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

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Acquisition of HD sEMG signals using the WPM-SEMG device
Sponsored by
Alain Kaelin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy volunteers Written Informed Consent 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 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)

Sites / Locations

  • Istituto di Neuroscienze Cliniche della Svizzera Italiana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Static contractions in healthy volunteers

Dynamic contractions in healthy volunteers

Static contractions in post-stroke patients

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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: 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. Availability (0 or 1): all data recordings are stored separately in the SD card. 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.
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: 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. 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.
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.
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).
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).
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

Secondary Outcome Measures

Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction
As assessed by reported adverse event.

Full Information

First Posted
March 29, 2023
Last Updated
April 28, 2023
Sponsor
Alain Kaelin
Collaborators
Scuola Universitaria Professionale della Svizzera Italiana (SUPSI), Clinical Trial Unit Ente Ospedaliero Cantonale
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1. Study Identification

Unique Protocol Identification Number
NCT05849896
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alain Kaelin
Collaborators
Scuola Universitaria Professionale della Svizzera Italiana (SUPSI), Clinical Trial Unit Ente Ospedaliero Cantonale

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Static contractions in healthy volunteers
Arm Type
Experimental
Arm Description
Acquisition of HD SEMG signals of an upper limb muscle and a lower limb muscle while the participant executes simple static exercises.
Arm Title
Dynamic contractions in healthy volunteers
Arm Type
Experimental
Arm 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
Arm Title
Static contractions in post-stroke patients
Arm Type
Experimental
Arm Description
Acquisition of HD SEMG signals of a lower limb muscle while the participant executes simple static exercises.
Intervention Type
Device
Intervention Name(s)
Acquisition of HD sEMG signals using the WPM-SEMG device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical performance of the device (0 to 2)
Description
Assessed during signal acquisitions in static and/or dynamic contractions in healthy volunteers by checking the following parameters: 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. Availability (0 or 1): all data recordings are stored separately in the SD card. 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.
Time Frame
1 day
Title
Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals (0 to 2)
Description
Assessed during signal acquisitions in static and/or dynamic contractions, both in healthy volunteers and post-stroke patients by measuring the following parameters: 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. 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.
Time Frame
30 days
Title
Correlation between the properties of populations of Motor Unit (MU) with the type of the stroke.
Description
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.
Time Frame
30 days
Title
Correlation between the properties of populations of Motor Unit (MU) with the severity of the stroke.
Description
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).
Time Frame
30 days
Title
Correlation between the properties of populations of Motor Unit (MU) with the location of the stroke.
Description
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).
Time Frame
30 days
Title
Percentage of tracked MU
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction
Description
As assessed by reported adverse event.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers Written Informed Consent 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Kaelin, Prof.
Phone
+41 91 811 62 57
Email
alain.kaelin@eoc.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Kaelin, Prof.
Organizational Affiliation
Istituto di Neuroscienze Cliniche della Svizzera Italiana
Official's Role
Study Director
Facility Information:
Facility Name
Istituto di Neuroscienze Cliniche della Svizzera Italiana
City
Lugano
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Kaelin, Prof.
Phone
+41 091 811 62 57
Email
alain.kaelin@eoc.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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