This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Motor Imagery Intervention for Improving Gait and Cognition in the Elderly (NCT02762604), a randomized na study. The primary outcome is Change in Walking Speed During Single and Dual-task Walking Conditions.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02762604 |
| Phase | NA |
| Condition | Motor Activity |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 49 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Albert Einstein College of Medicine |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerns older adults. The registry reports enrollment of 49 participants and describes the primary-outcome analysis population as randomized participants with baseline measures. It does not give a more detailed age range or other eligibility characteristics in the record.
Intervention
The intervention was a phone-based imagined gait program. Participants were called by an experimenter three times a week and asked to imagine walking, talking, and walking while talking. The description also says participants rated visual and kinesthetic qualities of their images on a 1-5 scale, but the registry text ends before the full rating procedure is described.
Comparator
The comparison was a phone-based visual imagery program. Participants were called three times a week and asked to imagine concrete objects, with octopus, teapot, and shovel given as examples. They were asked to rate the visual qualities of their images; the registry description does not include the full details of that procedure.
Primary question
The primary outcome was change in walking speed during normal-pace walking and walking while talking, measured at baseline and 3 months. The question was whether the recorded mean change in gait speed differed between the imagined gait and visual imagery groups. The registry record does not report the numerical outcome estimates or a statistical comparison.
3. Trial Design
The registry identifies NCT02762604 as a completed, randomized, single-blind, parallel-group clinical trial. It lists the phase as not applicable and the condition as motor activity. Enrollment was 49. The sponsor was Albert Einstein College of Medicine. The recorded study start was 2017-10-16, and primary completion was 2022-06-21.
Participants were assigned to an imagined gait intervention or a visual imagery intervention. In the imagined gait group, the phone-based sessions involved imagining walking, talking, and walking while talking. In the comparator group, sessions involved imagining concrete objects. Both descriptions specify calls three times a week. The registry calls the study single-blind, but does not identify who was masked or explain how masking was maintained. The allocation method is listed as randomized; further details about sequence generation and allocation concealment are not reported in the registry record.
The primary outcome covered change in gait speed during normal-pace and walking-while-talking conditions. It was measured in centimeters per second at baseline and 3 months, using an instrumented pathway. The record lists several secondary outcomes, including cognitive performance during walking while talking, BOLD signal during dual-task imagined walking while talking, Trail Making Test measures, Letter Number Sequencing, Stroop interference, and a Flanker interference task.
The record lists 26 outcome measures and 23 analyses, but does not provide a complete statistical analysis plan in the information available. The reason for the enrollment target, whether there were interim analyses, and the details of the randomization procedure are not reported in the registry record. The trial is marked completed, but that status alone does not supply evidence about the 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: Randomization goal was 48 but two extra randomization slots were added as a buffer. Once 24 in each condition had been randomized, recruitment stopped, resulting in a total of 49 randomized participants.
Overall Study
| Stage | Imagined Gait Intervention | Visual Imagery Intervention |
|---|---|---|
| STARTED | 25 | 24 |
| COMPLETED | 22 | 14 |
| NOT COMPLETED | 3 | 10 |
Reasons for not completing this period:
| Reason | Imagined Gait Intervention | Visual Imagery Intervention |
|---|---|---|
| Lost to Follow-up | 2 | 7 |
| Study Suspension due to COVID pandemic | 1 | 3 |
Analysis population for the primary outcome, as defined in the registry: Overall number of participants analyzed includes all randomized participants with baseline measures. Data was unable to be analyzed for 14 participants in the Visual Imagery group due to a protocol deviation (incorrect intervention procedure).
