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Motor DisordersFTEXESNCT07922980

Usability of the FTEXES Wearable Textile Platform for Functional Electrical Stimulation and EMG

A study testing FTEXES wearable system in people with Motor Disorders and Neuromuscular Diseases, run by Politecnico di Milano at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
What is being tested?
FTEXES wearable system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteItaly
Study dates
26 Oct 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Healthy adults: age 18 years or older; no neuromotor disability; written informed consent.
  • Patients: age 18 years or older, or 12-17 years with parental/guardian consent and minor's assent; neuromotor disability compatible with the use of the FTEXES system; indication for FES confirmed by a physiatrist. Previous FES experience is not required.
  • Healthcare professionals: professional qualification consistent with study activities (physiotherapist or physiatrist).

Who cannot join

  • Missing informed consent (for minors: missing parental/guardian consent and/or minor's assent).
  • Inability to understand study aims and procedures or to follow instructions.
  • Clinical, functional, cognitive, behavioral or skin conditions that make participation unsafe or inappropriate, in the investigator's judgment.
  • Skin lesions, abrasions, dermatitis, irritation, infection or other dermatological conditions in device contact areas.
  • Healthy adults: known neuromuscular disease, recent trauma, direct involvement in FTEXES development, or professional/academic dependency on the Principal Investigator.
  • Patients: absence of motor disability compatible with the FTEXES system, or no indication for / unsuitability to FES in the physiatrist's judgment.
  • Healthcare professionals: lack of professional qualification or of competence in the use/configuration of FES systems.
  • Any other condition that, in the investigator's judgment, may interfere with study conduct or endpoint assessment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Leonardo Boccuni, PhD contact

+39 031 877111

leonardo.boccuni@lanostrafamiglia.it

Italy1 site

  • IRCCS Eugenio Medea - Associazione La Nostra Famiglia

    Bosisio Parini, Lecco, 23842

Other trials in Italy

About this study

Official title: Interventional Clinical Trial Evaluating the Usability of the FTEXES System (Functionalized TEXtiles for Electrical Stimulation), a Wearable Textile-Based Platform for Functional Electrical Stimulation and Surface Electromyography

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.

Being tested
FTEXES wearable system
Keywords
functional electrical stimulation, surface electromyography, smart textiles, wearable devices, textile electrodes, usability, rehabilitation
Medical subject headings
Motor Disorders, Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FTEXES wearable systemDevice

    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.

Study groups in NCT07922980
Study groupRoleWhat they receive
Healthy adultsExperimentalFive adults aged 18 years or older without neuromotor disability use the FTEXES system in a single session.
Receives: Device: FTEXES wearable system
Patients with neuromotor disabilityExperimentalFive 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.
Receives: Device: FTEXES wearable system
Healthcare professionalsOtherFive healthcare professionals (3 physiotherapists, 2 physiatrists) configure and operate the FTEXES system and evaluate its usability from the operator's perspective.
Receives: Device: FTEXES wearable system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived usability: System Usability Scale (SUS) score

    SUS is a 10-item questionnaire scored from 0 to 100; higher scores indicate better perceived usability.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

  2. 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.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

  3. 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.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

  4. 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.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

  5. 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.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

Secondary outcomes (2)

  1. 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.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

  2. 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.

    Measured: During and at the end of the single experimental session (approximately 60 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start26 Oct 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Three non-randomized groups (healthy adults, patients with neuromotor disability, healthcare professionals), each taking part in a single usability session with the FTEXES system.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07922980
Sponsor's protocol ID
380-26
Other IDs
CUP B53C22006960001, L2-648
Acronym
FTEXES
Status last verified
Oct 2026
First submitted
22 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing FTEXES wearable system in people with Motor Disorders and Neuromuscular Diseases, run by Politecnico di Milano at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Leonardo Boccuni, PhD (+39 031 877111, leonardo.boccuni@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived usability: System Usability Scale (SUS) score (time frame: During and at the end of the single experimental session (approximately 60 minutes)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07922980.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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