Effectiveness of NMES in Swallowing Rehabilitation in Children With CP

Necmettin Erbakan University

Status: Completed

Conditions: Cerebral Palsy (CP)

Treatments: Device: Sham Neuromuscular Electrical Stimulation; Device: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07329387

2017/22

Details and patient eligibility

About

Purpose: The aim is to investigate the effectiveness of NMES in the functional and electrophysiological rehabilitation of swallowing difficulties in dysphagic children with cerebral palsy.

Methods: Twenty-six children diagnosed with dysphagia, with a mean age of 7.02±2.40 years, were included in the study and randomly allocated into two groups (NMES,n=16;Sham NMES,n=10). In addition to swallowing rehabilitation, stimulation was applied to the groups. Participants were assessed using the Pediatric Eating Assessment Tool, Penetration-Aspiration Scale, Karaduman Chewing Performance Scale, Swallowing Ability and Function Evaluation and Electrophysiological Evaluation of the Suprahyoid Muscle in four consistencies.

Full description

This study has already been completed; however, at the time of the study, registration in the public trial database had not been performed. Since the journal requires a registration number upon submission, we have completed a retrospective registration to fulfill this requirement. The registration reflects the actual study dates and ensures transparency and compliance with publication standard

Enrollment: 26 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients whose relatives provided written informed consent
• Patients suitable for the planned intervention (assumed from context)

Exclusion criteria

• History of maxillary, head or neck surgery
• History of botulinum toxin treatment
• Structural oropharyngeal abnormality
• Gastroesophageal reflux disease (GERD)
• Receiving medical and/or physical therapy for dysphagia
• Severe cognitive, visual, auditory, or sensory impairments
• Drug use due to seizure or spasticity
• Serious pulmonary or cardiac disease
• Increased bleeding risk

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

NMES

Experimental group

Description:

In addition to the conventional swallowing rehabilitation approaches, neuromuscular electrical stimulation (NMES) was applied to the experimental group, while Sham-NMES was administered to the control group. For NMES applied to the suprahyoid muscle group, a frequency of 80 Hz with a pulse duration of 300-400 microseconds was used, and VitalStim therapy was administered for 40 minutes per session. In the Sham-NMES application, electrodes were placed on the same anatomical region, and the same amplitude and frequency settings were used as in the NMES protocol; however, no electrical current was delivered during the 40-minute session. To address ethical considerations, participants in the Sham-NMES group received 12 sessions of active NMES after completion of data collection, thereby minimizing potential bias.

Treatment:

Device: Neuromuscular Electrical Stimulation

Sham-NMES

Sham Comparator group

Description:

Sham NMES (Sham Neuromuscular Electrical Stimulation) is a placebo version of neuromuscular electrical stimulation used in clinical studies

Treatment:

Device: Sham Neuromuscular Electrical Stimulation