"Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?": Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for "Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?" (NCT03403400), a randomized na study. The primary outcome is Modified Clinical Test of Sensory Integration for Balance (mCTSIB).

2. Clinical Question

The stated purpose has two parts. One is to evaluate walking as an exercise component of vestibular rehabilitation using primary outcomes listed as mCTSIB, TUG, DGI, and DHI. The other is to assess whether pedometers increase adherence to a walking program among older adults with vestibular issues. The description identifies IPAQ Walking MET-minutes/week and IPAQ Total Physical Activity as measures for the physical-activity question.

The detailed primary outcome information in the record concerns change in mCTSIB from up to week 9 of treatment to up to 16 weeks of treatment. The registry also lists total number of visits and length of interventions in weeks as secondary outcomes. Numerical results for these outcomes are not reported in the registry record, so the stated research questions can be described, but their answers cannot be determined from the available results.

3. Trial Design

The registry identifies this as a randomized, parallel-group study with no masking. It is marked completed, with enrollment listed as 17. The study start date is 2018-07-18, and primary completion is recorded as 2019-09-05. The phase is listed as NA, and AdventHealth is named as the sponsor.

The arm descriptions identify three groups: vestibular rehabilitation with walking and a pedometer (VRWP), vestibular rehabilitation with walking without a pedometer (VRW), and vestibular rehabilitation alone (VR). The intervention entries name the VRWP and VRW behavioral interventions. The VR group is described in the arm information as the control group, receiving conventional vestibular rehabilitation without encouragement of walking or walking specified in the home exercise program. The registry’s detailed mCTSIB description presents pretest and posttest means for VR, VRWP, and VRW, and also describes a combined prescribed-walking group formed from VRWP and VRW data.

Random assignment is intended to make treatment groups comparable on average, but a small enrollment can leave meaningful differences between groups by chance. The record does not report the randomization method, concealment procedures, or allocation ratio. It also does not report whether the analyses followed the assigned groups regardless of adherence, or whether participants changed groups or discontinued treatment.

No masking is recorded. For behavioral interventions such as walking programs, participants and treating personnel may be aware of the assigned program, but the registry record does not describe who knew assignment or whether outcome assessors were masked. Details of treatment delivery, adherence, and the timing of assessments beyond the stated mCTSIB timeframe are 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.

Before assignment: After the subject signed the informed consent, the study coordinator was notified by the research staff to conduct a retrospective chart review of the medical record of the subject. Based on the retrospective chart review, the study coordinator determined if the subject was eligible to participate in the study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Pretest and posttest means of VR (n=5), VRWP (n=4) and VRW (n=6) were presented. Another arm was added combining VRWP and VRW data into a group representing prescribed walking (n=10)

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 Modified Clinical Test of Sensory Integration for Balance (mCTSIB), measured over Change from up to week 9 of treatment to up to 16 weeks of treatment.

The Modified Clinical Test of Sensory Integration for Balance (mCTSIB) is a timed measure intended to assess how effectively a person uses somatosensory, visual, and vestibular information for postural stability. The registry describes four test conditions: standing on a firm surface with eyes open, standing on a firm surface with eyes closed, standing on a compliant surface with eyes open, and standing on a compliant surface with eyes closed. The test uses feet together, and the record notes that it omits the visual-conflict conditions in the original CTSIB.

In the registry description, each condition is timed for 30 seconds and the average score of three trials is obtained. The stated unit is seconds, and the outcome is described as a mean with standard deviation. The specified timeframe is change from up to week 9 of treatment to up to 16 weeks of treatment.

This measure is relevant to the study question because walking is being evaluated as part of vestibular rehabilitation, and postural stability is one of the intended areas of assessment. A timed balance measure can describe performance under different combinations of sensory conditions. It does not, by itself, establish whether a change is meaningful to participants or whether it reflects effects on falls, daily function, or participation. The registry record does not report numerical mCTSIB estimates or a threshold for interpreting change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Several statistical ideas help interpret a randomized study of continuous outcomes such as mCTSIB time. They can clarify what kinds of evidence would be useful, but the registry record does not report a complete statistical analysis plan or numerical outcome estimates.

What does a mean represent?

A mean is a measure of the central value of observations. For a continuous measure such as mCTSIB time, a group mean can describe average performance in that group at a specified assessment. The record identifies the outcome parameter as MEAN and its dispersion as standard deviation. A standard deviation describes how spread out individual observations are around the group mean. It is not the same as the uncertainty in the estimated mean: uncertainty also depends on the amount of information available and the analysis method.

The registry describes pretest and posttest means for each named group. A pretest-to-posttest change can be summarized within a group, but the intervention question generally concerns how outcomes differ between assigned groups. A comparison of changes between groups is distinct from asking whether each group changed from its own baseline. The statistical method used to make that comparison is not reported in the registry record.

Why does randomization matter?

Randomization assigns participants to groups by chance. In general, this helps limit systematic differences in baseline characteristics and supports a causal interpretation of between-group comparisons, provided that assignment and follow-up are handled appropriately. Randomization does not guarantee that groups will be similar in every characteristic, especially when enrollment is limited. The registry identifies the study as randomized but does not report the sequence-generation or allocation-concealment methods.

The study is described as parallel-group and unmasked. In a parallel design, participants remain in assigned groups for comparison rather than crossing over between treatments. Lack of masking can matter when outcomes involve participant effort, subjective reporting, or decisions made during treatment. The mCTSIB is described as a timed balance test, but the record does not state whether assessors were masked or how test administration was standardized across groups.

How should precision be assessed?

In general, confidence intervals communicate the uncertainty around an estimated effect. They are more informative than a point estimate alone because they show the range of effects compatible with the data under the interval method. A narrow interval indicates greater precision than a wide one. A confidence interval also helps readers assess whether the data are compatible with effects that might be considered important, but such judgments require an appropriate clinical interpretation. No confidence intervals for the outcomes are reported in the registry record.

In general, a p-value summarizes how unusual the observed data would be under a specified statistical model and null hypothesis. It does not say how large an effect is, whether it matters to participants, or how likely the null hypothesis is to be true. The registry record does not report p-values for the outcomes.

What does the planning information mean?

The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, 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 planning values are expressed as participants per arm for 80% power or other stated planning levels. The numerical planning outputs and the effect values used are not reported in the registry record. These illustrations are planning calculations, not evidence that the completed study had a particular probability of detecting an effect. They are not observed power.

Planning based on an observed effect can be sensitive to how that effect was estimated. An effect estimated imprecisely in a small study may not provide a stable basis for planning a future study. Planning values also depend on the assumptions used, including the target effect, significance level, allocation, and statistical approximation. The record does not report the trial’s original sample-size justification, so the planning illustration should not be treated as the original design rationale.

Does over-dispersion apply?

In general, over-dispersion describes variability greater than a statistical model expects, often in count outcomes. It can make standard errors too small if the model does not account for the extra variation. The primary measure described in detail is continuous, expressed in seconds, so over-dispersion is not the central issue for interpreting that measure. The record does not report the analysis models used for the other outcomes or any diagnostics for model assumptions.

These concepts identify information needed for a full statistical reading: the outcome estimates, their uncertainty, the prespecified comparison, the analysis population, and the handling of missing observations. Those details are not reported in the registry record for the results described.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists several primary outcomes: mCTSIB, TUG test, DGI, and DHI. It also identifies secondary outcomes of total number of visits and length of interventions in weeks, and describes physical-activity measures for the adherence question. Testing multiple outcomes or comparisons can increase the chance of at least one apparently notable result arising by chance. Statistical approaches to address this can include prespecifying a primary comparison, adjusting for multiple testing, or interpreting results as exploratory. The registry record does not report a multiplicity strategy or identify how the several listed primary outcomes were prioritized for statistical inference.

The record notes that the primary outcome has several categories or time points and was not reduced to one comparison. This means a single summary comparison cannot be inferred from the available outcome description. The mCTSIB timeframe is described, but the analysis contrast, handling of the different test conditions, and any choice among outcome time points are not reported in the registry record.

Missing-data handling is also not reported. The record does not describe how missing assessments, missed visits, withdrawals, or incomplete physical-activity questionnaires were addressed. It does not state whether analyses used all randomized participants, only participants with observed outcomes, or another analysis population. These choices can affect interpretation, especially when the available outcome observations differ from the participants originally assigned to groups.

The available information does not establish whether interim analyses were conducted, whether there were protocol deviations, or whether a prespecified statistical analysis plan governed the reported comparisons. Each of those details is not reported in the registry record. Without these details, readers cannot assess how multiplicity, missing observations, or analysis-population choices may have influenced the results.

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 adverse-event information lists VRWP, VRW, and VR groups. For each listed group, the registry reports zero serious adverse events, zero other adverse events, and zero deaths. The listed at-risk counts are 5 for VRWP, 6 for VRW, and 6 for VR. These figures describe the registry’s reported safety entries for the groups and categories; they do not provide detailed event narratives or information about how events were collected.

Zero reported events should be read as no events recorded in those listed categories, not as proof that no adverse experiences occurred. The registry record does not report the surveillance procedures, definitions used for adverse events, duration of safety follow-up, or whether all participants had complete safety information. The record also does not provide information about events that may not have met the reporting categories.

Safety counts are separate from evidence about the study’s balance or dizziness outcomes. They do not establish whether walking or vestibular rehabilitation changed those outcomes. Because the registry record does not give further safety-collection details, the figures are best interpreted narrowly as the reported counts for serious events, other events, and deaths in the listed groups.

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

The registry describes a randomized comparison involving vestibular rehabilitation with prescribed walking, with and without a pedometer, and a vestibular-rehabilitation-only control group. It identifies balance, dizziness-related, physical-activity, and intervention-use outcomes as relevant to the study aims. It also describes the mCTSIB measure and its assessment timeframe.

What the registry information does not establish is whether any group had better outcomes, whether groups differed, or how precise any estimated difference might be. Numerical outcome estimates, confidence intervals, and p-values are not reported in the registry record. The mCTSIB group description indicates that means were presented, but the values themselves are not included in the record information described. Numerical results for the other listed outcomes are also not reported.

The listed safety entries show zero reported serious adverse events, zero other adverse events, and zero deaths in each named group. These counts are limited to the registry’s entries and should not be interpreted as proof that all possible adverse experiences were absent.

The enrollment listed as 17 and the mCTSIB group summaries give context for the scale of the study, but they do not resolve the absence of outcome estimates or participant-flow details. The registry record does not report the original sample-size justification, analysis populations, missing-data methods, or multiplicity approach. Those omissions limit assessment of how the study was planned and how the reported outcome summaries should be interpreted.

Overall, the registry record supports a description of the study question, design, and measurement approach. It does not support a conclusion about the direction, magnitude, or clinical relevance of treatment effects. The stated aims should therefore be distinguished from demonstrated findings: an aim to evaluate walking or pedometer monitoring is not, by itself, evidence that either changed the outcomes.

13. Why This Trial Matters Statistically

This trial is statistically interesting because it separates two questions that can otherwise be conflated: whether prescribed walking adds to vestibular rehabilitation, and whether pedometer monitoring changes engagement with walking. The VRWP and VRW descriptions address walking with and without a pedometer, while the VR group provides a vestibular-rehabilitation-only comparison. A design that distinguishes these components can, in principle, help clarify which part of a program is associated with measured outcomes.

The study also links a balance measure to broader questions about dizziness and activity. The mCTSIB assesses timed balance performance under different sensory conditions, while the stated adherence question uses IPAQ physical-activity measures. These outcomes represent different constructs. A difference in one would not automatically establish a difference in the others, and outcome-specific estimates are needed to evaluate each question.

Several statistical features are important for interpreting such a study: a randomized design, a parallel structure, multiple listed outcomes, and a limited enrollment. Randomization can support fair comparisons, but it does not remove uncertainty from a small study or substitute for reporting the estimated effects and their precision. Multiple outcomes also make it important to understand which comparisons were prioritized and how the analysis addressed multiplicity.

The registry record does not report numerical results, uncertainty estimates, or the statistical plan needed to judge those issues. Consequently, the study’s questions and measurement choices can be examined, but its result cannot be evaluated from the information recorded. This distinction matters: a well-defined research question and a completed randomized study do not, on their own, establish an effect.

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 most immediate limitation for interpretation is that numerical results for the listed outcomes are not reported in the registry record. The record describes mCTSIB group means as presented but does not include their values. It also does not report numerical estimates for TUG, DGI, DHI, physical-activity measures, total visits, or intervention length. Without estimates and measures of uncertainty, the size and precision of any group differences cannot be assessed.

The registry describes multiple primary outcomes and states that the primary outcome has several categories or time points, without reducing it to one comparison. The statistical plan for selecting or comparing these outcomes is not reported in the registry record. The approach to multiplicity, missing outcome data, and analysis populations is also not reported, so the potential impact of those decisions cannot be evaluated.

Although the study is identified as randomized and unmasked, details of random-sequence generation, allocation concealment, assessor masking, treatment adherence, and participant flow are not reported in the registry record. The detailed mCTSIB group summaries are not a substitute for a complete account of enrollment and follow-up. The record also does not report eligibility criteria in detail or explain the original sample-size justification.

The listed safety counts contain no reported events in the named categories, but the registry does not describe how adverse events were collected or the completeness of safety follow-up. These limitations are specific to interpreting the information recorded for this study; they do not establish that the study methods were inadequate, only that the relevant details are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: "Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?" — NCT03403400.
• Registry record last updated 2020-07-02; status last verified 2020-06.
• Results first posted 2020-07-02.
• 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

NCT03403400 is a completed randomized, unmasked, parallel-group study sponsored by AdventHealth. Enrollment is listed as 17. The study start date is 2018-07-18, and primary completion is recorded as 2019-09-05. The registry identifies vestibular rehabilitation with walking and a pedometer, walking without a pedometer, and vestibular rehabilitation alone in its arm descriptions.

The record lists mCTSIB, TUG, DGI, and DHI as primary outcomes and total visits and intervention length as secondary outcomes. It gives a detailed description of mCTSIB and names IPAQ measures for the physical-activity and adherence question. Numerical outcome estimates and the statistical analysis plan are not reported in the registry record. The safety entries list zero serious adverse events, zero other adverse events, and zero deaths in each named group.