Effectiveness of NMES in Swallowing Rehabilitation in Children With CP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-01-02

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Cerebral Palsy (CP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study procedures The study was performed by a group of independent experts blinded to treatment allocation. The study was conducted by a group of independent experts blinded to the treatment allocation. An ear, nose, and throat specialist performed the physical examination, videofluoroscopic (Philips, Amsterdam, Netherlands) swallowing evaluation and electrophysiological evaluation. Unaware of the evaluation, swallowing rehabilitation was administered by a swallowing therapist. Subsequently, the patients were reevaluated by another ear, nose, and throat specialist using endoscopic assessment, unaware of the initial findings and observations. The randomization of patients was arranged by a 4th expert in physical medicine and rehabilitation. Experimental and control groups were formed. The patients completed the study without knowing which group they were assigned to. However, the swallowing therapist who administered the treatment was aware of the group assignments. Evalu

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Randomization Randomization was performed in 32 patients according to the study criteria by independent (4nd) specialist. In accordance with the order of admission to the hospital, patients were randomly allocated by block randomization and a table of random numbers. The patients were numbered and grouped as 1.,4.,5.,8.,9.,… patients for Group 1, and 2.,3.,6.,7.,10.,... patients for Group 2. Allocation was performed before the initial evaluation. After randomization, 6 patients in Group 2 who were unable to adapt to rehabilitation programme were excluded and the study was completed with 26 patients.

Study Groups

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NMES

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.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

For NMES applied to the suprahyoid muscle group, a 80 Hertz frequency, with a transition time of 300-400 microseconds, 40 minutes of Vital Stim application was performed

Sham-NMES

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

Group Type SHAM_COMPARATOR

Sham Neuromuscular Electrical Stimulation

Intervention Type DEVICE

Sham NMES involves applying the electrical stimulation device without delivering therapeutic current, serving as a placebo control in randomized clinical trials

Interventions

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Neuromuscular Electrical Stimulation

For NMES applied to the suprahyoid muscle group, a 80 Hertz frequency, with a transition time of 300-400 microseconds, 40 minutes of Vital Stim application was performed

Intervention Type DEVICE

Sham Neuromuscular Electrical Stimulation

Sham NMES involves applying the electrical stimulation device without delivering therapeutic current, serving as a placebo control in randomized clinical trials

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No