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 Cognitive Remediation to Improve Mobility in Sedentary Seniors (NCT02567227), a randomized na study. The primary outcome is Change in Walking Speed During Single and Dual-task Conditions..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02567227 |
| Phase | NA |
| Condition | Mobility Limitation, Motor Activity, Difficulty Walking |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 383 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Albert Einstein College of Medicine |
| Results posted | Yes |
2. Clinical Question
Population
Sedentary seniors at risk for mobility limitation. The primary analysis description covers randomized participants, with participants diagnosed with dementia excluded post-hoc.
Intervention
An individualized computerized cognitive remediation program.
Comparator
Individualized computer-based exposure and interactive health education classes, described as active control.
Primary question
Did change in walking speed differ between the groups during normal-pace walking and walking while talking, from baseline to 2 months?
The trial’s stated hypothesis was that executive functions would respond to cognitive remediation and, in turn, enhance locomotion. The registry describes a clinical question about whether a cognitive intervention is associated with a difference in walking-speed change relative to an active control, under both single-task and dual-task walking conditions.
The intervention and comparator were both individualized and computer based, but the registry describes their content differently. That makes the comparison one between cognitive remediation and an active educational control, not simply between receiving an intervention and receiving no contact. The primary outcome description identifies walking speed as the target measure and the two walking conditions as distinct contexts in which it was assessed.
The registry record does not report the numerical primary outcome results. It therefore does not establish the direction, size, or precision of any between-group difference. The question can be described from the registered objective and outcome, but the result cannot be interpreted from those descriptions alone.
3. Trial Design
The registry identifies this as a randomized, single-blind, parallel-group trial. Participants were assigned to Cognitive Remediation or Active Control. Enrollment was 383. The sponsor was Albert Einstein College of Medicine. The trial status is completed; the recorded start was 2016-03 and the primary completion was 2020-06.
The Cognitive Remediation arm received an individualized computerized cognitive remediation program. The Active Control arm received individualized computer-based exposure and interactive health education classes. The registry does not report which people were masked, so “single-blind” should not be interpreted as identifying a particular masked role.
The primary outcome was change in walking speed during single- and dual-task conditions, measured in centimeters per second. The outcome description gives baseline and 2 months as the measurement timeframe. Walking speed was measured during normal-pace walking and walking while talking using an instrumented GAITRite® electronic walkway system.
The primary analysis population is described as including all randomized participants, with participants diagnosed with dementia excluded post-hoc. The description lists n=6 in Experimental and n=5 in Active Comparator as excluded. The registry record does not report further details about the randomization procedure, allocation concealment, masking procedures, or the timing and basis of the post-hoc exclusions.
Secondary outcomes include the Short Physical Performance Battery, stride length, gait variability and gait domains, gait-speed change categories, and cognitive tests. The registry lists 25 outcome measures and 28 analyses. Those counts indicate that several outcomes or analyses were registered, but do not, on their own, specify how results were prioritized or adjusted for multiple testing.
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.
9 Weeks
| Stage | Cognitive Remediation | Active Control |
|---|---|---|
| STARTED | 192 | 191 |
| COMPLETED | 158 | 167 |
| NOT COMPLETED | 34 | 24 |
Reasons for not completing this period:
| Reason | Cognitive Remediation | Active Control |
|---|---|---|
| Adverse Event | 5 | 5 |
| Withdrawal by Subject | 18 | 8 |
| Study suspended due to COVID-19 pandemic | 11 | 11 |
6 Month
| Stage | Cognitive Remediation | Active Control |
|---|---|---|
| STARTED | 158 | 167 |
| COMPLETED | 113 | 127 |
| NOT COMPLETED | 45 | 40 |
Reasons for not completing this period:
| Reason | Cognitive Remediation | Active Control |
|---|---|---|
| Death | 2 | 0 |
| Lost to Follow-up | 43 | 40 |
12 Months
| Stage | Cognitive Remediation | Active Control |
|---|---|---|
| STARTED | 113 | 127 |
| COMPLETED | 82 | 93 |
| NOT COMPLETED | 31 | 34 |
Reasons for not completing this period:
| Reason | Cognitive Remediation | Active Control |
|---|---|---|
| Lost to Follow-up | 31 | 32 |
| Death | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator).
