Synergizing Home Health Rehabilitation Therapy: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Synergizing Home Health Rehabilitation Therapy (NCT05411393), a randomized na study. The primary outcome is The Motor Skills Score From the Assessment of Motor and Process Skills.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-arm trial with single masking, sponsored by the University of Florida. The registry lists the phase as NA and enrollment as 47. The study is described as a pilot test of an ADL-enhanced program used alongside usual home health rehabilitation, compared with usual home health rehabilitation alone. The record does not report the method used to generate or conceal the random allocation sequence.

Participants in the experimental arm were to receive the ADL-enhanced program and usual home health care rehabilitation. The added program consisted of six home visits by a study occupational therapist. Participants in the control arm were to receive usual home health care rehabilitation. The identity of the party or parties masked is not reported in the registry record; “single” masking alone does not establish whether participants, clinicians, outcome assessors, or another group were masked.

The registry lists the study start as 2022-10-06, primary completion as 2025-01-10, and status as COMPLETED. Completion status describes the trial’s administrative status, not whether outcome data were analyzed or whether an intervention had a particular effect. The registry does not report detailed eligibility criteria, recruitment procedures, or the specific usual-care regimen. It also does not report the protocol’s rationale for the enrollment target or whether the trial was designed for a definitive effectiveness comparison. The stated pilot objective cautions against treating the study as a conclusive test, especially in the absence of posted comparative results.

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.

Before assignment: There is no pre-assignment. After baseline assessment, participants were randomly assigned to the experimental group or the control group.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: At post-intervention assessments, three participants in the treatment group did not complete the assessment. At 1-month follow-up, five participants in the treatment group and one in the control group did not complete the assessment.

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 The Motor Skills Score From the Assessment of Motor and Process Skills, measured over Baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline).

The primary endpoint is the Motor Skills Score, a subscale of the Assessment of Motor and Process Skills. It evaluates the degree of motor performance when a person performs a challenging daily activity. The score is expressed in units on a scale ranging from -3 to +4, with a higher score indicating better motor performance. The registry records the endpoint as a mean with a standard deviation.

Motor performance during daily activities is relevant to a program intended to enhance activities of daily living in people receiving home health rehabilitation. The endpoint therefore describes a functional aspect that the intervention is intended to address. It is not, by itself, a complete measure of independence, quality of life, or every dimension of rehabilitation. The registry also lists other functional assessments, including the Activity Measure Post Acute Care: Home Care Short Form, Box and Block Test, Jebsen Hand Function Test, Timed-Up-and-Go Test, and Short Physical Performance Battery.

The Motor Skills Score was scheduled for assessment at baseline, post-intervention (approximately 2 months from baseline), and 1-month follow-up (approximately 3 months from baseline). The registry record gives the measurement description and timing but does not report the resulting group means, variability, or comparisons.

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 using a mean and standard deviation. A mean describes the center of a set of scores, while a standard deviation describes how spread out the scores are around that center. Together, these summaries help describe each group, but a comparison also requires an estimate of how far apart the groups are and an assessment of uncertainty. Such outcome summaries and comparisons are not reported in the registry record.

What would a treatment-effect estimate represent?

In a randomized parallel-arm trial, a treatment-effect estimate would quantify a contrast between outcomes under the assigned strategies. For this trial, the strategies are the ADL-enhanced program plus usual home health rehabilitation and usual home health rehabilitation alone. The exact contrast depends on the analysis: it might compare average scores at a specified follow-up, compare changes from baseline, or estimate a difference across the repeated assessments. These are general statistical possibilities, not descriptions of an analysis confirmed by the registry.

A confidence interval, in general, expresses the range of effect values reasonably compatible with the data and the method used to calculate the interval. A narrow interval indicates greater statistical precision than a wide interval, although precision is not the same as clinical importance. The registry record does not report a confidence interval for the primary endpoint. Without an estimate and its uncertainty, it is not possible to judge how precisely the trial distinguishes among plausible effects.

How do repeated assessments affect analysis?

Baseline, post-intervention, and follow-up measurements are repeated observations on participants, not independent collections of scores. In general, measurements from the same person may be related. An analysis that uses repeated observations should account for this dependence rather than treating every measurement as unrelated. The choice of model can also affect how information from participants with incomplete follow-up is used. The registry record does not report whether the investigators used a repeated-measures model, a baseline-adjusted comparison, separate time-point analyses, or another method.

Baseline scores may be useful for describing the groups and for adjusting a follow-up comparison. Random allocation is intended to make groups comparable on average, but it does not guarantee identical baseline values in a particular trial. Whether the primary analysis adjusted for baseline, and how it defined the analysis population, are not reported in the registry record. The reported randomization and parallel design do not, on their own, specify the statistical model.

