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NCT Number: NCT07626424

Local Vibration for 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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Mouth Diseases Nervous System Diseases Salivary Gland Diseases Sialorrhea Stomatognathic Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlas Özel Eğitim ve Rehabilitasyon Merkezi

Van, Turkey (Türkiye)

Location status: Recruiting

Location contact

Merve Tunçdemir Dursun

CONTACT

[email protected]

+90 507 725 4261

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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)

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve Tunçdemir, Asst. Prof.

CONTACT

[email protected]

5069452008 ext. +90

Ömer Dursun, Assoc. Prof.

CONTACT

[email protected]

5426088687 ext. +90

Sponsors and collaborators

Lead sponsor

Bitlis Eren University

Other

Registry information

Official study title

Effects of Local Vibration on Orofacial Muscle Tone and Drooling in Children With Cerebral Palsy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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