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.
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator)
| Characteristic | Unit | Cognitive Remediation | Active Control | Total |
|---|---|---|---|---|
| Participants analysed | 186 | 186 | 372 | |
| Age, Continuous | years | 76.94 (SD 5.66) | 77.18 (SD 5.61) | 77.03 (SD 5.61) |
| Sex: Female, Male: Female | Participants | 135 | 136 | 271 |
| Sex: Female, Male: Male | Participants | 51 | 50 | 101 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 28 | 34 | 62 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 151 | 142 | 293 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 7 | 10 | 17 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 5 | 6 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 93 | 90 | 183 |
| Race (NIH/OMB): White | Participants | 57 | 47 | 104 |
| Race (NIH/OMB): More than one race | Participants | 28 | 34 | 62 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 7 | 10 | 17 |
| Region of Enrollment: United States | participants | 186 | 186 | 372 |
| Gait Speed, cm/s | centimeters per second | 75.82 (SD 17.73) | 75.92 (SD 16.81) | 75.87 (SD 17.25) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Walking Speed During Single and Dual-task Conditions., measured over Baseline and 2 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Error |
| Unit | centimeters per second |
| Endpoint classification | Continuous Endpoint |
The primary endpoint concerns change in walking speed, measured in centimeters per second, between baseline and 2 months. It covers normal-pace walking and walking while talking. The registry describes the target comparison as the between-group difference in change for each arm and condition, with walking speed assessed using an instrumented walkway.
Walking speed is a continuous measure: it can take a range of values rather than being limited to an event/no-event classification. A change score focuses on how a participant’s measured speed differs across the stated assessment times. Comparing change between randomized groups is intended to distinguish the groups’ average trajectories, rather than treating a single follow-up measurement as the entire outcome.
Including normal-pace and walking-while-talking conditions allows the registered question to address walking under two task demands. The registry names these conditions but does not provide a numerical result for either one. It also does not report the operational details of the walkway assessment beyond naming the GAITRite® electronic walkway system.
The registry identifies the endpoint parameter as a mean and its dispersion as a standard error. A mean describes the average measured outcome in a group; a standard error describes uncertainty in an estimated mean. The primary outcome description contains several conditions and time points and is not reduced to one comparison in the registry record. No numerical estimate, standard error, confidence interval, or test result for the primary endpoint is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial record establishes the design and the intended primary comparison, but it does not report the numerical primary outcome findings. In particular, the registry record does not report the between-group changes in walking speed, their uncertainty, or a statistical test for the primary outcome. The direction and magnitude of the result, and how precisely it was estimated, therefore cannot be determined from the registry information.
The primary endpoint includes normal-pace walking and walking while talking, measured from baseline to 2 months. Since the outcome description has several conditions and time points, a single summary number would not necessarily capture all of the registered comparisons. The registry record does not state a rule for selecting among these comparisons or identify a single result as the sole estimate to interpret.
As a general statistical explanation, an estimate describes the observed contrast, while a confidence interval describes the range of values compatible with the data under the method used. A narrow interval indicates greater precision than a wide interval, but precision is not the same as importance. Neither an estimate nor its interval is reported for the primary outcome in the registry record, so no such assessment is possible.
The registered hypothesis connects cognitive remediation with executive function and locomotion. The listed primary outcome directly concerns walking speed, while several secondary outcomes concern physical performance, gait characteristics, or cognitive tests. The registry record does not report results that would establish whether changes in cognitive measures were associated with changes in walking speed, nor does it report a mediation analysis. The proposed link in the hypothesis should therefore be read as a rationale, not as a demonstrated mechanism.
The posted adverse-event figures describe events and deaths in each arm, but they do not supply the missing primary efficacy estimates. Safety counts and efficacy outcomes answer different questions and should not be combined into a judgment about the walking-speed contrast.
The sample-size assumptions describe a planning illustration based on an observed effect. Such an illustration is not observed power and does not replace an estimate of the outcome with its uncertainty. The registry record does not report the trial’s own sample-size justification or the numerical planning results.
