Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System (NCT04333758), a na na study. The primary outcome is Fugl Meyer Upper Limb Motor Assessment.

2. Clinical Question

The trial’s stated aim was to evaluate the feasibility and potential benefits of using Jintronix to deliver rehabilitation from clinic to home, with caregiver supervision, as a complement to outpatient services. The registry describes the program as individualised and intended for post-stroke users. That aim is broader than the primary endpoint listed in the record: the endpoint is a motor-assessment score at Week 0, not a reported measure of change or a comparison between treatment groups.

Consequently, the record establishes what intervention was being evaluated and identifies a baseline motor measure, but it does not answer whether participants’ scores changed during the program or whether changes differed from what would have occurred without it. The study’s single-group structure is important to that distinction. Without a concurrent control group, an observed before-and-after change, if reported elsewhere, would not by itself isolate the contribution of the intervention. Participant eligibility criteria, baseline characteristics, and further details about the intended outcome assessments are not reported in the registry record.

3. Trial Design

This completed study enrolled 35 participants and is recorded as a single-group trial. The allocation field is NA, and masking is listed as NONE. The registry identifies the condition as stroke and the intervention as the Jintronix Virtual Reality Telerehabilitation System, a device. The sponsor is Tan Tock Seng Hospital. The recorded study start was 2017-01-05, and the primary completion date was 2018-11-14.

The arm description says all participants received two consecutive phases of intervention using Jintronix virtual reality telerehabilitation software. Phase 1 consisted of 9 clinic-based sessions, described as 3/week for 3 weeks, with each session lasting 45 minutes. A study team therapist conducted those sessions, and caregiver training took place concurrently. The remaining phase description is incomplete in the registry record; its full schedule, setting, and delivery details are therefore not reported in the registry record.

Because the trial has one group and no separate comparator, it is not a randomized or controlled comparison. The posted design can support a description of the participants who enrolled, the intervention they received, and any outcomes that were actually reported. It cannot provide a direct concurrent estimate of how outcomes would have differed under another treatment or usual care. No protocol details about allocation concealment, planned follow-up visits, adherence definitions, or a control condition are reported in the registry record.

The registry lists 23 outcome measures but 0 analyses. This means that the record identifies a set of outcome measures without posting an analysis count in the information available for this account. The named primary endpoint is the Fugl-Meyer Upper Limb Motor Assessment at Week 0. A completed trial status does not itself establish that results were entered or that the primary endpoint was analyzed.

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.

6. Primary Endpoint

The registry lists the primary outcome as Fugl Meyer Upper Limb Motor Assessment, measured over Week 0.

The primary endpoint is the Fugl-Meyer Upper Limb Motor Assessment for the upper limb, recorded as a mean score with standard deviation at Week 0. The registry describes the measure as assessing motor impairment of upper limb recovery from a neurological insult. Scores range from 0-66 points, with higher scores indicating better arm motor functions.

A motor assessment can describe the level of impairment in a defined domain and provide a common numerical outcome for reporting participants’ status. Reporting a mean gives a summary of the group’s scores; the standard deviation describes the spread of individual scores around that mean. Neither summary, by itself, shows how much each participant changed or whether a change was attributable to the intervention.

The specified timeframe matters: Week 0 is a starting assessment, not a post-program time point in the information reported. The registry record does not provide the mean, standard deviation, number assessed, or a later score for this endpoint. It therefore does not permit a numerical description of baseline arm motor function or a conclusion about change during rehabilitation. Follow-up timing and any additional endpoint results are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The endpoint is specified as a mean and standard deviation. In general, a mean summarizes the central value of a set of measurements, while a standard deviation describes how dispersed those measurements are around the mean. They answer different questions: the mean describes the group’s average score, whereas the standard deviation describes variation among scores. These summaries do not reveal the full distribution, identify individual responses, or establish why participants obtained their scores.

For this trial, the measure is scored from 0-66 points, and higher scores indicate better arm motor functions. The registry identifies Week 0 as the timeframe but does not report the mean or standard deviation. It also does not report how many participants contributed data to that endpoint. Consequently, there is no posted numerical summary to interpret, and no estimate of variability can be assessed.

What would a confidence interval add?

In general, a confidence interval expresses the statistical uncertainty around an estimate under a specified analysis. It can show which values are reasonably compatible with the observed data and the method’s assumptions. An interval around a mean is not the range containing every participant’s score, and it is not a guarantee about an individual outcome. Its interpretation depends on the underlying data and the analysis used.

No confidence interval for the primary endpoint is reported in the registry record. Without an estimate and its uncertainty, the precision of the group’s Week 0 score cannot be evaluated from the posted information. A confidence interval for a treatment contrast would also require an appropriate contrast and its analysis; no such contrast is reported for this single-group trial.

Why does the single-group design matter?

In general, a control group helps estimate what might have happened to a comparable group under a different condition. Random allocation, when used, helps make treatment groups comparable on average, including for factors that are not measured. This trial is recorded as single-group, allocation NA, and masking NONE. There is no randomized control comparison in the recorded design.

Within-group measurements can still describe participants’ observed status at different times if those measurements are collected and reported. But a before-and-after difference is not automatically a treatment effect. Participants can change over time for reasons other than the intervention, and follow-up data can differ from baseline data in who is observed. This is a general limitation of interpreting uncontrolled change, not a statement that any particular alternative explanation occurred in this trial.

How should planning illustrations be read?

In general, sample-size planning uses assumptions about the outcome, the effect one wants to detect, the significance level, statistical power, and the analysis design. A planning calculation asks how much information a proposed study might need under those assumptions. It does not show that a trial achieved that power, nor does it describe observed outcomes.

The stated planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Those assumptions do not describe the recorded single-group design. The registry record does not report the numerical observed effect or the resulting planning sample sizes. These illustrations should therefore be understood as hypothetical planning exercises rather than as estimates of this trial’s observed evidence. Sample-size calculations cannot replace reporting an outcome estimate and its uncertainty.

What does over-dispersion mean in general?

For some statistical models, over-dispersion means that the observed variability is greater than the model assumes. If it is ignored, standard errors and uncertainty intervals can be too small, making estimates appear more precise than warranted. Model choice should reflect the outcome type and its observed variation. This is a general statistical point; the registry record does not identify an analysis model or report a finding of over-dispersion for this trial.

The primary measure is continuous and is listed with a mean and standard deviation. The record does not state whether any model-based analysis was planned or conducted. No assumptions about model diagnostics, adjustment variables, or estimation procedures should be inferred from the endpoint’s summary format alone.

What can be evaluated from the posted analysis information?

The registry lists 23 outcome measures and 0 analyses. It does not report a statistical analysis plan, a hypothesis test, an estimated change, a treatment contrast, or uncertainty intervals for the primary endpoint. The outcome-measure count describes how many measures are listed; it does not establish which were analyzed or how they were prioritized in practice beyond the endpoint marked primary.

Because numerical outcomes and analysis details are absent, the precision, direction, and statistical significance of any treatment-related result cannot be assessed. General statistical methods can clarify what such quantities would mean, but they cannot fill in results 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("Jintronix Intervention")
n   <- c(32)
m   <- c(36.52)
sp  <- c(16.55)
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  Jintronix Intervention  32  36.520  16.550  30.553  42.487

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 23 outcome measures and identifies the Fugl-Meyer Upper Limb Motor Assessment at Week 0 as the primary endpoint. Considering multiple outcomes can raise a multiplicity issue: in general, conducting many statistical tests can increase the chance of at least one apparently notable result occurring by chance. Prespecifying a primary endpoint and analysis can help readers distinguish the main planned question from additional outcomes. Whether a multiplicity adjustment or another strategy was planned or used is not reported in the registry record.

The record lists 0 analyses. It does not provide a statistical analysis plan, hypothesis tests, or results for the primary or other outcome measures. The number of listed outcome measures alone does not show how many were tested or whether any adjustment was applied. No conclusion about the handling of multiplicity can be made from the posted information.

Missing-data methods are also not reported in the registry record. There is no reported number assessed at Week 0, number with follow-up data, description of withdrawals, or account of how missing measurements were handled. In general, missing observations can affect an estimate when the people with observed outcomes differ in relevant ways from those without observed outcomes. The possible direction and size of such effects depend on the actual data and assumptions; they cannot be determined from this record.

The analysis population is not reported in the registry record. It is not stated whether analyses used all enrolled participants, only those with an observed measurement, or another defined population. Accordingly, the enrollment count should not be assumed to be the endpoint analysis count.

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 reports 35 participants at risk for serious adverse events in the Jintronix Intervention group and 0 serious adverse events affecting participants in that group. It reports 35 participants at risk for other adverse events and 0 affected. Deaths are recorded as 0. These are the posted event counts; they are not evidence that every possible harm was ruled out.

In general, an at-risk count identifies the group size used for the adverse-event record, while the affected count records participants with an event in the relevant category. The registry does not provide serious adverse event terms, and the list of top serious terms is empty. The event definitions, collection procedures, observation period, and completeness of follow-up are not reported in the registry record.

These figures should therefore be read as registry-reported counts for this group, not as a full account of safety or as a comparison against another treatment. With no separate control group, the record cannot establish comparative event rates. The zero counts also do not establish that an event could not occur outside the recorded observation or that all participants had identical monitoring.

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

The record shows that Tan Tock Seng Hospital sponsored a completed, single-group trial of a Jintronix virtual reality telerehabilitation program for people with stroke. It documents an intended clinic-to-home approach, caregiver training alongside the clinic sessions, and a primary endpoint defined as the mean Fugl-Meyer Upper Limb Motor Assessment score at Week 0. It also records 35 enrolled participants.

