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

NANot yet recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

November 1, 2025

Study Completion Date

November 1, 2025

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.

Trial Locations (1)

34758

Fatih Sultan Mehmet Training and Research Hospital, Ataşehir

All Listed Sponsors
collaborator

Istanbul Medipol University Hospital

OTHER

lead

Fatih Sultan Mehmet Training and Research Hospital

OTHER

NCT07069257 - Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy | Biotech Hunter | Biotech Hunter