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 To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients (NCT02410629), a randomized na study. The primary outcome is Box and Block Test.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02410629 |
| Phase | NA |
| Condition | Cerebrovascular Accident |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | Single |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | David Reinkensmeyer |
| Results posted | Yes |
2. Clinical Question
Population
People with subacute stroke, described in the registry record under the condition Cerebrovascular Accident. Enrollment was 17. The record does not provide further eligibility details or a fuller description of the enrolled population.
Intervention
The Music Glove, a sensor-equipped glove linked to a musical software program. Participants follow musical cues by moving their fingers. The planned schedule described in the record was exercise at least 3 times a week for 3 weeks, with a minimum of 3 hours of exercise time per week.
Comparator
A conventional hand exercise program designed by an occupational therapist, including range of motion, strengthening, and coordination exercises for the hand and fingers. The record describes a randomized AB and BA sequence, with participants receiving the other intervention at 3-month post stroke.
Primary question
How did Box and Block Test scores change from baseline to the end of the first 3-week therapy period, and from 12-week post-stroke to the end of the second 3-week therapy period? The registry record describes these two intervention-period changes, but numerical results and a statistical comparison between interventions are not reported in the registry record.
3. Trial Design
This was a randomized, single-masked crossover trial, marked completed in the registry record. The record lists a planned enrollment of 17 and identifies the two sequences as Music Glove first and conventional exercise second, or conventional exercise first and Music Glove second. It does not state who was masked or how masking was maintained.
Participants were to exercise at least 3 times a week for 3 weeks, for a minimum of 3 hours of exercise time per week. The brief summary says participants would receive the other intervention at 3-month post stroke. It lists clinical evaluations at baseline, after therapy following the first intervention, at 3-week post-intervention follow-up, at 3-month post stroke, after therapy following the second intervention, at 3-week post-second-intervention follow-up, and at 6-month post-stroke follow-up. The primary outcome description focuses on change during each 3-week therapy period.
The crossover structure means participants were intended to receive both interventions in sequence, so each participant could contribute observations during both treatment periods. In general, crossover analyses need to account for period and sequence, and may need to consider whether effects of an earlier intervention persist into a later period. The registry record does not report the analysis approach, whether any washout period was used, or how period or carryover effects were handled. It also does not report how many participants completed both periods or the outcome assessments.
The record lists the study start as 2015-03 and primary completion as 2016-07. It does not give further detail about deviations from the planned schedule or the conduct of follow-up.
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 | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
|---|---|---|
| STARTED | 8 | 9 |
| COMPLETED | 5 | 6 |
| NOT COMPLETED | 3 | 3 |
Reasons for not completing this period:
| Reason | Music Glove First Then Conventional Hand Exercise Program | Conventional Hand Exercise Program First Then Music Glove |
|---|---|---|
| Family cannot commit to the study | 2 | 1 |
| Subject returned to work | 1 | 0 |
| Subject moved back to home country | 0 | 1 |
| Subject underwent heart surgery | 0 | 1 |
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 | Music Glove First - Conventional Second | Conventional Hand Exercise Program First - Music Glove Second | Total |
|---|---|---|---|---|
| Participants analysed | 6 | 5 | 11 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 5 |
| Age, Categorical: >=65 years | Participants | 4 | 2 | 6 |
| Age, Continuous | years | 64 (SD 17) | 59 (SD 13) | 62 (SD 15) |
| Sex: Female, Male: Female | Participants | 3 | 4 | 7 |
| Sex: Female, Male: Male | Participants | 3 | 1 | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 1 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 6 | 4 | 10 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): White | Participants | 6 | 2 | 8 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Region of Enrollment: United States | participants | 6 | 5 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Box and Block Test, measured over From baseline to end of therapy (3 weeks).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | blocks |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Box and Block Test, reported as a mean number of 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 is counted; multiple blocks moved at the same time count as a single block. The registry record states that higher scores indicate a better outcome.
The endpoint is used to assess hand and finger motor performance through a timed task involving repeated reaching, grasping, and movement of objects. It is a performance measure: the recorded score is the number of blocks moved during the test, rather than a report of symptoms or a broader measure of daily functioning. This description explains the test's task and scoring, but does not establish how well it represents every aspect of hand use in daily life.
