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 Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training (NCT01050231), a randomized na study. The primary outcome is Box & Blocks Test.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01050231 |
| Phase | NA |
| Condition | Cerebrovascular Accident |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, Irvine |
| Results posted | Yes |
2. Clinical Question
Population
People with cerebrovascular accident, described in the study summary as people with stroke, were the intended population. The registry lists an enrollment of 20. Further eligibility details and participant characteristics are not reported in the registry record.
Intervention
Functional, task-oriented multi-joint activities with the BONES robot. In one sequence, this training came first, followed by individual-joint training; in the other sequence, it came second.
Comparator
Individual-joint training with the BONES robot. The study compared the two training approaches in a randomized crossover design, with each sequence receiving both interventions in a different order.
Primary question
How did Box & Blocks Test scores change across baseline, after each intervention, and follow-up? The test counts blocks moved in 60 seconds, with higher scores indicating a better measured outcome. The registry record does not report the scores or a statistical comparison between training approaches.
The clinical question concerns the measured performance of an upper-extremity task after two forms of robotic training, rather than a comparison between robotic treatment and no training. Because participants received both intervention types in different sequences, the contrast of interest could involve within-participant changes as well as the timing and order of treatment. The registry describes the interventions and their sequence, but it does not report an estimated difference in Box & Blocks Test performance, uncertainty around such a difference, or an analysis that accounts for the crossover structure.
3. Trial Design
The registry describes a randomized, single-masked, crossover study of robotic rehabilitation training. Its listed enrollment is 20, and its status is completed. Randomization assigned participants to one of two treatment sequences: functional, task-oriented multi-joint training first and individual-joint training afterward, or individual-joint training first and functional training afterward. Both approaches used the BONES robot. A one-week break was provided between interventions.
A crossover design gives participants exposure to both interventions in sequence. That structure can support a comparison of responses within participants, but interpretation depends on how the analysis handles treatment order, time or period effects, and possible carryover from the earlier intervention. The registry record does not report the statistical model or other analytic details used to address these issues. It also does not say whether the one-week break was intended or shown to eliminate carryover.
The outcome was measured at baseline, after the first intervention at 5 weeks, after the second intervention at 11 weeks, and at a 3-month follow-up after completion of the second intervention. These repeated measurements describe the intended assessment schedule; they do not, on their own, establish which time point was the primary between-treatment contrast. The registry record does not report a single comparison across the several outcome time points.
The record identifies single masking but does not specify who was masked or how masking was maintained. Details of the randomization procedure, intervention duration or dose, eligibility criteria, and sample-size justification are not reported in the registry record. The completed status and listed enrollment describe the study record, but the number included in an outcome analysis is 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
| Stage | Individual Joints and Functional Multi-joints Tasks | Functional Multi-joints Activities and Individual Joints |
|---|---|---|
| STARTED | 10 | 10 |
| COMPLETED | 10 | 10 |
| NOT COMPLETED | 0 | 0 |
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 | Type I Robotic Therapy (Functional Activities Then Individual Joint Exercises) | Type II Robotic Therapy (Individual Joints Exercises Then Functional Activities) | Total |
|---|---|---|---|---|
| Participants analysed | 10 | 10 | 20 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 9 | 16 |
| Age, Categorical: >=65 years | Participants | 3 | 1 | 4 |
| Age, Continuous | years | 60 (SD 7) | 60 (SD 7) | 60 (SD 7) |
| Sex: Female, Male: Female | Participants | 6 | 4 | 10 |
| Sex: Female, Male: Male | Participants | 4 | 6 | 10 |
| Region of Enrollment: United States | participants | 10 | 10 | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Box & Blocks Test, measured over Baseline, Post first intervention at 5 weeks, post second intervention at 11 weeks, and 3-month after the completion of the second intervention..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | blocks |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Box & Blocks Test, a continuous measure reported as a mean with standard deviation and measured in blocks. During the test, a participant moves blocks one at a time from one compartment of a box to another over a divider for 60 seconds. Each block moved counts as one; multiple blocks moved at the same time count as a single block. The registry states that higher scores indicate a better outcome.
This test is used to quantify performance on a timed task requiring arm and hand movement. In this trial, that makes it relevant to the stated goal of developing robotic training for upper-extremity movement practice. A continuous score can describe average performance and variation among participants, and repeated assessments can track measured performance over the study schedule.
