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 5 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Show all 11Show fewer
- 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.
Turkey (Türkiye)1 site
Atlas Özel Eğitim ve Rehabilitasyon Merkezi
Van
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 completion5 Nov 2026 (estimated)
- Study completion5 Nov 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
- Oct 2026
- First submitted
- 17 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Vibration on Orofacial Muscle Tone and Drooling in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07626424
- Acronym / sponsor ID
- Beuftr_4
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Drooling, Local vibration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local Vibration Group | Experimental | Other: Local Vibration TherapyIn 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. |
| Sham Vibration Group | Sham comparator | Other: Sham VibrationIn 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local Vibration TherapyLocal 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. | Other | Local Vibration Group |
| Sham VibrationSham 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. | Other | Sham Vibration Group |
Primary outcome
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.
3 secondary outcomes
Change in drooling severity and frequency
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Global Rating of Change Scale
Time frame: Immediately after the third intervention session and 1-week follow-up
Caregiver-reported drooling burden
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Tunçdemir, Asst. Prof. principal investigator
Bitlis Eren University
Ömer Dursun, Assoc. Prof. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local Vibration Therapy in people with Cerebral Palsy (CP), run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Tone (time frame: Baseline, immediately after the third intervention session, and 1-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.