[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598266":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":52,"locations":61,"responsibleParty":79,"collaborators":82,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":30,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":113,"whyStopped":30,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Fatih Sultan Mehmet Training and Research Hospital","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Motor Therapy Plus NMES","EXPERIMENTAL","Participants assigned to this arm will receive oral motor therapy combined with active neuromuscular electrical stimulation (NMES) applied to the masseter and orbicularis oris muscles.",[13,14],"Behavioral: Oral Motor Therapy","Device: Neuromuscular Electrical Stimulation (NMES)",{"label":16,"type":6,"description":17,"interventionNames":18},"Oral Motor Therapy","Participants assigned to this arm will receive oral motor therapy without any NMES. This is a behavioral therapy.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Oral Motor Therapy Plus Sham NMES","SHAM_COMPARATOR","Participants assigned to this arm will receive oral motor therapy combined with sham NMES that does not deliver active stimulation.",[13,24],"Device: Sham Neuromuscular Electrical Stimulation (Sham NMES)",[26,31,36],{"type":27,"name":16,"description":28,"armGroupLabels":29,"otherNames":30},"BEHAVIORAL","Structured oral motor exercises will be applied to the lips, tongue, cheeks, and jaw. Facial massage and thermal stimulation (warm and cold) will be performed. Intraoral sensory stimulation will be applied using a brush, lemon juice, and a cold metal probe.",[16,9,20],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DEVICE","Neuromuscular Electrical Stimulation (NMES)","Active NMES will be applied bilaterally to the masseter muscles and to the orbicularis oris muscle in addition to oral motor therapy sessions, using a Chattanooga NMES device. Each application will be performed in cycles of 5 seconds of stimulation and 10 seconds of rest. The stimulation parameters will be set to a frequency of 10-15 Hz and a pulse width of 300 microseconds. The current intensity will be gradually increased to a level just above the motor threshold, sufficient to elicit a noticeable pulling sensation without causing discomfort, and will be adjusted according to each participant's tolerance. NMES will be delivered for a total duration of 15 minutes per session. For the electrical stimulation of the orbicularis oris muscle, a pen-type electrode will be used. In this procedure, four regions of the orbicularis oris muscle (upper, lower, right, and left) will be stimulated in two cycles of 45 pulses each.",[9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Sham Neuromuscular Electrical Stimulation (Sham NMES)","Simulated neuromuscular electrical stimulation will be applied without delivering active electrical current after oral motor therapy sessions to mimic the treatment experience without producing physiological effects.",[20],[41,45,49],{"name":42,"affiliation":43,"role":44},"Zehra Aycan","Health Sciences University Fatih Sultan Mehmet Training and Research Hospital","PRINCIPAL_INVESTIGATOR",{"name":46,"affiliation":47,"role":48},"Esra Giray, Assoc. Prof.","Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital","STUDY_CHAIR",{"name":50,"affiliation":47,"role":51},"Aslinur Keles Ercisli, MD, PhD","STUDY_DIRECTOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":30,"email":57},"ZEHRA AYCAN","CONTACT","+90 553 450 00 22","zehrabir.123@gmail.com",{"name":59,"role":55,"phone":30,"phoneExt":30,"email":60},"Aslinur Keles","aslinur.ercisli@gmail.com",[62],{"facility":5,"status":30,"city":63,"state":64,"zip":65,"country":66,"countryCode":30,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Ataşehir","Istanbul","34758","Turkey (Türkiye)",{"type":68,"coordinates":69},"Point",[70,71],29.1167,40.9833,{"lat":71,"lon":70},[74,75,77],{"name":42,"role":44,"phone":30,"phoneExt":30,"email":30},{"name":46,"role":76,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"name":78,"role":76,"phone":30,"phoneExt":30,"email":30},"Aslinur Keles, MD, PhD",{"type":80,"investigatorFullName":50,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Investigator",[83],{"name":5,"class":6},"100598266","effectiveness-of-neuromuscular-electrical-stimulation-added-to-oral-motor-therapy-in-cerebral-palsy-100598266",false,"NCT07069257","Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy","Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Children With Cerebral Palsy Experiencing Drooling Problems: A Randomized Controlled Trial","NOMES-CP","Inclusion Criteria:\n\n* Diagnosis of cerebral palsy (unilateral\u002Fbilateral spastic, ataxic, dyskinetic, or mixed type)\n* Presence of drooling control problems\n* Age between 4 and 17 years\n* Gross Motor Function Classification System (GMFCS) levels 2, 3, 4, or 5\n* Stable drooling severity for at least one month prior to enrollment\n* Drooling Severity and Frequency Scale (DSFS) score of 3 or higher\n\nExclusion Criteria:\n\n* Diagnosis of dysphagia\n* Use of medications affecting drooling within the past 72 hours\n* Upper respiratory tract infection and\u002For salivary gland infection during the study period\n* History of botulinum toxin injection to the salivary glands","ALL","4 Years","17 Years",{"count":96,"type":97},30,"ESTIMATED","INTERVENTIONAL",[100],"NA","This randomized, controlled, single-blind trial aims to investigate the effectiveness of neuromuscular electrical stimulation (NMES) combined with oral motor therapy in reducing drooling severity among children with cerebral palsy. Participants will be allocated to an intervention group (oral motor therapy plus NMES), a control group (oral motor therapy alone) and a sham group (oral motor therapy with placebo NMES).",[103,104],"Cerebral Palsy (CP)","Drooling",[106,104,107,16,108,109,110,111,112],"Cerebral Palsy","Sialorrhea","Neuromuscular Electrical Stimulation","Pediatric Rehabilitation","Ultrasound","Masseter Muscle","Orbicularis Oris Muscle","NOT_YET_RECRUITING","2026-04-10",{"date":116,"type":117},"2026-04-15","ACTUAL",{"date":119,"type":97},"2026-05-01",{"date":121,"type":97},"2026-08-01",{"name":50,"class":6},1]