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 Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI). (NCT02202538), a na na study. The primary outcome is Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02202538 |
| Phase | NA |
| Condition | Spinal Cord Injury |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Parker Hannifin Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes people with spinal cord injury who are non-ambulatory or poorly ambulatory. It does not report further eligibility details or participant characteristics in the record used for this analysis.
Intervention
Participants were assigned to the single listed intervention, the Indego device. The study description says the evaluation concerns standing and walking under a variety of conditions, including walking with the device and a stability aid for the primary outcome.
Comparator
No separate comparator group is listed. The study is recorded as single-group, with allocation listed as NA and masking as none. The record therefore does not support a like-for-like comparison between Indego and a control treatment.
Primary question
The primary outcome asks what percentage of participants could complete the 600 Meter Walk Test after the listed 8-week timeframe. The test is described as walking 600 meters on a level surface with the Indego and a stability aid at the end of the study. The registry record does not report the percentage who completed it.
3. Trial Design
The registry identifies this as a completed, single-group device study sponsored by Parker Hannifin Corporation. Enrollment is listed as 53. The study began in 2014-08, and primary completion is listed as 2015-10. The record lists the phase as NA, allocation as NA, and masking as none. The only listed intervention is Indego; no separate control arm appears in the record.
The study description says the device would be evaluated for safety and effectiveness in allowing people with spinal cord injury who are non-ambulatory or poorly ambulatory to stand and walk under a variety of conditions. This is the study's stated purpose, not a report of what the results established. The primary outcome is the percentage able to complete the 600 Meter Walk Test at the end of the study, with a timeframe listed as 8 weeks.
The design matters for interpretation. A single-group result can describe outcomes among participants in that group, but without a concurrent comparator it cannot show how outcomes would have differed under another condition. The record does not report a randomized allocation process, a control group, or masking. The stated allocation value is NA, so the record does not give further allocation details.
The registry lists three secondary outcomes: the Walking Index for Spinal Cord Injury assessment, the Functional Independence Measure score for walking indoors, and the Borg Rating of Perceived Exertion for walking indoors. It records 8 outcome measures overall and 0 analyses. The remaining outcome details and their results are not reported in the registry record. The enrollment figure is a registry description of the study, not evidence that every enrolled participant contributed data to every outcome.
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 | All Subjects |
|---|---|
| STARTED | 53 |
| Screen Failure | 2 |
| COMPLETED | 45 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | All Subjects |
|---|---|
| Withdrawal by Subject | 5 |
| Did not meet all inclusion criteria | 2 |
| Investigator Decision | 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 | All Subjects |
|---|---|---|
| Participants analysed | 53 | |
| Age, Continuous | years | 35.9 (SD 13.0) |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 42 |
| Region of Enrollment: United States | participants | 53 |
| Level of Injury: T3 | participants | 3 |
| Level of Injury: T4 | participants | 9 |
| Level of Injury: T5 | participants | 6 |
| Level of Injury: T6 | participants | 5 |
| Level of Injury: T7 | participants | 3 |
| Level of Injury: T8 | participants | 6 |
| Level of Injury: T9 | participants | 1 |
| Level of Injury: T10 | participants | 7 |
| Level of Injury: T11 | participants | 5 |
| Level of Injury: T12 | participants | 5 |
| ASIA Impairment Scale Score: A | participants | 36 |
| ASIA Impairment Scale Score: B | participants | 5 |
| ASIA Impairment Scale Score: C | participants | 11 |
| ASIA Impairment Scale Score: D | participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Subjects Able to Complete the 600 Meter Walk Test (600MWT), measured over 8 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants able to complete the 600 Meter Walk Test. The test is described as walking 600 meters on a level surface with the Indego and a stability aid at the end of the study. The listed timeframe is 8 weeks. The registry describes this distance as proposed to represent a person's ability to ambulate in the community.
As a binary outcome, each participant's test status is classified in terms of whether the stated completion criterion was met. The percentage is a way to describe the share of the analyzed group meeting that criterion. In general, a functional task can provide an interpretable measure of task completion, but its meaning is tied to the particular test conditions. Here those conditions include a level surface, the device, and a stability aid; the result would not, by itself, describe walking in every environment or without those supports.