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.
| Characteristic | Unit | Imagined Gait Intervention | Visual Imagery Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 25 | 24 | 49 | |
| Age, Continuous | years | 72.92 (SD 5.28) | 72.79 (SD 4.84) | 72.86 (SD 5.02) |
| Sex: Female, Male: Female | Participants | 8 | 9 | 17 |
| Sex: Female, Male: Male | Participants | 17 | 15 | 32 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 | 4 | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 | 19 | 39 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 10 | 6 | 16 |
| Race (NIH/OMB): White | Participants | 10 | 12 | 22 |
| Race (NIH/OMB): More than one race | Participants | 2 | 4 | 6 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 3 | 2 | 5 |
| Region of Enrollment: United States | participants | 25 | 24 | 49 |
| Years of Education | years | 15.60 (SD 3.06) | 16.52 (SD 2.95) | 16.04 (SD 3.01) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Walking Speed During Single and Dual-task Walking Conditions, measured over Baseline and 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | centimeters per second |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in walking speed, expressed as a mean in centimeters per second. The measure is based on walking at a normal pace and walking while talking, with assessments at baseline and 3 months. An instrumented pathway was used to measure gait speed. The registry defines a positive mean change as an increase in speed after intervention and a negative mean change as a decrease.
Walking speed is a continuous measure: it can take a range of values rather than only indicating whether an event occurred. A mean summarizes the central value of measurements in a group, while the standard deviation describes how spread out those measurements are around the mean. These summaries can describe both the average change and variation among participants, but do not show every individual trajectory.
Including normal-pace and walking-while-talking conditions makes the endpoint relevant to more than one walking context. The walking-while-talking condition also connects to the trial’s interest in mobility during a task involving cognition. The registry record does not provide results for either condition, the group-level mean changes, standard deviations, or a comparison between groups. It therefore does not establish the size or precision of any observed difference in the primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison of imagined gait training and visual imagery training, with walking-speed change as the primary outcome. It does not report the numerical primary-outcome results. In particular, the record contains no group means, standard deviations, confidence intervals, or test results for the change in gait speed. Without those estimates, the magnitude, direction, and precision of the primary comparison cannot be assessed from the registry information.
The outcome definition makes the direction of a mean change interpretable: positive values indicate an increase in gait speed after intervention, and negative values indicate a decrease. However, that definition is not itself evidence that either group experienced an increase or decrease. Nor does the description of the study hypothesis establish what the trial found. The investigators proposed that imagined walking might improve mobility and cognition; a hypothesis is a rationale for testing, not a result.
The registry describes two walking conditions, normal pace and walking while talking. It also records the primary outcome as having several categories or time points, rather than reducing it to one comparison. Since no category-specific estimates or analysis results are reported, it is not possible to tell whether findings differed by walking condition, or whether any one condition drove a group-level pattern.
The primary-outcome analysis population is described as including randomized participants with baseline measures. The record additionally states that data could not be analyzed for 14 participants in the Visual Imagery group because of a protocol deviation involving an incorrect intervention procedure. This is important context for interpreting any analysis, but the record does not give the full participant flow, the number analyzed in each group for each outcome, or the handling of missing measurements. The impact of this loss of data on the estimated comparison cannot be determined from the registry record.
The adverse-event entries are separate from the primary endpoint and should not be used as a substitute for efficacy results. The registry lists serious adverse events and other events by group, but does not report a statistical comparison of those events. In the same way, the presence of many secondary outcomes does not reveal whether the primary outcome met any prespecified criterion. The statistical analysis plan, including the analysis model and any adjustment for multiple outcomes, is not reported in the registry record.
Accordingly, the posted information supports a description of the design, endpoint, and certain data limitations, but not a conclusion about the estimated effect on walking speed. The absence of numerical primary results in the record should be distinguished from a finding of no difference: without the estimates and their uncertainty, neither a clear difference nor a lack of difference can be inferred.
9. Statistical Methods Explained
The trial has a randomized parallel-group design. In a parallel-group study, participants are assigned to an intervention group and remain in that group for comparison, rather than each participant receiving both study conditions in sequence. Random assignment is intended, in general, to support a fair comparison by reducing systematic differences between groups at the point of assignment. The registry lists randomization, but does not describe the sequence-generation method or whether assignment was concealed before enrollment.
