Moving Mindfully for Freezing of Gait: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Moving Mindfully for Freezing of Gait (NCT05923229), a randomized na study. The primary outcome is Recruitment of Sample: Number of Participants Recruited.

2. Clinical Question

The clinical rationale is broader than the primary endpoint. The investigators describe mindfulness as a way to cultivate conscious awareness and self-compassion while addressing stress and anxiety, and propose a walking intervention that engages mobility as well as mental health. The active comparator offers education about freezing of gait and asks participants to track usual care. These descriptions clarify the intended contrast, but they do not establish that the trial measured or demonstrated changes in symptoms or daily functioning. The posted primary result addresses whether participants were recruited, rather than whether one program produced better clinical outcomes than the other.

3. Trial Design

NCT05923229, titled “Moving Mindfully for Freezing of Gait,” is listed as a randomized, parallel-group trial with no masking. The registry lists the phase as NA and the status as completed. Washington University School of Medicine is named as the sponsor. The recorded start date is 2023-06-07, and the primary completion date is 2024-04-26.

The registry records enrollment of 24 participants. The Mindfulness-Based Walking Therapy (MBWT) arm has 12 participants, and the Freezing of Gait (FOG) Education arm has 12. Participants in the MBWT arm received the intervention; those in the education arm received FOG educational materials and tracked usual care. The record does not describe the randomization sequence or allocation concealment, so those details are not reported in the registry record.

The primary endpoint is the number of participants recruited, measured over a 14-week timeframe. The stated recruitment benchmark was a target sample of 24 participants to randomize. The arm counts and recorded enrollment are consistent with that target being reached. This is a feasibility-oriented primary question: it evaluates recruitment, not an effect of the intervention on freezing, mobility, stress, or quality of life.

The registry lists four outcome measures and no posted secondary results. It lists no statistical analyses. Details such as intervention delivery schedules, adherence criteria, follow-up assessments, the intended analysis population, and the statistical analysis plan are not reported in the registry record. The record also does not state a treatment phase or describe a masked assessment process. These absences limit how fully the conduct and planned analysis can be reconstructed from the registry information alone.

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: We consented people via an online format and conducted phone interview screening prior to in-person evaluations. Participants were excluded after the phone interview if they had significant cognitive impairment (MOCA-Telephone Version \<13, noted they were not diagnosed with idiopathic Parkinson disease, or could not walk more than five minutes.

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 Recruitment of Sample: Number of Participants Recruited, measured over 14 weeks.

The primary endpoint is the number of participants recruited, with a stated timeframe of 14 weeks. The investigators identify a target sample of 24 participants to randomize as the benchmark for meeting the recruitment feasibility objective. The registry records enrollment of 24, with 12 participants assigned to each arm. On the recruitment measure, the recorded enrollment matches the stated target.

A recruitment endpoint is useful in an early or feasibility-focused trial because it addresses whether the study can enroll its intended participant group. Recruitment can inform whether the proposed trial procedures are workable enough to consider further evaluation. It does not, by itself, measure how participants respond to an intervention or whether the intervention changes clinical outcomes.

The endpoint’s interpretation therefore needs to stay close to its definition. A count of recruited participants is not a symptom score, a change from baseline, or a measure of treatment benefit. Although the trial compares MBWT with FOG education, the posted primary result does not estimate a comparative effect on freezing of gait or other health outcomes. The registry record does not report the recruitment rate over time, reasons for non-enrollment, or screening figures, so the count cannot describe those aspects of feasibility.

7. Results Posted in the Registry

• Freezing of Gait (FOG) Education: 100.0% (12/12) versus 100.0% (12/12) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measurement is a count: how many participants were recruited. Counts differ from continuous outcomes such as a measured distance or symptom score, and they differ from event outcomes such as whether a participant experienced an event. Here, the substantive benchmark is the target number of participants to randomize. The registry records an enrollment of 24 and arm counts of 12 each.

What does the risk difference describe?

As a general statistical explanation, a risk difference compares the proportion meeting a defined outcome in one group with the corresponding proportion in another group. It is often useful when the outcome is binary, because it expresses the difference on the same scale as the underlying proportions. In this record, the posted values are tied to recruitment: each arm has a reported value of 1.0, and the risk difference is 0.0. They should not be recast as treatment response rates, because recruitment—not improvement in a clinical condition—is the primary endpoint.

The registry also reports a risk ratio of 1.0. In general, a risk ratio compares the proportions in two groups by division rather than subtraction. The reported ratio indicates equal values for the recruitment comparison as recorded. It does not convey a relative clinical benefit or harm. Both the risk difference and ratio depend on how the outcome is defined; the endpoint definition matters more than the label of the statistic.

How should the interval be read?

In general, a confidence interval describes a range of values compatible with the observed data under a statistical model and its assumptions. It communicates precision as well as the direction and scale of an estimate. The posted interval for the risk difference runs from 0.0 to 0.0. The registry record does not name the interval method or explain its construction. Since the reported arm-specific recruitment values are equal, the interval should be understood in that context rather than as a general guarantee of certainty about recruitment, study conduct, or clinical outcomes.

Randomized parallel-group allocation means participants were assigned to one of two groups intended to be compared. The registry says there was no masking. General statistical reasoning recognizes that masking can affect expectations and assessment, especially for outcomes that involve judgment or participant report. The record does not say whether outcome assessors were masked, or describe assessment procedures, so no stronger characterization can be made.

What do the planning assumptions mean?

The record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. In general, such sample-size planning asks how many participants per arm would be needed to detect a specified effect under stated assumptions. The illustrations are not observed power, and they are not evidence about what the original investigators planned. No numerical planning results or protocol justification are reported in the registry record.

Here the primary contrast is a recruitment measure and its reported risk difference is 0.0. Planning illustrations that scale an effect as a fraction of the observed effect need careful interpretation in that setting: they do not supply an independently established clinical effect to detect. They should not be treated as proof that the trial was adequately powered for clinical outcomes. The registry does not report a sample-size justification for an efficacy question, and no such justification can be inferred from a feasibility benchmark.

General statistical methods also depend on the analysis population, missing observations, outcome definitions, and model assumptions. For a recruitment count, key operational details could include how eligibility, consent, and randomization were defined, but these are not described in the available registry entries. The specific analysis population, missing-data procedures, and statistical plan are not reported in the registry record. Those omissions prevent evaluation of whether the posted comparison followed a prespecified approach.

10. Confidence Intervals and Precision

The primary recruitment count is reported as 24 participants, with 12 in each arm. The stated target was 24 participants to randomize, and the recorded total matches that target. The registry’s comparative summary reports a risk difference of 0.0, an interval from 0.0 to 0.0, and a risk ratio of 1.0. These figures describe equal recruitment values in the two groups, not the precision of an intervention effect on a health outcome.

As a general statistical concept, an interval estimate conveys the uncertainty associated with an estimate under a particular method and set of assumptions. A narrow interval can indicate greater precision for the quantity being estimated, but it cannot establish that the quantity is clinically important or that the study addressed a different question. Here, the endpoint is recruitment. The displayed interval’s zero width may reflect the particular comparison and calculation used, but the interval method is not reported in the registry record, so its construction cannot be assessed.

The equal arm counts are informative about the recorded allocation totals, but they do not quantify how many people were screened, declined, were ineligible, or withdrew. Those counts are not reported in the registry record. Nor does the recruitment interval characterize uncertainty about symptoms, mobility, safety outside the reported adverse-event figures, or longer-term outcomes. The registry reports no secondary results or analyses to assess those questions.

Precision must therefore be matched to the estimand—the quantity the analysis is intended to estimate. The reported values address recruitment in the randomized groups. They should not be used to claim precise knowledge of treatment effects. No confidence interval for a comparative clinical outcome is reported in the registry record.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures, but it reports no secondary results and no statistical analyses. The primary endpoint is recruitment. The registry record does not identify which outcomes were designated secondary, how many comparisons were planned, or whether any outcomes were exploratory. These details are not reported in the registry record.

As a general statistical issue, multiplicity arises when several hypotheses or outcomes are tested. Conducting multiple tests can increase the chance that at least one result appears noteworthy by chance, so prespecified outcomes and analysis plans help readers understand how results should be interpreted. The record does not report whether any multiplicity adjustment or hierarchy of outcomes was planned. Since secondary results are absent, the available information cannot support a review of multiplicity across clinical endpoints.

Missing-data methods and analysis populations are also not reported in the registry record. The recorded enrollment and arm counts do not show whether every randomized participant contributed to every outcome, or how withdrawals and incomplete assessments were handled. For recruitment, the total count is recorded, but the registry does not report screening, eligibility, consent, or retention counts that would give a fuller account of the enrollment pathway.

The fact that no secondary analyses are posted should not be interpreted as proof that none were performed. The registry record does not supply enough information to determine whether analyses were planned, completed, or omitted from the posted results. A prespecified statistical analysis plan, analysis population definitions, missing-data procedures, and any multiplicity strategy are not reported in the registry record.

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 lists 0 serious adverse events and 0 other adverse events in the MBWT arm, among 12 participants at risk. It reports the same figures for the FOG Education arm: 0 serious adverse events and 0 other adverse events among 12 at risk. Deaths are listed as 0 in both groups.

These are the event counts recorded in the registry. They do not establish that no adverse experiences occurred outside the registry’s reported categories, nor do they show how events were elicited, defined, reviewed, or followed over time. The adverse-event observation period and detailed collection methods are not reported in the registry record.

