Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 2 years - 18 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 23 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This randomized-controlled trial evaluates local vibration therapy for drooling and orofacial muscle biomechanics in children with cerebral palsy. Participants receive either local vibration plus conventional physiotherapy or sham vibration plus conventional physiotherapy.
Read the full description
This randomized-controlled trial aims to evaluate the effects of local vibration therapy on drooling severity and perioral and submandibular muscle biomechanics in children with cerebral palsy. Participants will be allocated to either an experimental group receiving local vibration in addition to conventional physiotherapy or a control group receiving sham vibration with conventional physiotherapy. Local vibration will be applied to the perioral and submandibular regions for 5 minutes each over three consecutive days. Assessments will be conducted at baseline, immediately after the third intervention session, and at 1-week follow-up.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- Diagnosis of cerebral palsy
- Age between 2 and 18 years
- Presence of anterior drooling
- Drooling severity and frequency score ≥ 3 on a standardized drooling scale
Exclusion Criteria:
- History of surgical intervention for drooling management
- History of botulinum toxin injection for drooling management
- Use of medications affecting salivary control
- Presence of progressive neurological disease
- Presence of salivary gland pathology or active upper respiratory tract infection
- History or symptoms of aspiration pneumonia within the last 6 months
- Indication for surgical treatment of drooling (e.g., more than four clothing changes per day and presence of chin or neck dermatitis)
- Uncontrolled seizures
- Presence of oral or perioral lesions
- Presence of gastrostomy tube
- Treatment adherence below 85%
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Double masked
Local Vibration Group
In this group, participants will receive conventional physiotherapy combined with local vibration therapy. Local vibration will be applied to the perioral and submandibular regions for 5 minutes each (total 10 minutes per session) once daily for three consecutive days using a vibration device.
Other: Local Vibration Therapy
Sham Vibration Group
In this group, participants will receive conventional physiotherapy combined with sham vibration. The vibration device will be activated but not applied to the skin surface. The procedure will mimic the experimental protocol in duration and setting and will be performed once daily for three consecutive days.
Other: Sham Vibration
Local Vibration Therapy OTHER
Local vibration therapy will be applied to the perioral and submandibular regions using a vibration device for 5 minutes each (total 10 minutes per session), once daily for three consecutive days.
Sham Vibration OTHER
Sham vibration will be administered using the same device without contact with the skin. The intervention will be delivered for 10 minutes per session, once daily for three consecutive days.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Muscle Tone
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Muscle tone of the perioral and submandibular muscles (orbicularis oris and anterior digastric muscles) will be evaluated using a portable hand-held myotonometer (MyotonPRO). The MyotonPRO applies a short mechanical impulse to the skin overlying the muscle or fascia. The tissue response generates a signal that is recorded, and the internal software produces an acceleration graph.
Muscle Stiffness
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Muscle stiffness of the perioral and submandibular muscles (orbicularis oris and anterior digastric muscles) will be evaluated using a portable hand-held myotonometer (MyotonPRO). The MyotonPRO applies a short mechanical impulse to the skin overlying the muscle or fascia. The tissue response generates a signal that is recorded, and the internal software produces an acceleration graph.
Muscle Elasticity (logarithmic decrement)
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Muscle elasticity of the perioral and submandibular muscles (orbicularis oris and anterior digastric muscles) will be evaluated using a portable hand-held myotonometer (MyotonPRO). The MyotonPRO applies a short mechanical impulse to the skin overlying the muscle or fascia. The tissue response generates a signal that is recorded, and the internal software produces an acceleration graph.
Secondary measures
Change in drooling severity and frequency
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Drooling severity and frequency will be assessed using a standardized drooling scale, with severity scored from 1 (no drooling) to 5 (severe drooling) and frequency scored from 1 (no drooling) to 4 (constant drooling)
Global Rating of Change Scale
Time frame: Immediately after the third intervention session and 1-week follow-up
Parent-reported global rating of change using the Global Rating of Change Scale. Scores range from -7 (very much worse) to +7 (very much improved), with higher scores indicating greater perceived improvement.
Caregiver-reported drooling burden
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Caregivers will report the frequency of clothing changes and use of tissues related to drooling.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Atlas Özel Eğitim ve Rehabilitasyon MerkeziVan, Turkey (Türkiye)Status unknown
Study team and timeline
- Lead sponsor
- Bitlis Eren University
- Study start
- Jun 15, 2026 Actual
- Primary completion
- Nov 5, 2026 Actual
- Study completion
- Nov 5, 2026 Actual
- First posted
- Jun 4, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Effects of Local Vibration on Orofacial Muscle Tone and Drooling in Children With Cerebral Palsy
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026