Usability of the FTEXES Wearable Textile Platform for Functional Electrical Stimulation and EMG
NCT07922980, Not applicable, Not yet recruiting, Politecnico di Milano
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Usability of the FTEXES Wearable Textile Platform for Functional Electrical Stimulation and EMG | ClinicalTrials.gov |
| NCT number | NCT07922980 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Politecnico di Milano | ClinicalTrials.gov |
| Conditions | Motor Disorders, Neuromuscular Diseases, Healthy Volunteers | ClinicalTrials.gov |
| Interventions | FTEXES wearable system | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Perceived usability: System Usability Scale (SUS) score | During and at the end of the single experimental session (approximately 60 minutes) | SUS is a 10-item questionnaire scored from 0 to 100; higher scores indicate better perceived usability. | ClinicalTrials.gov |
| Primary | Wearable comfort: Comfort Rating Scale (CRS) score | During and at the end of the single experimental session (approximately 60 minutes) | Comfort of the textile garments and textile electrodes assessed with the Comfort Rating Scale (CRS); higher scores indicate greater discomfort. | ClinicalTrials.gov |
| Primary | Stimulation-related pain/discomfort (NRS/VAS 0-10) | During and at the end of the single experimental session (approximately 60 minutes) | Global and localized discomfort, perceived fatigue and pain associated with functional electrical stimulation, rated on a 0-10 numeric/visual analogue scale; 0 = none, 10 = worst imaginable. | ClinicalTrials.gov |
| Primary | Satisfaction with the assistive device: adapted QUEST 2.0 | During and at the end of the single experimental session (approximately 60 minutes) | Satisfaction with the FTEXES system assessed with an adapted version of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0); items scored 1-5, higher scores indicate greater satisfaction. | ClinicalTrials.gov |
| Primary | Acceptability and intention to use: Net Promoter Score (NPS) and intention-to-use questionnaire | During and at the end of the single experimental session (approximately 60 minutes) | Likelihood to recommend the system (NPS, 0-10 rating, summarized as -100 to +100) and intention to use the platform in the future, including at home. | ClinicalTrials.gov |
| Secondary | Coherence score (0.0-1.0) of EMG signal quality: amplitude and frequency spectrum | During and at the end of the single experimental session (approximately 60 minutes) | Coherence score (0.0 if signal amplitude \<50% of amplitude with standard Ag/AgCl electrodes -1.0 = signal amplitude = 100% of amplitude with standard Ag/AgCl electrodes) of Amplitude and frequency spectrum (% coveragle of signal spectrum) of surface EMG signals recorded with the textile electrodes of the FTEXES garments. | ClinicalTrials.gov |
| Secondary | FES artifact rejection in EMG signals | During and at the end of the single experimental session (approximately 60 minutes) | Effectiveness of rejection of functional electrical stimulation artifacts in surface EMG signals recorded during stimulation scored as number number of artifacts recorded as number of artifacts out of 10 test events. | ClinicalTrials.gov |
| Other | Skin tolerability: visual skin inspection | During and at the end of the single experimental session (approximately 60 minutes) | Presence of redness, pressure marks, abrasions or other skin reactions in device contact areas, assessed by visual inspection at the end of the session. | ClinicalTrials.gov |
| Other | Number of participants with adverse events | During and at the end of the single experimental session (approximately 60 minutes) | Adverse events recorded during the session using the study adverse event form. | ClinicalTrials.gov |
| Other | Donning and setup performance | During and at the end of the single experimental session (approximately 60 minutes) | Time to don/doff the garments and connect/configure the system, level of assistance required and number of non-critical procedural errors, assessed by observation. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
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 | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)