Overall, the registry supports a description of what was compared and how the primary outcome was defined. It does not support a conclusion about the size, direction, statistical uncertainty, or practical meaning of the primary between-group result.
9. Statistical Methods Explained
The registry describes the primary parameter as a mean and the dispersion as a standard error. These terms distinguish the target summary from the uncertainty around its estimate. The mean is an average of measured walking speeds or changes. The standard error reflects the sampling uncertainty of an estimated mean; it is not the spread of individual participants’ measurements. The registry record does not report the numerical means or standard errors for the primary outcome.
What does a change comparison represent?
The primary outcome description focuses on between-group differences in change. In general, a change comparison asks how the average measurement shifts between assessment times in one group and compares that shift with the average shift in another group. Random assignment is intended to make groups comparable on average at the outset, although it does not guarantee that every characteristic is balanced in a particular trial. The registry record does not report the detailed statistical model or adjustment variables used for this endpoint.
Walking speed is assessed during normal-pace walking and while talking. These are distinct conditions, so an estimate for one condition need not describe the other. As a general point, when an outcome is measured repeatedly or under more than one condition, analysis choices should account for the structure of those measurements. The registry record does not report whether the conditions were analyzed jointly, separately, or through a model that accounts for within-participant correlation.
How should uncertainty be read?
As a general statistical explanation, a confidence interval gives an interval of plausible values for an estimated quantity under the assumptions of the analysis. Its width conveys precision, and its endpoints help show which effect sizes remain compatible with the data. A p-value, when reported, measures how unusual data at least as inconsistent with a specified null hypothesis would be under that hypothesis and the model assumptions. Neither a p-value nor a confidence interval alone describes the clinical importance of an effect. The registry record does not report the primary outcome confidence intervals or p-values.
The registry identifies standard error as the dispersion measure, but a standard error is not itself a confidence interval. General methods can use a standard error to quantify uncertainty, but the exact calculation depends on the analysis and its assumptions. Since the primary estimates and analysis details are not reported in the registry record, no interval can be reconstructed or interpreted from the listed endpoint description.
Why can several outcome comparisons complicate interpretation?
The primary endpoint covers two walking conditions and multiple assessment times, and the registry lists secondary outcomes and analyses. As a general statistical issue, conducting many tests can increase the chance that at least one result appears noteworthy by chance. A prespecified testing strategy, outcome hierarchy, or multiplicity adjustment can help define how to interpret a family of comparisons. The registry record does not report a multiplicity strategy, a testing hierarchy, or whether any adjustment was used.
In general, over-dispersion means that observed variability is greater than a model expects. If a model assumes less variability than is present, its uncertainty estimates can be too small and tests can be misleading. This concept is relevant when choosing models for outcomes whose variability does not match a simple model, but the registry record does not identify over-dispersion as an issue or report a model for which it was assessed. The primary outcome is described as a continuous mean measure, so no specific over-dispersion claim can be made from the record.
What do the planning assumptions mean?
The sample-size assumptions state that the planning illustration uses a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. The record says that time-to-event planning tables use total events and other planning tables use participants per arm. These are planning conventions, not observed trial outcomes. The record explicitly describes the illustration as based on the observed effect and not as the trial’s own design. It does not report the trial’s sample-size justification. A planning illustration should not be interpreted as observed power or as evidence that an effect was or was not detected.
The registry record does not report a complete statistical analysis plan, including the precise primary model, handling of missing measurements, confidence-interval method, or multiplicity approach. Without those details and the numerical outcome results, a methods-based reanalysis cannot establish the primary finding.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome involves walking speed in normal-pace and walking-while-talking conditions, measured at baseline and 2 months. The registry description therefore contains more than one condition and time point, and it states that the primary outcome has several categories or time points and is not reduced to one comparison. The record lists 25 outcome measures and 28 analyses, including secondary physical-performance, gait, and cognitive outcomes.
As a general statistical matter, multiple comparisons create more opportunities for chance findings. Interpretation depends on which outcomes and contrasts were prespecified, whether a hierarchy was used, and whether any adjustment was planned. The registry record does not report a multiplicity strategy or specify how the primary comparisons were prioritized. It is therefore not possible to determine from the record whether reported tests, if any, were adjusted or how a family of results was intended to be interpreted.
