About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written Informed Consent

Female or male

18 years or older

Ability to understand the investigation

Disqualifiers

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)

Trial design

Design model

Sequential

Treatments tested in this trial

Acquisition of HD sEMG signals using the WPM-SEMG device
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 will be instructed by the investigator how to execute the static or the dynamic exercises. Visual feedback will help the subject to track the trajectory.

Treatment groups

40 Participants

are divided into 3 treatment groups

Group A: Static contractions in healthy volunteersExperimental treatment 1 intervention

Group B: Dynamic contractions in healthy volunteersExperimental treatment 1 intervention

Group C: Static contractions in post-stroke patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical performance of the device (0 to 2)

Assessed during signal acquisitions in static and/or dynamic contractions in healthy volunteers by checking the following parameters: 1. Interaction (0 or 1): when the WPM-SEMG-V2 is connected to the component for trapezoidal force measurement, both the sEMG signals and force data are recorded by the device on the device's SD card. 2. Availability (0 or 1): all data recordings are stored separately in the SD card. 3. Integrity of the final data (0 or 1): the recorded signals have the same duration of the recordings after post-processing of the data timestamp. The technical performance of the device is defined as Interaction\*(availability+integrity) in static contractions. The technical performance of the device is the sum of the scores for availability and integrity in dynamic contractions.

Time frame

1 day

2

Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals (0 to 2)

Assessed during signal acquisitions in static and/or dynamic contractions, both in healthy volunteers and post-stroke patients by measuring the following parameters: 1. Signal amplitude (0 or 1): the peak-to-peak sEMG signal amplitude is within the anatomical range of few-tens of µV to 2 mV. 2. Signal spectrum (0 or 1): the sEMG signal spectrum is within the anatomical range (sEMG power is mostly accounted for by the frequency components \< 350 Hz). Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals is the sum of the scores given to signal amplitude and signal spectrum.

Time frame

30 days

3

Correlation between the properties of populations of Motor Unit (MU) with the type of the stroke.

Assessed during signal acquisitions in static contractions in post-stroke patients. The following properties will be extracted from the MUs populations: discharge rate (pulses/seconds), recruitment threshold (percentage of the maximum voluntary force contraction), motor unit conduction velocity (meter/seconds), Muscle Fiber Conduction Velocity (meter/seconds. Type of stroke: acute or subacute.

Time frame

30 days

4

Correlation between the properties of populations of Motor Unit (MU) with the severity of the stroke.

Assessed during signal acquisitions in static contractions in post-stroke patients. The following properties will be extracted from the MUs populations: discharge rate (pulses/seconds), recruitment threshold (percentage of the maximum voluntary force contraction), motor unit conduction velocity (meter/seconds), Muscle Fiber Conduction Velocity (meter/seconds. The severity of the stroke will be measured by the National Institutes of Health Stroke Scale (score 0-42).

Time frame

30 days

Secondary outcomes

1

Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction

As assessed by reported adverse event.

Time frame

30 days

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts