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 Robotic Gait Rehabilitation in Parkinson's Disease (NCT05218187), a randomized na study. The primary outcome is Comfortable Walking Speed (CWS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05218187 |
| Phase | NA |
| Condition | Parkinson Disease, Gait Disorder, Sensorimotor |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Indiana University |
| Results posted | Yes |
2. Clinical Question
Population
People with Parkinson’s disease and gait disability. The record also lists gait disorder, sensorimotor, as a condition. It reports an enrollment of 15 participants, but the number included in each outcome analysis could vary by assessment time because outcome data were not available for all participants at every time point.
Intervention
Conventional physical therapy combined with G-EO end-effector gait training. The record describes physical therapy sessions that included warm-up, stretching, progressive strength training, and balance training, with gait training using the G-EO trainer. The full intervention details are not reported in the registry record.
Comparator
Conventional physical therapy, including gait training using traditional over-ground walking. The description also mentions warm-up, stretching, progressive strength training, and balance training. Some details of the treatment description are incomplete in the registry record.
Primary question
Does adding G-EO gait training to conventional physical therapy change comfortable walking speed, measured in meters per second, at baseline, after treatment, and at follow-up? The primary outcome is described, but a numerical comparison or statistical analysis is not reported in the registry record.
The study’s stated aims include establishing the safety and feasibility of G-EO gait training and investigating its impact on mobility, function, quality of life, and participation. The record lists comfortable walking speed as the primary outcome and lists other measures covering walking, transfers, balance confidence, balance control, and Parkinson’s disease-related quality of life. These outcomes provide a wider context for the intervention, but the registry record does not report analyzed results for them.
The registry describes a randomized trial with a parallel-group design. It does not report which participants were masked, how allocation was generated or concealed, or the planned statistical comparison for the primary question. The record therefore identifies the clinical comparison and the intended outcome, but does not establish whether the groups differed in the posted data.
3. Trial Design
This study is registered as a randomized, parallel-group trial of gait rehabilitation for people with Parkinson’s disease and gait disability. It compares conventional physical therapy with conventional physical therapy combined with G-EO end-effector gait training. The registry record lists Indiana University as the sponsor and an enrollment of 15 participants. The study status is terminated. Its listed start date is 2022-01-10, and its primary completion date is 2025-08-22.
The record describes the study as single-blinded. It does not identify which people involved in the trial were masked, or describe how masking was maintained. Details of the randomization process, allocation concealment, eligibility criteria, recruitment setting, and reasons for termination are not reported in the registry record. The study phase is listed as NA.
In the conventional physical therapy group, the treatment description includes a warm-up using a cycle ergometer or treadmill walking, stretching, progressive strength training, balance training, and traditional over-ground gait training. For the group receiving G-EO training as well, the description includes similar warm-up and exercise components, with gait training delivered using end-effector protocols. The complete descriptions of both treatment arms are not reported in the registry record.
The stated research aims include safety and feasibility as well as possible changes in mobility, function, quality of life, and participatory outcomes. Comfortable walking speed is the primary outcome. Its assessment is specified at baseline, after the intervention within one week after the last therapy session, and 30 days after the post-intervention visit. Other listed outcomes include the Six Minute Walk Test walking speed, Five Times Sit to Stand Test, Activities-Specific Balance Confidence Scale, Mini-Balance Evaluation Systems Test subscales, and Parkinson’s Disease Questionnaire-39 summary index score.
The registry record lists 11 outcome measures, but reports 0 analyses. It does not report a numerical primary-outcome comparison, a statistical test, a confidence interval, or a p-value. As a result, the design and intended measurements can be described, but the treatment contrast cannot be evaluated from reported outcome estimates.
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 | Conventional Physical Therapy (CPT) Group | Conventional Physical Therapy (CPT) Group With G-EO Training (CPT-GEO) |
|---|---|---|
| STARTED | 9 | 6 |
| COMPLETED | 8 | 5 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Conventional Physical Therapy (CPT) Group | Conventional Physical Therapy (CPT) Group With G-EO Training (CPT-GEO) |
|---|---|---|
| Injury unrelated to study prior to intervention | 1 | 0 |
| Did not initiate assigned intervention | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The number of participants included in the analysis differs from the overall number of participants because outcome data were not available for all participants at every assessment time point. Participants with available data were included in the analysis for the applicable assessment time point; therefore, the number analyzed varies across baseline, post-intervention, and one-month follow-up assessments.
