changes from (Baseline) Weeks 1,2,3,4,6,13,14 to (Intervention) Weeks 1, 3, 4, 6, 8 and to (Retention) Weeks 1, 2, 3, 4, 5.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The Dynamic Gait Index (DGI) is the primary endpoint. The registry describes it as a clinical measure of dynamic balance and coordination during daily activities. Its eight items assess abilities such as walking while turning the head, changing speed, and navigating obstacles. Scores range from 0 to 24 units, with higher scores indicating higher dynamic balance function.
Such a measure is used because balance in motion involves more than standing still: walking tasks can require coordination while the person responds to changes in direction, pace, and surroundings. The DGI is intended to capture these dynamic tasks in a structured clinical assessment. That makes it relevant to the study’s balance objective, although a measure’s relevance does not establish that an intervention changes it.
The registry identifies the primary outcome parameter as a median, with standard deviation as the dispersion measure. It describes the endpoint as changes across baseline, intervention, and retention assessment periods. However, no DGI scores, medians, standard deviations, or change estimates are reported in the registry record. Therefore, the stated scale and assessment schedule explain what was intended to be measured, but do not show whether the participant’s scores changed or how large any change might have been.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s purpose and basic design, but it does not provide the primary outcome values needed to judge the observed balance pattern. It names the Dynamic Gait Index and describes the assessment schedule; it does not report the participant’s scores at those assessments, a summary of change, or an inferential result. The study hypothesis that balance improvements would occur is a planned expectation, not evidence that improvement was observed.
The same distinction applies to cardiovascular fitness. Heart rate at the beginning and end of a mini-game is listed among the secondary outcomes, but the corresponding observed measurements are not reported in the registry record. Limits of Stability directional control is also listed, without outcome values. No conclusion about a change in those measures can be drawn from their inclusion as outcomes alone.
The design is a single-group study with an enrollment of 1. That design can describe the experience and measurements of the participant, but it cannot provide a randomized comparison against a control group. Changes across time, if reported, would not by themselves distinguish an intervention effect from other explanations such as ordinary fluctuation, practice with the assessment, or changes in the participant’s circumstances. These are general considerations for interpreting repeated observations without a concurrent comparator; the record does not report whether any such factors occurred.
The registry lists zero analyses. It also does not report effect estimates, confidence intervals, p-values, or a statistical analysis plan. A confidence interval, in general, describes the range of values compatible with an estimate under the assumptions of the analysis; without an estimate and interval, the precision of a treatment-effect claim cannot be assessed. A p-value, also in general, is a measure tied to a specified statistical model and null hypothesis. No such result is reported, so there is no basis for an inferential claim.
In short, the record documents a completed study, its one-person design, its intervention, and its selected outcomes. It does not document the observed endpoint results. The appropriate interpretation is therefore about what the study set out to measure and the limits of the design, rather than about whether balance or cardiovascular fitness changed.
9. Statistical Methods Explained
What does a single-group design estimate?
A single-group study follows participants receiving an intervention without a separate concurrent comparator group. In this record, the group consists of one participant. Repeated assessments can describe measurements over time for that participant, but they do not create an untreated comparison. General statistical interpretation therefore distinguishes a change over time from a causal effect of the intervention. Without a comparator, other explanations for a change cannot be separated reliably by the design alone.
The registry lists allocation as NA and identifies the model as SINGLE GROUP. It also lists masking as NONE. These design details matter because random allocation and masking can reduce some sources of bias in comparative trials. They are not features of this study as registered. The record does not report a rationale for the design or further procedures intended to address possible bias.
What does the median communicate?
The primary outcome parameter is listed as MEDIAN. In general, the median is the middle value when observations are ordered, and it is often used to describe a distribution’s typical location while being less affected by extreme values than the mean. A median can be useful when values are skewed or when unusual observations might pull the mean away from much of the data.
The listed dispersion measure is standard deviation. In general, standard deviation describes how spread out measurements are around their mean. It is conventionally paired with a mean rather than a median, so the combination of a median and standard deviation may be less straightforward to interpret than a median with a measure designed to describe spread around the median. This is a general point about statistical summaries, not a finding about the participant’s data. The registry does not report the actual median or standard deviation, nor does it explain why this pairing was selected.
How should repeated assessments be understood?
The primary outcome schedule spans baseline, intervention, and retention periods. Repeated measurements can show a trajectory rather than a single before-and-after contrast. In general, observations from the same person over time are related: measurements close in time may share influences and cannot automatically be treated as independent observations. A statistical analysis of repeated measurements needs to account for that dependence if it is intended to estimate uncertainty or test a pattern.
With a single participant, repeated observations can still document that person’s course, but they do not provide the same information as observations from many independent participants. The registry lists no analyses and does not describe a model for repeated measurements, a way of handling within-person dependence, or a procedure for estimating uncertainty. Those methods are not reported in the registry record.
What can an inferential result tell a reader?
General inferential methods combine an estimate with a description of its uncertainty. A confidence interval communicates how uncertain an estimate is under the analysis assumptions. A hypothesis test evaluates data relative to a specified null hypothesis and model. Neither kind of result replaces the estimate itself, and neither removes design limitations. This record reports no confidence interval, p-value, or treatment-effect estimate, so the statistical strength and precision of any change cannot be assessed from the posted results.
A small study can yield measurements that are meaningful as a description of an individual case, but a statistical estimate from one person has limited reach beyond that person. It does not characterize the range of responses among people with TBI. This general limitation is especially relevant when readers might otherwise interpret a repeated individual trajectory as evidence about a wider population.
What do the planning assumptions mean?
The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. Those assumptions describe hypothetical planning calculations, not the design of this single-group study. In particular, equal allocation between two arms is not the registered design, which has one group and an enrollment of 1.
Planning illustrations are not observed power. In general, power calculations describe the probability of detecting a specified effect under assumptions about the design and analysis; they do not establish that an effect occurred, and they should not be used as a substitute for the observed estimate and its uncertainty. The assumptions also do not establish that the study itself was planned using those values. The registry record does not report the study’s own sample-size justification.
Because the observed outcome values and analysis results are not reported, the planning assumptions cannot supply the missing clinical results. Nor can they convert a single-group observation into a randomized comparison. Their meaning is limited to the hypothetical design assumptions stated in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The study lists a primary outcome and secondary outcomes, with repeated assessments across baseline, intervention, and retention periods. The registry lists six outcome measures overall. When several outcomes or assessment times are examined, there are generally more opportunities for apparently notable patterns to arise by chance. Statistical approaches to multiplicity can adjust inference or designate a primary analysis in advance, but the registry record does not report a multiplicity strategy or identify analyses addressing it.
The registry identifies the DGI as primary, which distinguishes it from the listed secondary outcomes. However, the analysis plan, any hierarchy among outcomes, and any adjustment for repeated testing are not reported in the registry record. The outcome listings alone do not establish which comparisons were conducted or how their results were interpreted.
Missing-data procedures and analysis populations are also not reported in the registry record. The record does not say whether every scheduled assessment was completed, how unavailable measurements were handled, or whether any imputation was considered. It does not define an analysis population beyond the registered one-person enrollment. With repeated measurements, missing observations can affect the description of a trajectory; in general, the impact depends on why measurements are missing and how they are handled. No such details are available in the registry record.
The registry lists zero analyses and does not report outcome values, statistical methods, or a missing-data plan. This absence does not establish what may have been done outside the registry; it means those details cannot be evaluated from 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 |
|---|---|---|---|
| Xbox One Kinect Gaming | 0 | 1 | 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 |
|---|---|
| Xbox One Kinect Gaming | 0 of 1 |
The adverse-event entry lists one participant at risk in the Xbox One Kinect Gaming group. It records zero participants affected by serious adverse events and zero participants affected by other adverse events. The death count is null, which means it is not reported in the registry record; it should not be read as a recorded zero. No serious-event terms are listed.
These figures describe the safety entries in the registry, not a comprehensive assessment of risk. With an enrollment of 1, an event count can only describe what was recorded for that participant; it cannot characterize how often events might occur in a larger group or rule out events that were not captured or reported. In general, zero recorded events in a small study do not establish that an intervention is free of risk.
The record does not provide additional detail about safety monitoring, the duration of adverse-event follow-up, or how events were collected. It is therefore appropriate to state what the registry recorded while keeping the scope clear: zero serious and zero other affected participants are entered, and the death count is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
This record is informative about the scope and structure of a small study: one participant with a history of traumatic brain injury was to receive supervised Xbox One Kinect gaming, and the primary outcome was the Dynamic Gait Index. The intervention description specifies 15 sessions. The planned assessments cover baseline, intervention, and retention periods, and the study also lists measures related to stability and heart rate.
