Clinical Relevance of the HD sEMG Signals in the Post-stroke Rehabilitation

Официальное название

Assistance and Evaluation of the Post-stroke Rehabilitation Process Via the Analysis of High-Density Surface EMG Signals Acquired With the WPM-SEMG-V2 Device: A Single Centre, Prospective, Feasibility Investigation in Healthy Volunteers and Post-stroke Patients

Обзор

The goal of this clinical trial is to learn about the WPM-SEMG-V2 device (Wireless Portable and Multi-Channel, WPM) designated to acquire high-density (HD) surface electromyography (sEMG) signals in healthy volunteers and post-stroke patients. The main objectives are: 1) to technically and clinically validate the WPM-SEMG-V2 device in healthy volunteers; 2) to demonstrate the clinical relevance of the HD sEMG signals to support the process of rehabilitation of post-stroke patients. Participants will be asked to perform simple exercises using the muscles of the hand or the leg in static or dynamic contractions while wearing the WPM-SEMG-V2 device.

Подробное описание

The participant will be instructed how to execute static or the dynamic exercises while wearing the WPM-SEMG-V2 device. The WPM-SEMG-V2 device will be initially tested in a small number of healthy volunteers to evaluate the technical and clinical performance of the device in different settings (i.e., static and dynamic muscle contractions). Preliminary information gathered in the first part of the investigation may eventually guide further device modifications. The second part will capture preliminary clinical performance of the device in post-stroke patients. The main aim is to study the behaviour of the neuromuscular system in voluntary muscle activations and demonstrate the clinical relevance of the HD sEMG signals to support the process of rehabilitation of post-stroke subjects.

Вмешательства

• Устройство Acquisition of HD sEMG signals using the WPM-SEMG device
  The WPM-SEMG-V2 device will be placed over the muscle of the participant to be investigated. A reference electrode over a bone close to the muscle of investigation will be applied. A sensor combing an accelerometer, gyroscope and magnetometer integrated in the WPM-SEMG-V2 device will be also used for the acquisition of body movement measures. An additional component for trapezoidal force measurement will be used during the acquisition in static contractions to measure the force. The participant

Первичные конечные точки

• Technical performance of the device (0 to 2) [Срок оценки: 1 day]
• Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals (0 to 2) [Срок оценки: 30 days]
• Correlation between the properties of populations of Motor Unit (MU) with the type of the stroke. [Срок оценки: 30 days]
• Correlation between the properties of populations of Motor Unit (MU) with the severity of the stroke. [Срок оценки: 30 days]
• Correlation between the properties of populations of Motor Unit (MU) with the location of the stroke. [Срок оценки: 30 days]
• Percentage of tracked MU [Срок оценки: 30 days]

Вторичные конечные точки (1)

• Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction [Срок оценки: 30 days]

Критерии участия

Критерии включения

Healthy volunteers

• Written Informed Consent
• Female or male
• 18 years or older
• Ability to understand the investigation
• Willingness to complete all the investigation assessments
• Ability to perform the procedures of the investigation
• Ability to perform maximal voluntary muscle extension of the target muscle and limb

Additional inclusion criteria only for the recreationally active or athletic, healthy volunteers :

• Subjects who participated in at least 150 min of moderate activity per week over the last six months.
• between 18 and 20 years (preferably)

Post-stroke patients

• Written informed consent
• Female or male
• 18 years or older
• Have a first-time stroke
• Ability to perform maximal voluntary muscle extension of the target muscle and limb
• Preserved cognitive capacity to perform the task
• Ability to understand the investigation
• Willingness to complete all the investigation assessments
• Ability to perform the procedures of the investigation

Критерии исключения

Healthy volunteers

• Any significant acute disease state
• Skin disorders/allergies at the site of contact with the investigational device
• History of skin disease
• Known hypersensitivity or allergy to component of the investigational product (e.g. metal alloys) or other materials used (e.g., abrasive gel, foam with polystyrene markers)
• Chronic use of medications or treatment

Post-stroke patients

• History of spinal cord injury or traumatic brain damage
• Serious medical illness that precludes performing the task
• Severe locomotion disorder due to other causes
• Severe neurological disease other than stroke
• Any significant acute disease state
• Skin disorders/allergies at the site of contact with the investigational device
• History of skin disease
• Known hypersensitivity or allergy to component of the investigational product (e.g. metal alloys) or other materials used (e.g., abrasive gel, foam with polystyrene markers)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швейцария · 1 центр

• Istituto di Neuroscienze Cliniche della Svizzera Italiana — Lugano

Идентификаторы

NCT: NCT05849896 · SUPSI-SEMG-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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