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 | Conventional Physical Therapy (CPT) Group | Conventional Physical Therapy (CPT) Group With G-EO Training (CPT-GEO) | Total |
|---|---|---|---|---|
| Participants analysed | 8 | 5 | 13 | |
| Age, Continuous | years | 76 (68 to 81) | 66 (50 to 75) | 70 (50 to 81) |
| Sex: Female, Male: Female | Participants | 1 | 1 | 2 |
| Sex: Female, Male: Male | Participants | 7 | 4 | 11 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| 10 Meter Walk Test: Comfortable Walking Speed | Meters/second | 0.980 (SD .185) | 0.749 (SD 0.235) | 0.891 (SD 0.228) |
| 10 Meter Walk Test: Fast Walking Speed | Meters/second | 1.398 (SD 0.142) | 1.048 (SD 0.399) | 1.264 (SD 0.310) |
6. Primary Endpoint
The registry lists the primary outcome as Comfortable Walking Speed (CWS), measured over Baseline, Post-Intervention (within 1 week after last therapy session), and 30 days after Post-intervention Visit.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Meters/second |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is comfortable walking speed, measured in meters per second. Participants are asked to walk at their usual comfortable pace over a 14-foot pressure mat. Walking begins 5 feet before the mat, and participants cross the mat 2 times; the average speed is calculated. The record says the test takes 5 minutes and is performed first.
Walking speed is used as a measure of gait performance. In general, a continuous measure such as speed retains information about the magnitude of a participant’s observed performance rather than reducing the result to a category. Measurements at baseline, after the intervention, and at 30 days after the post-intervention visit can describe performance at different assessment times. Comparing groups at those times, or comparing changes over time, would require a specified analysis and reported data; those results are not reported in the registry record.
The record states that the number of participants included in an analysis can differ from overall enrollment because outcome data were not available for all participants at every assessment time. It says participants with available data were included for the applicable time point. The reasons for unavailable measurements, and how those patterns might affect interpretation, are not reported in the registry record.
The measure is a walking-performance endpoint, not a complete account of the study’s broader aims. The other listed outcomes address aspects of walking, transfers, balance, and quality of life. Their presence signals the range of domains the study intended to assess, but the registry record does not report numerical findings for these measures.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record defines a clinical comparison and identifies comfortable walking speed as the primary outcome, but it does not report a numerical analysis of that outcome. No group means, standard deviations, treatment contrast, confidence interval, or p-value for comfortable walking speed are reported in the registry record. The record lists 0 analyses. Consequently, the direction and size of any observed difference between the groups, and the precision of any estimate, cannot be described from this record.
This distinction matters because an outcome definition is not an outcome result. The protocol description explains what was intended to be measured and when; it does not establish what the measurements showed. The stated aims concern safety, feasibility, mobility, function, quality of life, and participation. The presence of those aims does not demonstrate that those outcomes were achieved or that a treatment effect was present.
The enrollment was 15 participants, while the adverse-event summaries list 8 participants at risk in the conventional physical therapy group and 5 in the group receiving G-EO training with conventional physical therapy. The primary-outcome description explicitly notes that analysis counts may vary by assessment time because data were unavailable for some participants. The number analyzed at each time point is not reported in the registry record. Enrollment alone should therefore not be treated as the denominator for every outcome.
In general, a confidence interval describes the range of effect sizes compatible with the data and the statistical method used. Its width conveys precision: a wider interval indicates less precise estimation than a narrower interval. Since no primary-outcome confidence interval or effect estimate is reported in the registry record, neither the likely magnitude nor its precision can be assessed. The absence of a reported p-value also means there is no basis for describing statistical significance.
The record includes sample-size planning assumptions for illustrations based on an observed effect: a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. Such planning illustrations are not observed power and do not substitute for an estimate of the treatment effect. The record does not report its own sample-size justification. The numerical illustration results and the observed effect used for them are not reported in the registry record.
