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

Last updated: September 2, 2024
Sponsor: Alain Kaelin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Acquisition of HD sEMG signals using the WPM-SEMG device

Clinical Study ID

NCT05849896
SUPSI-SEMG-002
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thelast 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

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 polystyrenemarkers)

  • 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 polystyrenemarkers)

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Acquisition of HD sEMG signals using the WPM-SEMG device
Phase:
Study Start date:
March 13, 2023
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Istituto di Neuroscienze Cliniche della Svizzera Italiana

    Lugano,
    Switzerland

    Site Not Available

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