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| Name | Class |
|---|---|
| University of Applied Sciences and Arts of Southern Switzerland | OTHER |
| Clinical Trial Unit Ente Ospedaliero Cantonale | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Static contractions in healthy volunteers | Experimental | Acquisition of HD SEMG signals of an upper limb muscle and a lower limb muscle while the participant executes simple static exercises. |
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| Dynamic contractions in healthy volunteers | Experimental | Acquisition of HD SEMG signals of a leg muscle while the participant executes simple dynamic exercises.This arm will recruited recreationally active or athletic volunteers, preferably between 18 and 20 years |
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| Static contractions in post-stroke patients | Experimental | Acquisition of HD SEMG signals of a lower limb muscle while the participant executes simple static exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | 1 day |
| 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:
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. | 30 days |
| 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. | 30 days |
| Correlation between the properties of populations of Motor Unit (MU) with the severity of the stroke. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction | As assessed by reported adverse event. | 30 days |
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Inclusion Criteria:
Healthy volunteers
Additional inclusion criteria only for the recreationally active or athletic, healthy volunteers :
Post-stroke patients
Exclusion Criteria:
Healthy volunteers
Post-stroke patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Kaelin, Prof. | Contact | +41 91 811 62 57 | alain.kaelin@eoc.ch |
| Name | Affiliation | Role |
|---|---|---|
| Alain Kaelin, Prof. | Istituto di Neuroscienze Cliniche della Svizzera Italiana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto di Neuroscienze Cliniche della Svizzera Italiana | Recruiting | Lugano | Switzerland |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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). |
| 30 days |
| Correlation between the properties of populations of Motor Unit (MU) with the location 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 location of the stroke is obtained from MRI imaging (left hemispheric, right hemisferic, cortical, subcortical, brain stem). | 30 days |
| Percentage of tracked MU | Defined as the number of tracked MU / number of detected MUs in the baseline session, among the baseline, medium term, and long term sessions. Assessed during signal acquisitions in static contractions, both in healthy volunteers and post-stroke patients | 30 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |