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

NCT ID: NCT05849896

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2026-04-30

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Static contractions in healthy volunteers

Acquisition of HD SEMG signals of an upper limb muscle and a lower limb muscle while the participant executes simple static exercises.

Group Type: EXPERIMENTAL

Acquisition of HD sEMG signals using the WPM-SEMG device

Intervention Type: 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.

Dynamic contractions in healthy volunteers

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

Group Type: EXPERIMENTAL

Acquisition of HD sEMG signals using the WPM-SEMG device

Intervention Type: 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.

Static contractions in post-stroke patients

Acquisition of HD SEMG signals of a lower limb muscle while the participant executes simple static exercises.

Group Type: EXPERIMENTAL

Acquisition of HD sEMG signals using the WPM-SEMG device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• 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

Exclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Applied Sciences and Arts of Southern Switzerland

OTHER

Sponsor Role: collaborator

Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role: collaborator

Alain Kaelin

OTHER

Sponsor Role: lead

Responsible Party

Alain Kaelin

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alain Kaelin, Prof.

Role: STUDY_DIRECTOR

Istituto di Neuroscienze Cliniche della Svizzera Italiana

Locations

Istituto di Neuroscienze Cliniche della Svizzera Italiana

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Alain Kaelin, Prof.

Role: CONTACT

alain.kaelin@eoc.ch

+41 91 811 62 57

Facility Contacts

Alain Kaelin, Prof.

Role: primary

alain.kaelin@eoc.ch

+41 091 811 62 57

Other Identifiers

SUPSI-SEMG-002

Identifier Type: -

Identifier Source: org_study_id