Using a new device to improve rehabilitation after stroke
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
This study is testing a new device that helps track muscle activity during exercises to see if it can improve rehabilitation for people recovering from a stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Lugano) |
| Trial ID | NCT05849896 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the WPM-SEMG-V2 device, which captures high-density surface electromyography (sEMG) signals, in both healthy volunteers and post-stroke patients. Initially, the device will be tested on healthy individuals to assess its technical and clinical performance during various muscle contractions. Following this, the study will focus on post-stroke patients to explore how the HD sEMG signals can aid in their rehabilitation process. Participants will perform exercises while wearing the device to gather data on muscle activation and neuromuscular behavior.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced a first-time stroke and can perform specific muscle tasks.
Not a fit: Patients who have had multiple strokes or those with significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for post-stroke patients, potentially improving their recovery outcomes.
How similar studies have performed: While the use of HD sEMG in rehabilitation is a growing field, this specific approach with the WPM-SEMG-V2 device is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lugano
- Istituto di Neuroscienze Cliniche della Svizzera Italiana — Lugano, Switzerland (Recruiting)
Study contacts
- Study coordinator: Alain Kaelin, Prof.
- Email: alain.kaelin@eoc.ch
- Phone: +41 91 811 62 57
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.