What does a mean change describe?
The primary outcome is continuous and is summarized as a mean change in walking speed. A change score expresses how a measurement differs from baseline at a later assessment. The record specifies baseline and 3 months and identifies the unit as centimeters per second. It also states how to interpret the sign: a positive mean indicates an increase in speed after intervention, while a negative mean indicates a decrease. A mean is a group summary, not a statement that every participant changed in the same direction.
The standard deviation describes spread among observed values around the group mean. It is not the same as the uncertainty around the mean or around a difference between groups. A confidence interval, if reported, would convey a range of values compatible with the data and analysis under the method used. The registry record does not report standard deviations, confidence intervals, or other numerical summaries for the primary endpoint, so precision cannot be evaluated.
Why distinguish the two walking conditions?
Gait speed was assessed during normal-pace walking and walking while talking. These are distinct conditions and may yield separate measurements. A result for one condition cannot automatically be treated as a result for the other. The record describes the primary outcome across both conditions, but does not provide condition-specific estimates or explain how results across conditions were combined. It therefore does not support an interpretation of a single overall effect beyond the endpoint description.
What does the planning illustration mean?
The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says the effect considered for detection is a stated fraction of the observed effect. These are planning assumptions, not the trial’s own design justification. The registry does not report the trial’s sample-size rationale, and the numerical planning outputs are not reported in the registry record.
A sample-size illustration estimates how many participants per arm might be needed under specified assumptions. It is not an estimate of the probability that this completed trial found a true effect, and it is not observed power. Such an illustration depends on the effect chosen for planning and on assumptions about variability and analysis. Since the primary outcome estimates are not reported in the registry record, the planning exercise cannot be independently interpreted as evidence about the actual result.
Why can over-dispersion matter?
For count outcomes, over-dispersion means that the observed variability is greater than a simple model assumes. In general, ignoring over-dispersion can make uncertainty appear smaller than it is. This concept is not central to the primary endpoint here, which is continuous gait speed, and the registry does not report an over-dispersion analysis. It may be relevant to some count-based outcomes in other settings, but it should not be attributed to this trial’s analyses without a reported method.
What is missing about the analysis?
The registry does not describe the statistical model used for the primary comparison, whether baseline measurements were included as covariates, how repeated or condition-specific measurements were handled, or whether the analysis followed an intention-to-treat principle. It also does not state a primary hypothesis test or report a p-value. The sample-size planning significance level does not establish which threshold, if any, governed the final outcome analysis. These details matter because different analysis choices can affect estimates and their uncertainty.
Randomization supports the design of a group comparison, but does not by itself resolve missing data, protocol deviations, or multiple testing. Interpretation requires the endpoint estimates, their uncertainty, the analyzed populations, and enough information about the analysis to understand how those estimates were produced. Those elements are not reported for the primary endpoint in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The trial lists multiple outcome measures and analyses: 26 outcome measures and 23 analyses. The secondary outcomes include cognitive performance during walking while talking, BOLD signal during dual-task imagined walking while talking, Trail Making Test Form A and Form B, the difference between those Trail Making forms, Letter Number Sequencing, Stroop interference, and the Flanker interference task. The registry does not explain how these outcomes were prioritized for statistical testing or whether multiplicity adjustments were planned.
In general, testing many outcomes can increase the chance of at least one apparently unusual result, even when there is no underlying effect. A prespecified hierarchy or adjustment can help address that issue, but the statistical plan and any adjustment are not reported in the registry record. The planning illustration’s two-sided significance level of 0.05 should not be read as evidence of the threshold used for the trial’s outcome analyses.
For the primary outcome, the registry says that data could not be analyzed for 14 participants in the Visual Imagery group because of a protocol deviation involving an incorrect intervention procedure. The stated analysis population includes randomized participants with baseline measures. The record does not give the complete flow from randomization to analysis, the number contributing to each outcome, or the method used to handle missing follow-up measurements. It also does not report whether missingness was addressed through imputation, a model-based approach, or another method.
