Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy

NCT07069257 | Not Yet Recruiting

• 2 other identifiers: 2025-SP-SC-NMESOMT-01Ethics Committee No: 1295 (20-
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cerebral Palsy (CP); Drooling

Keywords

Cerebral Palsy; Drooling; Sialorrhea; Oral Motor Therapy; Neuromuscular Electrical Stimulation; Pediatric Rehabilitation; Ultrasound; Masseter Muscle; Orbicularis Oris Muscle

Outcome Measures

Primary Outcomes (2)

• Change in Drooling Severity and Frequency Scale (DSFS) Score

  The Drooling Severity and Frequency Scale (DSFS) is a validated clinical tool that assesses drooling in two domains: severity and frequency. Severity is rated on a 5-point scale from 1 (dry; never drools) to 5 (profuse; clothing, hands, tray, and objects wet). Frequency is rated on a 4-point scale from 1 (never) to 4 (constantly). Higher scores in each subscale indicate more severe and frequent drooling. The total score reflects the combined impact of both dimensions.

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

• Change in Drooling Impact Scale (DIS) Score

  The Drooling Impact Scale (DIS) assesses the impact of drooling on daily life. It consists of 10 items, each scored from 1 (barely) to 10 (extremely), resulting in a total score range of 10 to 100. Higher scores indicate a greater negative impact of drooling on quality of life.

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

Secondary Outcomes (6)

• Change in Orofacial Muscle Thickness Measured by Ultrasound

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

• Change in Visual Analog Scale (VAS) Drooling Severity Score

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

• Change in Drooling Quotient (DQ5)

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

• Change in Karaduman Chewing Performance Scale (KCPS) Score

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

• Change in Tongue Thrust Rating Scale (TTRS) Score

  At Baseline and at 4th Week (after completion of 12 therapy sessions)

Study Arms (3)

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.

Behavioral: Oral Motor Therapy; Device: Neuromuscular Electrical Stimulation (NMES)

Oral Motor Therapy

OTHER

Participants assigned to this arm will receive oral motor therapy without any NMES. This is a behavioral therapy.

Behavioral: Oral Motor Therapy

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.

Behavioral: Oral Motor Therapy; Device: Sham Neuromuscular Electrical Stimulation (Sham NMES)

Interventions

Oral Motor Therapy 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.

Oral Motor Therapy; Oral Motor Therapy Plus NMES; Oral Motor Therapy Plus Sham NMES

Sham Neuromuscular Electrical Stimulation (Sham NMES) DEVICE

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.

Oral Motor Therapy Plus Sham NMES

Neuromuscular Electrical Stimulation (NMES) DEVICE

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 Plus NMES

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of cerebral palsy (unilateral/bilateral spastic, ataxic, dyskinetic, or mixed type)
• 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

You may not qualify if:

• Diagnosis of dysphagia
• 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

Sponsors & Collaborators

• Aslinur Keles Ercisli, MD, PhD: lead
• Fatih Sultan Mehmet Training and Research Hospital: collaborator

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Ataşehir, Istanbul, 34758, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 36357332 BACKGROUND

• 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.

  PMID: 24101813 BACKGROUND

• 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.

  BACKGROUND

• 1. Fatima et al (2019), Study of the effectiveness of oromotor exercises to reduce drooling in cerebral palsy children

  BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Sialorrhea

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Zehra Aycan

  Health Sciences University Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Esra Giray, Assoc. Prof.

  Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

  STUDY CHAIR

• Aslinur Keles Ercisli, MD, PhD

  Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

ZEHRA AYCAN

CONTACT

+90 553 450 00 22; zehrabir.123@gmail.com

Aslinur Keles

CONTACT

aslinur.ercisli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to group assignment. The clinician performing ultrasound assessments is also blinded. The therapist delivering the interventions and administering the scales is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: Participants were randomly assigned to three parallel groups: (1) oral motor therapy plus neuromuscular electrical stimulation (NMES), (2) oral motor therapy alone, and (3) oral motor therapy plus sham NMES.

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)