Zero recorded events in a group does not by itself establish that a treatment is safe, and equal zero counts do not provide a comparative estimate of safety. The trial enrolled 24 participants, so the reported safety figures should be read as a description of the events recorded in this study, not as a broad estimate for other settings or populations. No medical advice or safety conclusion beyond these posted counts follows from the registry figures.

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

The main result has a narrow, useful meaning: the registry records 24 participants enrolled against a stated recruitment target of 24 to randomize. The arm counts are 12 for MBWT and 12 for FOG Education. In that sense, the recorded recruitment count is consistent with meeting the feasibility benchmark.

That result does not establish whether mindfulness-based walking changes freezing of gait, mobility, anxiety, frustration, quality of life, or falls. Although those concerns motivate the intervention, the primary endpoint is recruitment, and no comparative clinical outcome results or statistical analyses are posted. The reported risk difference of 0.0 and risk ratio of 1.0 concern equal values in the recruitment comparison; they are not treatment-effect estimates for health outcomes.

The trial’s randomized design describes how participants were allocated, but design alone does not supply results for endpoints that are not reported. The record does not provide enough detail to assess adherence, acceptability, intervention fidelity, clinical outcomes, or follow-up. The listed zero adverse-event counts are descriptive and do not establish absence of risk.

Accordingly, the result supports a statement about the recruitment count recorded in this trial. It does not answer whether either program is more effective, whether the intervention is clinically meaningful, or whether findings would generalize beyond the enrolled participants. Those questions would require relevant outcome data and sufficient reporting of the methods and analyses.

14. Why This Trial Matters Statistically

Feasibility questions are important because a study can only evaluate clinical outcomes if it can recruit the intended participants. For a population defined by Parkinson disease and freezing of gait, the registry’s recruitment target and recorded enrollment provide a direct, concrete measure of one aspect of study conduct. The recorded enrollment matches the stated target, while the equal arm counts show how participants were distributed between the randomized groups.

Statistically, this example also illustrates why the endpoint must guide interpretation. A randomized comparison may produce a risk difference and risk ratio, but the meaning of those statistics depends on the event being compared. Here, the comparison concerns recruitment values rather than a clinical response. Reading the estimates as treatment effects would confuse the statistical scale with the clinical question.

The record also demonstrates the value of complete outcome reporting. Four outcome measures are listed, yet no secondary results or analyses appear in the registry. Without those details, readers cannot assess whether the trial collected additional feasibility or clinical information, or how it was analyzed. Clear reporting of planned outcomes, analysis populations, missing-data handling, and analysis methods would help distinguish recruitment success from other dimensions of feasibility and from clinical effectiveness.

The trial therefore matters statistically as a bounded feasibility result and as a reminder that a numerical comparison is not self-interpreting. The endpoint, design, and reporting determine what can reasonably be concluded.

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 endpoint is recruitment, so the posted result does not establish an effect on freezing of gait or another clinical outcome. Although the registry lists four outcome measures, no secondary results or analyses are posted. This leaves the clinical and broader feasibility questions unresolved in the registry record.

The trial enrolled 24 participants, with 12 in each arm. Those counts describe this study but do not, by themselves, show how recruitment proceeded or how representative enrolled participants were. Screening numbers, ineligibility counts, refusals, and withdrawal details are not reported in the registry record.

The study is listed as having no masking. The record does not specify whether outcome assessors were masked or detail the procedures used to assess outcomes. The randomization sequence, allocation concealment, adherence, intervention fidelity, and follow-up procedures are also not reported in the registry record. These omissions constrain assessment of potential bias and study conduct.

The risk difference is reported as 0.0 with an interval from 0.0 to 0.0, but the method used to calculate that interval is not described. It relates to the recruitment comparison and cannot establish precision for clinical effects. The record does not report a sample-size justification for a clinical efficacy question or an analysis plan. Finally, the zero adverse-event counts are limited to the registry’s reported categories and do not include enough detail about the observation period or collection methods to support broader safety conclusions.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Moving Mindfully for Freezing of Gait — NCT05923229.
• Registry record last updated 2025-06-17; status last verified 2025-05.
• Results first posted 2025-06-17.
• 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

NCT05923229 is a completed, randomized, parallel-group trial with no masking, sponsored by Washington University School of Medicine. The registry lists 24 participants enrolled: 12 assigned to Mindfulness-Based Walking Therapy and 12 assigned to Freezing of Gait education. The primary endpoint is recruitment over a 14-week timeframe, with a target of 24 participants to randomize.

The posted enrollment matches that recruitment target. The reported risk difference is 0.0, with an interval from 0.0 to 0.0, and the risk ratio is 1.0. These statistics describe the recruitment comparison, not clinical effects. The registry lists four outcome measures but no secondary results or statistical analyses. Serious adverse events, other adverse events, and deaths are each recorded as 0 in both arms. Further details about analysis methods, missing data, and clinical outcomes are not reported in the registry record.