A Telerehabilitation Program for SCI: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Telerehabilitation Program for SCI (NCT04977037), a randomized na study. The primary outcome is Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).

2. Clinical Question

The trial record describes randomized allocation, double masking, and a parallel-group design. Enrollment was 20. The reported baseline GRASSP summaries are for the active and sham groups, but they are not a measure of change over the intervention. The study also registered outcomes concerning attendance, drop-outs, perceived usefulness, grip strength, and self-care. The registry record does not give results for those outcomes in the registry record for this analysis.

3. Trial Design

The registry record describes NCT04977037 as a randomized, double-masked, parallel study sponsored by The University of Texas Health Science Center, Houston. It lists the condition as incomplete spinal cord injury and records the study as completed. The start date is 2021-07-01, and the primary completion date is 2024-04-02. The phase is listed as NA.

The study enrolled 20 participants. The results list 13 participants in the Active tDCS group and 7 in the Sham tDCS group. The active intervention is described as anodal tDCS targeting the primary motor cortex, delivered at 2mA for 20 minutes. The sham intervention is described as sham tDCS to the same target, also delivered at 2mA for 20 minutes. The brief study description says the program was remotely supervised and home-based. Further details about the rehabilitation activities, session schedule, or conduct of masking are not reported in the registry record.

Randomization is intended to support comparable groups by assigning participants through a chance-based process, while masking is intended to limit the influence of treatment knowledge on participants or study assessments. These are general design purposes; the registry record does not explain how allocation was generated or concealed, who was masked, or how masking was maintained. A parallel design means that participants are assigned to one group rather than crossing between the interventions.

The primary outcome is the GRASSP score at baseline. The posted summaries give a mean and standard deviation in each group, but the registry record does not give an estimable two-arm comparison for this continuous endpoint. It also does not report follow-up primary-outcome results in the record used for this analysis. Consequently, the baseline group summaries should not be read as evidence of an intervention effect or as a comparison of change over time.

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 Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP), measured over Baseline.

The registered primary endpoint is arm and hand function measured with the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP). The registry description says the measure assesses the integration of sensorimotor hand and upper-limb impairment and function. The planned reported measure is the GRASSP total score, which ranges from 0 to 116; a higher score indicates a higher level of arm and hand function.

GRASSP is relevant to the study question because the intervention is intended to address upper-limb voluntary movement in people with tetraplegia caused by incomplete spinal cord injury. A measure that brings together aspects of sensorimotor impairment and function can describe the status of arm and hand function on the study’s chosen scale. This is a general explanation of why such an endpoint may be useful, not a claim about how well the measure captures every aspect of daily function.

The registry record specifies the primary outcome timeframe as baseline. That timing matters: a baseline score describes participants’ status at the start of the assessed period, rather than improvement attributable to an intervention. The posted group summaries are means with standard deviations. They do not include an estimable two-arm analysis, and no follow-up primary endpoint comparison is reported in the registry record. The baseline data therefore describe the enrolled groups but cannot establish how either group changed during the program.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group study. In general, random allocation is used to reduce systematic differences between groups at the point of assignment. Masking can help limit bias that might arise if participants or assessors know which intervention was assigned. These design features do not by themselves guarantee that groups are balanced or that all later analyses are unbiased. The registry record does not report the method of sequence generation, allocation concealment, who was masked, or whether masking was assessed.

What do the primary summaries describe?

The primary endpoint is continuous: GRASSP total score at baseline. For a continuous measure, a mean describes the average score in a group, while a standard deviation describes the spread of individual scores around that mean. The posted summaries are a mean of 64.9 and standard deviation of 25.5 for the 13 participants in the Active tDCS group, and a mean of 58.3 and standard deviation of 31.1 for the 7 participants in the Sham tDCS group. These values describe baseline observations. They are not a post-treatment contrast, and they do not report change from baseline.

A comparison of group means would ordinarily be accompanied by an estimate of the contrast and an indication of its uncertainty. A confidence interval is a general way to communicate that uncertainty: it gives a range of effect values compatible with the observed data under the analysis assumptions. A p-value is a different summary, addressing how inconsistent the data are with a specified null hypothesis under those assumptions. Neither a confidence interval nor a p-value for the primary two-arm comparison is reported in the registry record. The record instead says the continuous endpoint values are missing or not estimable for a two-arm comparison.

Why does dispersion matter?

Variation among participant scores affects how precisely a group average or a difference between group averages can be estimated. Greater dispersion generally makes estimates less precise when other design features are held constant. This is a general statistical principle, not a new calculation from the posted summaries. Standard deviations should not be mistaken for uncertainty intervals around the means, and comparing standard deviations alone does not test whether the groups differ.