These omissions limit assessment of how representative the analyzed data are of all randomized participants and how robust the estimates might be to missingness. The registry does not report an analysis population definition beyond the baseline-measure description, nor does it describe sensitivity analyses. Thus, the scope and consequences of the missing data and protocol deviation cannot be determined from the posted information.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Imagined Gait Intervention | 0 | 25 | 0.0% |
| Visual Imagery Intervention | 1 | 24 | 4.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Imagined Gait Intervention | 0 of 25 |
| Visual Imagery Intervention | 0 of 24 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Imagined Gait Intervention | 5 of 25 |
| Visual Imagery Intervention | 11 of 24 |
Most frequent serious adverse event terms
| Event term | Organ system | Imagined Gait Intervention | Visual Imagery Intervention |
|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 25 | 1 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Imagined Gait Intervention | Visual Imagery Intervention |
|---|---|---|---|
| Back/shoulder pain | Musculoskeletal and connective tissue disorders | 3 of 25 | 1 of 24 |
| Fall | Musculoskeletal and connective tissue disorders | 1 of 25 | 2 of 24 |
| Arthritis | Musculoskeletal and connective tissue disorders | 0 of 25 | 2 of 24 |
| Pain in lower extremities | Musculoskeletal and connective tissue disorders | 1 of 25 | 1 of 24 |
| Anemia | Blood and lymphatic system disorders | 0 of 25 | 1 of 24 |
| Tinnitus | Ear and labyrinth disorders | 0 of 25 | 1 of 24 |
| Pain in upper extremities | Musculoskeletal and connective tissue disorders | 0 of 25 | 1 of 24 |
| Enlarged prostate | Reproductive system and breast disorders | 0 of 25 | 1 of 24 |
| Dizziness | Ear and labyrinth disorders | 0 of 25 | 1 of 24 |
Serious events with the highest arm-level rate: pneumonia (4.2%).
The registry lists serious adverse events for the Imagined Gait Intervention group as 0 affected participants among 25 at risk, and for the Visual Imagery Intervention group as 1 among 24. Deaths are listed as 0 in both groups. These are event counts and denominators recorded in the registry; they do not by themselves establish whether an event was caused by an intervention.
For other adverse events, the record lists 5 affected participants among 25 at risk in the Imagined Gait Intervention group and 11 among 24 at risk in the Visual Imagery Intervention group. These figures are descriptive. The record does not provide a statistical comparison, event-level timing, severity categories for these other events, or an assessment of causal relationship. The counts should therefore not be interpreted as a demonstrated difference in risk.
Pneumonia is listed among the top serious adverse-event terms at 4.2%. The registry excerpt does not identify the group associated with that term or provide further context for the percentage. Serious events and other events are distinct categories in the record, and they should not be combined. Small event counts can be imprecise summaries; the record does not report uncertainty intervals for these safety figures.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed as a randomized comparison of a phone-based imagined gait intervention with a phone-based visual imagery intervention. It identifies change in walking speed during normal-pace and walking-while-talking conditions as the primary outcome, measured from baseline to 3 months. It also describes several cognitive and imaging-related secondary outcomes, as well as adverse-event counts.
Those design details do not answer whether the interventions differed in the primary outcome. The record does not report the mean changes, their variability, an estimate of the between-group difference, confidence intervals, or test results. Without these statistics, the size and precision of the primary comparison are unknown from the registry record. It is not appropriate to infer a benefit, a lack of benefit, or equivalence from the absence of a posted estimate.
The trial’s stated hypothesis is that imagined walking might be used as a rehabilitative tool because it engages neural systems related to walking and cognition. That rationale explains why the question was studied, but it does not demonstrate that the proposed mechanism occurred or that an outcome changed. The listed secondary outcomes also do not establish a cognitive effect in the absence of their numerical results and analysis details.