The registry record does not report the percentage able to complete the test, the number analyzed for this endpoint, or an uncertainty interval. It also does not report further operational details such as how incomplete or unattempted tests were classified. Those omissions prevent a numerical description of the observed endpoint from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry describes the primary outcome but does not post its result. The stated endpoint is the percentage able to complete the 600 Meter Walk Test, yet no percentage, numerator, denominator for the endpoint, confidence interval, or test result is reported in the registry record. Consequently, the record does not permit a numerical estimate of completion or its precision.
The study is single-group, and no comparator is listed. Any reported outcome from this design would describe the participants assessed under the study conditions. It would not, on its own, quantify a difference relative to another device, usual care, or a no-device condition. There is no randomized comparison in the registry record, and its own study-design note cautions that arms are not a like-for-like control comparison. There is only one listed arm in the design details.
For a percentage, precision depends on both the observed proportion and the amount of outcome information. In general, a confidence interval communicates the range of values reasonably compatible with the observed data under the interval's method; it does not guarantee that the true value lies in that range, nor does it address bias from missing data or study design. No interval is reported for the primary outcome, so its precision cannot be judged from the posted record.
The listed enrollment is 53, but that figure should not be treated as the endpoint denominator. The registry record does not say how many participants completed the walk test, whether everyone enrolled was assessed, or how missing or unusable assessments were handled. The outcome-specific denominator is not reported in the registry record.
The record lists 8 outcome measures and 0 analyses. It names several secondary measures but gives no results for them in the information recorded. There are no posted estimates, hypothesis tests, or uncertainty measures from which to assess statistical evidence across outcomes. The absence of an analysis in the registry record should be read as absence of a posted analysis, not as proof that no analysis was conducted elsewhere.
Accordingly, the registry record supports a description of the study question, design, and selected adverse-event counts, but it does not support a quantitative conclusion about the primary walking outcome. It also cannot establish comparative effects, explain how outcomes varied across participants, or distinguish a device-related effect from other influences. The study's stated aim and the completion status are not substitutes for outcome estimates.
9. Statistical Methods Explained
The registry identifies the primary endpoint as a percentage: the proportion of participants able to complete a specified walking task. The analysis that would ordinarily produce this type of summary uses a binary classification for each participant, such as meeting or not meeting the completion criterion, followed by a numerator and an outcome-specific denominator. The registry record does not provide those counts or the resulting percentage. It is therefore not possible to reconstruct the endpoint estimate from the record.
What does a confidence interval add?
In general, a confidence interval expresses statistical uncertainty around an estimate. For a percentage, it indicates how much the estimate might vary because it is based on a finite set of observations, under the assumptions of the chosen method. A narrower interval generally indicates greater statistical precision, while a wider one indicates less precision. An interval does not correct for systematic measurement problems, selection effects, missing outcomes, or lack of a comparator. No confidence interval for the primary endpoint is reported in the registry record.
Why does the single-group design matter?
The record lists a single-group study and no separate comparator. A single-group proportion can describe the observed result in the participants assessed, if that result and its denominator are reported. It does not estimate a between-group contrast. In general, comparisons with an external benchmark or with outcomes from another study can be affected by differences in eligibility, assessment, follow-up, and other features. No such comparative analysis is reported in the registry record, and a comparison should not be inferred from the study's stated purpose.
What can the enrollment figure tell us?
Enrollment is listed as 53. Enrollment is not necessarily the same as the number included in a particular endpoint analysis. Participants may lack an assessment, may not meet an analysis definition, or may contribute to some outcomes but not others. These are general possibilities, not claims about what occurred in this study. The registry record does not report the number analyzed for the 600 Meter Walk Test or the rules used to form an analysis population.
How should planning calculations be understood?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. These are planning assumptions, not a description of the actual single-group design, which lists no second arm. In general, a planning calculation asks what sample size might be needed under specified assumptions for a future study. It is not an observed outcome and is not observed power. No numerical planning result or observed primary effect is reported in the registry record used for this analysis.
Why do model assumptions matter?
For a binary endpoint, the analysis method should reflect the outcome scale and the way participants were sampled and assessed. In general, over-dispersion means that observed variability exceeds what a model's assumed distribution allows; accounting for it can prevent uncertainty from being understated. That is a general statistical consideration, not a claim that over-dispersion was present or modeled in this study. The registry record lists 0 analyses and does not report a statistical model, interval method, or hypothesis-testing procedure for the primary endpoint.
Because no primary estimate or analysis method is posted, it is not possible to assess model fit, reproduce a test, or compare a recalculated estimate with a sponsor analysis. No recalculated endpoint result is available in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including the primary 600 Meter Walk Test measure and secondary measures for walking function and perceived exertion. It records 0 analyses. Results and analysis details for these measures are not reported in the registry record.
When a study evaluates multiple outcomes, multiplicity is a general statistical concern: testing many hypotheses can increase the chance of at least one apparently unusual result even when no corresponding effect exists. Researchers may address this through a prespecified hierarchy, adjustment procedures, or a clearly defined distinction between confirmatory and exploratory outcomes. The registry record does not report a multiplicity strategy, an outcome hierarchy beyond identifying the primary measure, or which analyses were considered confirmatory.
Missing-data handling is also not reported in the registry record. In general, missing endpoint assessments can affect both the denominator and the interpretation of a percentage. The impact depends on how many assessments are unavailable and why; treating missing observations as failures, excluding them, or using a model can lead to different estimands and assumptions. No missingness counts, imputation method, or sensitivity analysis are reported for the primary outcome.
The registry record does not define an analysis population for the primary endpoint. It is therefore unclear from the record whether the endpoint was intended to include all enrolled participants or a subset defined by assessment availability or other criteria. The enrollment figure alone cannot resolve this issue.
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 |
|---|---|---|---|
| All Subjects | 0 | 53 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| All Subjects | 19 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Subjects |
|---|---|---|
| Scrape/Cut/Abrasion | Skin and subcutaneous tissue disorders | 10 of 53 |
| Hypertension | Vascular disorders | 7 of 53 |
| Bruise | Skin and subcutaneous tissue disorders | 6 of 53 |
| Tachycardia | Cardiac disorders | 4 of 53 |
| Pain | Musculoskeletal and connective tissue disorders | 3 of 53 |
| Skin Redness | Skin and subcutaneous tissue disorders | 3 of 53 |
The registry's adverse-event summary lists an All Subjects group with 53 at risk for serious adverse events and 0 affected. It also lists 53 at risk for other adverse events and 19 affected. These are registry counts, not comparative estimates, because no separate control group is listed.
The serious-event count should be read as no serious adverse events recorded in this summary, rather than as proof that serious events were impossible or that the risk is zero. In general, an observed count describes what was recorded in the study population; it does not by itself establish the frequency that would occur in another population or under different follow-up. The record does not provide further detail about event definitions, assessment procedures, or follow-up completeness.
The 19 other adverse events are reported in the registry's affected count. The record does not provide the event terms in its listed serious-event terms, and no serious-event terms are listed. Death information is not reported in the registry record. These data should be kept separate from the primary walking endpoint: they do not supply the missing 600 Meter Walk Test result, and they do not support a comparison of safety between treatments.
12. What the Result Does, and Does Not, Mean
The registry record establishes what the study set out to assess: the Indego device in people with spinal cord injury described as non-ambulatory or poorly ambulatory, with a primary outcome based on completing the 600 Meter Walk Test under specified conditions. It also establishes that the study is listed as completed, single-group, and enrolled 53 participants. These design and registration details help define the context for interpreting any outcome information.
The record does not report the primary outcome percentage or its denominator. It therefore does not show how many participants completed the task, how common completion was in the assessed group, or how precise that estimate might be. No posted analysis gives a statistical comparison or an uncertainty interval. The registry's description of the test as proposed to represent community ambulation is a rationale for the measure, not evidence that test completion predicts mobility in other settings.
