Local Vibration for Drooling in Children With Cerebral Palsy
ConditionCerebral Palsy (CP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorBitlis Eren University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Local Vibration Therapy
Other interventionLocal 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 interventionSham 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Local Vibration GroupExperimental treatment 1 intervention
Group B: Sham Vibration GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, immediately after the third intervention session, and 1-week follow-up2
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.
Time frame
Baseline, immediately after the third intervention session, and 1-week follow-up3
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.
Time frame
Baseline, immediately after the third intervention session, and 1-week follow-upSecondary outcomes
1
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)
Time frame
Baseline, immediately after the third intervention session, and 1-week follow-up2
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.
Time frame
Immediately after the third intervention session and 1-week follow-up3
Caregiver-reported drooling burden
Caregivers will report the frequency of clothing changes and use of tissues related to drooling.
Time frame
Baseline, immediately after the third intervention session, and 1-week follow-upSponsors and contacts
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Source ClinicalTrials.gov