An interventional study of FTEXES wearable system in Motor Disorders, Neuromuscular Diseases and Healthy Volunteers, sponsored by Politecnico di Milano. Not yet recruiting at 1 site in Italy. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Politecnico di Milano · Not applicable, Interventional, and Other
FTEXES (Functionalized TEXtiles for Electrical Stimulation) is a wearable platform based on sensorized garments (Smart Pants and Smart T-shirt) with integrated textile electrodes for surface electromyography (EMG) recording and functional electrical stimulation (FES). This single-center, open-label, non-randomized study evaluates the usability of the system in a controlled laboratory setting. Fifteen participants (5 healthy adults, 5 patients with neuromotor disability, 5 healthcare professionals) take part in a single 45-60 minute session including donning, system setup, calibration, functional tasks (gait for the lower limb; reaching and grasping for the upper limb), doffing and skin inspection. Comfort, skin tolerability, stimulation-related discomfort, perceived usability, satisfaction and acceptability are assessed with standardized questionnaires. The quality of EMG signals recorded with textile electrodes is evaluated as a secondary objective. The study has no therapeutic purpose for individual participants.
73 studies on the registry are indexed under Motor Disorders; 24 are open to participants now.
This study's planned enrollment of 15 is below the median of 41 across 52 interventional studies indexed under Motor Disorders.
Browse Motor Disorders studies →Politecnico di Milano is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Five adults aged 18 years or older without neuromotor disability use the FTEXES system in a single session.
Device: FTEXES wearable system
Five patients aged 12 years or older with neuromotor disability compatible with FES, as assessed by a physiatrist, use the FTEXES system in a single session.
Device: FTEXES wearable system
Five healthcare professionals (3 physiotherapists, 2 physiatrists) configure and operate the FTEXES system and evaluate its usability from the operator's perspective.
Device: FTEXES wearable system
Sensorized textile garments (Smart Pants for the lower limb, Smart T-shirt for the upper limb) with integrated textile electrodes, connected to a CE-marked FES stimulator (HASOMED RehaMove3) and a CE-marked surface EMG system (FreeEMG 1000). Single session of about 45-60 minutes: donning, setup, calibration, functional tasks (gait cycle or reaching/grasping), doffing and skin inspection.
Perceived usability: System Usability Scale (SUS) score
SUS is a 10-item questionnaire scored from 0 to 100; higher scores indicate better perceived usability.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Wearable comfort: Comfort Rating Scale (CRS) score
Comfort of the textile garments and textile electrodes assessed with the Comfort Rating Scale (CRS); higher scores indicate greater discomfort.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Stimulation-related pain/discomfort (NRS/VAS 0-10)
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.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Satisfaction with the assistive device: adapted QUEST 2.0
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.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Acceptability and intention to use: Net Promoter Score (NPS) and intention-to-use questionnaire
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.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Coherence score (0.0-1.0) of EMG signal quality: amplitude and frequency spectrum
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.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
FES artifact rejection in EMG signals
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.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Skin tolerability: visual skin inspection
Presence of redness, pressure marks, abrasions or other skin reactions in device contact areas, assessed by visual inspection at the end of the session.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Number of participants with adverse events
Adverse events recorded during the session using the study adverse event form.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Donning and setup performance
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.
Time frame: During and at the end of the single experimental session (approximately 60 minutes)
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Politecnico di Milano