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Search / Trial NCT05849896

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

Launched by ALAIN KAELIN · Apr 28, 2023

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the WPM-SEMG-V2, which is designed to measure muscle activity in both healthy individuals and patients who have had a stroke. The researchers want to see how well this device works and how the information it gathers can help in the rehabilitation process for stroke patients. Participants will wear the device while doing simple hand or leg exercises, allowing the researchers to collect important data about muscle function.

To join the study, healthy volunteers need to be at least 18 years old and willing to perform the exercises. They should also be able to understand the study and give their consent. For stroke patients, eligibility includes being at least 18 years old and having experienced a first-time stroke, while also meeting certain health criteria. Participants can expect to take part in exercises while wearing the device, and they will be helping to advance our understanding of stroke rehabilitation.

Gender

ALL

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)

About Alain Kaelin

Alain Kaelin is a dedicated clinical trial sponsor specializing in the advancement of innovative therapies across various therapeutic areas. With a strong focus on enhancing patient outcomes, the organization is committed to conducting rigorous clinical research that adheres to the highest ethical standards and regulatory requirements. Leveraging a collaborative approach, Alain Kaelin engages with healthcare professionals, researchers, and regulatory bodies to ensure the successful design and implementation of clinical trials. The sponsor's mission is to contribute to the scientific community and improve healthcare by bringing new treatment options to market through meticulous study planning and execution.

Locations

Lugano, , Switzerland

Patients applied

0 patients applied

Trial Officials

Alain Kaelin, Prof.

Study Director

Istituto di Neuroscienze Cliniche della Svizzera Italiana

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported