FitMi PD Home Therapy for Parkinson's Disease: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for FitMi PD Home Therapy for Parkinson's Disease (NCT05655377), a na na study. The primary outcome is Number of Participants That Successfully Used FitMi PD to Exercise at Home.

2. Clinical Question

The question is about successful at-home use, rather than a comparison of health outcomes between treatment groups. That distinction matters: a count of participants who could use the device can describe whether the intended activity was feasible for the enrolled participants, but it does not by itself establish what would have happened without the device. The registry describes an at-home usability study of a newly developed device. It does not give an operational definition of “successfully” used, explain how successful use was determined, or report the primary count. Those details are not reported in the registry record, so the outcome cannot be interpreted more specifically from the registered information.

3. Trial Design

The registry describes FitMi PD as an at-home usability study for individuals with Parkinson's disease. It is marked completed, with a single-group model and no allocation. The record lists enrollment as 9. The intervention is a device, FitMi PD, intended for use during home exercise. Participants were instructed to use the system for three hours per week over a 3-week period. The device's embedded sensors track and record movement direction and degree while the user performs exercises described on a computer.

There is no control group or randomized treatment assignment in the registry record. Consequently, the design is not a randomized comparison and cannot estimate a treatment contrast between FitMi PD and another intervention or usual activity. Masking is recorded as none. The study phase is recorded as NA. The registry lists a start date of 2021-03-01 and a primary completion date of 2022-10-15; the study status is completed. These dates describe the registry record and do not establish when each participant began or finished using the device.

The primary outcome is a count of participants who were successfully able to use the device at home to exercise over the 3-week period. Its stated timeframe is immediately post-treatment, an average of 3 weeks. The registry also lists Mini Mental State Examination (MMSE) as a secondary outcome and indicates two outcome measures. It lists zero analyses. The record does not describe the primary-outcome analysis population, a statistical analysis plan, a sample-size justification, or how outcome data were handled. These details are not reported in the registry record. With no comparator and no reported primary numerical result, the design and available record support a description of the study question and its reporting, but not an estimate of comparative 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

Reasons for not completing this period:

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 Number of Participants That Successfully Used FitMi PD to Exercise at Home, measured over Immediately Post-Treatment, an average of 3 weeks.

The primary endpoint is the number of participants who were successfully able to use FitMi PD to exercise at home over the 3-week period. It is recorded as a participant count and assessed immediately post-treatment, described as an average of 3 weeks. The endpoint is directly aligned with the study's stated usability focus: it asks whether participants could use the device in the setting for which it was intended, rather than measuring a between-group treatment effect.

A participant count can be an intuitive way to report an outcome defined as successful use. To interpret such a count, readers need to know the number of participants assessed, the number meeting the success definition, what counted as success, and whether participants with missing or incomplete assessments were included. The registry lists enrollment as 9, but does not report the primary count, analysis denominator, operational success criteria, or missing-data handling. Those details are not reported in the registry record.

The outcome should not be taken to measure exercise benefit, change in Parkinson's disease, or a comparison with another approach. It records a use-related outcome as defined in the registry. Without a reported result and fuller measurement details, the endpoint's observed frequency and precision cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count: the number of participants meeting a definition of successful at-home device use. A count is a descriptive statistic. To place it in context, analysts commonly report both the count and the number of participants whose outcome was assessed. If the outcome is treated as binary at the participant level—success or not success—an estimated proportion can also be reported. The registry does not give the observed count, analysis denominator, or success rule, so no such estimate can be interpreted from the registry record.

What does a confidence interval express?

In general, a confidence interval describes uncertainty around an estimated quantity. For a binary participant outcome, an interval around a proportion helps show how compatible the data are with a range of underlying success frequencies. It is not a guarantee that the true value lies within the interval, and it does not remedy unclear outcome definitions or missing observations. No confidence interval for the primary outcome is reported in the registry record. Without the count and the denominator, its width and location cannot be assessed.

Why does the denominator matter?

The denominator is the group of participants whose outcome data contribute to the estimate. Enrollment, intervention completion, and outcome assessment are not interchangeable. A report should make clear whether all enrolled participants were assessed, whether anyone withdrew or lacked an outcome, and how such cases were handled. The registry lists enrollment as 9 but does not report the primary analysis denominator or missing-data handling. It would be incorrect to assume that every enrolled participant contributed an observed primary outcome.

What can a single-group design estimate?

