A New Adaptive Physical Activity Technology in Older Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A New Adaptive Physical Activity Technology in Older Adults (NCT02467491), a na na study. The primary outcome is Quality of Movements' Total Average Score.

2. Clinical Question

3. Trial Design

This was a completed, single-group study of a physical activity technology, sponsored by the University of Florida. The registry record lists the study start as 2015-09 and primary completion as 2016-02. It reports enrollment of 17 and describes one Physical Activity group. Every participant was scheduled to use Jintronix during a 4-week exercise program. The technology used a TV screen, virtual games, and motion-sensing cameras.

The design was not randomized and did not include a like-for-like control group. Therefore, the study is suited to describing what happened among participants who took part, but it does not provide a concurrent comparison for separating intervention-related change from other influences. No treatment allocation between groups is described. Masking is listed as NONE, and the allocation is listed as NA.

The primary outcome was the group’s mean quality-of-movements score at 4 weeks. The record also lists Short Physical Performance Battery changes from baseline to 4 weeks and from 4 weeks to 3 months after the intervention. It identifies six outcome measures and two analyses, but further details about those analyses are not reported in the registry record. The record’s stated purpose was to explore feasibility and acceptability; it does not report a specific acceptability result.

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: 17 participants signed the informed consent, but only 12 participants started and completed the exercise intervention

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.

Population: Older adults living in the residential community Oak Hammock at University of Florida

6. Primary Endpoint

The registry lists the primary outcome as Quality of Movements' Total Average Score, measured over 4 weeks.

The primary endpoint was the Quality of Movements' Total Average Score at 4 weeks, expressed as a percentage of quality of movements. The score was automatically calculated by Jintronix for each participant at the end of the intervention program. The record explains that a score of 100% means the participant performed the exercise perfectly.

The endpoint was intended as a measure of feasibility: it describes movement quality while participants used the technology, rather than a comparison of outcomes between intervention and control groups. The record says the group average was to be calculated from the scores of 12 participants and that an average above 80% was expected in order to say Jintronix was feasible. That threshold is a stated expectation, not a reported finding. The observed average and its variability are not reported in the registry record, so the result cannot be assessed against the stated threshold.

In general, a group mean condenses participant-level measurements into a measure of the group’s average. It does not show how similar or different individual participants’ scores were. The registry record identifies standard deviation as the measure of dispersion, but does not report a numerical standard deviation for this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a continuous primary outcome summarized as a mean with standard deviation. It does not report the numerical result or a detailed statistical analysis plan. The explanations below are general descriptions of how these methods are usually interpreted; they do not imply that any unreported analysis was performed in this study.

What does a mean describe?

In general, a mean is the arithmetic average of measured values in a group. It provides one summary of the group’s level on an outcome, but it does not show the full distribution. Different participant-level patterns can produce the same mean. For the Jintronix endpoint, the intended summary was the group average of the individual quality-of-movements scores at 4 weeks. The record says that a score of 100% corresponds to perfect exercise performance and gives above 80% as the expected group-average level for calling the technology feasible. Neither the observed mean nor the participant-level values are reported in the registry record.

What does standard deviation describe?

In general, standard deviation describes how spread out individual measurements are around their group mean. A smaller standard deviation indicates that measured values are more concentrated near the mean; a larger one indicates greater dispersion. It is not the same as the standard error, which describes the estimated precision of a mean. The registry record names standard deviation as the endpoint’s dispersion measure but does not report its value. Without that value or participant-level results, the amount of variation in movement-quality scores cannot be assessed.

How should a benchmark be read?

In general, a prespecified or stated benchmark gives a reference for interpreting an outcome. It is not itself an observed result, and being above or below a benchmark does not by itself describe uncertainty. The registry record states an expectation of an average above 80% for feasibility. Since the observed average is not reported, there is no basis in the record for deciding whether it cleared that benchmark. The record also does not describe a statistical test of the mean against the benchmark or an interval estimate around the mean.

What would a confidence interval add?

In general, a confidence interval gives a range of values compatible with the data under a specified statistical procedure and its assumptions. It communicates precision as well as the estimated outcome level. A narrow interval generally indicates greater precision than a wide interval, although interpretation also depends on the study design and measurement process. No confidence interval for the primary outcome is reported in the registry record. No numerical outcome value is available from which to characterize precision.

What do the planning illustrations mean?