Scores were scheduled at baseline, after the first intervention at 5 weeks, after the second intervention at 11 weeks, and at the 3-month follow-up after the second intervention. The registry record does not provide score values, group means, standard deviations, or a defined contrast between treatment approaches. It therefore does not establish the size or precision of any observed difference in this endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record establishes that the study was completed, randomized, single-masked, and organized as a crossover comparison of two robotic training approaches. It lists an enrollment of 20 and specifies Box & Blocks Test performance as the primary outcome. Those design details explain what the study set out to compare, but they are not themselves evidence of an outcome difference.
The registry record does not report the Box & Blocks Test results at baseline, after either intervention, or at follow-up. It also does not report an estimated treatment contrast, confidence interval, p-value, or analysis description. Without these results, the direction, magnitude, and precision of any difference between functional multi-joint activities and individual-joint training cannot be determined from the registry record. The completed status does not fill this reporting gap.
Several measurements were scheduled over time, and participants were assigned to different treatment orders. A meaningful comparison would need to make clear which measurements and contrast were used and how the crossover structure was handled. For example, an analysis might need to distinguish intervention effects from changes associated with period or sequence. This is a general consideration for crossover trials; the registry record does not report which model, if any, was used for these purposes.
Precision matters as well as the direction of an estimate. A confidence interval describes a range of values compatible with the data and analysis under its assumptions. Since no estimate or confidence interval is reported in the registry record, the precision of any treatment comparison cannot be assessed. The listed enrollment alone does not reveal how precisely an effect was estimated, particularly when the analyzed population and amount of missing outcome data are not reported.
The registry lists zero serious adverse events, zero other adverse events, and zero deaths in the entries for each intervention, with 20 at risk in each entry. These are the recorded safety figures; they do not substitute for the missing outcome analysis. Because participants received both interventions in sequence, the intervention-specific entries should not be added together or interpreted as separate, non-overlapping populations.
Overall, the registry record supports a description of the design, assessment schedule, and recorded safety counts. It does not support a conclusion about whether one training approach produced a larger Box & Blocks Test change, whether any difference was clinically meaningful, or how uncertain a comparison would be. Those judgments require outcome estimates and their analysis, which are not reported in the registry record.
9. Statistical Methods Explained
The study is described as randomized, single-masked, and crossover. Each label addresses a different design feature. Randomization concerns how participants were assigned to treatment sequence. Masking concerns whether someone involved in the study was kept unaware of an assignment or treatment information. Crossover means participants received both interventions in a sequence rather than remaining in only one intervention group. The registry does not give further details about the randomization or masking procedures.
What does a crossover comparison require?
In a crossover study, measurements from the same participant are related. A statistical analysis should account for that within-participant relationship rather than treat every measurement as if it came from an unrelated person. The sequence can also matter: outcomes may change over time regardless of intervention, or an earlier intervention may affect measurements during a later period. These are general analytic considerations, not findings about this trial. The registry record does not report whether the analysis adjusted for participant, period, sequence, or carryover effects, or whether any such effects were assessed.
The record specifies two sequences. One began with functional, task-oriented multi-joint activities and then used individual-joint training. The other began with individual-joint training and then used functional activities. A one-week break separated the interventions. That description tells readers the order and interval, but does not establish whether the break was sufficient to prevent residual effects. Evidence or a protocol rationale about washout is not reported in the registry record.
What does the endpoint summary describe?
The Box & Blocks Test is continuous and is described using a mean and standard deviation. A mean gives a measure of the average score in a group or at a time point. A standard deviation describes the spread of individual scores around that mean. These summaries can help characterize performance, but by themselves they do not show whether an observed contrast is statistically precise or attributable to an intervention.
A treatment comparison would ordinarily report an effect estimate, such as a difference in scores, along with a measure of uncertainty. A confidence interval expresses uncertainty around an estimate under the analysis assumptions. A p-value is one way to summarize how compatible the observed data are with a specified null hypothesis; it is not a measure of the size or importance of an effect. The registry record reports none of these outcome-analysis quantities. No new effect estimate can be reconstructed from the information in the registry record because the outcome summaries are not reported.
How should the assessment schedule be read?
