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

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

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 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.

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.

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital

  collaborator OTHER

• Aslinur Keles Ercisli, MD, PhD

  lead OTHER

Principal Investigators

• Zehra Aycan · Health Sciences University Fatih Sultan Mehmet Training and Research Hospital

• Esra Giray, Assoc. Prof. · Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

• Aslinur Keles Ercisli, MD, PhD · Istanbul University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2026-07-01

Completion

2026-08-01

Countries

• Turkey (Türkiye)

Study Locations