The safety summary lists no serious adverse events, other adverse events, or deaths in either group. These are observed event counts within the reported at-risk groups. They do not establish that the chance of an adverse event is absent, and they do not provide a precise estimate of safety. The small enrollment and lack of additional event detail limit what can be concluded from these counts. The registry record also does not report reasons for termination or a fuller account of study conduct.
Overall, the record supports a description of the research question, study structure, outcome measures, and listed safety counts. It does not support a conclusion about whether the groups differed in walking speed or other outcomes, how large any difference might have been, or how uncertain an estimate would be.
9. Statistical Methods Explained
What does a mean and standard deviation describe?
The primary outcome is continuous, and the registry specifies a mean and standard deviation as its summary measures. In general, a mean describes the central level of a set of measurements. A standard deviation describes how dispersed individual measurements are around that mean. The two statistics answer different questions: the mean concerns the average level, while the standard deviation concerns variation among observations. Neither alone describes the uncertainty in a comparison between groups.
A standard deviation is not a confidence interval. A confidence interval concerns uncertainty in an estimated quantity, such as a group difference, under a statistical model. It depends on the estimate, the amount and structure of data, and the chosen method. The registry record does not report a mean, standard deviation, group contrast, or confidence interval for comfortable walking speed, so none of these quantities can be interpreted as a result for this trial.
What would a treatment comparison need to establish?
In general, a comparison should define the outcome, the groups being compared, and the assessment time or change being analyzed. A treatment contrast could compare group means at a specified time or compare changes from baseline, but these answer different questions and may rely on different assumptions. The registry identifies multiple assessment times, but the statistical plan for relating those measurements is not reported in the registry record. It is therefore not possible to say which comparison was intended for the primary analysis.
Randomization is intended to support fair comparison by assigning participants to groups through a chance process. It does not guarantee that the groups will be identical in every characteristic, especially in a study with limited enrollment. A sound interpretation also depends on how allocation was implemented, how missing measurements were handled, and whether the analysis followed the planned comparison. Those details are not reported in the registry record.
How should uncertainty and p-values be understood?
In general, a p-value measures how incompatible the observed data are with a specified null model, assuming the model and analysis are appropriate. It does not measure the probability that a treatment works, nor the size or clinical importance of an effect. A confidence interval is often more useful for showing plausible effect sizes and estimation precision. Neither a p-value nor an interval is reported for the primary outcome in the registry record. No statistical test for that outcome is reported either.
Statistical significance and practical importance are distinct concepts. A small estimated difference may be precisely estimated, while a larger estimated difference may remain uncertain when data are sparse. Interpretation of comfortable walking speed would require its estimate and uncertainty, along with context about what differences matter for the population. A threshold for an important difference is not reported in the registry record, and the numerical outcome results are not reported.
What do the sample-size illustrations represent?
The record describes planning illustrations using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is described as a fraction of the observed effect. In general, a sample-size calculation estimates how many participants would be needed under specified assumptions to have a chosen chance of detecting an effect of a specified size at the selected significance level. The result is conditional on those assumptions; it is not a guarantee that a future or completed study will detect an effect.
The record’s sample-size description calls the calculations planning illustrations based on an observed effect, not the trial’s own design. It also makes clear that sample sizes are expressed per arm for outcomes other than time-to-event outcomes. No time-to-event outcome is described among the listed measures. The numerical illustrations and the observed effect used as their basis are not reported in the registry record. They should not be read as observed power, which is not an appropriate substitute for interpreting an estimated effect and its uncertainty.
Why can over-dispersion matter?
In general, over-dispersion occurs when the observed variability in data exceeds what a chosen statistical model expects. If ignored, it can make standard errors too small and uncertainty intervals too narrow. Whether over-dispersion is relevant depends on the outcome type and model. The primary outcome is described as a continuous measure summarized by a mean and standard deviation; the registry record does not report a fitted model or an assessment of over-dispersion. It would therefore be inappropriate to claim that over-dispersion was present, assessed, or adjusted for in this study.
What analysis details are unavailable?