The primary outcome description specifies change from baseline to the end of 3-week therapy for the first intervention, and change from 12-week post-stroke to the end of 3-week therapy for the second intervention. Those are changes within treatment periods; interpreting them as a direct comparison of interventions would require an analysis that accounts for the crossover design. Numerical scores, changes, uncertainty estimates, and the analysis used are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the trial question and outcome definition, but it does not provide numerical Box and Block Test results. It therefore does not show the size or direction of the score changes during either intervention period, nor whether the changes differed between the Music Glove and conventional hand exercise. The record also does not report confidence intervals, p-values, or another measure of uncertainty for the primary outcome. A relative treatment effect and its precision cannot be assessed from the record.
The outcome description indicates that higher Box and Block Test scores are better, but this direction alone is not enough to interpret a trial result. Interpretation would require the observed scores or changes, the comparison between interventions, and information about variability and the analysis. Without those results, it is not possible to judge whether any observed difference was small or large, precise or imprecise, or compatible with more than one plausible effect.
In general, a confidence interval describes a range of estimates compatible with the data and the method used to calculate it. A narrow interval indicates greater statistical precision than a wide interval, but neither width nor statistical significance alone establishes clinical importance. The registry record does not report a confidence interval or a threshold for a clinically important Box and Block Test change.
The crossover design makes sequence and period relevant to interpretation. In general, participants can serve as their own comparison across treatment periods, which can reduce the influence of stable differences between participants. At the same time, a valid interpretation depends on how the analysis handles period effects, sequence, and any lingering effect from the first intervention. Those analysis details are not reported in the registry record.
The registry record lists 17 as enrollment, and the safety record gives participants at risk for adverse-event summaries by sequence. These figures do not supply the missing primary-outcome analysis. The record marks the study completed, but completion status does not itself indicate that a result favored either intervention. No conclusion about comparative benefit can be drawn from the posted primary-outcome information.
9. Statistical Methods Explained
What kind of outcome is this?
The Box and Block Test is a continuous outcome summarized as a mean and standard deviation. In general, a mean describes the average score in a group, while a standard deviation describes the spread of individual scores around that average. These summaries answer different questions: the mean describes the group’s central score, and the standard deviation describes variation among scores. Neither summary is reported numerically for the primary outcome in the registry record.
The endpoint description focuses on change over a treatment period rather than only a score at a single visit. In general, a change score is calculated by comparing a participant’s measurement at the end of a period with a measurement at its start. A comparison of average changes between interventions can address whether outcomes changed differently during the two treatment periods. The registry record describes the intended periods but does not report the numerical changes or how they were compared.
Why does the crossover design matter?
In general, a crossover trial assigns participants to sequences of interventions, and each participant receives the interventions in a specified order. The AB and BA sequences described in this record correspond to Music Glove followed by conventional exercise, or the reverse. Because measurements are made across periods within participants, an analysis may need to account for the relationship between a participant’s repeated measurements. Treating all period measurements as if they came from unrelated participants can fail to represent that structure.
Period effects are changes that may occur over time, regardless of which intervention is being received. In a stroke rehabilitation study, recovery and the timing of assessment could matter to outcomes; this is a general design consideration, not a finding reported for this trial. Sequence effects refer to differences associated with the order in which interventions are received. Carryover refers to an effect of an earlier intervention persisting into a later period. These are general concerns in crossover studies. The registry record does not state whether a washout period was planned or whether period, sequence, or carryover were assessed in the analysis.
How should uncertainty be assessed?
In general, a treatment contrast estimates the difference in outcomes between interventions, and a confidence interval indicates the statistical uncertainty around that estimate. A p-value, when reported, relates the observed data to a specified statistical model and null hypothesis; it is not a measure of effect size or clinical importance. The registry record does not report a primary-outcome contrast, confidence interval, or p-value. There is therefore no basis in the record for describing the statistical significance or precision of the primary result.
The trial’s outcome is measured in blocks, so a contrast in the original scale would be interpretable as a difference in the average number of blocks moved, if such a contrast were reported. Whether that difference would matter in practice would require context, including an appropriate threshold for meaningful change. A threshold for clinically important change is not reported in the registry record.
