Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
NCT ID: NCT07069257
Last Updated: 2026-01-16
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-03-01
2026-06-01
Brief Summary
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Detailed Description
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This randomized, controlled, single-blind study will include children aged 4 to 17 years diagnosed with cerebral palsy and presenting with moderate to severe drooling (Drooling Severity and Frequency Scale score ≥3). Participants will be randomly assigned to one of three groups: oral motor therapy alone, oral motor therapy plus active NMES, and oral motor therapy with sham NMES. The intervention comprises twelve therapy sessions over four weeks, delivered by a trained therapist.
Oral motor therapy involves exercises targeting lips, tongue, cheeks, and jaw, in addition to thermal and tactile stimulation (using brushes, spoons, cold packs, and heat packs). NMES will be applied bilaterally to the masseter muscles and to the orbicularis oris muscle using a Chattanooga NMES device. Sham NMES will simulate the procedure without delivering active stimulation.
Outcome measures will be assessed before and after the intervention and will include both subjective and objective drooling scales: Drooling Severity and Frequency Scale (DSFS), Drooling Impact Scale (DIS), Visual Analog Scale for drooling severity, Drooling Quotient (DQ5), and caregiver reports of bib usage. Orofacial muscle thickness will be measured with ultrasound imaging. Additional assessments will include functional classification systems (GMFCS, MACS, CFCS, VFCS, EDACS, FOIS) and the Pediatric Eating Assessment Tool (PEDI EAT-10).
This study is approved by the Ethics Committee of Istanbul Medipol University.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oral Motor Therapy Plus NMES
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.
Oral Motor Therapy
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.
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.
Oral Motor Therapy
Participants assigned to this arm will receive oral motor therapy without any NMES. This is a behavioral therapy.
Oral Motor Therapy
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.
Oral Motor Therapy Plus Sham NMES
Participants assigned to this arm will receive oral motor therapy combined with sham NMES that does not deliver active stimulation.
Oral Motor Therapy
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.
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.
Interventions
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Oral Motor Therapy
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Presence of drooling control problems
* Age between 4 and 17 years
* Gross Motor Function Classification System (GMFCS) levels 2, 3, 4, or 5
* Stable drooling severity for at least one month prior to enrollment
* Drooling Severity and Frequency Scale (DSFS) score of 3 or higher
Exclusion Criteria
* Use of medications affecting drooling within the past 72 hours
* Upper respiratory tract infection and/or salivary gland infection during the study period
* History of botulinum toxin injection to the salivary glands
4 Years
17 Years
ALL
No
Sponsors
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Fatih Sultan Mehmet Training and Research Hospital
OTHER
Aslinur Keles Ercisli, MD, PhD
OTHER
Responsible Party
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Aslinur Keles Ercisli, MD, PhD
Investigator
Principal Investigators
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Zehra Aycan
Role: PRINCIPAL_INVESTIGATOR
Health Sciences University Fatih Sultan Mehmet Training and Research Hospital
Esra Giray, Assoc. Prof.
Role: STUDY_CHAIR
Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
Aslinur Keles Ercisli, MD, PhD
Role: STUDY_DIRECTOR
Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital
Locations
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Fatih Sultan Mehmet Training and Research Hospital
Ataşehir, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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References
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Assoratgoon I, Shiraishi N, Tagaino R, Ogawa T, Sasaki K. Sensory neuromuscular electrical stimulation for dysphagia rehabilitation: A literature review. J Oral Rehabil. 2023 Feb;50(2):157-164. doi: 10.1111/joor.13391. Epub 2022 Nov 28.
Sigan SN, Uzunhan TA, Aydinli N, Eraslan E, Ekici B, Caliskan M. Effects of oral motor therapy in children with cerebral palsy. Ann Indian Acad Neurol. 2013 Jul;16(3):342-6. doi: 10.4103/0972-2327.116923.
2. Awan, W. A., Aftab, A., Janua, U. I., Ramzan, R., & Khan, N. (2017). EFFECTIVENESS OF KINESIO TAPING WITH OROMOTOR EXERCISES IN IMPROVING DROOLING AMONG CHILDREN WITH CEREBRAL PALSY: soi: 21-2017/re-trjvol01iss02p21. The Rehabilitation Journal, 1(02), 21-27.
1. Fatima et al (2019), Study of the effectiveness of oromotor exercises to reduce drooling in cerebral palsy children
Other Identifiers
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Ethics Committee No: 1295 (20-
Identifier Type: OTHER
Identifier Source: secondary_id
2025-SP-SC-NMESOMT-01
Identifier Type: -
Identifier Source: org_study_id
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