The statistical analysis plan, handling of repeated measurements, covariate adjustment, treatment of protocol deviations, and approach to missing data beyond use of available observations at applicable assessment times are not reported in the registry record. The record does not report interim analyses, a sample-size justification for the trial, or the prespecified method for any primary comparison. These are not details that can be inferred from the outcome names or the randomized design. The absence of reported analyses also means that recalculations from summary statistics are not possible for the primary outcome.
10. Multiplicity, Missing Data and Analysis Populations
The study lists 11 outcome measures, including comfortable walking speed and measures of walking, transfers, balance, and quality of life. Assessing several outcomes can raise multiplicity concerns. In general, when many hypotheses are tested, the chance of at least one apparently unusual result may increase unless the analysis accounts for the testing strategy. Appropriate interpretation depends on which outcomes were prespecified as primary or secondary, how many comparisons were planned, and whether any adjustment or hierarchy was used. The registry record identifies a primary outcome and lists secondary outcomes, but its multiplicity strategy is not reported.
The primary outcome has assessments at baseline, after intervention, and 30 days after the post-intervention visit. Multiple time points can also create more than one possible comparison. The registry record does not state which time point or contrast was designated for the primary treatment comparison, or whether multiplicity across times was addressed. No numerical analysis is reported, so there are no findings on which to assess the impact of multiple testing.
The record says outcome data were not available for all participants at every assessment time. It states that participants with available data were included for the applicable assessment time point. This describes an available-data approach, but does not identify why data were missing, whether the same participants contributed at each time, or whether missingness differed between groups. The statistical method for handling missing values and the assumptions behind it are not reported in the registry record.
In general, missingness can affect interpretation if the participants with recorded outcomes differ systematically from those without them. The direction and size of any resulting bias depend on the reasons for missing data and the analysis method. The number included at each time point and the planned analysis population are not reported in the registry record. There is no basis to infer an intention-to-treat analysis or a particular sensitivity analysis.
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 |
|---|---|---|---|
| Conventional Physical Therapy (CPT) Group | 0 | 8 | 0.0% |
| Conventional Physical Therapy (CPT) Group With G-EO Training (CPT-GEO) | 0 | 5 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Conventional Physical Therapy (CPT) Group | 0 of 8 |
| Conventional Physical Therapy (CPT) Group With G-EO Training (CPT-GEO) | 0 of 5 |
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 |
|---|---|
| Conventional Physical Therapy (CPT) Group | 0 of 8 |
| Conventional Physical Therapy (CPT) Group With G-EO Training (CPT-GEO) | 0 of 5 |
The registry record lists 0 serious adverse events and 0 other adverse events in the conventional physical therapy group, among 8 participants at risk. It also lists 0 serious adverse events and 0 other adverse events in the conventional physical therapy group with G-EO training, among 5 participants at risk. The reported deaths are 0 in both groups. No serious adverse-event terms are listed.
These figures are counts of events observed in the reported groups. They are not evidence that the underlying risk is zero. When no events are observed, uncertainty about the true event rate can remain, particularly when the number of participants is limited. The registry record does not report follow-up duration for safety monitoring, event definitions, the method used to collect events, or further details about severity or relatedness. The safety figures therefore describe the events recorded in this summary but do not establish the full safety profile of either treatment approach.
The at-risk counts are not the same as a complete account of treatment exposure or follow-up. Reasons for the difference between those counts and overall enrollment are not reported in the registry record. These counts should be read alongside the stated study status, without assuming why the study was terminated.
12. What the Result Does, and Does Not, Mean
The record describes a randomized comparison of conventional physical therapy with conventional physical therapy plus G-EO gait training for people with Parkinson’s disease and gait disability. It specifies comfortable walking speed as the primary endpoint and lists assessment times and additional outcomes. This information makes the study question and intended measurements identifiable.
However, the record does not report numerical results for the primary endpoint or the other outcomes. It reports 0 analyses. There is therefore no reported estimate of the difference between groups, no indication of its direction, and no confidence interval or p-value with which to describe precision or statistical evidence. The record cannot establish whether comfortable walking speed changed, whether one group had a different result from the other, or whether any change persisted at follow-up.
The safety summary reports no serious or other adverse events and no deaths in the listed at-risk groups. Those counts describe what is recorded, but do not show that risk is absent. The record does not provide enough safety detail to assess event ascertainment or duration of monitoring.
