The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation (NCT05672628), a na na study. The primary outcome is Feasibility as Assessed by the Number of Sessions Attended.

2. Clinical Question

The main quantitative question is about attendance, not a comparison of VR with another rehabilitation approach. Session attendance can describe whether participants took part in the planned activity, but by itself it does not establish how much rehabilitation benefit occurred. The stated threshold gives context for interpreting attendance; it is not an observed result.

The broader research question includes participant and caregiver experiences. The registry describes semi-structured interviews intended to explore the impact of caregiver involvement on rehabilitation and on the participant-caregiver dyad. It also lists qualitative outcomes based on themes derived from interviews. The findings from those interviews are not reported in the registry record.

Changes in upper-extremity and cognition scores are included among the study aims, but the registry record does not report their results. With no control group described, changes over time would not by themselves separate the effect of the intervention from other influences or the course of recovery.

3. Trial Design

This is a completed, single-group study of Oculus VR in stroke survivors. The registry lists the study as completed, with a start date of 2023-03-05 and primary completion date of 2024-07-17. The sponsor is The University of Texas Health Science Center, Houston. The phase is recorded as NA, allocation as NA, and masking as none.

The registry lists enrollment of 32. The primary outcome description specifies data for all 16 stroke survivor participants. The record does not explain how the enrollment figure relates to the primary outcome population, so the figures should not be treated as interchangeable or used to infer participant flow. Recruitment, discontinuation, and outcome-specific missingness details are not reported in the registry record.

The intervention is named Oculus VR and classified as a device. The study description says the technology was to be used for upper-extremity and cognitive rehabilitation in chronic stroke survivors with mild-moderate cognitive and unilateral arm impairment. The primary endpoint timeframe is described as the end of intervention, about 4 weeks from baseline. The registry does not report the actual intervention schedule beyond the expected minimum attendance stated for the endpoint.

Because there is no separate comparison group or randomized allocation, the design is suited to describing feasibility within the study group, not estimating a between-group treatment effect. The registry lists 63 outcome measures and zero analyses. It includes qualitative interview aims and outcomes as well as quantitative measures, but findings for these outcomes are not reported in the registry record.

The registry also contains planning assumptions for hypothetical sample-size illustrations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. Those assumptions do not describe the single-group study design. A protocol-based sample-size justification, including the rationale for the planned enrollment, is not reported in the registry record.

4. Participant Flow and Accounting

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

Before assignment: 32 individuals (16 dyads) were enrolled in total: 16 stroke survivor participants, each enrolled with a caregiver.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Includes data for all 16 stroke survivor participants.

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 Feasibility as Assessed by the Number of Sessions Attended, measured over end of intervention( about 4 weeks from baseline).

The primary endpoint is feasibility assessed by the number of sessions attended. It is a continuous measure summarized in the registry as a mean with standard deviation. Its timeframe is the end of intervention, about 4 weeks from baseline. The registry states that the minimum expected for a user is 2 sessions per week (8 sessions).

Attendance is a practical indicator of whether participants engage with the intervention schedule. It can help describe whether the delivery approach is workable for participants in the study context. Comparing attendance with the stated expectation may provide context, but the expectation is not itself a result, and the registry record does not report the observed mean, standard deviation, or distribution of attendance.

General statistical interpretation: a mean describes the average attendance, while a standard deviation describes how much individual attendance values vary around that average. A mean alone can hide variation between participants, so the spread matters when judging whether attendance was consistent or differed substantially across the group. The registry identifies these summary measures but gives no values for them.

Attendance is not a direct measure of improvement in arm function or cognition. The study description separately mentions changes in standardized upper-extremity and cognition measurements, as well as usability, acceptability, and interview-based assessment. Their results are not reported in the registry record. Accordingly, the primary endpoint as recorded can address participation in sessions, but not whether participants experienced functional or cognitive change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as the mean number of sessions attended, with standard deviation, at the end of intervention, about 4 weeks from baseline. This is a continuous endpoint: each participant can have an attendance value, and the mean and standard deviation summarize its center and spread. The record states an expected minimum of 2 sessions per week (8 sessions), but gives no observed summary statistics.

What does the mean describe?

General statistical explanation: the mean is the arithmetic average of observed values. It offers a compact description of typical attendance, but it can be affected by unusually high or low values. It also does not show how attendance is distributed across individuals. The standard deviation is a measure of spread around the mean; a larger spread indicates more variability in the observed values. Neither statistic can be interpreted without the actual reported values and context about missing observations.

What would uncertainty add?

General statistical explanation: a confidence interval combines an estimate with information about its sampling uncertainty. A narrower interval indicates greater precision under the assumptions of the method, while a wider interval indicates less precision. An interval does not measure all sources of uncertainty, such as selection or measurement limitations, and it does not establish causality. No confidence interval for the primary outcome is reported in the registry record.

Why does the design matter?

The study is listed as single-group, with allocation recorded as NA and masking as none. There is no separate comparison group in the registry description. General statistical explanation: a single-group study can describe what happened among participants receiving an intervention, but it cannot directly compare their outcomes with outcomes under a different intervention or usual care. If a measure changes over time, a single-group result alone cannot distinguish intervention-related change from other explanations, including background change, co-interventions, or measurement variation.

Masking is recorded as none. General statistical explanation: masking can reduce the risk that knowledge of treatment assignment affects measurement or reporting. Its relevance depends on the outcome. Session attendance may be recorded directly, while usability, acceptability, and interview findings may involve judgments or participant reports. The registry does not report further procedures for outcome assessment.

How should planning illustrations be read?

The record describes sample-size illustrations using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is framed as a stated fraction of the observed effect. For time-to-event outcomes, the record says the planning quantity is total events; for other outcomes, it is participants per arm. These are planning assumptions, not results from this single-group study. They are not observed power and should not be read as the study's own design justification.

General statistical explanation: sample-size calculations depend on an assumed effect, variability, significance level, power target, allocation, and analysis method. Changing assumptions can change the calculated sample size. An illustration based on an observed effect is especially dependent on that estimate and should not be confused with a prespecified hypothesis or a guarantee that a future study will detect an effect. The protocol's sample-size rationale and any prespecified statistical plan are not reported in the registry record.

What is the role of qualitative analysis?

The registry describes semi-structured interviews and outcomes based on the number of themes derived from interviews. General explanation: qualitative analysis can identify patterns in participants' or caregivers' accounts, helping describe experience and perceived barriers or benefits that attendance scores cannot capture. Theme counts do not, by themselves, establish how common an experience is in a broader population. The interview methods, coding procedures, and resulting themes are not reported in the registry record.

The registry lists 63 outcome measures and zero analyses. It identifies a mean and standard deviation for the primary endpoint, but does not report those results or inferential statistics. No p-value, confidence interval, adjusted estimate, or prespecified modeling approach for the primary outcome is reported in the registry record. General statistical explanation: a p-value, when used, measures how incompatible observed data are with a specified null model; it is not the probability that the null hypothesis is true and does not measure clinical importance. Without a reported analysis and its assumptions, statistical significance and precision cannot be assessed.

General statistical explanation: over-dispersion arises when observed variability exceeds what a chosen statistical model expects. If present, a model that ignores it can understate uncertainty. The registry does not report a count-data model or dispersion assessment for attendance, so no claim about over-dispersion or its handling is possible. Given the absent outcome summary and analysis, the most defensible interpretation is descriptive: the endpoint and expected attendance criterion are identified, but the observed feasibility result is not reported in the registry record.

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("Oculus VR")
n   <- c(16)
m   <- c(11.06)
sp  <- c(1.12)
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  Oculus VR  16  11.060  1.120  10.463  11.657

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 63 outcome measures, spanning the primary attendance endpoint, other quantitative aims, and qualitative outcomes. It lists zero analyses. The registry record does not report which outcomes were analyzed, how outcome priorities were handled, or whether any multiplicity adjustment was planned. A prespecified statistical analysis plan is not reported in the registry record.

