Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease (NCT05160025), a na na study. The primary outcome is Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback.

2. Clinical Question

3. Trial Design

NCT05160025 is listed as a completed, single-group study sponsored by Rutgers, The State University of New Jersey. The registry records enrollment of 22 and identifies Parkinson Disease as the condition. Allocation is listed as NA, masking as NONE, and the study model as SINGLE GROUP. The phase is listed as NA. These registry entries describe a study without separate randomized treatment arms; they do not establish that the different bicycling conditions were assigned in a particular order or that condition order was randomized.

The intervention is named Virtual reality bicycling. The arm description says that all participants execute the same three bicycling tasks over one session, with exercise intensity and enjoyment measured in a virtual reality environment while wearing goggles. The description is incomplete in the registry record, so the full task procedures and the duration of all conditions are not reported there. The primary endpoint timeframe specifies Session 1 and the 8-minute feedback bout.

The stated objectives address the effects of visual feedback and competition on neuromuscular and cardiovascular intensity, user experience, and attention. The listed primary endpoint is limited to cadence during the feedback bout. Secondary outcome titles include perceived exertion at different points in feedback, self-competition, and other-competition conditions. The registry lists 28 outcome measures and 7 analyses, but does not report the analysis methods or numerical results in the registry record.

The registry records a start date of 2022-10-27, a primary completion date of 2023-02-17, and status COMPLETED. Participant eligibility criteria, recruitment details, condition sequence, and study-specific sample-size justification are not reported in the registry record. Consequently, the listed design supports describing a single-group session-based assessment, not a controlled between-group 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

5. Baseline Characteristics

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

Population: Of the 22 participants with PD, 21 were included in the final analyses as 1 participant was unable to complete the 3 bicycling conditions, terminating each of the 3 trials before the full 5 minutes elapsed.

6. Primary Endpoint

The registry lists the primary outcome as Neuromuscular Intensity (Bicycling Cadence, Revolutions Per Minute) - Feedback, measured over Session 1 - During the 8-minute feedback bout.

The primary endpoint is mean bicycling cadence, measured in revolutions per minute (rpm), during the 8-minute feedback bout in Session 1. The registry describes cadence as collected continuously at 1 value per second (1 Hz). It specifies the endpoint summary as a mean and its dispersion as a standard deviation. The measurement is intended to capture a component of neuromuscular exercise intensity while participants bicycle with visual feedback.

In general, cadence summarizes how quickly a person pedals. A mean can describe the typical cadence across the measurement period, while the standard deviation describes how spread out the recorded values are around that mean. Reporting both can help distinguish a similar average achieved with relatively steady pedaling from one accompanied by more variability. This is a general interpretation of those summaries; the registry does not provide the observed mean or standard deviation for this endpoint.

The endpoint is specific to the feedback condition. It is not, by itself, a direct estimate of the difference between feedback and competition conditions, nor does it measure motivation, enjoyment, attention, or cardiovascular intensity. Those broader topics appear in the objectives and other outcome measures. Numerical results, a comparison estimate, and an uncertainty interval for the primary endpoint are not reported in the registry record. Readers should therefore treat this endpoint description as a definition of the intended measurement, not as evidence about the size or direction of an observed effect.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a continuous measure summarized by a mean, with standard deviation as the dispersion measure. It does not identify the statistical test, model, estimator, or confidence-interval method used for the primary analysis. The distinction matters: an endpoint definition tells readers what was measured, whereas an analysis plan specifies how observations are combined and how a comparison or uncertainty estimate is obtained. The latter details are not reported in the registry record.

What does the mean describe?

In general, a mean is a way to summarize the center of a set of numerical observations. Here, the observations are cadence values, expressed in revolutions per minute, during the feedback bout. The registry states that cadence was collected continuously at 1 value per second (1 Hz). A mean can provide a concise summary of the measured cadence, but it does not show the full pattern over time. It can conceal changes within a bout, including increases, decreases, or brief periods of unusually high or low cadence. The registry record does not include a time-series plot or numerical mean for this endpoint.

What does the standard deviation add?

In general, the standard deviation describes the dispersion of observations around their mean. A smaller or larger standard deviation can help characterize how consistent the recorded cadence values were, but it is not the same as uncertainty in the estimated mean. The standard deviation describes variation in the measurements; a standard error or confidence interval would address uncertainty in an estimated summary. The registry lists standard deviation for dispersion but does not report its observed value or a confidence interval.

What can a within-participant design address?

