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

NCT05849896 | Recruiting

• 1 other identifier: SUPSI-SEMG-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• Technical performance of the device (0 to 2)

  Assessed during signal acquisitions in static and/or dynamic contractions in healthy volunteers by checking the following parameters: 1. Interaction (0 or 1): when the WPM-SEMG-V2 is connected to the component for trapezoidal force measurement, both the sEMG signals and force data are recorded by the device on the device's SD card. 2. Availability (0 or 1): all data recordings are stored separately in the SD card. 3. Integrity of the final data (0 or 1): the recorded signals have the same duration of the recordings after post-processing of the data timestamp. 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.

  1 day

• Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals (0 to 2)

  Assessed during signal acquisitions in static and/or dynamic contractions, both in healthy volunteers and post-stroke patients by measuring the following parameters: 1. Signal amplitude (0 or 1): the peak-to-peak sEMG signal amplitude is within the anatomical range of few-tens of µV to 2 mV. 2. Signal spectrum (0 or 1): the sEMG signal spectrum is within the anatomical range (sEMG power is mostly accounted for by the frequency components \< 350 Hz). 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.

  30 days

• Correlation between the properties of populations of Motor Unit (MU) with the type of the stroke.

  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.

  30 days

• Correlation between the properties of populations of Motor Unit (MU) with the severity of the stroke.

  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).

  30 days

• Correlation between the properties of populations of Motor Unit (MU) with the location of the stroke.

  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).

  30 days

• Percentage of tracked MU

  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

  30 days

Secondary Outcomes (1)

• Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction

  30 days

Study Arms (3)

Static contractions in healthy volunteers

EXPERIMENTAL

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

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

Dynamic contractions in healthy volunteers

EXPERIMENTAL

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

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

Static contractions in post-stroke patients

EXPERIMENTAL

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

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

Interventions

Acquisition of HD sEMG signals using the WPM-SEMG device 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; Static contractions in healthy volunteers; Static contractions in post-stroke patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Written Informed Consent
• Female or male
• 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
• years or older
• Have a first-time stroke

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alain Kaelin: lead
• University of Applied Sciences and Arts of Southern Switzerland: collaborator
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (1)

Istituto di Neuroscienze Cliniche della Svizzera Italiana

Lugano, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Alain Kaelin, Prof.

  Istituto di Neuroscienze Cliniche della Svizzera Italiana

  STUDY DIRECTOR

Central Study Contacts

Alain Kaelin, Prof.

CONTACT

+41 91 811 62 57; alain.kaelin@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: May 9, 2023
• Study Start: March 13, 2023
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

CH (1)