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

November 2, 2026 updated by: Giuseppe Andreoni, Politecnico di Milano

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • IRCCS Eugenio Medea - Associazione La Nostra Famiglia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy adults

Five adults aged 18 years or older without neuromotor disability use the FTEXES system in a single session.
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.
Experimental: Patients with neuromotor disability

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

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.
Other: Healthcare professionals

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived usability: System Usability Scale (SUS) score
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)
Wearable comfort: Comfort Rating Scale (CRS) score
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)
Stimulation-related pain/discomfort (NRS/VAS 0-10)
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)
Satisfaction with the assistive device: adapted QUEST 2.0
Time Frame: 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.
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
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coherence score (0.0-1.0) of EMG signal quality: amplitude and frequency spectrum
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)
FES artifact rejection in EMG signals
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Skin tolerability: visual skin inspection
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)
Number of participants with adverse events
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)
Donning and setup performance
Time Frame: 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.
During and at the end of the single experimental session (approximately 60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Politecnico di Milano

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IRCCS Eugenio Medea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leonardo Boccuni, PhD, IRCCS Eugenio Medea
  • Study Chair: Giuseppe Andreoni, Politecnico di Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 380-26
  • CUP B53C22006960001 (Other Grant/Funding Number: Italian Ministry of University and Research - PNC Fit4MedRob (PNC0000007))
  • L2-648 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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