It does not establish whether the participant’s balance changed. The DGI scores and summary values are not reported in the registry record, and the registry lists zero analyses. The study’s stated hypothesis about balance improvement is not an outcome result. Likewise, the listed heart-rate and Limits of Stability outcomes do not establish a cardiovascular or stability finding without reported observations.
Even if a change in DGI had been reported, a single-group trajectory would not establish that the gaming caused it. General alternative explanations include practice effects, natural fluctuation, and other changes over time. A control group and a clear analysis plan can help distinguish an intervention-related difference from some of these explanations; neither a randomized comparator nor reported inferential results are present in this record.
The study also cannot establish how results would vary across people with TBI. A single participant’s measurements describe that individual’s experience, not the distribution of outcomes in a broader population. The record does not provide enough participant detail to assess how closely that individual resembles any particular clinical population.
Accordingly, the record supports a description of the research question, intervention, measures, and design limitations. It does not support a claim that the intervention improved or failed to improve balance or cardiovascular fitness. Those conclusions require results that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study matters statistically because it illustrates the difference between measuring a clinical outcome and establishing an intervention effect. The DGI is a defined measure with a stated scale and a rationale connected to dynamic balance. A clear measure helps specify what the investigators intended to observe. But the presence of a suitable endpoint does not replace reporting the observed values, the analysis, or the uncertainty around any estimated change.
The single-person, single-group design also makes the scope of inference important. Repeated measurements can provide a detailed account of one participant’s course, and that kind of case-level information may motivate further research. It cannot by itself establish what would have happened without the intervention or how other people would respond. Those are distinct questions requiring a design and data suited to comparison and broader inference.
The registry also highlights why outcome reporting matters. It identifies the primary and secondary measures and the schedule, but lists zero analyses and does not report outcome values. Readers can understand what was intended to be measured, yet cannot judge the observed direction, magnitude, or precision of change. A hypothesis, protocol objective, or measure description is not a substitute for results.
Finally, the stated planning assumptions should be read separately from the registered study design. Hypothetical two-arm calculations do not make a single-group study comparative, and sample-size planning is not evidence of an observed effect. Keeping design, outcome measurement, analysis, and inference distinct is central to a careful statistical reading of this record.
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 most direct limitation is that observed outcome results are not reported in the registry record. The DGI is identified as primary, but the record gives no participant scores, summary values, changes, confidence intervals, or analysis results. The secondary outcome names are listed without their measurements. The registry also lists zero analyses, so the results cannot be independently interpreted from its entries.
The design has an enrollment of 1 and no separate comparator. This restricts interpretation to the registered individual and prevents a like-for-like comparison with another group. Repeated observations can describe a person’s course, but without a concurrent control group, change over time cannot be attributed to the intervention alone. The record does not report whether assessment practice, natural variation, or other circumstances affected measurements.
The assessment schedule is detailed, but the registry does not say whether all scheduled assessments were completed. It does not describe missing-data handling, analysis populations, statistical models, or how repeated observations were treated. It also does not report a multiplicity strategy despite listing several outcome measures and assessment periods.
Participant characteristics beyond a history of traumatic brain injury are not reported in the registry record. That limits readers’ ability to understand the context of the individual’s results or judge applicability to other people. The registry also does not report the study’s sample-size justification. The planning assumptions do not fill that gap because they describe a hypothetical two-arm illustration rather than the registered single-group design.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Using the Xbox Kinect for Chronic TBI — NCT02889289.
- Registry record last updated 2017-06-15; status last verified 2016-10.
- Results first posted 2017-06-15.
- 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.
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18. Record Summary
NCT02889289 is a completed, single-group study sponsored by the Washington D.C. Veterans Affairs Medical Center. The registry records a start of 2015-05, primary completion of 2015-12, and enrollment of 1. The intervention was supervised Xbox One Kinect gaming, described as 15 physical-therapy sessions using two commercially available games.
The primary outcome is the Dynamic Gait Index, a measure of dynamic balance and coordination scored from 0 to 24, with higher scores indicating higher dynamic balance function. Secondary outcomes include Limits of Stability directional control and heart rate at the beginning and end of a mini-game. The registry lists six outcome measures and zero analyses.
Observed outcome values, statistical results, and a detailed analysis plan are not reported in the registry record. The design therefore documents the study’s aims and measurements but does not establish an observed change or a comparative intervention effect.