When the same participants experience multiple conditions, a comparison can use the fact that measurements come from the same people. In general, this may account for stable differences between participants, but it also requires an analysis that respects the repeated measurements and the condition sequence. The registry describes one arm and three bicycling tasks in one session. It does not report the order of tasks, whether order was balanced, or the statistical method used to compare conditions. It would therefore be inappropriate to assume a particular repeated-measures test, paired analysis, or adjustment for order.

The listed primary endpoint is cadence during the feedback bout, rather than a stated difference between feedback and a competition condition. The study objectives describe broader comparisons, but the primary analysis estimand—the precise quantity the analysis was intended to estimate—is not reported in the registry record. Neither the handling of repeated observations nor the treatment of participant-level summaries is specified there. Without that information, a reader cannot determine from the registry how the continuous cadence values were reduced or modeled for inference.

What do the planning illustrations mean?

The accompanying sample-size section is described as a planning illustration based on an observed effect, not the study’s own design justification. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For time-to-event tables, the stated convention is total events using the Schoenfeld method; all other tables give participants per arm. These are planning assumptions for hypothetical sample-size calculations, not evidence that this study had two arms, and not observed power. The present study is listed as single-group. A study-specific sample-size justification is not reported in the registry record.

In general, a planning calculation asks how many participants might be needed under specified assumptions to detect an effect at a chosen significance level. Its result depends on the assumed effect, variability, allocation, and analysis framework. It does not measure the probability that a completed study’s finding is true, and it does not replace the results of the planned analysis. Any sample sizes in the accompanying section should therefore be read as illustrations under their stated assumptions rather than as descriptions of this study’s enrollment rationale.

What can be inferred from the number of analyses?

The registry lists 7 analyses and 28 outcome measures. These counts indicate that the record encompasses multiple outcome or analysis entries, but do not specify the exact statistical procedures, hierarchy of endpoints, or which analyses were confirmatory. They do not establish whether the primary endpoint was analyzed once or in multiple ways. The analysis methods, model assumptions, and inferential results are not reported in the registry record. General statistical principles can help explain possible methods, but they cannot identify which method was actually used.

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("Virtual Reality Bicycling")
n   <- c(21)
m   <- c(85.44)
sp  <- c(13.7)
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  Virtual Reality Bicycling  21  85.440  13.700  79.204  91.676

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 28 outcome measures and 7 analyses, while identifying cadence during the feedback bout as the primary endpoint. Multiple outcomes or analyses can raise a multiplicity concern: in general, conducting many statistical tests can increase the chance of at least one apparently notable result even when no underlying effect exists. This is a general principle, not a claim about the analyses in this study. The registry record does not report whether the investigators controlled multiplicity, designated a testing hierarchy, adjusted p-values, or treated the analyses as exploratory.

The listed objectives cover several domains, including neuromuscular and cardiovascular intensity, user experience, and attention. The registry also lists perceived-exertion measures for several conditions and timepoints. The full analysis plan, endpoint hierarchy, and distinction between confirmatory and exploratory outcomes are not reported in the registry record. The count of outcomes alone cannot establish how many tests were performed or how their results were interpreted.

Missing-data handling is also not reported in the registry record. Although enrollment is listed as 22, this does not establish the number with complete cadence observations, the number included in each analysis, or whether any values were excluded. The analysis population, rules for incomplete or invalid measurements, and any imputation method are not reported. The record also does not describe interim analyses or a protocol-based stopping rule. Consequently, it is not possible to evaluate whether the analysis population matched the intended population or how missing measurements might affect the results.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry’s adverse-event figures list 22 participants at risk for serious adverse events and 0 affected. It also lists 22 at risk for other adverse events and 0 affected, with 0 deaths. No top serious adverse-event terms are listed. These are the safety counts recorded for the Virtual Reality Bicycling group.

In general, an affected count of zero means that the registry record reports no events in that category for the stated group; it does not establish that an event could not occur or that every possible event was captured. The at-risk count gives context for the reported figures, but does not describe exposure time, completeness of event collection, or the safety-monitoring procedures. Those details are not reported in the registry record. The figures should be read as registry-reported counts, not as a guarantee about safety or as a comparison with another group. This is a single-group study, so the record does not provide a separate control arm for a safety-rate comparison.

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

The record documents a study of immersive virtual reality bicycling in persons with Parkinson Disease, with all participants completing the same three bicycling tasks in one session. Its primary endpoint is mean cadence during the feedback bout, measured in revolutions per minute. The registry also describes broader objectives concerning exercise intensity, motivation, enjoyment, perceived intensity, and attention. These details make clear what the study set out to examine.