These design and endpoint details are useful for understanding what the study set out to examine. They do not, on their own, establish whether the intervention was feasible in practice, whether participants’ motor scores changed, or whether any change was caused by the program. The registry does not report the primary endpoint value, a later measurement, or an analysis of change. A completed status does not supply those missing results.

The absence of a control group further limits causal interpretation. General changes in a single group cannot be separated from other influences using a concurrent comparison because no such comparison is recorded. This does not make descriptive observations meaningless; it means they answer a different question from a randomized treatment comparison.

The adverse-event record lists zero serious adverse events, zero other adverse events, and zero deaths in the intervention group, with 35 at risk in each adverse-event category. Those entries describe the registry counts, but the event definitions and monitoring details are not reported. The counts cannot be used to claim that risk was absent or to compare safety with another approach.

The most defensible reading is therefore descriptive: the registry records a feasibility study, its intervention structure, its enrollment, one baseline motor endpoint, and event counts. It does not provide the numerical outcome evidence needed to determine the direction, magnitude, or precision of an intervention-related change. No treatment-effect conclusion can be drawn from the record alone.

14. Why This Trial Matters Statistically

This trial is statistically notable because its stated aim concerns a clinic-to-home rehabilitation service, while its registry design is single-group and its named primary endpoint is measured at Week 0. Keeping the aim, design, and endpoint distinct helps prevent a baseline description from being mistaken for evidence of change or a comparative effect.

The trial also illustrates why outcome reporting matters. A defined scale, timeframe, and summary measure make the intended endpoint understandable, but without its numerical result and uncertainty, readers cannot judge the observed motor status or its precision. Listing 23 outcome measures alongside 0 analyses does not resolve which results were analyzed or how they were interpreted.

For researchers planning related work, the record’s intervention description shows that the program included therapist-led clinic sessions and caregiver training, while the later phase description is incomplete. The information may help identify design questions for future evaluation, but it does not establish participant adherence, feasibility outcomes, or effectiveness. Those details are not reported in the registry record.

The stated sample-size illustrations also highlight the importance of matching assumptions to design. Their assumptions describe equal allocation between two arms, whereas this record describes one group. Planning calculations can be useful when their assumptions and target effect are explicit, but they do not substitute for a suitable comparison or for reported outcome estimates. Nor do they constitute observed power.

In statistical terms, the record helps readers identify what was planned and what evidence is absent. That distinction is particularly important when a feasibility aim is discussed alongside a clinical outcome measure. Transparent reporting of analysis populations, missing data, uncertainty, and follow-up would be necessary to support stronger interpretation.

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.

Several trial-specific limitations affect interpretation. The study is recorded as single-group, with allocation listed as NA and masking as NONE. There is no concurrent control group in the record, so outcomes cannot be compared directly with another condition. The registry’s stated primary endpoint is at Week 0, and no result or follow-up value is reported. This prevents assessment of change in the named motor measure.

The intervention description is incomplete for its second phase. The registry notes two consecutive phases for all participants and gives details for Phase 1, but the remaining phase description ends after “20 (5/”. The full schedule and delivery details are not reported in the registry record. It is therefore not possible to characterize the complete intervention dose from this account.

Eligibility criteria, participant characteristics, follow-up completion, adherence, and feasibility findings are not reported in the registry record. Nor are the analysis population, missing-data methods, statistical analysis plan, or numerical results for the 23 listed outcome measures. The record lists 0 analyses, but this does not establish whether analyses were conducted elsewhere; it means they are not represented in the listed analysis count.

The safety entries give event counts but not definitions, monitoring procedures, or observation duration. These omissions limit how fully the event counts can be interpreted. Finally, the stated planning illustration assumes a two-arm design, which does not match the recorded single-group trial. No numerical planning results or observed effect are available in the registry record for evaluation.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System — NCT04333758.
• Registry record last updated 2024-06-18; status last verified 2024-05.
• Results first posted 2024-06-18.
• 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

NCT04333758 is a completed, single-group feasibility trial sponsored by Tan Tock Seng Hospital. It enrolled 35 participants with stroke and evaluated the Jintronix Virtual Reality Telerehabilitation System. The recorded start date is 2017-01-05, and the primary completion date is 2018-11-14. Masking is listed as NONE.

The intervention description identifies consecutive clinic-based and home-based phases; Phase 1 involved 9 therapist-led, 45-minute clinic sessions and concurrent caregiver training. The second phase description is incomplete in the registry record. The primary endpoint is the mean Fugl-Meyer Upper Limb Motor Assessment score at Week 0, with standard deviation; scores range from 0-66 points, with higher scores indicating better arm motor functions.

The registry lists 23 outcome measures and 0 analyses. It does not report a numerical result for the primary endpoint, a treatment-effect analysis, or missing-data methods. The intervention group’s adverse-event record lists 0 serious adverse events, 0 other adverse events, and 0 deaths, with 35 at risk in each reported event category.