StrokeNCT05849896
Clinical Relevance of the HD sEMG Signals in the Post-stroke Rehabilitation
A study testing Acquisition of HD sEMG signals using the WPM-SEMG device in people with Stroke, run by Alain Kaelin at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Acquisition of HD sEMG signals using the WPM-SEMG device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Mar 2023to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Written Informed Consent
- Female or male
- 18 years or older
- Ability to understand the investigation
- Willingness to complete all the investigation assessments
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Istituto di Neuroscienze Cliniche della Svizzera Italiana
Lugano
Alain Kaelin, Prof., +41 091 811 62 57, alain.kaelin@eoc.ch
About this study
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
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.
Read the 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
- Being tested
- Acquisition of HD sEMG signals using the WPM-SEMG device
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of HD sEMG signals using the WPM-SEMG deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Device: Acquisition of HD sEMG signals using the WPM-SEMG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: 30 days
Secondary outcomes (1)
Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction
As assessed by reported adverse event.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start13 Mar 2023
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alain Kaelin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor-investigator, Alain Kaelin, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Alain Kaelin, Prof., Study director, Istituto di Neuroscienze Cliniche della Svizzera Italiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849896
- Sponsor's protocol ID
- SUPSI-SEMG-002
- Status last verified
- Sep 2024
- First submitted
- 29 Mar 2023
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05849896
- Acronym / sponsor ID
- SUPSI-SEMG-002
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Alain KaelinUniversity, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Static contractions in healthy volunteers | Experimental | Device: Acquisition of HD sEMG signals using the WPM-SEMG deviceAcquisition of HD SEMG signals of an upper limb muscle and a lower limb muscle while the participant executes simple static exercises. |
| Dynamic contractions in healthy volunteers | Experimental | Device: Acquisition of HD sEMG signals using the WPM-SEMG deviceAcquisition 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 |
| Static contractions in post-stroke patients | Experimental | Device: Acquisition of HD sEMG signals using the WPM-SEMG deviceAcquisition of HD SEMG signals of a lower limb muscle while the participant executes simple static exercises. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Healthy volunteers
- Written Informed Consent
- Female or male
- 18 years or older
- Ability to understand the investigation
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acquisition of HD sEMG signals using the WPM-SEMG deviceThe 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. | Device | Dynamic contractions in healthy volunteers, Static contractions in healthy volunteers, Static contractions in post-stroke patients |
Primary outcome
Technical performance of the device (0 to 2)
Time frame: 1 day
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.
Quality of the WPM-SEMG-V2 device in the acquisition of HD sEMG signals (0 to 2)
Time frame: 30 days
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.
Correlation between the properties of populations of Motor Unit (MU) with the type of the stroke.
Time frame: 30 days
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.
Time frame: 30 days
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.
Time frame: 30 days
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
Time frame: 30 days
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
1 secondary outcome
Incidence of serious and non-serious adverse event, adverse device effect, device deficiency and malfunction
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Kaelin, Prof. study director
Istituto di Neuroscienze Cliniche della Svizzera Italiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acquisition of HD sEMG signals using the WPM-SEMG device in people with Stroke, run by Alain Kaelin at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Kaelin, Prof. (+41 91 811 62 57, alain.kaelin@eoc.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical performance of the device (0 to 2) (time frame: 1 day). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.