[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603150":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":42,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running.",[13],"Device: Active full-body stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham","SHAM_COMPARATOR","Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running.",[19],"Other: Sham full-body stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active full-body stimulation","Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham full-body stimulation","Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Arun Jayaraman, PhD","CONTACT","312-238-6875","ajayaraman@sralab.org",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":26},"Sara Prokup, DPT","312-238-1355",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-87.65005,41.85003,{"lat":52,"lon":51},[55],{"name":56,"role":34,"phone":39,"phoneExt":26,"email":26},"Sara Prokup",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Arun Jayaraman, PT, PhD","Director - Max Nader Center for Rehabilitation Technologies and Outcomes Research",[62],{"name":63,"class":64},"Otto Bock Healthcare Products GmbH","INDUSTRY","100603150","evaluation-of-the-safety-and-efficacy-of-a-full-body-electrostimulation-garment-for-individuals-with-neurological-and-neuromuscular-conditions-that-cause-spasticity-hyperreflexia-and-pain-100603150",false,"NCT07132775","Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain","Inclusion Criteria:\n\n1. Age 18 to 75 years old\n2. Medical clearance from physician\n3. Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia\n4. For participants with a diagnosis of Multiple Sclerosis:\n\n   1. having a definite diagnosis for at least one month\n   2. Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) \\\u003C 7).\n   3. Absence of relapses in the last three months\n   4. Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)\n   5. Berg Balance Scale (BBS) score of \\\u003C 46 (associated in the literature with a risk of fall)\n5. For participants with a diagnosis of Fibromyalgia:\n\n   a. having a definite diagnosis for at least three months\n6. Able to follow instructions and inform study staff of pain and\u002For discomfort\n7. Able to ambulate 10m without body weight support with or without assistive devices and\u002For caregiver assistance\n\nExclusion Criteria:\n\n1. Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)\n2. Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used\n3. No established somatic or neuropsychiatric diagnosis prior to enrollment in the study\n4. Pregnant and\u002For nursing","ALL","18 Years","75 Years",{"count":75,"type":76},15,"ESTIMATED","INTERVENTIONAL",[79],"NA","The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and\u002For pain.",[82,83,84,85],"Multiple Sclerosis","Fibromyalgia","Neurologic Disorder","Neuromuscular Disorders","2025-09-02",{"date":88,"type":89},"2025-09-09","ACTUAL",{"date":91,"type":89},"2025-07-23",{"date":93,"type":76},"2027-07",{"name":5,"class":6},1]