What do the planning assumptions mean?

The registry’s planning description refers to illustrations based on the observed effect, a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It also says that the effect targeted in those illustrations is a stated fraction of the observed effect. These are planning assumptions, not evidence about the trial’s observed effect. The record does not report the trial’s own sample-size justification, nor does it report the numerical effect or planning outputs needed to interpret a particular illustration.

Such illustrations describe how a future study’s required number of participants per arm could vary under selected assumptions. They are not the number of people actually analyzed, and they are not observed power. In general, planning calculations depend on the target effect, outcome variability, allocation, significance level, and desired power. A calculation based on an observed effect can be especially uncertain when that effect comes from a pilot study. The registry’s planning description should therefore not be read as a guarantee that the trial could detect a specific effect.

Why can over-dispersion matter?

Over-dispersion is a general issue for outcomes whose observed variability is greater than a statistical model assumes. When the model understates variability, standard errors may be too small and confidence intervals may be too narrow. The primary endpoint is described as a continuous score with a standard deviation; the registry does not report evidence of over-dispersion or a model that would require an over-dispersion correction. This concept is relevant as a general principle, not as a claim about this trial’s data.

What does the record establish about analysis?

The registry lists six outcome measures and reports zero analyses. It does not provide the statistical analysis plan, hypothesis tests, effect estimates, uncertainty intervals, or details of covariate adjustment. Therefore, the statistical methods that were actually used to analyze the primary endpoint are not reported in the registry record. General explanations of contrasts, uncertainty, repeated measurements, and planning assumptions clarify how trial results are often evaluated, but they cannot substitute for the missing estimates and methods specific to this study.

10. Multiplicity, Missing Data and Analysis Populations

The Motor Skills Score was assessed at baseline, post-intervention, and 1-month follow-up. The registry also lists secondary outcomes: the Activity Measure Post Acute Care: Home Care Short Form, Box and Block Test, Jebsen Hand Function Test, Timed-Up-and-Go Test, and Short Physical Performance Battery. With multiple outcomes or time points, a study may face multiplicity: the more comparisons considered, the greater the chance of finding an apparently notable result by chance if each is treated as a separate test. General approaches include prespecifying a primary comparison, using a testing hierarchy, or adjusting for multiple comparisons. The registry record does not report whether any such approach was planned or used.

The record does not reduce the primary endpoint’s several time points to one reported comparison, and it lists zero analyses. It does not report a prespecified primary time point, a hierarchy among secondary outcomes, or any multiplicity adjustment. As a result, there are no posted tests to interpret in light of multiple comparisons.

Assessment non-completion is reported for the primary endpoint: three treatment-group participants did not complete the post-intervention assessment; at 1-month follow-up, five treatment-group participants and one control-group participant did not complete the assessment. The registry does not report reasons for missing assessments, whether participants withdrew from the study, or whether missing values were imputed or otherwise addressed. In general, missing-data methods rely on assumptions about the relationship between observed and unobserved outcomes. The assumptions and methods used in this trial are not reported in the registry record.

The analysis population is also not reported in the registry record. It is therefore unclear whether an analysis was intended to include everyone randomized, only participants with observed measurements, or another defined group. These gaps prevent assessment of how incomplete follow-up and multiplicity might affect any primary or secondary outcome conclusions.

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 safety record lists zero serious adverse events in the experimental arm and zero in the control arm. It also lists zero other adverse events in each arm. The registry records one death in the experimental arm and zero in the control arm. These are separate counts in the safety record; the listed death should not be assumed to have been caused by the intervention. The registry does not report a causal assessment linking the death to treatment.

Counts should be interpreted in relation to how safety events were defined, collected, and followed. The registry record does not report the event-collection period, severity definitions, relatedness assessments, or detailed event narratives. It also lists no leading serious adverse-event terms. A count of zero in a category means that the registry lists no events in that category; it does not establish that no event could occur, or that all possible harms were assessed with equal sensitivity.

These safety figures are descriptive, not a comparative statistical analysis. The registry does not report uncertainty estimates or a formal comparison of safety between arms. The counts therefore describe what the record lists but do not establish that the arms have equivalent safety profiles.

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

The registry record establishes that this randomized pilot trial compared an ADL-enhanced program plus usual home health rehabilitation with usual home health rehabilitation alone. It describes an intervention delivered through six home visits by a study occupational therapist and a primary functional endpoint measured at baseline, post-intervention, and follow-up. The record also documents incomplete endpoint assessments and descriptive safety counts.

