Clinical trial NCT05849896: Clinical Relevance of the HD sEMG Signals in the Post-stroke Rehabilitation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences and Arts of Southern Switzerland
name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2023-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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

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)

Primary outcomes:
measure: Technical performance of the device (0 to 2)
timeFrame: 1 day
measure: Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals (0 to 2)
timeFrame: 30 days
measure: Correlation between the properties of populations of Motor Unit (MU) with the type of the stroke.
timeFrame: 30 days
measure: Correlation between the properties of populations of Motor Unit (MU) with the severity of the stroke.
timeFrame: 30 days
measure: Correlation between the properties of populations of Motor Unit (MU) with the location of the stroke.
timeFrame: 30 days
measure: Percentage of tracked MU
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction
timeFrame: 30 days
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Istituto di Neuroscienze Cliniche della Svizzera Italiana
Study officials:
affiliation: Istituto di Neuroscienze Cliniche della Svizzera Italiana
name: Alain Kaelin, Prof.
role: STUDY_DIRECTOR
References: