Menu
Recruiting NCT07626424

Local Vibration for Drooling in Children With Cerebral Palsy

No phase Interventional Cerebral Palsy (CP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local Vibration Therapy, Sham Vibration.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP). Basic parameters: 2 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Local Vibration Therapy
    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.
  • Other Sham Vibration
    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 outcome measures

  • Muscle Tone [Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up]
  • Muscle Stiffness [Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up]
  • Muscle Elasticity (logarithmic decrement) [Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Atlas Özel Eğitim ve Rehabilitasyon Merkezi — Van

Identifiers

NCT: NCT07626424 · Beuftr_4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