However, the numerical outcomes and inferential results are not reported in the registry record. The record does not provide the observed cadence mean or standard deviation, a comparison estimate between conditions, a confidence interval, or a p-value. It therefore cannot establish the size, direction, or precision of any observed difference. Nor can the listed objectives be treated as findings: an objective is a research question, not a result.

In general, an outcome measurement can describe what happened during a task, while a statistical comparison estimates how measurements differ under defined conditions. Interpreting a comparison also depends on the design, analysis method, uncertainty, and completeness of the data. Here, condition order, the precise comparison method, analysis populations, and missing-data handling are not reported in the registry record. Those omissions constrain what can be concluded even beyond the absence of numerical results.

The single-group structure also means this record is not a randomized comparison between virtual reality bicycling and a separate control intervention. It may address differences across conditions performed by the same participants, as suggested by the objectives and outcome titles, but the registry does not provide the numerical analyses needed to assess such differences. The appropriate conclusion is therefore about the scope and limits of the record: it describes a planned assessment of cadence and other exercise-related outcomes, but does not provide results sufficient to quantify or judge the effects of the different bicycling conditions.

14. Why This Trial Matters Statistically

This trial is statistically interesting because its question spans several outcome domains while the registry identifies a single primary measure: cadence during the feedback bout. That distinction highlights why a clear endpoint and analysis target matter. Cadence is a continuous measure that can be summarized with a mean and standard deviation, but it represents only one aspect of the broader questions about exercise intensity and user experience.

The single-group structure also makes the comparison framework important. Participants performed three tasks in one session, so any comparison among conditions would involve observations linked to the same participants rather than independent groups. In general, repeated measurements can provide useful within-person information, but their interpretation depends on the analysis method and the order in which conditions occur. Those details are not reported in the registry record, so the design’s potential statistical strengths cannot be fully assessed from this entry.

The registry’s listing of 28 outcome measures and 7 analyses underlines the importance of distinguishing a primary question from other analyses and of explaining how multiple outcomes are handled. This is a general reporting issue, not a claim that multiplicity was or was not controlled in this study. The registry record does not describe the analysis hierarchy or adjustment approach.

Finally, this record illustrates the difference between a study description and a report of findings. It identifies the population, session-based intervention, primary measure, and safety counts, but does not include numerical efficacy results or inferential estimates. Statistical interpretation requires those results and their uncertainty; a well-defined research question alone cannot answer whether or how much the measured outcomes differed.

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 main limitation for interpreting this specific record is that numerical primary and secondary outcome results are not reported in the registry record. The endpoint is defined, but there is no observed cadence mean, standard deviation, effect estimate, confidence interval, or p-value. This prevents assessment of the direction, magnitude, and precision of any condition difference.

The detailed intervention description is incomplete. The registry states that participants performed three tasks in one session and wore virtual reality goggles, but the full descriptions and durations of all tasks are not reported in the registry record. The order of the conditions and any procedures to address order effects are also not reported. These details are important when interpreting measurements collected across repeated tasks.

The record lists 22 enrolled participants but does not report endpoint-specific analysis counts, participant characteristics, eligibility criteria, or the analysis population. Missing-data rules and the handling of incomplete or unusual cadence measurements are not reported. The registry also does not identify the statistical tests or models, the comparison estimand, or the approach to multiplicity across the outcomes and analyses.

Because the study is listed as single-group, it does not offer a separate randomized control arm. The stated objectives concern feedback and competition conditions, but the available record does not establish the precise within-participant comparison design or its analysis. Safety figures are counts in the study group and are not a comparative safety assessment. These limitations concern what can be learned from the registry record; they do not establish whether the full study report contains additional information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease — NCT05160025.
• Registry record last updated 2023-12-22; status last verified 2023-12.
• Results first posted 2023-12-22.
• 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

NCT05160025, titled Immersive Virtual Reality Bicycling for Persons With Parkinson's Disease, is listed as a completed single-group study sponsored by Rutgers, The State University of New Jersey. The registry records enrollment of 22 and dates of 2022-10-27 for study start and 2023-02-17 for primary completion. Participants performed three virtual reality bicycling tasks in one session.

The primary endpoint is mean cadence in revolutions per minute during the 8-minute feedback bout, with standard deviation specified as the dispersion measure. Study objectives also address cardiovascular and neuromuscular intensity, user experience, and attention. The registry lists 28 outcome measures and 7 analyses. Numerical outcome results and details of the statistical analysis are not reported in the registry record. Safety counts list 0 serious adverse events, 0 other adverse events, and 0 deaths among the recorded group.