The record notes that data from 14 participants in the Visual Imagery group could not be analyzed for the primary outcome because of a protocol deviation. This could affect how closely the analyzed comparison represents the randomized groups, but the available information is insufficient to determine the extent of any effect. More detail about participant flow and missing-data handling would be needed for that assessment.
The safety counts describe recorded events in each group, not proof of causation or a complete comparison of safety. Overall, the posted information supports a careful description of the trial’s design and reporting gaps. It does not support a conclusion about the direction, magnitude, or clinical importance of the primary outcome.
13. Why This Trial Matters Statistically
This trial asks a statistical question that links a behavioral training approach with a measurable mobility outcome. Its primary measure is continuous walking speed, and it distinguishes normal-pace walking from walking while talking. That endpoint structure matters because the interpretation may depend on which condition is being considered and how the study combined or analyzed those measurements. The registry describes the conditions but does not report estimates for either one.
The randomized parallel design is relevant to the intended group comparison. At the same time, the registry’s note that 14 participants in the Visual Imagery group could not contribute primary-outcome data because of a protocol deviation highlights why analysis populations and missing-data procedures matter. Random assignment does not remove the need to report who was analyzed and how unavailable measurements were handled.
The trial also includes a broad set of secondary outcomes spanning cognitive performance, executive-function tests, and BOLD signal during an imagined dual-task condition. A broad outcome set can be scientifically informative, but it makes transparent outcome prioritization and multiplicity methods important. The record does not describe those methods, so it is not possible to judge how secondary findings would have been interpreted alongside the primary endpoint.
Finally, the registry distinguishes a planning illustration from the trial’s own design rationale. The stated planning assumptions are not a substitute for the outcome estimates and their uncertainty. Without those results, readers cannot assess the observed effect or its precision. The statistical importance of this record lies both in the structured design question and in the limits imposed by incomplete reporting of the primary analysis.
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 consequential limitation in the registry record is the absence of numerical results for the primary outcome. No group-level mean changes, standard deviations, between-group estimate, confidence intervals, or statistical test results are reported. The primary outcome includes normal-pace and walking-while-talking conditions, but the record does not provide results for each condition or explain how the multiple categories were handled analytically.
The record states that 14 participants in the Visual Imagery group could not be analyzed for the primary outcome because of a protocol deviation involving an incorrect intervention procedure. It does not describe the full participant flow, the number analyzed for each endpoint, or how missing data were handled. This prevents assessment of the potential influence of unavailable outcome data on the comparison.
Several design and analysis details are also absent. The registry does not identify who was masked, describe the randomization sequence or allocation concealment, state the rationale for the enrollment target, or provide the complete statistical analysis plan. It does not report whether interim analyses were conducted, how the multiple outcomes were addressed, or whether sensitivity analyses were used. These details are not established by the completed status of the trial.
The intervention descriptions are incomplete in the registry text: both describe phone-based sessions three times a week, but the rating-scale descriptions end before all procedural details are given. The record also does not provide detailed eligibility criteria in the information available. These reporting limitations constrain interpretation of implementation and generalizability, in addition to the uncertainty about the unreported outcome results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Motor Imagery Intervention for Improving Gait and Cognition in the Elderly — NCT02762604.
- Registry record last updated 2024-06-04; status last verified 2024-06.
- Results first posted 2024-06-04.
- 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.
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18. Record Summary
NCT02762604 is a completed, randomized, single-blind, parallel-group trial sponsored by Albert Einstein College of Medicine, with enrollment of 49. It compared phone-based imagined gait training with phone-based visual imagery training. The primary outcome was mean change in walking speed during normal-pace and walking-while-talking conditions, measured in centimeters per second at baseline and 3 months using an instrumented pathway.
The registry lists cognitive and imaging-related secondary outcomes, as well as adverse-event counts. It reports that primary-outcome data could not be analyzed for 14 participants in the Visual Imagery group because of a protocol deviation. Numerical primary-outcome results and key analysis details are not reported in the registry record. The study’s listed dates are start on 2017-10-16 and primary completion on 2022-06-21.