Electrophysiological Investigation of the Effectiveness of NMES Swallowing Difficulty Rehabilitation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pedi-EAT-10
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose relatives provided written informed consent
- •Patients suitable for the planned intervention (assumed from context)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Neuromuscular Electrical Stimulation (Device)
Sham-NMES
Sham NMES (Sham Neuromuscular Electrical Stimulation) is a placebo version of neuromuscular electrical stimulation used in clinical studies
干预措施: Sham Neuromuscular Electrical Stimulation (Device)
结局指标
主要结局
Pedi-EAT-10
时间窗: Baseline (pre-intervention)
The Pedi-EAT-10 is a caregiver-administered, symptom-based questionnaire designed to screen for signs of oropharyngeal dysphagia in children aged 18 months and older. It consists of 10 items, each rated on a 5-point Likert scale (0 = no problem, 4 = severe problem), assessing observable feeding and swallowing difficulties.Time Frame: Baseline (pre-intervention)
次要结局
未报告次要终点
研究者
Neslihan Altuntas Yilmaz
Principal Investigator
Necmettin Erbakan University