Trial · NCT03296904
The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study
NCT03296904, Not applicable, Completed, Fondazione Don Carlo Gnocchi ETS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study. Trials, record NCT03296904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The CYBERnetic LowEr-Limb CoGnitive Ortho-prosthesis Plus Plus, 1st Clinical Study
- NCT number
- NCT03296904
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 8 participants, actual
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Conditions
- Transfemoral Amputation
- Interventions
- CLs++
- First posted
- 2017-09-29
- Last updated
- 2019-12-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules. | Before and after the familiarization/training period lasting one month. | While performing the six-minute walk test, oxygen uptake will be assessed using a portable gas analyzer and will be considered as an objective measure of the physical effort. |
| Secondary | Change in the self-perceived physical effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules. | Before and after the familiarization/training period lasting one month. | At the end of the six-minute walk test, the Borg Scale (CR-10) will be administered and the score will be considered as a measure of the perceived physical effort. |
| Secondary | Change in the cognitive effort needed for walking with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules | Before and after the familiarization/training period lasting one month. | The cognitive effort will be assessed through changes in the galvanic skin response (GSR), heart rate variability (HRV) and brain electrical activity (EEG) while performing two Dual Task tests, namely the backward counting and the Stroop test. |
| Secondary | Change in the performance during stair climbing/descending with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules. | Before and after the familiarization/training period lasting one month. | The performance in the above locomotion-related task will be assessed using the Stair Climbing Test (SCT). |
| Secondary | Change in the performance during sitting down/standing-up and turning with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules | Before and after the familiarization/training period lasting one month. | The performance in the above locomotion-related task will be assessed using the Timed get-Up and Go test (TUG) |
| Secondary | Change in gait asymmetry with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules | Before and after the familiarization/training period lasting one month. | Gait asymmetry will be assessed using a motion capture system, either optoelectronic or marker-less. |
| Secondary | Change in muscle electrical activity with the participant's own prosthesis vs. with the customized combination of CLs++ ortho-prosthesis modules | Before and after the familiarization/training period lasting one month. | Muscle electrical activity will be assessed using surface electromyography (sEMG) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03296904
GET https://conductscience.org/api/trials/v1/NCT03296904/registered