Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorAslinur Keles Ercisli, MD, PhD
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Oral Motor Therapy
BehavioralStructured 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)
DeviceActive 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)
DeviceSimulated 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.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Oral Motor Therapy Plus NMESExperimental treatment 2 interventions
Group B: Oral Motor TherapyOther 1 intervention
Group C: Oral Motor Therapy Plus Sham NMESSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
At Baseline and at 4th Week (after completion of 12 therapy sessions)2
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.
Time frame
At Baseline and at 4th Week (after completion of 12 therapy sessions)Secondary outcomes
1
Change in Orofacial Muscle Thickness Measured by Ultrasound
Ultrasound measurement of masseter and orbicularis oris muscle thickness to evaluate changes in muscle structure following intervention.
Time frame
At Baseline and at 4th Week (after completion of 12 therapy sessions)2
Change in Visual Analog Scale (VAS) Drooling Severity Score
Participants or caregivers rate the perceived severity of drooling using a 10 cm visual analog scale (VAS), ranging from 0 (no drooling) to 10 (extremely severe drooling). Higher scores indicate greater severity of drooling. The VAS is a widely used subjective assessment tool in clinical settings.
Time frame
At Baseline and at 4th Week (after completion of 12 therapy sessions)3
Change in Drooling Quotient (DQ5)
The Drooling Quotient (DQ5) is an observational measure used to quantify the frequency of drooling in individuals with drooling disorders. Observations are conducted during two separate 5-minute periods: one during rest (passive state) and one during activity (active state such as talking or playing). During each 5-minute period, the presence or absence of drooling is recorded every 15 seconds, for a total of 20 intervals per condition. The DQ5 is calculated as the percentage of intervals in which drooling is observed (e.g., drooling observed in 6 out of 20 intervals = 30%). Higher percentages indicate more frequent drooling. Scores from both rest and activity conditions are reported.
Time frame
At Baseline and at 4th Week (after completion of 12 therapy sessions)4
Change in Karaduman Chewing Performance Scale (KCPS) Score
The Karaduman Chewing Performance Scale (KCPS) evaluates chewing function in children with cerebral palsy, scored from Level 1 (normal chewing) to Level 4 (severely impaired chewing).
Time frame
At Baseline and at 4th Week (after completion of 12 therapy sessions)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Aslinur Keles Ercisli, MD, PhD
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Sponsor institution
Fatih Sultan Mehmet Training and Research Hospital
Collaborator
Source ClinicalTrials.gov
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