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

Official title

Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Children With Cerebral Palsy Experiencing Drooling Problems: A Randomized Controlled Trial

Overview

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).

Detailed description

Drooling is a common and disabling problem in children with cerebral palsy, adversely affecting health, social participation, and quality of life. Oral motor therapy is frequently used to improve oral control, and neuromuscular electrical stimulation (NMES) has been suggested as an adjunctive treatment to enhance orofacial muscle function.

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.

Interventions

• Behavioral 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.
• 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 notice
• Device 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.

Primary outcome measures

• Change in Drooling Severity and Frequency Scale (DSFS) Score [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]
• Change in Drooling Impact Scale (DIS) Score [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]

Secondary outcome measures (6)

• Change in Orofacial Muscle Thickness Measured by Ultrasound [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]
• Change in Visual Analog Scale (VAS) Drooling Severity Score [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]
• Change in Drooling Quotient (DQ5) [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]
• Change in Karaduman Chewing Performance Scale (KCPS) Score [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]
• Change in Tongue Thrust Rating Scale (TTRS) Score [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]
• Change in Daily Number of Wet Bibs and Cloths [Time frame: At Baseline and at 4th Week (after completion of 12 therapy sessions)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Fatih Sultan Mehmet Training and Research Hospital — Ataşehir

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07069257 · 2025-SP-SC-NMESOMT-01 · Ethics Committee No: 1295 (20-

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