In general, a randomized design can support a causal comparison when allocation and analysis are appropriately conducted, but the design label alone is not sufficient to assess the validity of a result. Information about the analysis plan, missing data, masking, and study conduct also matters. Several such details are not reported in the registry record, and the study is listed as terminated. The reason for termination is not reported.
The findings should therefore be understood as a record of the study’s design, aims, outcome definitions, enrollment, status, and reported adverse-event counts—not as evidence for or against an effect of G-EO training. Any claim about treatment benefit, lack of benefit, comparative effectiveness, or the size of a change would go beyond the results reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a well-described research question and a reported analysis. The registry record identifies a randomized parallel-group comparison, names the primary endpoint, describes its measurement, and specifies assessment times. Those features help readers understand what the investigators intended to study.
At the same time, the record lists 0 analyses and does not report numerical outcome comparisons. Without estimates and uncertainty, statistical interpretation cannot move from the question to a conclusion about the observed data. An outcome name and a measurement protocol cannot substitute for a treatment contrast, and a safety count with no events cannot establish that risk is absent.
The study also illustrates why denominators require attention. Overall enrollment is 15, while the safety summaries list different at-risk counts for the groups. The primary outcome description says that analysis counts can differ across assessment times because some measurements were unavailable. Readers need outcome-specific counts to understand who contributed to each estimate; those counts are not reported in the registry record.
Multiple outcomes and assessment times make a prespecified analysis strategy important. The record lists 11 outcome measures and several time points for the primary endpoint, but does not report how testing across outcomes or times was handled. In general, clear specification of the primary contrast and missing-data approach helps distinguish planned inference from exploratory analysis.
The statistical lesson is not a claim about the treatment. It is that interpretation depends on reported estimates, precision, denominators, and analysis methods. When these elements are absent, the responsible conclusion is limited: the clinical question and planned measurements are clear, but the outcome effect and its uncertainty are not reported.
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 interpreting this trial record is the absence of reported outcome analyses. Although the registry identifies comfortable walking speed as the primary outcome and lists 11 measures, it provides no numerical outcome estimates or comparisons. The stated aims therefore cannot be evaluated from the reported results.
The enrollment was 15, and outcome availability varied across assessment times. The registry record says available data were used for each applicable time point, but does not report the number analyzed at each time, the reasons measurements were unavailable, or a missing-data analysis. This prevents assessment of how representative the analyzed participants were at each time point.
Important design and analysis details are not reported in the registry record. These include the identity of the masked parties, randomization procedures, allocation concealment, eligibility criteria, the primary statistical contrast, adjustment for baseline measurements or other variables, multiplicity handling, and any sensitivity analyses. The reason for the terminated status is also not reported.
The treatment descriptions are incomplete in the registry record. The listed safety counts contain no events, but additional details about event collection, definitions, and follow-up duration are not reported. The sample-size description refers to planning illustrations based on an observed effect, but the trial’s own sample-size justification and the numerical illustrations are not reported in the registry record.
These limitations prevent a reliable assessment of the magnitude, precision, and robustness of any treatment effect. They do not show that an effect was absent; they mean that the registry record does not report enough outcome analysis to estimate one.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Robotic Gait Rehabilitation in Parkinson's Disease — NCT05218187.
- Registry record last updated 2026-11-05; status last verified 2026-11.
- Results first posted 2026-11-05.
- 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
NCT05218187, titled Robotic Gait Rehabilitation in Parkinson’s Disease, is listed as a randomized, single-blinded, parallel-group study sponsored by Indiana University. It enrolled 15 participants and is listed as terminated. The record describes a comparison of conventional physical therapy with conventional physical therapy plus G-EO end-effector gait training for people with Parkinson’s disease and gait disability.
Comfortable walking speed, measured in meters per second, is the primary outcome. Assessments are specified at baseline, after intervention, and 30 days after the post-intervention visit. The registry lists 11 outcome measures and 0 analyses. Numerical outcome results, the reason for termination, and the detailed statistical analysis plan are not reported in the registry record.
The safety summary lists 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. These are recorded counts and do not establish that risk is absent. The record supports an account of the study question and design, but not a conclusion about comparative outcome effects.