The primary analysis description says it includes all randomized participants, but also excludes participants diagnosed with dementia post-hoc: n=6 in Experimental and n=5 in Active Comparator. The record does not report further details about how those diagnoses were determined or how the post-hoc exclusion was handled in analysis.
Missing-data methods, reasons for missing measurements, and the amount of missing primary outcome data are not reported in the registry record. As a general point, missing data can affect both the analyzed population and the interpretation of estimates, especially if the likelihood of missingness is related to outcomes or participant characteristics. The record does not report imputation, sensitivity analyses, or another missing-data strategy.
Although the outcome description refers to all randomized participants, the post-hoc exclusions mean the stated analysis population is not simply all randomized participants without qualification. The registry record does not report enough detail to evaluate the consequences of the exclusions or missing data for the primary estimates.
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 |
|---|---|---|---|
| Cognitive Remediation | 5 | 192 | 2.6% |
| Active Control | 1 | 191 | 0.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cognitive Remediation | 2 of 192 |
| Active Control | 2 of 191 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cognitive Remediation | 49 of 192 |
| Active Control | 34 of 191 |
Most frequent serious adverse event terms
| Event term | Organ system | Cognitive Remediation | Active Control |
|---|---|---|---|
| Chest pain | Cardiac disorders | 2 of 192 | 0 of 191 |
| Fall | Musculoskeletal and connective tissue disorders | 1 of 192 | 1 of 191 |
| High blood pressure | Cardiac disorders | 1 of 192 | 0 of 191 |
| Leg pain | Musculoskeletal and connective tissue disorders | 1 of 192 | 0 of 191 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cognitive Remediation | Active Control |
|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | 34 of 192 | 34 of 191 |
| Leg pain | Musculoskeletal and connective tissue disorders | 15 of 192 | 7 of 191 |
Serious events with the highest arm-level rate: chest pain (1.0%), fall (0.5%), high blood pressure (0.5%), leg pain (0.5%).
The registry lists serious adverse events for 192 participants at risk in the Cognitive Remediation group and 191 at risk in the Active Control group. Serious adverse events affected 5 participants in Cognitive Remediation and 1 participant in Active Control. The listed numbers of deaths were 2 in each group.
For other adverse events, the registry lists 192 participants at risk in Cognitive Remediation, with 49 affected, and 191 at risk in Active Control, with 34 affected. These figures should be read as the record’s reported participant counts, not as a complete account of event timing, severity, or cause. The registry does not report the definition used for each adverse-event category in the information.
The listed serious-event terms and rates are Chest pain, 1.0%; Fall, 0.5%; High blood pressure, 0.5%; and Leg pain, 0.5%. The record does not establish from these terms alone whether events were caused by an intervention. Nor do the figures describe duration, recurrence, or the relationship of an event to treatment.
As a general statistical point, adverse-event counts are descriptive and should be interpreted with attention to the number at risk, how events were collected, and the definitions used. The registry figures do not replace the primary walking-speed results and do not by themselves establish a comparative safety conclusion.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized comparison of an individualized cognitive remediation program with an individualized active control, and defines a primary outcome involving walking-speed change under two conditions. It also identifies an assessment timeframe of baseline and 2 months and a measurement instrument. These details clarify the intended question and the outcome used to address it.
The record does not report the numerical primary outcome results. Consequently, it does not show whether the groups’ average changes differed, in which direction any difference went, or how precise an estimate was. It also does not provide the evidence needed to judge whether an observed difference, if present in the complete results, would be substantial in context.
The registered hypothesis proposes that cognitive remediation might affect executive functions and thereby enhance locomotion. A hypothesis is a proposed explanation to test, not a result. The listed outcomes include measures of gait, physical performance, and cognition, but the registry record does not report findings that connect these outcomes or establish a pathway between them.
The adverse-event counts and terms are separate descriptive information. They do not answer the primary efficacy question, and the registry’s event counts alone do not establish causality. Similarly, the sample-size assumptions are described as a planning illustration based on an observed effect, not as observed power or as the trial’s own design justification.
