Local Vibration for Drooling in Children With Cerebral Palsy

NCT07626424 | Recruiting

• 1 other identifier: Beuftr_4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

Drooling; Local vibration

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, immediately after the third intervention session, and 1-week follow-up

Secondary Outcomes (3)

• Change in drooling severity and frequency

  Baseline, immediately after the third intervention session, and 1-week follow-up

• Global Rating of Change Scale

  Immediately after the third intervention session and 1-week follow-up

• Caregiver-reported drooling burden

  Baseline, immediately after the third intervention session, and 1-week follow-up

Study Arms (2)

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.

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.

Other: Sham Vibration

Interventions

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.

Local Vibration Group

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.

Sham Vibration Group

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Atlas Özel Eğitim ve Rehabilitasyon Merkezi

Van, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Sialorrhea

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Merve Tunçdemir, Asst. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

• Ömer Dursun, Assoc. Prof.

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Tunçdemir, Asst. Prof.

CONTACT

5069452008; merve.kd@hotmail.com

Ömer Dursun, Assoc. Prof.

CONTACT

5426088687; fztomrdrsn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: June 4, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): August 27, 2026
• Study Completion (Estimated): August 27, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

TU (1)