Cerebral Palsy (CP)NCT07626424
Local Vibration for Drooling in Children With Cerebral Palsy
A study testing Local Vibration Therapy in people with Cerebral Palsy (CP), run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
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 more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Local Vibration Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 27 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atlas Özel Eğitim ve Rehabilitasyon Merkezi
Van
Merve Tunçdemir Dursun, +90 507 725 4261, merve.kd@hotmail.com
About this study
Official title: Effects of Local Vibration on Orofacial Muscle Tone and Drooling in Children With Cerebral Palsy
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 detailed 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Local Vibration Therapy, Sham Vibration
- Keywords
- Drooling, Local vibration
- Medical subject headings
- Cerebral Palsy, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local Vibration TherapyOther
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 VibrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Local Vibration Group | Experimental | 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. Receives: Other: Local Vibration Therapy |
| Sham Vibration Group | Sham comparator | 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. Receives: Other: Sham Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Tone
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.
Measured: Baseline, immediately after the third intervention session, and 1-week follow-up
Muscle Stiffness
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.
Measured: Baseline, immediately after the third intervention session, and 1-week follow-up
Muscle Elasticity (logarithmic decrement)
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.
Measured: Baseline, immediately after the third intervention session, and 1-week follow-up
Secondary outcomes (3)
Change in drooling severity and frequency
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)
Measured: Baseline, immediately after the third intervention session, and 1-week follow-up
Global Rating of Change Scale
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.
Measured: Immediately after the third intervention session and 1-week follow-up
Caregiver-reported drooling burden
Caregivers will report the frequency of clothing changes and use of tissues related to drooling.
Measured: Baseline, immediately after the third intervention session, and 1-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start15 Jun 2026
- Primary completion27 Aug 2026 (estimated)
- Study completion27 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Tunçdemir, Bitlis Eren University
- Investigators
- Merve Tunçdemir, Asst. Prof., Principal investigator, Bitlis Eren UniversityÖmer Dursun, Assoc. Prof., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626424
- Sponsor's protocol ID
- Beuftr_4
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No