Measurements were scheduled at baseline, after the first intervention at 5 weeks, after the second intervention at 11 weeks, and at a 3-month follow-up after the second intervention. These are repeated outcome time points, not separate treatment arms. Changes from baseline, differences between intervention periods, and longer-term follow-up address different questions. The registry record does not identify a single contrast that resolves those questions or report results for the time points.
When outcomes are examined at multiple time points, there can be multiple opportunities to find an apparently notable result. In general, multiplicity methods can control or describe the increased chance of false-positive findings from multiple comparisons. The registry record does not report a multiplicity strategy or identify which comparisons were prespecified for inference. It would therefore be inappropriate to assume a particular adjustment or to select a preferred time point after the fact.
What do the planning assumptions mean?
Any sample-size figures associated with planning are illustrations, not observed power and not evidence that the study achieved a particular level of power. The stated planning approach uses a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are assumptions for a planning calculation, not a report of the trial's own design rationale. The sample-size justification and the trial's original statistical plan are not reported in the registry record.
In general, a planning calculation estimates the number of participants needed to detect a specified effect under chosen assumptions. Its result depends on the effect size, outcome variability, design, and analysis. A calculation based on an observed effect is especially dependent on that effect estimate and should not be presented as the trial's observed power. The record does not report the sample-size rationale used when the trial was planned. No planning figure can establish that the outcome analysis was adequately powered.
What can be concluded from the analysis record?
The record lists no outcome analyses and does not reduce the primary outcome, which has several categories or time points, to one comparison. It does not report analytic populations, handling of missing observations, model specifications, or inferential results. These omissions limit reproducibility and interpretation: a reader cannot determine which observations entered an analysis, how dependence from repeated measurements was handled, or how the final estimate and uncertainty were obtained. This describes what is not reported in the registry record, rather than proving that no analyses were performed outside the record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome was assessed at baseline, after the first intervention at 5 weeks, after the second intervention at 11 weeks, and at the 3-month follow-up after the second intervention. Multiple time points can support different questions, such as change over time or response during one intervention period. If multiple contrasts are tested, the chance of a false-positive finding can increase unless the analysis plan addresses multiplicity. This is a general statistical issue. A prespecified comparison and any multiplicity procedure are not reported in the registry record.
The registry record does not describe missing outcome data, the number of participants contributing measurements at each time point, or the method used to handle missing observations. It also does not identify an analysis population, such as all randomized participants or participants with complete measurements. The listed enrollment of 20 should not be read as the number included in every outcome analysis.
For a crossover design, an analysis population and handling of missingness are particularly relevant because participants may have data for one intervention period but not another. The registry record does not say whether incomplete sequences were included, excluded, or handled using a particular model. It does not report sensitivity analyses for missing data.
These omissions prevent assessment of whether results, had they been reported, were robust to missingness or to the choice of time point and comparison. They also mean that no claim about the completeness of outcome follow-up or the analysis population can be made from the registry record.
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 |
|---|---|---|---|
| Individual Joints | 0 | 20 | 0.0% |
| Functional Multi-Joint Activities | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Individual Joints | 0 of 20 |
| Functional Multi-Joint Activities | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Individual Joints | 0 of 20 |
| Functional Multi-Joint Activities | 0 of 20 |
The registry lists 0 participants affected by serious adverse events and 0 affected by other adverse events in the Individual Joints entry. It lists 0 deaths for that entry. The corresponding entry for Functional Multi-Joint Activities also lists 0 affected by serious adverse events, 0 affected by other adverse events, and 0 deaths. Each entry records 20 at risk.
These figures describe what the registry record reports for the intervention entries; they do not establish that no event occurred outside the scope or reporting period captured by those entries. The record lists no serious adverse event terms. It does not provide further detail about event definitions, collection procedures, observation periods, or how events were attributed to treatment.
Because the study used a crossover design, participants could receive both intervention types. The two entries therefore should not be treated as non-overlapping groups or added to derive a count of distinct participants. The safety counts also do not supply the missing Box & Blocks Test results or establish a comparative treatment effect.
12. What the Result Does, and Does Not, Mean
The registry record describes a randomized crossover study of two robotic upper-extremity training approaches and identifies the Box & Blocks Test as its primary outcome. It also provides the treatment sequence descriptions, assessment schedule, listed enrollment, and recorded adverse-event counts. This information is useful for understanding the study question and design.
