Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Cerebral Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorAslinur Keles Ercisli, MD, PhD
About this trial
This randomized, controlled, single-blind trial aims to investigate the effectiveness of neuromuscular electrical stimulation (NMES) combined with oral motor therapy in reducing drooling severity among children with cerebral palsy. Participants will be allocated to an intervention group (oral motor therapy plus NMES), a control group (oral motor therapy alone) and a sham group (oral motor therapy with placebo NMES).
Eligibility criteria
Qualifiers
Diagnosis of cerebral palsy (unilateral/bilateral spastic, ataxic, dyskinetic, or mixed type)
Presence of drooling control problems
Age between 4 and 17 years
Gross Motor Function Classification System (GMFCS) levels 2, 3, 4, or 5
Disqualifiers
Diagnosis of dysphagia
Use of medications affecting drooling within the past 72 hours
Upper respiratory tract infection and/or salivary gland infection during the study period
History of botulinum toxin injection to the salivary glands
Trial design
Treatments tested in this trial
- Oral Motor Therapy
- Neuromuscular Electrical Stimulation (NMES)
- Sham Neuromuscular Electrical Stimulation (Sham NMES)
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Aslinur Keles Ercisli, MD, PhD
Lead sponsor
Fatih Sultan Mehmet Training and Research Hospital
Sponsor institution
Fatih Sultan Mehmet Training and Research Hospital
Collaborator
Source ClinicalTrials.gov