Task-oriented Training for Stroke: Impact on Function Mobility: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Task-oriented Training for Stroke: Impact on Function Mobility (NCT01322607), a randomized na study. The primary outcome is Economy of Gait.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group trial with no masking reported. The registry lists the study as completed and gives enrollment as 20. The two behavioral interventions were high-intensity treadmill exercise and a low-intensity lifestyle intervention described as group exercise. The study compared these programs in people with stroke, with the stated goal of examining movement economy during over-ground walking and activities of daily living.

The primary outcome was economy of gait at 3 months. It was measured in ml/kg/min and summarized as a mean with a standard deviation. The registry record describes measurement during a 6-minute walk at a comfortable, self-selected walking speed, using portable metabolic monitoring. The mean oxygen consumption was to be calculated from the final 3 minutes under steady-state conditions. The outcome description interprets higher oxygen consumption during the walk as less efficient gait economy.

The posted outcome summaries list 10 participants for the high-intensity program and 9 for the low-intensity program. These are the group counts associated with the primary outcome summaries; they should not be assumed to describe every analysis population. The record separately lists safety denominators, and does not explain the relationship between those denominators and the outcome counts.

The registry lists muscular strength, muscular endurance, and balance as secondary outcomes. It does not report detailed eligibility criteria, recruitment procedures, allocation concealment, intervention duration or frequency, adherence, follow-up beyond the stated primary time frame, or a statistical analysis plan. Those details 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.

Overall Study

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 Economy of Gait, measured over 3 months.

Economy of gait is the primary endpoint. It represents the rate of oxygen consumption, measured in ml/kg/min, while a participant walks over ground during a 6-minute walk. Participants walked at their comfortable, self-selected speed. A portable metabolic monitoring system collected breath-by-breath measurements, and the outcome was defined as mean oxygen consumption during the final 3 minutes, when the description specifies steady-state oxygen consumption.

The endpoint is intended to capture the energy cost of walking rather than walking distance alone. The study description explains that residual neurological deficits after stroke can make gait less efficient and that movement economy is relevant to ambulatory capacity and daily activities. It states that a higher oxygen-consumption value during the walk represents less efficient gait economy. This interpretation concerns the direction of the measurement, not whether a particular program caused a change.

The registry record posts one mean and standard deviation for each arm at the 3-month time frame. It does not post baseline values, participant-level measurements, changes from baseline, or a direct between-arm estimate with uncertainty. As a result, the endpoint summaries describe the observed group values but do not, on their own, establish the size or precision of a treatment contrast.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a randomized, parallel-group design and posts continuous outcome summaries as means and standard deviations. A mean is the arithmetic average of the recorded outcome values in a group. A standard deviation describes how dispersed those values are around the mean. It conveys variability among observations, not the precision of the estimated mean or of a comparison between groups.

What would a between-arm estimate show?

For a continuous outcome, a between-arm estimate expresses the contrast between the group summaries under a defined analysis. Its interpretation depends on the chosen scale and on whether the analysis uses endpoint values, changes from baseline, or an adjusted model. The registry record does not report a primary comparative estimate or say which of these approaches was planned. Therefore, the arm means should not be treated as a substitute for a trial-level estimate with uncertainty.

A confidence interval is a statistical range expressing uncertainty about an estimated quantity under the assumptions of the analysis. For a treatment comparison, an interval would help readers judge which effects are compatible with the data and how precisely the contrast was estimated. No confidence interval for the primary comparison is reported in the registry record. A p-value is also not reported; without it, there is no posted hypothesis-test result to interpret.

Why does variation matter?

Participants can differ in their gait economy, so the spread of observations matters when estimating a group mean and comparing groups. A standard deviation describes that spread, while the standard error concerns the sampling uncertainty of an estimate. Those are different quantities. The record gives standard deviations but does not give standard errors or confidence intervals for the means or their contrast. General statistical interpretation therefore cannot recover the precision of the treatment comparison from the posted summaries alone.

In general, an analysis of a continuous outcome may use assumptions about the distribution of observations and the variability within groups. If variability is not well represented by the model, or if observations are unusually skewed or contain influential values, model-based estimates and uncertainty can be affected. The registry record does not report distributional checks, transformations, robust methods, or other diagnostics. No conclusion about whether these issues arose in this trial is possible from the posted information.

What does randomization contribute?