Some continuous outcomes can have more variability than is well represented by a simple normal model, or their distributions can be asymmetric or concentrated at scale limits. General methods may need to account for such distributional features. The registry record does not report diagnostic checks, the distribution of GRASSP scores, a model for the endpoint, or any adjustment for baseline or other covariates. It is therefore not possible to describe a specific model or assess its assumptions from this record.

What do the design and sample-size notes mean?

The record’s sample-size assumptions describe a planning illustration based on a stated fraction of the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. For non-time-to-event outcomes, the stated convention is participants per arm for 80% power or another listed planning level. Such calculations are illustrations of how a study might be planned under assumptions; they are not observed power and do not establish what design rationale the investigators used. The registry record does not report the trial’s own sample-size justification or its original planning assumptions. No numerical planning estimates are described in this interpretation.

Power is a general property of a design and analysis under a specified effect and assumptions. It is not a measure of whether an observed result is true, and a calculation based on an observed effect should not be read as observed power. A planning illustration also cannot replace an analysis of the collected data. Here, the registry record does not report an estimable two-arm primary comparison, so the baseline summaries cannot be used to make a conclusion about a treatment effect.

What can be inferred from the registry’s analysis fields?

The registry entries list zero analyses and indicate that a two-arm continuous-endpoint comparison was not estimable from the posted values. The record does not give a statistical analysis plan, test choice, model specification, missing-data method, or a definition of the analysis population. These details are important because the same endpoint can be analyzed in different ways, and those choices can affect estimates and uncertainty. They are not reported in the registry record and should not be inferred.

Randomization and a parallel design describe how the trial was structured, but they do not supply missing outcome analyses. Baseline means and standard deviations can be useful as descriptive information, while a treatment comparison generally requires outcome data at a relevant follow-up time or a prespecified change analysis. The primary timeframe listed is baseline. No post-baseline GRASSP results or treatment comparison are reported in the available record. Thus the statistical information supports a description of baseline scores and study structure, not an estimate of intervention effectiveness.

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("Active tDCS", "Sham tDCS")
n   <- c(13, 7)
m   <- c(64.9, 58.3)
sp  <- c(25.5, 31.1)
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  Active tDCS  13  64.900  25.500  49.491  80.309
CARM  Sham tDCS  7  58.300  31.100  29.537  87.063

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 15 outcome measures and 12 posted secondary outcomes. The secondary outcomes include attendance, participant drop-outs, perceived usefulness of the home intervention, grip strength, and self-care. Some outcome descriptions recur in the record. It does not report how many hypotheses were formally tested, which outcomes were analyzed, or whether any adjustment for multiple comparisons was planned or used.

Multiplicity is a general concern when many outcomes or comparisons are examined: the chance of finding an apparently notable result by chance can increase as the number of tests grows. A prespecified hierarchy, adjustment method, or clear distinction between primary and exploratory outcomes can help readers understand the role of each result. None of those analysis details are reported in the registry record. No multiplicity correction should be presumed.

The record lists zero analyses in the registry record for this analysis. It does not describe missing-data amounts or reasons, how missing observations were handled, or whether any sensitivity analyses were performed. The primary endpoint is specified at baseline, but the record does not provide a follow-up primary outcome comparison. No analysis-population definition, such as an intention-to-treat or per-protocol population, is reported in the registry record. These gaps prevent assessment of how participants with incomplete outcome data were treated and which participants contributed to any inferential analysis.

These are reporting limitations, not proof that no analyses or procedures took place outside the registry record. The interpretation must be confined to what the record documents: baseline GRASSP summaries, listed outcomes, and no estimable two-arm continuous-endpoint comparison.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent non-serious adverse event terms

The adverse-event record reports zero serious adverse events among 13 participants at risk in the Active tDCS group and zero among 7 participants at risk in the Sham tDCS group. It reports zero deaths in both groups. The top serious adverse-event terms list is empty.

For other adverse events, the record reports 1 affected participant among 13 at risk in the Active tDCS group and 2 affected participants among 7 at risk in the Sham tDCS group. These are the posted counts, not a statistical comparison. No inference about a difference between groups follows from these small descriptive counts alone. The registry record does not provide event descriptions, severity details for these other events, timing, relatedness assessments, or an analysis comparing event rates.

Safety counts should be read in the context of the participants represented and the reporting definitions used. A report of zero serious events is not proof that a risk is absent, and the available record does not provide enough detail to characterize the full safety profile. These figures describe what was entered in the registry record and should not be interpreted as medical advice or as a conclusion about the safety of either intervention.

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

The registry record documents a randomized, double-masked, parallel trial of active versus sham tDCS in a home-based telerehabilitation study for adults with tetraplegia caused by incomplete spinal cord injury. It identifies GRASSP arm and hand function as the primary outcome and reports baseline means and standard deviations for each group. Those data describe the baseline participants; they do not show whether arm or hand function changed during the intervention.