However, the outcome results are not reported in the registry record. There are no Box & Blocks Test means or standard deviations, no treatment-effect estimate, and no confidence interval or p-value. As a result, the record does not show whether scores changed after either approach, whether the approaches differed, or how precisely any difference was estimated. It does not support a conclusion that one approach was better, worse, or equivalent to the other.
Even if a numerical contrast were available, its interpretation would depend on the analysis, the treatment sequence, repeated measurements, missing data, and the clinical meaning of a score difference. Those details are not reported in the registry record. The test's direction is clear—higher scores indicate a better outcome—but that direction alone cannot determine the effect of either intervention.
The recorded safety counts are also limited. The registry entries report zero serious events, zero other events, and zero deaths for each intervention, but provide little detail on collection or attribution. These entries should be read as registry reporting, not as a guarantee that risk is absent.
In short, the record documents what was intended and how the trial was organized, but it does not provide the outcome analysis needed to judge comparative performance. The absence of reported findings is not evidence that the interventions had no effect; it means the effect cannot be assessed from the registry record.
13. Why This Trial Matters Statistically
This trial raises statistical issues that are common in rehabilitation studies. A crossover design allows both approaches to be given to participants, but it makes the order of treatments and the timing of assessments important. The two sequences differ in which approach came first, and the registry describes a one-week break between interventions. Appropriate interpretation depends on accounting for repeated observations and considering whether period or carryover effects could influence the comparison. The analysis details needed to assess this are not reported in the registry record.
The outcome schedule also matters. Baseline, post-intervention, and follow-up measurements can describe different aspects of performance. Without a clearly reported primary contrast, readers cannot know which comparison was intended to support the main conclusion. Multiple time points also make prespecification and multiplicity handling relevant, yet these methods are not reported.
Another statistical lesson is the difference between a completed study and a reportable estimate. The record lists a completed status and enrollment, but not the outcome values or inferential analysis. A study design can be described in detail while its treatment effect remains unavailable for evaluation. Enrollment alone cannot reveal precision or determine how many participants contributed to a particular analysis.
Finally, this record illustrates why an endpoint definition is not a result. The Box & Blocks Test is described clearly, including the scoring rule and the meaning of higher scores. But without observed scores and uncertainty estimates, the measure's relevance cannot be translated into a conclusion about the comparative effects of the two training approaches. Transparent reporting of estimates, analysis populations, missingness, and crossover methods would be necessary for that assessment.
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 interpretation is that the registry record does not report primary outcome results or a statistical comparison. It gives the Box & Blocks Test definition and assessment schedule but no score summaries, treatment-effect estimate, confidence interval, or p-value. The record also states that the outcome has several categories or time points and is not reduced to one comparison.
Important design and analysis details are absent. The registry does not specify who was masked, how randomization was performed, what the analysis population was, how missing outcome data were handled, or how the crossover structure was modeled. It does not report whether period, sequence, or carryover effects were evaluated. The one-week interval between interventions is documented, but its adequacy as a washout cannot be established from the record.
Participant eligibility criteria and baseline characteristics are not reported in the registry record, limiting assessment of who the findings would represent even if outcome results were available. The record also does not report intervention dose or detailed adherence information. A sample-size justification and the trial's statistical plan are not reported.
Safety reporting is limited to event counts in the intervention entries, without further details about event definitions, observation periods, or attribution. These limitations concern the information available in the registry record; they do not establish that the study itself lacked methods or analyses beyond what was recorded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Robotics For Rehabilitation Therapy: Functional Versus Individual Joint Training — NCT01050231.
- Registry record last updated 2021-04-19; status last verified 2021-03.
- Results first posted 2021-03-18.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT01050231 is a completed randomized, single-masked crossover study sponsored by the University of California, Irvine. The registry lists enrollment of 20 and identifies cerebrovascular accident as the condition. Participants were assigned to receive functional, task-oriented multi-joint robotic training and individual-joint robotic training in different orders, with a one-week break between interventions.
The primary outcome was the Box & Blocks Test, measured at baseline, after the first intervention at 5 weeks, after the second intervention at 11 weeks, and at the 3-month follow-up after the second intervention. Higher scores indicate a better outcome. The registry record does not report outcome estimates or an analysis comparing the approaches. It lists zero serious adverse events, zero other adverse events, and zero deaths in each intervention entry.