Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke (NCT05369533), a randomized phase 1, phase 2 study. The primary outcome is Change in Action Research Arm Test Score From Baseline to 3 Months.

2. Clinical Question

3. Trial Design

This is a randomized, parallel-group phase 1 and phase 2 study sponsored by the University of California, Los Angeles. The registry lists quadruple masking. It does not identify which roles were masked, so the masking label alone does not establish whether participants, treating personnel, outcome assessors, or analysts were masked in a particular way. The study status is completed. The recorded start date is 2022-08-01, and the primary completion date is 2024-03-11.

The registry describes three groups: telerehabilitation with Sinemet, telerehabilitation with placebo, and usual care. The two telerehabilitation groups receive sessions targeting arm motor function. The descriptions specify 36 sessions, with half supervised by a licensed therapist and the remainder completed independently. The usual-care group receives no study telerehabilitation or pill during the study and continues recommendations made by its care team. All participants are described as being offered telerehabilitation at the end of the study.

The exercise schedule is described differently in two parts of the record. The brief summary says activities take 70 minutes a day, 6 days a week for 6 weeks. The arm descriptions state 70 minutes a day, 6 days a week for 6-8 weeks. The record does not explain this difference. The registry enrollment is 25, and the reported group sizes for the primary outcome are 6 for telerehabilitation with Sinemet, 10 for telerehabilitation with placebo, and 9 for usual care. These are the group sizes attached to the posted outcome results, rather than a basis for inferring how many participants completed each study activity.

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 Action Research Arm Test Score From Baseline to 3 Months, measured over Measured at baseline and 3 months later.

The primary endpoint is change in Action Research Arm Test score from baseline to 3 months. The Action Research Arm Test measures arm function on a scale from 0 to 57 points, with higher scores indicating greater arm function. The registry identifies the endpoint as a continuous measure and reports a mean and standard deviation for each study group.

Change from baseline expresses how a measure differs from a participant’s starting value by the follow-up assessment. In general, examining change can help describe the course of an outcome over the study period while acknowledging that participants may begin with different scores. A group mean summarizes the average reported change in that group; it does not show the pattern of every participant’s outcome. The standard deviation describes the spread of the individual results around the group mean.

The registry specifies measurement at baseline and 3 months later. It does not report a threshold for a clinically important change, so the posted group summaries alone cannot establish whether a difference would be meaningful to patients. Nor does the registry report an adjusted comparison or uncertainty interval for the group means. The endpoint measures arm function, but its group-level summary should be interpreted alongside the absence of a reported two-arm comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary endpoint as a continuous outcome and gives a mean and standard deviation for each arm. It does not report an estimable two-arm continuous comparison. The methods below explain what those summaries can and cannot convey in general, and distinguish that general statistical context from analyses actually reported in this record.

What does a group mean describe?

In general, the mean is the arithmetic average of the observed values in a group. For a change outcome, it summarizes the average change recorded among the participants contributing to that group’s result. It is useful for describing the group’s central tendency, but it does not indicate whether all participants had changes near that average. Nor does it identify the distribution of scores or the experience of a particular participant. The posted means are 23.5 for telerehabilitation with Sinemet, 24.0 for telerehabilitation with placebo, and 15.1 for usual care.

What does the standard deviation add?

In general, the standard deviation describes the spread of observations around their group mean. It is not the same as a confidence interval and does not directly quantify uncertainty in a treatment comparison. The posted standard deviations are 6.8, 13.7, and 7.8, respectively. The value of 13.7 indicates greater dispersion around the telerehabilitation-plus-placebo mean than the spreads reported in the other two groups. A standard deviation cannot, by itself, establish why the outcomes vary or whether the variation differs beyond what might occur by chance.

Why is an inferential comparison important?

In general, a comparison of randomized groups estimates how their outcomes differ, while accounting for sampling variability under a specified statistical method. A confidence interval expresses uncertainty around an estimated effect; its width reflects both the observed variability and the amount of information available. A hypothesis test may also be used, but a p-value alone would not communicate the size or precision of an effect. None of these group-comparison results is reported for the primary continuous endpoint in the posted record.

The registry specifically indicates that values are missing or not estimable for a two-arm comparison of this continuous endpoint. That statement is not a substitute for an effect estimate, standard error, confidence interval, or test result. Since the record does not report a comparison, readers should not calculate one from the arm summaries and treat it as the trial’s analysis. A simple recalculation from summaries would not necessarily match a sponsor’s analysis if that analysis used a model, adjusted for other variables, or handled missing observations differently; the sponsor’s own analysis takes precedence when a discrepancy is reported. No discrepancy is indicated in this record, but no sponsor comparison is posted either.

Why does variability matter?