The primary outcome timeframe is baseline, and the posted record indicates that values are missing or not estimable for a two-arm comparison of the continuous endpoint. There is no reported estimate of a treatment contrast, confidence interval, or p-value in the registry entries. Therefore, the record does not establish whether active and sham groups differed in post-treatment function, nor does it quantify the precision of such a difference. It also does not support a claim that either intervention did or did not improve function.

The results are not a substitute for a complete trial report. The record does not give the analysis methods, follow-up primary outcome results, missing-data handling, or analysis populations. It also does not report results for the listed secondary outcomes in the registry record for this analysis. Absence of these details limits what can be concluded; it should not be converted into a finding of no effect.

As a general principle, interpretation of a clinical trial depends on the outcome measured, when it was measured, the comparison made, and the uncertainty around the estimate. Here, baseline descriptions are available, but an inferential comparison is not. The appropriate conclusion is narrow: the registry record contains descriptive baseline data and limited adverse-event counts, while leaving the primary treatment-effect question unresolved in the posted statistical results.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the distinction between a registered clinical question and the results needed to answer it. The study is randomized, double-masked, and parallel, and it targets an outcome relevant to upper-limb function after incomplete spinal cord injury. Yet design labels and baseline group summaries do not by themselves provide an estimate of the effect of active versus sham stimulation.

The primary measure, GRASSP, is described as combining aspects of sensorimotor hand and upper-limb impairment and function. Reporting a measure and its scale helps readers understand what the study intended to assess. The fact that the timeframe is baseline is equally important: an initial measurement characterizes participants but does not demonstrate change during treatment. The registry record does not provide an estimable two-arm comparison for this continuous outcome.

The record also illustrates why analysis transparency matters. Without a reported model, missing-data approach, analysis population, or multiplicity plan, readers cannot evaluate key choices that would shape an inferential result. Reporting the sample-size assumptions as planning illustrations is not a substitute for a trial-specific justification or an analysis of observed outcomes. Likewise, posted adverse-event counts are descriptive and do not amount to a comparative safety analysis.

These points matter to biostatisticians and clinical researchers because conclusions depend on more than enrollment and intervention descriptions. Clear reporting of outcome timing, estimates, uncertainty, analysis decisions, and missing-data handling allows readers to judge how strongly results address the clinical question. In this record, the main statistical contribution available for interpretation is a description of baseline GRASSP scores and study structure; the treatment-effect question remains unanswered by the posted comparison data.

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 primary endpoint is reported at baseline, and the registry record does not contain an estimable two-arm comparison for that continuous outcome. This prevents interpretation of a treatment effect from the posted primary data. The group summaries are descriptive and cannot show change during the program.

The listed group sizes are 13 for Active tDCS and 7 for Sham tDCS. The record does not explain the unequal allocation in the posted results, whether all enrolled participants contributed to the baseline summaries, or whether any participants were excluded from particular outcomes. It also does not report recruitment or eligibility details beyond the broad population description.

Intervention descriptions specify the stimulation type, target, intensity, and duration, and the brief summary characterizes the program as remotely supervised and home-based. The registry record does not provide further details about rehabilitation content, adherence results, intervention fidelity, or how masking was implemented. Those omissions make it difficult to understand the full treatment contrast.

The record lists many outcome measures but provides no analyses in the registry record for this analysis. It does not report a statistical analysis plan, multiplicity approach, missing-data handling, follow-up primary outcome values, or analysis-population definitions. Nor does it provide inferential safety comparisons or detail on the reported other adverse events. These specific reporting gaps limit assessment of the strength, precision, and completeness of the trial’s findings.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Telerehabilitation Program for SCI — NCT04977037.
• Registry record last updated 2025-04-20; status last verified 2025-04.
• Results first posted 2025-04-20.
• 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

NCT04977037 is a completed, randomized, double-masked, parallel study sponsored by The University of Texas Health Science Center, Houston. It enrolled 20 participants with incomplete spinal cord injury. The listed interventions are active and sham tDCS, each targeting the primary motor cortex and described as delivered at 2mA for 20 minutes. The study start date is 2021-07-01, and the primary completion date is 2024-04-02; phase is listed as NA.

The primary outcome is baseline GRASSP total score, a measure of arm and hand function with a range from 0 to 116 and higher scores indicating higher function. Baseline means and standard deviations are reported for 13 participants in the active group and 7 in the sham group. The registry record indicates that a two-arm comparison for the continuous endpoint is not estimable. It lists 15 outcome measures, 12 secondary outcomes, and zero analyses in the registry record for this analysis. The primary treatment-effect comparison and further analysis details are not reported in the registry record.