Istituto di Neuroscienze Cliniche della Svizzera Italiana
Lugano, Switzerland
Location status: Recruiting
NCT Number: NCT05849896
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Interventional
Not applicable
Lugano, Switzerland
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
Time frame: 1 day
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.
Time frame: 30 days
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.
Time frame: 30 days
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
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
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).
Time frame: 30 days
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
Time frame: 30 days
As assessed by reported adverse event.
Contact information is provided by the study sponsor or research team.
Alain Kaelin
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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