Usability of the FTEXES Wearable Textile Platform for Functional Electrical Stimulation and EMG (FTEXES)
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Leonardo Boccuni, PhD
- Telefonnummer: +39 031 877111
- E-post: leonardo.boccuni@lanostrafamiglia.it
Studiesteder
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Lecco
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Bosisio Parini, Lecco, Italia, 23842
- IRCCS Eugenio Medea - Associazione La Nostra Famiglia
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Healthy adults
Five adults aged 18 years or older without neuromotor disability use the FTEXES system in a single session. |
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. |
|
Eksperimentell: 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. |
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. |
|
Annen: Healthcare professionals
Five healthcare professionals (3 physiotherapists, 2 physiatrists) configure and operate the FTEXES system and evaluate its usability from the operator's perspective. |
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived usability: System Usability Scale (SUS) score
Tidsramme: 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)
|
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Wearable comfort: Comfort Rating Scale (CRS) score
Tidsramme: 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)
|
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Stimulation-related pain/discomfort (NRS/VAS 0-10)
Tidsramme: 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)
|
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Satisfaction with the assistive device: adapted QUEST 2.0
Tidsramme: 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)
|
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Acceptability and intention to use: Net Promoter Score (NPS) and intention-to-use questionnaire
Tidsramme: During and at the end of the single experimental session (approximately 60 minutes)
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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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Coherence score (0.0-1.0) of EMG signal quality: amplitude and frequency spectrum
Tidsramme: 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)
|
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FES artifact rejection in EMG signals
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Skin tolerability: visual skin inspection
Tidsramme: 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)
|
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Number of participants with adverse events
Tidsramme: 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)
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Donning and setup performance
Tidsramme: During and at the end of the single experimental session (approximately 60 minutes)
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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)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Leonardo Boccuni, PhD, IRCCS Eugenio Medea
- Studiestol: Giuseppe Andreoni, Politecnico di Milano
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 380-26
- CUP B53C22006960001 (Annet stipend/finansieringsnummer: Italian Ministry of University and Research - PNC Fit4MedRob (PNC0000007))
- L2-648 (Annen identifikator: Comitato Etico Territoriale Lombardia 2)
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