What does over-dispersion mean in general?
Over-dispersion is a concern when observed variation is greater than assumed by a statistical model. If a model understates variation, standard errors can be too small and uncertainty can appear less than it is. The primary endpoint is described as a continuous measure summarized by a mean and standard deviation; the registry record does not report a model or indicate that over-dispersion was assessed. This general concept should not be taken as a description of an observed issue in this trial.
What can be inferred from the analysis record?
The registry record lists 4 outcome measures and zero analyses. It describes the primary outcome and names secondary measures, but does not provide a statistical analysis plan, model specification, covariate adjustment, handling of repeated measures, or inferential results. It also does not report a sample-size justification. A planning illustration based on an observed effect, if considered, is not observed power and cannot substitute for a reported analysis or uncertainty estimate. The planning assumptions listed in the record include a two-sided significance level of 0.05, equal allocation, and a normal approximation; no numerical planning result is stated in the record. Those assumptions do not establish the trial’s original design rationale or the method used for the completed trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 outcome measures: the Box and Block Test as the primary outcome, with the Fugl-Meyer Motor Assessment of the Upper Extremity, Action Research Arm Test, and 9-Hole Peg Test as secondary outcomes. It does not report results for those measures or describe a plan for handling multiple outcomes or comparisons.
Multiplicity arises when several outcomes, time points, or comparisons are examined. In general, testing many hypotheses can increase the chance of finding an apparently unusual result by chance. A prespecified analysis plan can explain which outcomes are primary, how comparisons are prioritized, and whether any adjustment or other strategy is used. The registry record identifies a primary outcome but does not report an adjustment strategy or a hierarchy for interpreting the secondary outcomes. The primary outcome description itself includes changes across both intervention periods; the record does not report how those period-specific results were combined or contrasted.
Information about missing outcome data is also not reported in the registry record. The record does not state how many participants contributed primary-outcome measurements at each assessment, whether any observations were missing, why data might be missing, or how missing values were handled. It does not report analysis populations, such as whether the analysis followed randomized sequence assignment or included only participants with measurements in both periods. These details matter because incomplete follow-up can affect which participants contribute to an estimate and how representative that estimate is.
The registry record lists zero analyses. Consequently, it does not provide enough information to assess multiplicity procedures, missing-data assumptions, or the analysis population actually used.
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 |
|---|---|---|---|
| Music Glove First - Conventional Second | 0 | 8 | 0.0% |
| Conventional Hand Exercise Program First - Music Glove Second | 0 | 9 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Music Glove First - Conventional Second | 0 of 8 |
| Conventional Hand Exercise Program First - Music Glove Second | 0 of 9 |
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 |
|---|---|
| Music Glove First - Conventional Second | 0 of 8 |
| Conventional Hand Exercise Program First - Music Glove Second | 0 of 9 |
The adverse-event summaries are organized by assigned sequence. For Music Glove first and conventional exercise second, 8 participants were listed as at risk for serious adverse events and 0 were reported as affected; 8 were listed as at risk for other adverse events and 0 were reported as affected. For conventional exercise first and Music Glove second, 9 were listed as at risk for serious adverse events and 0 were reported as affected; 9 were listed as at risk for other adverse events and 0 were reported as affected. Deaths were recorded as 0 in each sequence.
These figures describe the registry’s posted event summaries, not proof that no event occurred outside the recorded definitions, observation periods, or reporting process. The record does not give event-term details for serious events, and it does not report further detail about the collection or attribution of adverse events. The absence of reported affected participants should be read as a feature of the posted safety data, not as a guarantee of safety or a comparison showing one intervention is safer. The registry record does not provide a comparative statistical analysis of adverse events.
12. What the Result Does, and Does Not, Mean
The record describes a randomized crossover study of the Music Glove and a conventional hand exercise program for subacute stroke, with the Box and Block Test as the primary outcome. It specifies the task, the direction of scoring, and the intended assessment of change during each intervention period. It also records a completed study and safety summaries by intervention sequence.