General statistical explanation: when many outcomes or comparisons are tested, the chance of obtaining at least one apparently unusual result can increase. Multiplicity procedures can address that issue, but the appropriate approach depends on which outcomes are confirmatory, how they relate, and what the analysis plan specifies. No such approach can be inferred from the number of listed outcomes alone. With no analysis results reported, there is no basis to evaluate the impact of multiple testing.

Outcome-specific missing-data information is not reported in the registry record. The primary outcome description says that it includes data for all 16 stroke survivor participants, while the enrollment field lists 32. The record does not explain the relation between those figures or provide a participant flow account. It does not describe reasons for missing data, methods for handling missing observations, or whether the analysis population differed across outcomes.

General statistical explanation: missingness can affect interpretation if the people with observed data differ systematically from those without it. Complete-case summaries describe participants with recorded outcomes, but may not represent everyone who entered a study. Imputation or model-based approaches require assumptions and should be described transparently. No missing-data method is reported in the registry record, so the effect of missingness on the intended estimates cannot be assessed.

The analysis populations and any rules for including or excluding participants are not reported in the registry record. Consequently, the listed sample descriptions should be read literally rather than used to infer an unreported analysis set.

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.

Most frequent non-serious adverse event terms

The adverse-event record lists the Oculus VR group with 16 participants at risk for serious adverse events and 0 affected. For other adverse events, it lists 16 at risk and 6 affected. Deaths are reported as 0. No serious adverse-event terms are listed.

These counts describe what is recorded for the study group; they do not establish whether events were caused by the device or rehabilitation. The registry record does not give event descriptions for the other adverse events, their severity, timing, duration, or relationship to the intervention. It also does not describe how adverse events were collected or whether all events were captured consistently.

General statistical explanation: an at-risk count indicates the group size used for the adverse-event reporting, while an affected count indicates how many participants were recorded as having the specified category of event. A zero recorded serious-event count does not demonstrate that the risk is absent, particularly when the study is not a comparative safety trial. These figures should be interpreted as registry-reported counts, not as a precise estimate of risk or a comparison with another approach.

The record does not report a control group, so there is no comparative safety estimate. The listed counts do not answer whether event frequency differs from another treatment or usual care. Further details about event definitions and ascertainment are not reported in the registry record.

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

The registry identifies a study intended to evaluate whether Oculus VR can be used for upper-extremity and cognitive rehabilitation among chronic stroke survivors with mild-moderate cognitive and unilateral arm impairment. Its primary feasibility measure is the number of sessions attended, with an expected minimum of 2 sessions per week (8 sessions). The study also intended to assess usability, acceptability, standardized outcome changes, and caregiver engagement.

The record does not report the observed attendance summary or the results for the other stated aims. It therefore does not establish whether the attendance expectation was reached, what changes occurred in standardized measurements, what participants or caregivers reported, or how usable and acceptable the approach was. The absence of results in the registry record should not be interpreted as either a positive or negative finding.

The single-group design is important to what the data could show. It can describe experiences and outcomes among participants, but without a comparator it cannot isolate the effect of the intervention from other influences. The registry also records enrollment of 32 and a primary outcome population of all 16 stroke survivor participants, without explaining their relationship. These figures do not support an inference about completion or missingness.

General statistical explanation: a statistically detectable change, if reported, would not automatically establish that the change was important to participants. Conversely, an imprecise estimate would not prove that no change occurred. Interpretation would require the actual estimates, their uncertainty, outcome definitions, and context. Those results are not reported in the registry record.

The adverse-event counts report 0 serious events among 16 at risk, 6 participants affected by other adverse events among 16 at risk, and 0 deaths. They provide a limited safety description, not a comparison or a comprehensive account of event type and cause. The record's planning illustrations are not evidence of observed benefit, observed power, or a design justification for this single-group study.

