FitMi Plus Home Therapy for Stroke Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for FitMi Plus Home Therapy for Stroke Patients (NCT03935425), a randomized na study. The primary outcome is Change in Motor Activity Log.

2. Clinical Question

In statistical terms, the intended question is whether the recorded change in Motor Activity Log scores differs between participants assigned to FitMi Plus and those assigned to FitMi Basic. The primary outcome is described as a mean on a scale, with standard deviation as its dispersion measure. Higher scores are described as better, and the scale ranges from 0 to 5.

The distinction between the devices is the functional-module component of FitMi Plus compared with the FitMi Basic pucks. Both arm descriptions specify the same exercise schedule. The record does not establish how closely participants followed the schedule, whether actual exercise time was similar between arms, or what other care participants received.

The registry record lists a secondary outcome, change in Upper Extremity Fugl-Meyer. However, the posted primary outcome is not reduced to one comparison because it has several categories or time points. Without a reported arm-level estimate or a direct between-arm result, the direction and size of any difference in the primary outcome cannot be described.

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group study of FitMi Plus and FitMi Basic. The recorded enrollment is 50. The listed status is completed, with a start date of 2021-11-29 and a primary completion date of 2022-10-31. The phase is listed as NA. The sponsor is Flint Rehabilitation Devices, LLC.

Random allocation is intended to reduce systematic differences between treatment groups at the point of assignment. In a parallel design, participants are assigned to one intervention arm rather than receiving both interventions in sequence. The registry record identifies masking as double, but does not specify which people involved in the trial were masked or how masking was maintained. Those details are not reported in the registry record.

The FitMi Plus arm used functional modules, with participants asked to spend at least 50% of their exercise time interacting with them. The FitMi Basic arm used the Basic pucks, with exercise described and monitored on a computer. Both arms were asked to exercise at least 3 hours per week for 3 consecutive weeks. The record does not state whether these instructions were met, how adherence was measured, or whether the actual exercise dose was equivalent across arms.

The primary outcome was change in the Motor Activity Log, assessed at baseline and one-month post-treatment, at seven weeks. The record also lists change in Upper Extremity Fugl-Meyer as a secondary outcome. It does not describe the full assessment schedule, any outcome-assessor procedures, or the analysis population.

Although the primary outcome is identified as a mean of a continuous measure, the registry record does not provide a single primary-outcome comparison. It notes that the primary outcome has several categories or time points and was not reduced to one comparison. The statistical analysis plan, including any method for handling repeated measurements or choosing among time points, 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.

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 Change in Motor Activity Log, measured over Baseline and One-Month Post-Treatment, at seven weeks.

The primary endpoint is change in the Motor Activity Log. The registry describes this as a self-reported assessment of both the quality of movement and the amount of use of the impaired upper extremity across activities of daily living. Its scores range from 0 to 5, with higher scores indicating a better outcome. The intended assessment compares baseline with one-month post-treatment, at seven weeks.

This measure is relevant to the trial question because the intervention is designed to practice functional movements associated with everyday tasks. A measure that asks about movement quality and use during daily activities addresses a functional dimension, rather than only recording performance on an isolated exercise. As a self-reported measure, it reflects participants’ reports of their movement and use; it should not be interpreted as a direct sensor measurement or an independently observed task assessment.

The registry identifies the outcome as continuous and says it is represented by a mean with standard deviation. In general, a mean describes the average score or change, while a standard deviation describes variation among individual scores around that average. These summaries can help characterize an arm, but they do not by themselves establish the difference between arms. A comparative estimate and its uncertainty are needed to assess how precisely the trial distinguishes the assigned interventions.

The record does not provide the observed baseline or follow-up scores, the mean change in either arm, or a between-arm estimate. It also does not report how the several categories or time points were handled to define one primary comparison. Therefore, the endpoint’s measurement properties and scale can be described, but the trial’s primary outcome result cannot be quantified from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a mean of a continuous measure and names the standard deviation as its dispersion measure. These terms describe how an outcome can be summarized; they do not specify the full method used to compare randomized arms. The analysis model, treatment-effect estimate, uncertainty interval, and inferential test are not reported in the registry record.

What does a mean describe?

In general, a mean is an average of the observed values. For the Motor Activity Log, a mean could describe scores at an assessment time or changes between assessments. A mean is useful for summarizing a continuous outcome, but it does not show the spread of every individual score or reveal whether the distribution is symmetric, skewed, or concentrated near the scale limits.

The registry gives the Motor Activity Log scale as 0 to 5, with higher scores described as better. The record does not provide observed scores or changes. It also does not explain whether change is calculated for each participant before averaging, whether a follow-up score is adjusted for baseline, or how the several categories or time points contribute to the primary analysis. Those choices define different estimands and cannot be inferred from the label “change.”

What does the standard deviation add?

In general, the standard deviation describes variation in individual observations around the mean. It is not the same as the standard error, which describes uncertainty in an estimated mean. A group can have a particular mean while individual outcomes vary widely; reporting only the mean would conceal that variation. Conversely, the standard deviation alone does not establish whether a group difference is estimated precisely, because precision also depends on the analysis and the amount of usable outcome information.

The record identifies standard deviation as the dispersion measure but does not report any standard deviation values. It also does not report standard errors or confidence intervals. Thus, neither the spread of Motor Activity Log values nor the precision of an arm comparison can be evaluated from the registry record.

Why is the comparison between arms essential?

In a randomized parallel trial, the relevant treatment contrast is generally a comparison between outcomes in the assigned arms. A before-and-after change in one arm does not, by itself, isolate the contrast between interventions. Changes can reflect time, participation in exercise, other influences, or measurement variability. Randomization supports a fair comparison at assignment, but it does not replace reporting the outcome contrast or the methods used to estimate it.

General methods for continuous outcomes include comparing arm means, modeling follow-up scores with baseline adjustment, or modeling repeated measurements. These approaches can target related but not necessarily identical quantities and require suitable assumptions. This is general statistical context, not a description of the analysis used in this trial. The registry record does not report which method was used, whether a baseline-adjusted model was applied, or how repeated assessments were handled.

How should uncertainty be understood?

In general, a confidence interval gives a range of estimates compatible with the observed data and the stated statistical model at a chosen confidence level. Its width reflects precision: wider intervals indicate greater uncertainty about the effect estimate, while narrower intervals indicate greater precision. A confidence interval should be interpreted alongside the estimate and the outcome scale. It does not show that every value inside the interval is equally likely, nor does it address biases that arise from missing data, measurement, or trial conduct.

A p-value is a probability calculated under a specified null hypothesis and analysis model. It is not the probability that the null hypothesis is true, and it does not indicate whether an effect is large or important. The registry record does not report a p-value or confidence interval for a primary-outcome comparison, so neither statistical evidence against a null effect nor the precision of an estimated contrast can be assessed.

What do the planning assumptions mean?

The record describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect, and that non-time-to-event sample-size values are participants per arm. These are planning assumptions, not evidence that the trial was designed using those assumptions. The trial’s own sample-size justification is not reported in the registry record.

A sample-size calculation is a prospective planning exercise that depends on assumptions about an effect, variability, allocation, and statistical procedure. It does not measure the probability that a completed trial has found a true effect. In particular, a planning illustration based on an observed effect should not be read as observed power or as a substitute for the estimate and its confidence interval. No numeric planning outputs or observed primary-effect estimate are stated in the registry record.

General statistical practice also considers whether the outcome distribution and model assumptions are suitable. For example, unusual distributions, influential observations, or outcome values near scale boundaries can affect the interpretation of mean-based analyses. These are general considerations, not reported features of this trial; the registry record does not describe diagnostic checks or alternative analyses.

10. Multiplicity, Missing Data and Analysis Populations

Multiplicity can arise when a trial evaluates multiple outcomes, time points, subgroups, or statistical comparisons. In general, making many inferences can increase the chance that at least one result appears noteworthy by chance. Trials may address this through prespecified outcome hierarchies, adjustment procedures, or a clear distinction between primary and exploratory analyses. The registry record lists the Motor Activity Log as the primary outcome and change in Upper Extremity Fugl-Meyer as a secondary outcome, but the approach to multiplicity is not reported in the registry record.

The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. It does not explain whether one time point was intended to be primary, whether results were to be combined, or how any multiple comparisons were handled. The number of analyses is recorded as 1, but this does not resolve the stated issue that no single primary-outcome comparison was presented.

Missing outcome data can affect both the estimate and its uncertainty. In general, interpretation depends on how much data are missing, why they are missing, and what assumptions are made about unobserved outcomes. Common analysis approaches make different assumptions, so a description of participant flow and missing-data handling is important. The registry record does not report missingness by arm, reasons for missing assessments, imputation methods, or sensitivity analyses.

The analysis population is also not reported in the registry record. It is therefore unclear from the record whether the analysis followed assignment regardless of adherence, included only participants with certain data, or used another population definition. The record does not report protocol deviations or how they were addressed. These omissions limit assessment of whether the reported analysis, if any, preserves the randomized comparison.

11. 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 record lists serious adverse events for FitMi Plus as 0 among 25 participants at risk and for FitMi Basic as 0 among 25 participants at risk. It also lists other adverse events as 0 among 25 at risk in each arm, and deaths as 0 in each arm. No serious adverse event terms are listed.

These figures describe events recorded in the registry for the listed categories. A zero count means that no event in that category is recorded for the specified group in this record; it does not establish that no event could occur or that the intervention has no safety risks. The record does not report event definitions, the method or frequency of safety surveillance, the duration of safety follow-up, or whether events were collected systematically.

The counts should also be read separately from the trial’s primary efficacy outcome. They do not answer whether the Motor Activity Log changed differently between arms. Nor do the registry counts, by themselves, establish that safety profiles are equivalent: a comparative safety assessment would require appropriate context about event ascertainment and uncertainty. The record does not report such an analysis.

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

The registry record establishes the trial question and describes a randomized, double-masked, parallel comparison of FitMi Plus with FitMi Basic. It identifies the Motor Activity Log as the primary outcome and describes the scale, the direction of better scores, and the planned assessment timing. It also records the requested exercise schedules and the listed safety counts.

Those details do not establish the size or direction of a treatment difference. The record does not report a single primary-outcome comparison, arm-specific outcome means, change estimates, a confidence interval, or a p-value. Therefore, it is not possible to say from this record whether the primary outcome favored either arm, whether the arms were similar, or how precisely any difference was estimated.

Even when a trial reports a statistical comparison, a result must be interpreted in light of its estimate, uncertainty, outcome scale, design, missing data, and analysis choices. A p-value alone would not describe the size or importance of a difference. A confidence interval would add information about precision, but it would not correct problems in outcome reporting, missingness, or trial conduct.

The intervention contrast is specific: FitMi Plus uses functional modules, while FitMi Basic uses pucks, and both arms were asked to exercise on the same weekly schedule for the same consecutive weeks. The record does not report adherence or actual exercise time. As a result, it cannot show whether participants received the intended contrast or whether exercise exposure differed between arms.

The recorded zero adverse-event counts are likewise limited to the categories and participants listed. They should not be interpreted as proof of no risk. More detailed safety methods and follow-up information are not reported in the registry record.

In short, the record supports a description of the trial’s design and intended outcome, but not a conclusion about comparative efficacy or a complete safety assessment. Those conclusions require results and methods that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial poses a clear statistical contrast: a functional-module device versus a basic puck-based device, with both arms asked to follow the same exercise schedule. Randomization and a parallel design are relevant because they frame a between-arm comparison. The primary endpoint also aligns with the functional focus of the intervention by measuring self-reported movement quality and use during activities of daily living.

Its statistical importance also lies in the distinction between defining an outcome and reporting an estimable result. The registry identifies the Motor Activity Log and its scale, but notes that several categories or time points were not reduced to one comparison. Without a clearly reported contrast, readers cannot tell what quantity the primary analysis targets or evaluate its uncertainty. A sound statistical interpretation depends not only on naming an outcome, but on specifying how measurements become the comparison that answers the trial question.

The record illustrates why effect estimates and uncertainty are more informative than design labels alone. Randomization and masking describe features of trial conduct; they do not reveal the observed difference. Likewise, a mean and standard deviation are useful descriptive statistics but are not a substitute for a between-arm estimate and its precision. Reporting the analysis population, missing data, and multiplicity approach would further clarify the strength and limits of an inference.

The trial is therefore statistically informative as a case in outcome reporting: the intervention, comparator, scale, assessment timing, and exercise instructions are documented, while the comparative primary result and important analysis details are not reported in the registry record. This distinction helps readers separate what a design intends to estimate from what the available record can support.

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 primary limitation for interpretation is that the registry record does not report a single comparison of change in the Motor Activity Log. It identifies several categories or time points but does not state how they were handled to produce a primary estimate. Without an arm-level contrast and its uncertainty, the principal comparative question cannot be answered from the record.

The record does not report observed outcome summaries, confidence intervals, p-values, or the statistical model. It also does not describe the analysis population, missing outcome data, reasons for missingness, handling of missing values, protocol deviations, or sensitivity analyses. These omissions prevent assessment of how analysis choices or incomplete data may affect the estimate.

The registry describes the study as double-masked but does not identify who was masked or how masking was maintained. It gives exercise instructions for each arm but does not report adherence, actual exercise exposure, or whether the intended difference between the devices was maintained. Eligibility criteria and details of the enrolled participants are not reported in the registry record, limiting assessment of the population to which the results might apply.

The safety record lists zero serious adverse events, zero other adverse events, and zero deaths in each arm. It does not describe safety definitions, ascertainment, or follow-up duration, so the counts have limited interpretive context. More generally, registry entries do not replace a detailed account of trial conduct and analysis. The limitations concern what is not reported in the registry record; they do not establish that the corresponding procedures or analyses were not performed.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: FitMi Plus Home Therapy for Stroke Patients — NCT03935425.
• Registry record last updated 2024-03-12; status last verified 2024-03.
• Results first posted 2024-03-12.
• 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.

18. Record Summary

The registry record describes NCT03935425, FitMi Plus Home Therapy for Stroke Patients, with the official title FitMi Plus: Smart Functional Modules for Practicing Activities of Daily Living After Stroke. It lists a randomized, double-masked, parallel design, enrollment of 50, completed status, and Flint Rehabilitation Devices, LLC as sponsor. The recorded start date is 2021-11-29 and primary completion date is 2022-10-31.

The trial compares FitMi Plus functional modules with FitMi Basic pucks. Both arms were asked to exercise at least 3 hours per week for 3 consecutive weeks. The primary outcome is change in Motor Activity Log, assessed at baseline and one-month post-treatment, at seven weeks. Change in Upper Extremity Fugl-Meyer is listed as a secondary outcome.

The record does not present a single primary-outcome comparison or report its estimate and uncertainty. It lists zero serious adverse events, zero other adverse events, and zero deaths in each arm. Details of analysis methods, missing data, and safety ascertainment are not reported in the registry record.