Those details explain what the investigators intended to compare, but they do not establish what happened to Box and Block Test scores. Numerical primary-outcome results and analyses are not reported in the registry record. Accordingly, the posted data in this record do not show whether scores increased or decreased during either period, whether the changes differed by intervention, or how precise any difference might be. No conclusion about the comparative effect can be drawn from the outcome information available in the record.
In general, a change over time during a treatment period is not necessarily attributable to the intervention alone. In a crossover study, interpretation also depends on sequence, period, and the handling of any persistent effects from an earlier period. The registry record does not report the methods used to address these issues, so it is not possible to assess how they affected the results.
The recorded absence of affected participants in the adverse-event summaries is limited to those summaries and does not establish that either program has no risks. Likewise, the completed status and the planned enrollment do not provide evidence about the direction or size of an outcome effect. The record is useful for understanding the study question and design, but it does not contain the results needed to judge comparative outcome changes or their uncertainty.
13. Why This Trial Matters Statistically
This trial is statistically notable for its crossover structure and its repeated outcome assessments. Participants were randomized to an AB or BA sequence, and the primary outcome description considers change during both intervention periods. This creates an opportunity, in general, to compare interventions within participants, while also requiring attention to order and time-related effects. Understanding those features is essential before interpreting any treatment contrast.
The primary measure is a timed performance test with a clear unit: blocks moved during 60 seconds. A defined measure and scoring direction make the intended outcome understandable. However, statistical interpretation depends not only on the test definition but also on the observed results, the analysis model, and uncertainty. Those numerical results and analysis details are not reported in the registry record.
The record also lists three secondary outcome measures in addition to the primary endpoint. Multiple measures can offer a broader assessment, but they raise questions about how findings should be prioritized and how the possibility of chance findings is handled. The registry record does not report a multiplicity strategy or results for those secondary measures.
Finally, the record illustrates the distinction between trial registration details and a full results account. It provides the design, schedule, and outcome definitions, while leaving the primary effect estimate, its precision, missing-data handling, and analysis population unreported. A complete statistical interpretation depends on those elements; completion status alone cannot fill that gap.
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 central limitation for statistical interpretation is that numerical primary-outcome results and analyses are not reported in the registry record. No period-specific mean changes, treatment contrast, uncertainty estimate, or inferential result is available to assess. The record also does not provide results for the listed secondary outcome measures.
Important methods details are absent. The registry record does not report the statistical model, handling of repeated measurements, adjustment for period or sequence, or assessment of possible carryover. The masking designation is single, but who was masked and how masking was implemented are not stated. A washout period is not reported. These omissions prevent assessment of how the crossover design was handled in the analysis.
The record does not report participant flow through the intervention periods, completion of follow-up, analysis populations, or missing-data methods. The planned enrollment is recorded, but a sample-size justification is not reported in the registry record. The record also does not state a clinically important threshold for interpreting Box and Block Test changes.
The primary outcome description refers to changes over two intervention periods, while the listed timeframe names the end of therapy at 3 weeks. The registry record does not clarify how the two period-specific changes were represented in the final analysis. The brief summary gives the intended assessment schedule, but actual assessment completion is not reported. These limitations concern what can be established from the registry record; they do not show that particular methods were or were not used outside the information recorded there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients — NCT02410629.
- Registry record last updated 2022-10-13; status last verified 2022-10.
- Results first posted 2020-04-07.
- 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
NCT02410629 is a completed randomized, single-masked crossover trial titled To Determine the Therapeutic Effect of the Music Glove and Conventional Hand Exercises to Subacute Stroke Patients; its official title is Influence of Timing on Motor Learning. The record lists enrollment of 17 and compares the Music Glove with a conventional hand exercise program in AB and BA sequences.
The primary outcome is the Box and Block Test, measured as blocks moved during a 60-second task, with higher scores indicating a better outcome. The described endpoint concerns change during each 3-week therapy period. Secondary measures include the Fugl-Meyer Motor Assessment of the Upper Extremity, Action Research Arm Test, and 9-Hole Peg Test.
Numerical outcome results, statistical analyses, missing-data procedures, and a sample-size justification are not reported in the registry record. Safety summaries report 0 affected participants for serious and other adverse events in both sequences, with 0 deaths recorded in each.