14. Why This Trial Matters Statistically

Feasibility questions are important when an intervention uses a device and asks participants to attend repeated rehabilitation sessions. Session attendance can describe whether participants engage with the planned activity, while interviews can add information about how participants and caregivers experience rehabilitation. The registry's aims therefore encompass more than a change score alone.

Statistically, feasibility and efficacy questions call for different interpretations. Attendance is a participation measure. Standardized upper-extremity and cognition scores address different constructs, while interviews address experiences and perceived impact. Keeping these outcomes distinct avoids treating attendance as evidence of functional improvement or interview themes as a controlled treatment effect.

The record also illustrates why study design and result reporting must be read together. A single-group design can be useful for describing implementation, but it does not create a counterfactual comparison. The registry lists enrollment of 32 and says the primary endpoint includes data for all 16 stroke survivor participants, yet does not explain the relationship between those figures. Without participant flow and outcome results, even the intended feasibility assessment remains difficult to evaluate.

The registry's broad outcome listing and absence of analyses make transparent reporting especially relevant. A clear account of which outcomes were assessed, their estimates and uncertainty, and how missing observations were handled would help readers distinguish planned aims from findings. Qualitative methods and themes would also clarify how caregiver involvement was explored.

The study matters statistically as an example of an early-stage, multidimensional rehabilitation question. Its registry describes a practical attendance criterion, quantitative measurement aims, and qualitative exploration, but does not report findings for those aims. The design can motivate further research questions; it cannot, on the recorded information, establish a comparative intervention effect.

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 interpretation is that the registry record does not report the observed primary endpoint result. It identifies a mean and standard deviation as the planned summary but gives neither value. The expected minimum of 2 sessions per week (8 sessions) is a criterion, not an observed attendance finding.

The registry lists enrollment of 32 and states that the primary outcome includes data for all 16 stroke survivor participants. The record does not explain the relationship between these figures. It also does not give participant flow, outcome-specific denominators, reasons for missingness, or missing-data methods. As a result, the extent and possible consequences of incomplete data cannot be assessed.

The single-group design has no described comparator and no randomized allocation. Any outcome change could not be attributed to the intervention alone on the basis of this design. Masking is recorded as none; further details about assessment procedures are not reported in the registry record.

The study purpose includes usability, acceptability, standardized upper-extremity and cognition measurements, and caregiver interviews. Their results are not reported in the registry record. Interview sampling, coding methods, and theme findings are also not reported. The registry lists 63 outcome measures but zero analyses, and does not report a statistical analysis plan, multiplicity approach, or protocol-based sample-size rationale.

The adverse-event record gives counts but no descriptions for the other adverse events and no details about collection or attribution. The listed planning assumptions use a hypothetical two-arm framework, whereas the registered study is single-group. Those illustrations should not be mistaken for evidence about the original design or the intervention's effect.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: The Feasibility, Usability, and Acceptability of Using the Oculus™ Virtual Reality Gaming Technology in Stroke Survivors for Upper Extremity and Cognitive Rehabilitation — NCT05672628.
• Registry record last updated 2025-08-17; status last verified 2025-07.
• Results first posted 2025-08-17.
• 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

NCT05672628 is a completed study sponsored by The University of Texas Health Science Center, Houston. Its title concerns the feasibility, usability, and acceptability of Oculus VR for upper-extremity and cognitive rehabilitation in stroke survivors. The registry lists a start date of 2023-03-05 and primary completion date of 2024-07-17.

The study is single-group, with allocation recorded as NA and masking as none. Enrollment is listed as 32. The primary outcome is the number of sessions attended, summarized as a mean with standard deviation at the end of intervention, about 4 weeks from baseline. The registry states an expected minimum of 2 sessions per week (8 sessions), and says the primary outcome includes data for all 16 stroke survivor participants.

The record lists 63 outcome measures and zero analyses. It reports no observed primary endpoint result or findings for the other stated aims. Adverse-event entries report 0 serious events among 16 at risk, 6 affected by other adverse events among 16 at risk, and 0 deaths. The relation between enrollment and the primary outcome population, outcome-specific missingness, and analysis methods are not reported in the registry record.