In general, a single-group study can describe outcomes observed among its participants. Without a comparator, it cannot estimate a difference between FitMi PD and a control condition. A comparison with a hypothetical alternative would require information that this design does not collect, as well as assumptions that cannot be checked from the registry record. The design is therefore suited to describing the stated usability outcome, but not to attributing a comparative effect to the device.

What does the absence of a reported analysis mean?

The registry lists zero analyses. This means no analysis is recorded in the registry information available for this account; it does not establish what analyses may have been conducted elsewhere. No test statistic, p-value, adjusted estimate, or inferential model is reported for the primary outcome. There is also no statistical analysis plan in the registry record. In general, analysis choices—including which participants are included, how missing outcomes are handled, and which estimates are emphasized—can affect interpretation. The record does not supply those details.

How should planning calculations be read?

In general, sample-size calculations are planning tools: they describe the number of participants that would be needed under stated assumptions to detect an effect at a chosen significance level and power. They are not observed evidence about whether a study found an effect. The planning assumptions described for this record use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. For non-time-to-event calculations, results are expressed as participants per arm; time-to-event calculations are expressed as total events. These are planning conventions, not features of the completed single-group design. The registry does not report a comparator group or a primary outcome result, and no numerical planning result is reported in the registry record available for interpretation. Such calculations should not be described as observed power.

As a general matter, binary outcomes are often analyzed using methods that account for the fact that each participant contributes a categorical result. Choice of method depends on the study design, the amount of information in the data, and the estimand of interest. In a single-group usability study, descriptive counts and an uncertainty interval may be more directly interpretable than a test framed around a treatment contrast. But the registry does not specify an analysis method or provide the data needed to reproduce one.

These methodological principles help identify what a complete report would need to support interpretation: a precise definition of success, the number assessed, the number meeting the definition, missing-data details, and a clearly described estimation method. They do not permit reconstruction of an unreported outcome. Because no primary numerical result is reported in the registry record, no recalculated estimate or uncertainty measure is available to compare with a sponsor analysis.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("At Home Exercise Therapy With FitMi PD")
n      <- c(9)
events <- c(7)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  At Home Exercise Therapy With FitMi PD  9  7  77.8  40.0  97.2  45.3  93.7  44.4  93.3

11. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and identifies MMSE as a secondary outcome. It does not report a statistical analysis plan, a hierarchy of outcomes, or how multiple outcomes were handled. A multiplicity plan matters when several outcomes or statistical tests are examined, because interpreting each as though it were the only planned analysis can make chance findings easier to overstate. That general concern does not establish that any particular adjustment was required or used in this study. Such details are not reported in the registry record.

The registry lists zero analyses, and no numerical primary or secondary outcome result is reported in the information available for interpretation. There is therefore no basis to assess whether a multiplicity adjustment was applied, whether the primary outcome was analyzed as prespecified, or whether reported analyses were selected from a broader set. The analysis plan and any interim analyses are not reported in the registry record.

Missing-data handling is also not reported. The enrollment figure does not establish how many participants had outcome data, completed the instructed exercise schedule, or were included in an analysis. The record does not say whether missing outcomes were treated as unsuccessful use, excluded, or handled by another method. These choices can affect a binary outcome estimate and its interpretation. No analysis population—such as all enrolled participants or participants with an observed outcome—is identified for the primary endpoint. As a result, the available registry information cannot establish whether missingness occurred or how it would affect the result.

These omissions limit the ability to assess completeness and robustness. They should not be filled in by assumption. For a transparent interpretation, reports would need to state the analysis population, outcome availability, missing-data approach, and how the listed outcomes were treated in the analysis.

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 0 serious adverse events among 9 participants at risk and 0 deaths among 9 participants at risk for the at-home exercise therapy group. These are counts in the safety record, not a comparative safety estimate. Because the study is single-group and has no control group, the figures cannot describe a difference in risk between FitMi PD and another condition.

A zero count in a registry entry does not establish that the underlying risk is zero. It describes what was recorded for the stated group and categories. The registry lists no serious-event terms. It does not provide additional event details, follow-up completeness, or information about other adverse events. Those details are not reported in the registry record. The figures should therefore be read narrowly as no serious adverse events and no deaths recorded in the listed safety counts, not as proof that no adverse experiences occurred.

The number at risk in the safety record should not automatically be treated as the primary-outcome denominator. The registry does not report the primary endpoint’s analysis population or numerical result. Safety and usability outcomes are distinct, and the reported safety counts do not answer how many participants successfully used the device.

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

The registry record describes a completed home-use study of FitMi PD in people with Parkinson's disease. Participants were instructed to use the device for three hours per week over a 3-week period. Its primary question concerns the number of participants who successfully used the system to exercise at home. The record also describes the device's embedded sensors and lists MMSE as a secondary outcome.

However, the primary outcome's numerical result is not reported in the registry record. The record therefore does not show how many participants met the success definition or how precise an estimate would be. Enrollment is listed as 9, but that figure cannot substitute for the missing outcome count or analysis denominator. The record also does not define successful use in operational terms. Any conclusion about the observed level of usability would go beyond the information reported.

The study's single-group design also limits what the result could establish, even if the primary count were available. A count of successful use could describe participants in this study, but would not provide a randomized comparison with an alternative. It would not by itself demonstrate a change in health status, the effect of the device relative to another approach, or whether any observed use was caused by the device rather than other factors. The posted record does not report such comparative or causal estimates.

The safety record lists 0 serious adverse events and 0 deaths among 9 at risk in the intervention group. These are useful descriptive registry entries, but do not establish absence of all adverse events or quantify comparative safety. The primary outcome result, its analysis population, and missing-data handling are not reported. Accordingly, the record supports an account of the study's intended usability question and design, but not a conclusion about the primary outcome's observed frequency or broader clinical impact.

14. Why This Trial Matters Statistically

Usability studies address a practical question that differs from the question in a controlled efficacy comparison: whether participants can use a device in the setting for which it is intended. FitMi PD was developed for at-home exercise, and the registry describes sensors that track and record movement direction and degree during computer-described exercises. The stated schedule—three hours per week over a 3-week period—makes the home-use context central to the study question.

Statistically, the distinction between a feasibility or usability outcome and a comparative treatment effect is important. A participant count can be informative for describing observed use, provided the success definition, denominator, and missing outcomes are clear. Without those elements, a count may be difficult to interpret or compare across studies. In this record, the primary count and the operational definition of success are not reported, so the intended statistical description cannot be evaluated from the registry information.

The study also illustrates why design determines the scope of inference. A single-group study can document an outcome in its participants, but it has no concurrent comparator to support a treatment contrast. The registry records no allocation and no masking. Statistical methods cannot manufacture a control group or remove the limitations of an uncontrolled design.

The record's reporting gaps are relevant in their own right. The primary result, analysis population, missing-data approach, and statistical analysis plan are not reported in the registry record. This makes it difficult to assess precision, completeness, or analytic decisions. Clear reporting of these items would help readers distinguish what was observed from what remains unknown. The study is statistically notable as an example of how outcome definition and transparent reporting are necessary for even a straightforward participant-count endpoint to be interpretable.

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 primary limitation for interpretation is that the registry does not report the numerical result for the primary endpoint. It also does not provide the analysis denominator or define the criteria used to classify successful use. Although enrollment is listed as 9, the number enrolled cannot be assumed to equal the number assessed or included in an analysis. The record does not report intervention completion or primary-outcome completeness.

The single-group design has no comparator and no allocation. It cannot support a like-for-like estimate of how FitMi PD compares with another approach. Masking is recorded as none. Any interpretation must remain descriptive and cannot attribute a difference to the device, as no comparative difference is reported.

The registry lists MMSE as a secondary outcome and indicates two outcome measures, but it does not provide numerical results for the outcomes in the available record. It lists zero analyses. A statistical analysis plan, outcome hierarchy, multiplicity approach, interim analyses, and missing-data methods are not reported in the registry record. These omissions prevent assessment of analysis choices and outcome completeness.

The safety record reports no serious adverse events and no deaths in the listed group, but does not provide details about other adverse events or follow-up completeness. The device's sensor functions and intended exercise schedule are described, but the registry does not report how successful use was measured. These limitations are specific to the available record; they should not be interpreted as evidence that unreported procedures or events did or did not occur.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: FitMi PD Home Therapy for Parkinson's Disease — NCT05655377.
• Registry record last updated 2023-02-17; status last verified 2023-02.
• Results first posted 2023-02-17.
• 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

NCT05655377 is a completed, single-group home-use study of FitMi PD for individuals with Parkinson's disease. The registry lists enrollment as 9, no allocation, and no masking. Participants were instructed to use the device for three hours per week over a 3-week period. Its primary endpoint is the number of participants who successfully used the system to exercise at home; MMSE is listed as a secondary outcome.

The primary outcome result, its analysis denominator, and the definition of successful use are not reported in the registry record. The record lists zero analyses. The safety figures report 0 serious adverse events and 0 deaths among 9 at risk. Without a reported primary result, the study's observed usability frequency and its statistical precision cannot be assessed from the registry information.