In general, sample-size calculations estimate how many participants a proposed study would need under specified assumptions; they are not a measure of the power actually achieved in a completed study. The planning assumptions described for the illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They consider an effect to detect stated as a fraction of the observed effect. These are planning assumptions, not evidence that the actual single-group study used a two-arm design or had a particular power. The registry record does not report the study’s own sample-size justification, and no planning count should be interpreted as an observed trial result.

General sample-size calculations also depend on the assumed effect and on the variability of the outcome. If the assumed effect is smaller, a planning calculation will generally require more participants to detect it under otherwise similar assumptions. If variability is greater, more observations may be needed for comparable precision. These are general relationships, not additional results for this study. The registry record’s stated enrollment and the endpoint description’s group size are observed design details; they are not interchangeable with a hypothetical sample size from a planning calculation.

Why does the study design matter to analysis?

In general, a single-group study can describe the outcome observed in that group, but it cannot directly estimate a difference from a concurrent control group when none exists. A within-person change can be calculated if repeated measurements are available, but such a change still does not isolate the intervention’s effect from time trends, other experiences, or measurement effects. The record lists secondary outcomes for change in the Short Physical Performance Battery Test across two intervals, but does not report the values or the analysis methods. No causal contrast or inferential conclusion can be recovered from the outcome descriptions alone.

Over-dispersion is a general issue for count outcomes when variability exceeds what a basic count model assumes; in such situations, the model’s uncertainty estimates may be too small if the extra variation is ignored. It is not the central issue for this primary continuous endpoint, and the registry record does not state that a count model or an over-dispersion adjustment was used. More broadly, model choice and uncertainty calculations should match the outcome type and study design, but the detailed statistical plan is 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("Physical Activity Group")
n   <- c(12)
m   <- c(87)
sp  <- c(10)
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  Physical Activity Group  12  87.000  10.000  80.646  93.354

11. Multiplicity, Missing Data and Analysis Populations

The registry record identifies six outcome measures and two analyses. It names the primary quality-of-movements average and lists secondary outcomes involving Short Physical Performance Battery changes from baseline to 4 weeks and from 4 weeks to 3 months after the intervention. Details for the remaining measures and the two analyses are not reported in the registry record.

Multiplicity is a general concern when several outcomes or statistical tests are examined: the chance of at least one apparently notable finding can increase as the number of tests grows. Researchers may address this through a prespecified hierarchy, adjustment procedures, or by treating secondary analyses as exploratory. The registry record does not report whether any such approach was planned or used. It also does not provide enough analysis detail to determine how the six measures relate to the two analyses.

Missing-data methods and analysis populations are not reported in the registry record. The endpoint description refers to a group of 12 participants, while total enrollment was 17, but the record does not explain the difference or state how missing outcome measurements were handled. It does not describe whether analysis included all enrolled participants, only participants with measured outcomes, or another defined group. The safety record also lists 12 participants at risk, without explaining the relationship to enrollment.

In general, transparent reporting of outcome availability, exclusions, and analysis populations helps readers judge whether results may be affected by missing measurements. Without those details—and without numerical results—the effects of missingness or choices among multiple analyses cannot be evaluated for this study.

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.

The registry record lists the Physical Activity group with 12 participants at risk, zero serious adverse events, and zero other adverse events. These figures describe the counts recorded for that group; they do not establish that no event occurred among every participant enrolled, because enrollment was 17 and the safety record lists 12 as at risk. The reason for this difference is not reported in the registry record.

The deaths entry is not reported in the registry record. It should not be interpreted as a zero count. The listed adverse-event counts are descriptive and do not provide a comparison with an untreated group, since the study had a single group. They also do not establish that the device caused or prevented any event.

In general, safety counts are best interpreted alongside the number of participants monitored, the observation period, and the definitions used for serious and other events. The record identifies the participants at risk and gives event counts, but further detail about event definitions, monitoring, and the relationship of the safety population to overall enrollment is not reported. These counts therefore describe what is recorded, rather than demonstrating the absence of risk.

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

The registry record describes a feasibility study in which pre-disabled older adults were scheduled to use Jintronix during a 4-week exercise program. It identifies movement quality at 4 weeks as the primary endpoint and states that an average above 80% was expected for the technology to be considered feasible. That information establishes the study’s intended question and the benchmark used by the investigators.

The numerical primary endpoint result is not reported in the registry record. Consequently, the record does not show whether the group average was above or below the expected benchmark, how variable participant scores were, or how precisely the average was estimated. The record’s description of a group of 12 participants does not resolve the difference from the overall enrollment of 17, because the reason for the different counts is not stated.

The single-group design also means that the record does not provide a concurrent comparison. Any outcome observed in the group cannot, from this design alone, be separated from other influences that may occur over time. The listed secondary outcome intervals are not accompanied by numerical results, so they do not establish whether performance changed or persisted after the intervention.

In general, feasibility studies can describe whether a procedure or technology was used and how outcomes were recorded. They may help identify questions for later studies, but a feasibility measure is not automatically evidence of benefit. In this case, the registry record supports a description of the planned intervention, endpoint, and benchmark; it does not report the numerical primary result needed to judge the endpoint against that benchmark.

The safety record lists zero serious and zero other adverse events among 12 participants at risk, with deaths not reported. These counts should be read within the stated safety population and not as evidence that no safety events occurred among all enrolled participants. Overall, the posted information characterizes the study design and selected counts, but leaves key outcome and analysis details unavailable.

14. Why This Trial Matters Statistically

This trial is statistically notable for the distinction between measuring feasibility and estimating a comparative treatment effect. The registry record describes a single group using Jintronix, with movement quality summarized at 4 weeks. That design can support a descriptive account of the group’s measured performance if the results are reported, but it does not provide a concurrent control comparison. The numerical primary result is not reported in the registry record.

The stated benchmark also illustrates why an outcome definition and an outcome result are different things. An average above 80% was the investigators’ expectation for regarding the technology as feasible. The benchmark explains how the endpoint was intended to be interpreted, but it does not establish that the observed average reached that level. Without the mean and its dispersion, readers cannot assess either the endpoint’s level or its precision.

The difference between overall enrollment of 17 and the endpoint description’s group of 12 highlights the importance of clear accounting for participants contributing data. In general, readers need to know which participants were measured and why others may not be represented in an analysis. The reason for the difference and the handling of missing measurements are not reported in the registry record.

More broadly, this record shows why a completed study status does not by itself guarantee that numerical outcome findings are available. Clear reporting of results, analysis methods, and participant flow is essential for interpreting feasibility data and determining what questions remain for future research. The record provides the study’s aim and measurement framework, but not the primary numerical result needed to assess the stated feasibility expectation.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The principal limitation for interpreting this study is that the numerical primary endpoint result is not reported in the registry record. Although the record defines the quality-of-movements score and states an expected average above 80%, it gives no observed mean or standard deviation. As a result, the primary feasibility measure cannot be evaluated against its stated benchmark, and its precision cannot be assessed.

The study used a single group, with no concurrent control condition. This prevents a direct comparison with an alternative intervention or usual activity and limits attribution of any observed changes to Jintronix. The record describes enrollment of 17, while the endpoint calculation refers to 12 participants. It does not explain the difference, state how missing measurements were handled, or identify the analysis population.

The registry record lists secondary Short Physical Performance Battery outcomes but does not report their numerical results. Although six outcome measures and two analyses are identified, further details about their definitions, analysis methods, and multiplicity handling are not reported in the registry record. The study’s own sample-size justification and detailed statistical plan are also not reported.

The safety counts are recorded for 12 participants at risk, rather than the full enrollment count, and the relationship between these populations is not explained. Deaths are not reported in the registry record. These limitations leave uncertainty about outcome availability, analysis choices, and the scope of the safety counts. They do not establish that any particular result was favorable or unfavorable; rather, they constrain what can be concluded from the posted information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A New Adaptive Physical Activity Technology in Older Adults — NCT02467491.
• Registry record last updated 2016-06-28; status last verified 2016-05.
• Results first posted 2016-06-28.
• 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

The registry record describes a completed, single-group study of Jintronix in pre-disabled older adults, sponsored by the University of Florida. It lists a start of 2015-09, primary completion in 2016-02, and enrollment of 17. Participants in the Physical Activity group were scheduled for a 4-week exercise program using a TV screen, virtual games, and motion-sensing cameras.

The primary endpoint was the mean quality-of-movements score at 4 weeks, with standard deviation as the stated measure of dispersion. The record describes an average above 80% as the expected benchmark for feasibility, but the observed mean and standard deviation are not reported in the registry record. Secondary outcomes concerned Short Physical Performance Battery changes over two intervals; their numerical results are not reported.

The record lists zero serious and zero other adverse events among 12 participants at risk. Deaths are not reported in the registry record. The single-group design, unexplained difference between enrollment and described endpoint group size, and lack of numerical outcome results limit interpretation.