[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504558":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":39,"responsibleParty":54,"collaborators":58,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":28,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":28,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":28,"overallStatus":41,"whyStopped":28,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Ente Ospedaliero Cantonale, Bellinzona","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Acquisition of HD sEMG signals using the WPM-SEMG device",{"label":15,"type":10,"description":16,"interventionNames":17},"Dynamic contractions in healthy volunteers","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",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Static contractions in post-stroke patients","Acquisition of HD SEMG signals of a lower limb muscle while the participant executes simple static exercises.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Acquisition of HD sEMG signals using the WPM-SEMG device","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.",[15,9,19],null,[30],{"name":31,"affiliation":32,"role":33},"Alain Kaelin, Prof.","Istituto di Neuroscienze Cliniche della Svizzera Italiana","STUDY_DIRECTOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":28,"email":38},"CONTACT","+41 91 811 62 57","alain.kaelin@eoc.ch",[40],{"facility":32,"status":41,"city":42,"state":28,"zip":28,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Lugano","Switzerland","CH",{"type":46,"coordinates":47},"Point",[48,49],8.96004,46.01008,{"lat":49,"lon":48},[52],{"name":31,"role":36,"phone":53,"phoneExt":28,"email":38},"+41 091 811 62 57",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"SPONSOR_INVESTIGATOR","Alain Kaelin","Principal investigator",[59,61],{"name":60,"class":6},"University of Applied Sciences and Arts of Southern Switzerland",{"name":62,"class":6},"Clinical Trial Unit Ente Ospedaliero Cantonale","100504558","clinical-relevance-of-the-hd-semg-signals-in-the-post-stroke-rehabilitation-100504558",false,"NCT05849896","Clinical Relevance of the HD sEMG Signals in the Post-stroke Rehabilitation","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","Inclusion Criteria:\n\nHealthy volunteers\n\n* Written Informed Consent\n* Female or male\n* 18 years or older\n* Ability to understand the investigation\n* Willingness to complete all the investigation assessments\n* Ability to perform the procedures of the investigation\n* Ability to perform maximal voluntary muscle extension of the target muscle and limb\n\nAdditional inclusion criteria only for the recreationally active or athletic, healthy volunteers :\n\n* Subjects who participated in at least 150 min of moderate activity per week over the last six months.\n* between 18 and 20 years (preferably)\n\nPost-stroke patients\n\n* Written informed consent\n* Female or male\n* 18 years or older\n* Have a first-time stroke\n* Ability to perform maximal voluntary muscle extension of the target muscle and limb\n* Preserved cognitive capacity to perform the task\n* Ability to understand the investigation\n* Willingness to complete all the investigation assessments\n* Ability to perform the procedures of the investigation\n\nExclusion Criteria:\n\nHealthy volunteers\n\n* Any significant acute disease state\n* Skin disorders\u002Fallergies at the site of contact with the investigational device\n* History of skin disease\n* 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)\n* Chronic use of medications or treatment\n\nPost-stroke patients\n\n* History of spinal cord injury or traumatic brain damage\n* Serious medical illness that precludes performing the task\n* Severe locomotion disorder due to other causes\n* Severe neurological disease other than stroke\n* Any significant acute disease state\n* Skin disorders\u002Fallergies at the site of contact with the investigational device\n* History of skin disease\n* 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)",true,"ALL","18 Years","99 Years",{"count":75,"type":76},40,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.",[82],"Stroke","2024-09-02",{"date":85,"type":86},"2024-09-05","ACTUAL",{"date":88,"type":86},"2023-03-13",{"date":90,"type":76},"2026-04",{"name":56,"class":6},1]