It does not establish whether the added program improved, worsened, or left motor performance unchanged. The comparative primary outcome results are not reported in the registry record, and there are no posted effect estimates, confidence intervals, or p-values. A completed study status does not resolve this evidence gap. Neither the endpoint’s scale direction nor the study objective can be used to infer the observed result.

Even if comparative outcome estimates were available, their interpretation would depend on the size and precision of the estimated effect, the analysis approach, the missing-data handling, and the relevance of the endpoint to patients’ daily activities. The score measures motor performance during a challenging daily activity; it does not encompass every possible patient outcome. The registry lists additional functional assessments, but their results are not reported in the registry record.

The trial’s pilot description is also important context. A pilot study can inform whether a program and study procedures merit further evaluation, but the registry does not report the specific feasibility findings or the rationale for enrollment. The recorded planning assumptions do not constitute evidence of efficacy, and planning illustrations are not observed power. The registry record therefore supports a description of the research question and measurement plan, but not a conclusion that the intervention works or does not work.

The appropriate reading is bounded: the trial was completed and has a defined randomized comparison, yet its posted record does not include the analyses needed to estimate comparative outcome effects. The listed adverse-event counts can be described, but they do not by themselves establish a broader safety conclusion. Further interpretation would require results and methodological details not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically informative as an example of why a study’s design description and its results must be distinguished. Randomization identifies the intended comparison, and the endpoint description identifies what the investigators planned to measure. Neither supplies the actual contrast between groups. Without outcome estimates and uncertainty, readers cannot judge the magnitude or precision of an effect.

The repeated assessment schedule also raises a practical analysis issue. Baseline, post-intervention, and follow-up measurements can be analyzed in more than one way, and a study’s conclusions may depend on which time point or longitudinal contrast was selected. The registry record does not report the analysis that would resolve this question. This makes clear why a statistical analysis plan and transparent reporting of estimates are necessary for interpreting a trial.

Missing assessments are another reason to look beyond a headline endpoint. The registry records non-completion at post-intervention and follow-up, but does not give the reasons or describe how those data were handled. Missingness can influence both the population represented by an analysis and the uncertainty of its estimates. Without a reported analysis population and missing-data method, readers cannot evaluate that influence.

Finally, the trial is described as a pilot, and its planning assumptions should not be confused with observed evidence. Planning illustrations can help show how future studies might be designed under stated assumptions, but they do not report the effect actually observed or prove that a study was adequately powered. The registry record is useful for identifying the clinical question and the reporting gaps that matter for statistical interpretation, while remaining insufficient to establish an outcome conclusion.

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.

A central limitation of the available registry record is that it contains no comparative analysis of the primary endpoint. Group summaries, treatment-effect estimates, uncertainty intervals, and test results are not reported in the registry record. This prevents assessment of the direction, size, precision, or statistical compatibility of the observed effect.

Assessment non-completion is reported at post-intervention and 1-month follow-up, but the record does not explain why measurements were missing or how the analysis addressed them. The analysis population, outcome model, baseline adjustment, and treatment of repeated measures are also not reported in the registry record. These omissions limit evaluation of potential bias and the interpretation of any results that may exist outside the registry.

The intervention is described as six home visits by a study occupational therapist, but detailed content and usual-care delivery are not reported. Eligibility criteria and the identity of the masked party or parties are also not reported in the registry record. Those details would help readers assess how reproducible the intervention was and to whom the findings might apply.

The registry characterizes the study as a pilot but does not report its sample-size justification or a complete statistical analysis plan. It lists several outcomes and multiple primary-endpoint assessment times, without reporting how comparisons were prioritized or whether multiplicity was addressed. Safety counts are available, but detailed event definitions, collection procedures, and causality assessments are not reported in the registry record. These limitations concern what can be established from the record and should not be mistaken for evidence that the trial did not collect further information.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Synergizing Home Health Rehabilitation Therapy — NCT05411393.
• Registry record last updated 2026-01-22; status last verified 2025-07.
• Results first posted 2026-01-22.
• 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.

18. Record Summary

The University of Florida sponsored a randomized, single-masked, parallel-arm pilot trial titled “Synergizing Home Health Rehabilitation Therapy.” The registry lists enrollment as 47 and status as COMPLETED. The experimental arm received an ADL-enhanced program, consisting of six home visits by a study occupational therapist, in addition to usual home health rehabilitation; the control arm received usual rehabilitation.

The primary endpoint was the Motor Skills Score from the Assessment of Motor and Process Skills, assessed at baseline, post-intervention, and 1-month follow-up. The record lists five secondary functional measures. It reports some endpoint non-completion and descriptive adverse-event counts, including one death in the experimental arm. Comparative outcome analyses are not reported in the registry record, so the trial’s effect on the primary endpoint cannot be determined from the posted results.