Random allocation is intended to make treatment groups comparable, on average, with respect to measured and unmeasured characteristics before intervention. It does not ensure that every realized group is identical, especially in a small study. Nor does the design label by itself specify how the outcome was analyzed. The record does not report details of the randomization procedure, allocation concealment, baseline balance, or any adjustment variables, so those aspects cannot be assessed from the registry information.

The endpoint is recorded at 3 months. An analysis of the endpoint values and an analysis of change from baseline answer related but not identical questions. Baseline adjustment may also affect precision. The record does not state which outcome model was planned or used, whether baseline gait economy was measured, or how any repeated measurements were handled. These methods are not reported in the registry record.

What are planning illustrations?

Any sample-size illustrations based on an observed effect are hypothetical planning exercises, not evidence of the trial's achieved power and not observed outcomes. Such illustrations depend on assumptions, including the target effect and statistical model. The registry record does not report a trial-specific sample-size justification or statistical plan, so an illustrative planning calculation should not be mistaken for the original design rationale. It also cannot supply the missing uncertainty around the posted primary comparison.

Overall, the available statistics support a descriptive reading of each arm's mean and standard deviation. A formal comparative interpretation would require the analysis method, an estimate of the between-arm contrast, and an uncertainty measure. Those comparative results are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Arm 1: High-Intensity Program", "Arm 2: Low-Intensity Program")
n   <- c(10, 9)
m   <- c(13.44, 12.67)
sp  <- c(3.15, 3.51)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Arm 1: High-Intensity Program  10  13.440  3.150  11.187  15.693
CARM  Arm 2: Low-Intensity Program  9  12.670  3.510  9.972  15.368

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists muscular strength, muscular endurance, and balance as secondary outcomes in addition to economy of gait as the primary outcome. It does not report a multiplicity strategy, such as a prespecified hierarchy, adjustment of significance levels, or a plan to distinguish confirmatory from exploratory tests. Without that information, the status of any secondary comparisons cannot be determined. The posted record also contains no secondary outcome results for interpretation.

Missing-data handling is not reported in the registry record. The primary outcome summaries list 10 participants in the high-intensity arm and 9 in the low-intensity arm, while the safety summaries use different denominators. The record does not say whether outcome values were missing, whether participants discontinued, whether any imputation was used, or what rules determined inclusion in the primary summary. Those differences in counts should not be interpreted as proof of a particular pattern of missingness.

The record does not describe an intention-to-treat population, a per-protocol population, or another analysis population for the primary endpoint. It also does not report sensitivity analyses addressing missing outcomes. Consequently, the effects of missingness and population selection on the reported arm summaries cannot be assessed.

There are no posted primary analyses in the registry record. Accordingly, multiplicity procedures, missing-data methods, and analysis-population definitions cannot be checked against a reported comparative result. These gaps limit assessment of both the robustness and the confirmatory status of any treatment comparison.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: esophagitis/upper gastrointestinal bleed (9.1%).

The safety summaries list serious adverse events affecting 1 participant among 11 at risk in the high-intensity program and 0 participants among 9 at risk in the low-intensity program. The record lists Esophagitis/Upper Gastrointestinal Bleed as a serious event term with a frequency of 9.1%, but does not specify an arm for that term in the information available for this analysis. The registry record does not report deaths.

These are descriptive counts. They do not establish whether the interventions caused an event or whether the groups differ in safety. The denominators are the safety populations stated in the record; they are not interchangeable with the primary-outcome counts. The record does not explain how participants entered or left the safety population, how events were collected, or the event-monitoring period.

The record also lists other, non-serious adverse events affecting 6 participants among 11 at risk in the high-intensity program and 8 among 9 at risk in the low-intensity program. These summaries do not provide event-level detail or a comparative statistical analysis. Small event counts and the absence of analysis details call for a cautious descriptive reading rather than a conclusion about relative safety.

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

The registry record describes a randomized comparison of two exercise approaches and posts mean gait-economy values at 3 months. The high-intensity treadmill arm has a mean of 13.44 ml/kg/min, and the low-intensity group exercise arm has a mean of 12.67 ml/kg/min. The endpoint definition assigns less efficient gait economy to higher oxygen consumption. These values therefore describe the direction of the observed arm summaries, not a confirmed difference between interventions.

The record does not report a between-arm effect estimate, confidence interval, p-value, or primary statistical analysis. It is not possible from the posted summaries to determine how compatible the observed values are with no difference, how precise a treatment contrast would be, or whether an apparent contrast is likely to reflect sampling variation. The registry record also does not report baseline endpoint values or the method used to handle missing observations.

Randomization strengthens the design for comparing interventions, but it does not remove the need for a clearly reported analysis. Interpretation depends on knowing the analysis population, the chosen model, and the uncertainty around the estimated contrast. Those details are not reported in the registry record. Nor are results posted for the secondary outcomes of strength, endurance, and balance or for the stated question about whether those changes predict movement economy.

Accordingly, the available evidence supports describing the study design, endpoint, and arm-level summaries. It does not support a claim that either exercise program improved gait economy, was superior, or produced a particular causal effect. It also does not establish that there was no effect. The result is incomplete for comparative inference because the key estimate and its uncertainty are not reported.

14. Why This Trial Matters Statistically

This trial addresses a measurement question that is distinct from simply asking how far participants can walk. Its primary endpoint uses oxygen consumption during over-ground walking as an indicator of movement economy. The endpoint description connects energy use during walking with mobility and function after stroke, while defining the direction of the measure: higher oxygen consumption represents less efficient gait economy.

Statistically, the registry record illustrates why design labels and descriptive summaries are not enough to evaluate a treatment comparison. Randomization is important, and the posted means and standard deviations give readers a view of the observed group summaries. But the absence of a reported contrast and uncertainty interval leaves the central comparative question unresolved. Readers cannot judge the precision of the estimated difference or distinguish a descriptive ordering of means from evidence of a reliable between-arm effect.

The outcome counts and safety denominators also show why analysis populations need clear reporting. Different sets of participants contribute to the primary outcome and safety summaries, but the registry record does not explain the definitions or reasons. Without that context, the impact of missing measurements or population selection cannot be evaluated.

The study description includes several related domains—strength, endurance, and balance—and asks whether they predict changes in movement economy. Those questions involve additional statistical analyses, but results and multiplicity procedures are not reported. The case therefore highlights the importance of prespecified outcomes, transparent analysis methods, and complete reporting of estimates and uncertainty, particularly when a trial examines multiple connected measures.

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.

Several limitations arise from what the registry record reports and does not report. The primary outcome summaries are available only as arm-level means, standard deviations, and outcome counts. No between-arm estimate, confidence interval, p-value, or analysis method is reported. This prevents a direct assessment of the magnitude and precision of the comparison.

The record does not report baseline economy-of-gait values, changes from baseline, or whether the primary analysis adjusted for baseline. It also does not state how missing outcome data were handled or define the analysis population. The primary outcome counts and safety denominators differ, and the reason is not reported in the registry record. This limits assessment of completeness and possible selection effects.

Details of the randomization procedure, allocation concealment, eligibility criteria, participant characteristics, intervention dose, adherence, and fidelity are not reported in the registry record. Masking is listed as none, but further information about measurement procedures or assessor masking is not reported. The record also does not include comparative results for the secondary outcomes of strength, endurance, and balance, or explain how multiple outcomes were addressed.

Finally, the primary outcome is described at 3 months, and longer-term comparative results are not reported in the registry record. The posted information therefore supports a narrow description of the trial design and endpoint summaries, but not a broad assessment of durability, clinical importance, or the relative effects of the two programs.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Task-oriented Training for Stroke: Impact on Function Mobility — NCT01322607.
• Registry record last updated 2016-04-06; status last verified 2016-03.
• Results first posted 2016-04-06.
• 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

NCT01322607 is a completed randomized, parallel-group trial comparing high-intensity treadmill exercise with a low-intensity group exercise intervention for stroke. Masking is listed as none, and enrollment is listed as 20.

The primary outcome is economy of gait at 3 months, measured as mean oxygen consumption in ml/kg/min during the final 3 minutes of a 6-minute walk. The posted mean and standard deviation are 13.44 and 3.15 for the high-intensity arm, and 12.67 and 3.51 for the low-intensity arm. The corresponding primary outcome counts are 10 and 9.

Strength, endurance, and balance are listed as secondary outcomes. The registry record does not report a comparative primary analysis, uncertainty interval, missing-data method, or analysis population. Safety summaries are reported separately and use different denominators.