NCT05849896

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Alain Kaelin · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	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 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.

Timeline

• Start date: 2023-03-13
• Primary completion: 2026-02-01
• Completion: 2026-04-01
• First posted: 2023-05-09
• Last updated: 2024-09-05

Locations

1 site across 1 country: Switzerland