In general, greater variability makes it harder to estimate a group average or a difference between groups precisely, all else being equal. When groups are small, each observation can have appreciable influence on the mean and standard deviation. Unequal variability across groups can also affect the assumptions and choice of a comparison method. Over-dispersion, in general, means that observed variability is larger than a model assumes; accounting for it can affect estimated uncertainty. The registry does not report an analysis addressing unequal spread or over-dispersion, and these should not be assumed to have been evaluated.

These general principles do not establish that any particular method was used in this study. The statistical model, assumptions, treatment-effect estimate, confidence interval, test, and handling of potential outliers are not reported in the registry record. The summaries remain useful as descriptions of the posted outcome, but they cannot replace the absent inferential comparison.

What can randomization and masking establish?

In general, random assignment is intended to make treatment groups comparable in expectation, while masking can limit some forms of bias in treatment delivery or outcome assessment. The registry labels this study randomized and quadruple masked. It does not detail the randomization procedure, concealment, or which roles were masked. These design labels therefore describe the registered design but do not establish that all sources of bias were prevented or that a particular statistical model was used.

The record gives planning assumptions for sample-size illustrations: 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. Such illustrations are planning calculations rather than observed power, and the registry does not report a trial-design justification or the study’s own sample-size calculation. No numerical planning result is reported in the registry record for this outcome. A planning illustration cannot supply the missing comparison or establish the precision of the posted results.

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("Telerehabilitation + Sinemet", "Telerehabilitation + Placebo", "Usual Care")
n   <- c(6, 10, 9)
m   <- c(23.5, 24, 15.1)
sp  <- c(6.8, 13.7, 7.8)
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  Telerehabilitation + Sinemet  6  23.500  6.800  16.364  30.636
CARM  Telerehabilitation + Placebo  10  24.000  13.700  14.200  33.800
CARM  Usual Care  9  15.100  7.800  9.104  21.096

11. Multiplicity, Missing Data and Analysis Populations

The registry lists the primary endpoint as change in Action Research Arm Test score from baseline to 3 months. It also lists a secondary endpoint: change in Arm Motor Fugl-Meyer Scale from baseline to 3 months. The record gives two outcome measures and one posted secondary outcome. It does not report a statistical analysis for the secondary endpoint in the registry record for these results.

When a study evaluates multiple outcomes or multiple comparisons, general statistical practice may consider how repeated testing affects interpretation. A multiplicity strategy might define a primary analysis, adjust for a family of tests, or treat additional results as exploratory. The registry record does not report whether any adjustment was planned or used. It is not possible to infer from the number of listed measures whether multiplicity was addressed in the study analysis.

Missing-data methods can also affect an estimate. The record does not state how missing baseline or follow-up measurements were handled, whether any imputation was performed, or whether the analysis included all randomized participants or a different population. The posted group sizes describe the primary outcome summaries, but they do not establish the number randomized to each arm, the number with complete follow-up, or the analysis population definition.

The record reports no registered analyses in the registry record for these results and does not give a statistical analysis plan. The model, covariate adjustment, treatment of protocol deviations, and approach to missing outcome data are therefore not reported in the registry record. These gaps limit assessment of whether the reported means correspond to the intended primary analysis and how robust any comparison would be.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hospitalization due to fluid build-up (unrelated to study procedures) (20.0%), hospitalization (unrelated to study procedures) (16.7%), hospitalization due to gi-related issues (unrelated to study procedures) (11.1%), hospitalization due to cardiac issues (unrelated to study procedures) (11.1%), hospitalization due to neurological issue (unrelated to study procedures) (11.1%).

The registry reports serious adverse events affecting 1 participant in the telerehabilitation-plus-Sinemet group, 3 in the telerehabilitation-plus-placebo group, and 4 in the usual-care group. The corresponding groups at risk are reported as 6, 10, and 9. Other adverse events affected 2, 1, and 0 participants, respectively, with the same group-specific numbers at risk. No deaths are reported in any of the three groups. These are counts as recorded, not calculated rates.

The record lists hospitalization due to fluid build-up (unrelated to study procedures) at 20.0%, hospitalization (unrelated to study procedures) at 16.7%, and hospitalization due to GI-related issues, cardiac issues, and a neurological issue (each described as unrelated to study procedures) at 11.1%. The registry does not make clear in these term listings how the percentages relate to a particular group or denominator, so they should not be interpreted as group-specific risks.

Adverse-event counts describe events recorded during the study; they do not by themselves establish whether an event was caused by an intervention. The registry labels the listed serious event descriptions as unrelated to study procedures. The record does not provide further detail about event timing, severity beyond the serious classification, or a comparative safety analysis. The group counts should therefore be read descriptively, without calculating rates or inferring a treatment effect on safety.

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

The posted outcome summaries describe average change in arm function from baseline to 3 months in three randomized groups. The group means are 23.5 for telerehabilitation with Sinemet, 24.0 for telerehabilitation with placebo, and 15.1 for usual care. The associated standard deviations are 6.8, 13.7, and 7.8. These values show the observed group-level summaries recorded for the Action Research Arm Test; the scale ranges from 0 to 57, with higher scores indicating greater arm function.

The summaries do not establish that Sinemet added benefit to telerehabilitation, that telerehabilitation caused a particular change, or that any groups had equivalent outcomes. The two telerehabilitation group means are close as reported, and both exceed the usual-care mean descriptively, but the registry does not report a statistical comparison or an uncertainty interval for those contrasts. The values cannot answer whether observed differences are compatible with sampling variation, nor can they show the precision of a treatment-effect estimate.

General statistical interpretation also distinguishes a group average from an individual outcome. A mean does not imply that each participant changed by a similar amount. The standard deviation describes spread but does not identify each participant’s response, the distribution’s shape, or the presence of influential observations. The record does not report a clinically important change threshold, so it does not establish whether a group mean or a hypothetical contrast is important to patients.

The study is registered as randomized and quadruple masked, but important analysis details are not reported: the comparison model, missing-data handling, analysis population, and multiplicity approach. Those omissions matter when judging how the outcome summaries were generated and how confidently they can be generalized. The appropriate reading is therefore descriptive: the registry posts group means and standard deviations, while the evidence needed to interpret a formal between-group effect is not reported.

14. Why This Trial Matters Statistically

This study poses a statistical question with three clinically distinct groups: telerehabilitation combined with Sinemet, telerehabilitation with placebo, and usual care. The placebo group is relevant to separating the comparison of the study medication from the comparison of telerehabilitation against usual care. The design therefore makes the distinction between describing group outcomes and estimating specific contrasts especially important.

The primary endpoint is a change score measured over a defined follow-up period, and the record reports both a central summary and variability for each group. That is useful descriptive information. But the registry does not report the two-arm continuous comparison needed to quantify the uncertainty around differences between groups. Without that estimate and its precision, readers cannot determine how much weight to place on the apparent ordering of the means.

The group sizes associated with the endpoint are 6, 10, and 9. General statistical reasoning cautions that limited information can produce imprecise estimates and that individual outcomes may have more influence on group summaries. The variation differs across the reported groups as well. These characteristics make transparent reporting of the model, uncertainty intervals, missing-data approach, and analysis population particularly important.

The record also illustrates why registry labels and numerical results answer different questions. Randomization and masking describe design features; means and standard deviations describe observed outcomes; inferential analyses address the size and precision of comparisons. None of these substitutes for the others. For clinical researchers, the absence of a posted comparison is itself an important interpretive fact: descriptive results can be read, but they do not support a precise conclusion about comparative effects.

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 interpreting these results is that no two-arm continuous comparison is reported. The registry notes that the values were missing or not estimable for such a comparison. As a result, there is no posted treatment-effect estimate, confidence interval, or test result for the primary endpoint. The arm-level means cannot establish the magnitude or precision of a contrast.

The outcome summaries are attached to group sizes of 6, 10, and 9. The registry does not specify whether these are all randomized participants, all participants with observed follow-up, or another analysis population. It also does not report how missing outcome measurements were handled. The means may therefore be difficult to interpret in relation to the randomized groups without further information about outcome availability and analysis inclusion.

Several methodological details are not reported in the registry record: the statistical model, covariate adjustment, randomization procedure, allocation concealment, and the roles covered by quadruple masking. The analysis plan and multiplicity strategy are also not reported. These gaps limit assessment of the intended estimand and the assumptions underlying any analysis.

The intervention schedule is not entirely consistent across the descriptions. The brief summary states 6 weeks, while the arm descriptions state 6-8 weeks; the registry does not explain the difference. The serious-event term percentages are not clearly tied to a group-specific denominator in the listed results. Finally, the record does not report a clinically important threshold for the primary scale or provide participant-level outcome distributions. These limitations constrain interpretation of both effectiveness summaries and safety listings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke — NCT05369533.
• Registry record last updated 2025-03-24; status last verified 2025-03.
• Results first posted 2025-03-24.
• 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

The registry record describes NCT05369533, Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke, as a completed, randomized, parallel-group phase 1 and phase 2 study sponsored by the University of California, Los Angeles. It lists quadruple masking and an enrollment of 25. The study includes telerehabilitation with Sinemet, telerehabilitation with placebo, and usual care.

The primary endpoint is change in Action Research Arm Test score from baseline to 3 months. The posted group means are 23.5, 24.0, and 15.1, with standard deviations of 6.8, 13.7, and 7.8, respectively. The registry does not report an estimable two-arm continuous comparison. It also lists change in Arm Motor Fugl-Meyer Scale from baseline to 3 months as a secondary outcome.

The registry reports serious and other adverse-event counts by group and no deaths. Details on analysis methods, missing data, analysis populations, and multiplicity are not reported in the registry record.