Even if a single-group completion percentage were available, it would describe performance under the recorded test conditions: a level surface, the Indego, and a stability aid. It would not by itself establish what would have happened without the device or with another intervention. A single-group design cannot separate the effect of the device from other explanations using a concurrent randomized contrast.
The adverse-event summary provides counts for serious and other adverse events, but those counts do not answer the missing walking-outcome question. They are also not comparative evidence, since no control group is recorded. The study's completed status should not be mistaken for complete results in the registry record.
Overall, the posted information is sufficient to describe the intended endpoint, broad study design, enrollment, and the reported adverse-event counts. It is not sufficient to quantify the primary outcome, assess its statistical precision, or draw a comparative conclusion about the device. The results of the named secondary outcomes and the handling of missing assessments are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary endpoint is a straightforward functional completion measure, but the registry record does not post the result needed to estimate it. The contrast between a clearly described question and absent outcome analyses illustrates why registry design details and outcome data serve different purposes. Knowing what was planned does not reveal what participants achieved.
The single-group design also makes the distinction between description and comparison especially important. A percentage could characterize the participants assessed under the study conditions, but it would not supply a control-based estimate of what changed because of the device. This is a general design principle: treatment comparisons require an appropriate comparison strategy, and a single arm cannot provide a concurrent randomized contrast.
The record's 8 outcome measures and 0 analyses highlight another statistical issue. Multiple measures can capture different aspects of function or experience, but interpreting a collection of outcomes requires clarity about which questions were primary, how results were analyzed, and how multiplicity was handled. Those analysis details are not reported in the registry record.
Finally, the planning assumptions described for sample-size illustrations are distinct from the trial design and from observed results. A planning illustration under assumptions about two-arm allocation does not turn a single-group study into a controlled comparison and is not observed power. Keeping these distinctions clear helps readers avoid treating a study's intended aims, enrollment, or planning calculations as evidence of an outcome that the registry has 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 registry record leaves several trial-specific details unavailable. It does not report the primary endpoint estimate, the number of participants assessed for that endpoint, or a confidence interval. Without those elements, neither the observed completion percentage nor its precision can be evaluated.
The study is recorded as single-group, with allocation listed as NA and masking as none. No comparator arm is listed, so the record does not support a direct comparison with another treatment or condition. It also does not report participant characteristics beyond the broad spinal cord injury population described in the study summary. Further eligibility, injury, and baseline mobility details are not reported in the registry record.
The registry lists 8 outcome measures but 0 analyses. It names three secondary outcomes, but their results are not reported in the registry record. Analysis methods, outcome-specific populations, and any multiplicity approach are also not reported. Missing-data counts and procedures are unavailable, so the extent to which the reported enrollment corresponds to endpoint assessment cannot be established.
The primary outcome's specified test conditions include a level surface, the Indego, and a stability aid. The endpoint therefore describes a particular task configuration, and the registry rationale about community ambulation should not be taken as a direct measure of every aspect of mobility. The record does not report whether other conditions or settings were assessed in a way that would permit broader interpretation.
Safety information is limited to the registry's summarized counts. The record does not report death information or further context for the adverse-event categories. These limitations concern what is available in the registry record; they do not establish whether additional information exists elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI). — NCT02202538.
- Registry record last updated 2017-07-25; status last verified 2017-06.
- Results first posted 2016-12-20.
- 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.
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
NCT02202538 is listed as a completed, single-group study sponsored by Parker Hannifin Corporation. Enrollment is 53; the study began in 2014-08 and primary completion is listed as 2015-10. The intervention is the Indego device. The study description concerns safety and effectiveness in people with spinal cord injury who are non-ambulatory or poorly ambulatory.
The primary outcome is the percentage able to complete the 600 Meter Walk Test at the listed 8-week timeframe, walking on a level surface with the device and a stability aid. The outcome result and its analysis are not reported in the registry record. The record lists 8 outcome measures and 0 analyses.
The adverse-event summary lists 0 serious adverse events affected among 53 at risk and 19 other adverse events affected among 53 at risk. Death information is not reported in the registry record. No separate comparator group is listed.