As a general interpretive principle, a trial result is best understood through its estimate, uncertainty, analysis population, and the assumptions used to produce it. The registry record does not report enough of those primary outcome results or analysis details to support a conclusion about the intervention’s effect on walking speed. This limitation is about what the registry record reports; it is not evidence for a particular direction or size of effect.
13. Why This Trial Matters Statistically
This trial raises a statistical question that spans more than one kind of measurement. The primary endpoint concerns walking speed during normal-pace walking and while talking, while the secondary outcomes include physical-performance measures, gait characteristics, and cognitive tests. A sound interpretation must keep each outcome and condition distinct rather than treating a collection of measures as interchangeable evidence.
Randomization and an active control define an informative comparative design: the intervention is compared with another individualized computer-based program, not with an absence of contact. The registry describes the allocation as randomized, single-blind, and parallel-group. It does not report all details needed to evaluate the implementation of randomization or masking, so those features should be interpreted at the level documented.
The record also illustrates why reporting estimates and uncertainty matters. An endpoint definition explains what was measured, but it cannot show the size or precision of a group difference. Without numerical primary results, readers cannot distinguish a precise estimate near no difference from an imprecise estimate compatible with a range of effects.
Multiplicity is relevant because the registered outcome description includes multiple conditions and the record lists numerous outcomes and analyses. A stated hierarchy or testing strategy would clarify how to interpret a collection of comparisons, but such a strategy is not reported in the registry record. The stated post-hoc exclusions and unreported missing-data methods also matter when assessing which participants contribute to an estimate.
The statistical importance of the trial therefore lies in both its comparative question and the limits of the available reporting. The registry provides a structured description of design and measurement, while leaving the primary numerical results and several analysis details unreported. Those omissions prevent a full statistical assessment of the registered question.
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 main limitation for interpreting the primary endpoint is that the registry record does not report its numerical results. No between-group estimate, standard error, confidence interval, or p-value for walking-speed change is reported in the record. The primary outcome description includes multiple conditions and time points and is not reduced to one comparison, so a single primary contrast cannot be identified from the information reported.
The registry describes the primary analysis as including randomized participants while excluding participants diagnosed with dementia post-hoc, listing n=6 in Experimental and n=5 in Active Comparator. The record does not report further information about the basis for these exclusions or their effect on the analysis. This makes it difficult to assess the implications of the stated analysis population.
Missing-data methods and the extent or reasons for missing primary measurements are not reported in the registry record. The record also does not report a full statistical analysis plan, including the primary model, any covariate adjustment, the handling of repeated measurements or conditions, and the approach to multiplicity. These details are needed to evaluate how the intended estimand was translated into an analysis.
The masking label is single-blind, but the identity of the masked parties and the procedures used are not reported. Further operational details of the walking assessment are not reported beyond the named instrumented walkway system. The registry also does not report the trial’s own sample-size justification; the stated planning illustration is explicitly not the trial’s own design.
These limitations concern the information reported in the registry record. They do not establish that the trial lacked procedures or analyses that are not described there, and they do not indicate the direction or magnitude of the primary result.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cognitive Remediation to Improve Mobility in Sedentary Seniors — NCT02567227.
- Registry record last updated 2024-02-28; status last verified 2024-02.
- Results first posted 2021-06-07.
- 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
NCT02567227 is a completed randomized, single-blind, parallel-group trial titled “Cognitive Remediation to Improve Mobility in Sedentary Seniors.” The official title is “Cognitive Intervention to Improve Simple and Complex Walking.” Enrollment was 383, and the sponsor was Albert Einstein College of Medicine. The recorded start was 2016-03 and primary completion was 2020-06.
The trial compared an individualized computerized cognitive remediation program with individualized computer-based exposure and interactive health education classes. The primary outcome was change in walking speed during normal-pace walking and walking while talking, measured at baseline and 2 months in centimeters per second.
The registry lists multiple secondary outcomes involving physical performance, gait, and cognition. It describes a post-hoc exclusion of participants diagnosed with dementia from the primary analysis population. Numerical primary outcome results, missing-data methods, multiplicity procedures, and a complete statistical analysis plan are not reported in the registry record.