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

Alain Kaelin

Status: Enrolling

Conditions: Stroke

Treatments: Device: Acquisition of HD sEMG signals using the WPM-SEMG device

Study type: Interventional

Funder types: Other

Identifiers

NCT05849896

SUPSI-SEMG-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Additional inclusion criteria only for the recreationally active or athletic, healthy volunteers :

• 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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Static contractions in healthy volunteers

Experimental group

Description:

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

Treatment:

Device: Acquisition of HD sEMG signals using the WPM-SEMG device

Dynamic contractions in healthy volunteers

Experimental group

Description:

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

Treatment:

Device: Acquisition of HD sEMG signals using the WPM-SEMG device

Static contractions in post-stroke patients

Experimental group

Description:

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

Treatment:

Device: Acquisition of HD sEMG signals using the WPM-SEMG device