An interventional study of Local Vibration Therapy and Sham Vibration in Cerebral Palsy (CP), sponsored by Bitlis Eren University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Bitlis Eren University · Not applicable, Interventional, and Treatment
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's enrollment of 23 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
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Exclusion Criteria:
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
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
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 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.
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-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.
Time frame: 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.
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
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-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.
Time frame: 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.
Time frame: Baseline, immediately after the third intervention session, and 1-week follow-up
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Bitlis Eren University