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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Leonardo Boccuni, PhD
- Número de teléfono: +39 031 877111
- Correo electrónico: leonardo.boccuni@lanostrafamiglia.it
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
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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. |
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. |
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Otro: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived usability: System Usability Scale (SUS) score
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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)
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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
Periodo de tiempo: 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)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Coherence score (0.0-1.0) of EMG signal quality: amplitude and frequency spectrum
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skin tolerability: visual skin inspection
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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
Periodo de tiempo: During and at the end of the single experimental session (approximately 60 minutes)
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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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Leonardo Boccuni, PhD, IRCCS Eugenio Medea
- Silla de estudio: Giuseppe Andreoni, Politecnico di Milano
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 380-26
- CUP B53C22006960001 (Otro número de subvención/financiamiento: Italian Ministry of University and Research - PNC Fit4MedRob (PNC0000007))
- L2-648 (Otro identificador: Comitato Etico Territoriale Lombardia 2)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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