Effectiveness of Neuromuscular Electrical Stimulation Added to Oral Motor Therapy in Children With Cerebral Palsy Experiencing Drooling Problems: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Drooling Severity and Frequency Scale (DSFS) Score
研究概览
简要总结
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).
详细描述
Drooling is a common and disabling problem in children with cerebral palsy, adversely affecting health, social participation, and quality of life. Oral motor therapy is frequently used to improve oral control, and neuromuscular electrical stimulation (NMES) has been suggested as an adjunctive treatment to enhance orofacial muscle function.
This randomized, controlled, single-blind study will include children aged 4 to 17 years diagnosed with cerebral palsy and presenting with moderate to severe drooling (Drooling Severity and Frequency Scale score ≥3). Participants will be randomly assigned to one of three groups: oral motor therapy alone, oral motor therapy plus active NMES, and oral motor therapy with sham NMES. The intervention comprises twelve therapy sessions over four weeks, delivered by a trained therapist.
Oral motor therapy involves exercises targeting lips, tongue, cheeks, and jaw, in addition to thermal and tactile stimulation (using brushes, spoons, cold packs, and heat packs). NMES will be applied bilaterally to the masseter muscles and to the orbicularis oris muscle using a Chattanooga NMES device. Sham NMES will simulate the procedure without delivering active stimulation.
Outcome measures will be assessed before and after the intervention and will include both subjective and objective drooling scales: Drooling Severity and Frequency Scale (DSFS), Drooling Impact Scale (DIS), Visual Analog Scale for drooling severity, Drooling Quotient (DQ5), and caregiver reports of bib usage. Orofacial muscle thickness will be measured with ultrasound imaging. Additional assessments will include functional classification systems (GMFCS, MACS, CFCS, VFCS, EDACS, FOIS) and the Pediatric Eating Assessment Tool (PEDI EAT-10).
This study is approved by the Ethics Committee of Istanbul Medipol University.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are blinded to group assignment. The clinician performing ultrasound assessments is also blinded. The therapist delivering the interventions and administering the scales is not blinded.
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Stable drooling severity for at least one month prior to enrollment
- •Drooling Severity and Frequency Scale (DSFS) score of 3 or higher
排除标准
- •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
研究组 & 干预措施
Oral Motor Therapy Plus NMES
Participants assigned to this arm will receive oral motor therapy combined with active neuromuscular electrical stimulation (NMES) applied to the masseter and orbicularis oris muscles.
干预措施: Oral Motor Therapy (Behavioral)
Oral Motor Therapy Plus Sham NMES
Participants assigned to this arm will receive oral motor therapy combined with sham NMES that does not deliver active stimulation.
干预措施: Oral Motor Therapy (Behavioral)
Oral Motor Therapy Plus NMES
Participants assigned to this arm will receive oral motor therapy combined with active neuromuscular electrical stimulation (NMES) applied to the masseter and orbicularis oris muscles.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
Oral Motor Therapy
Participants assigned to this arm will receive oral motor therapy without any NMES. This is a behavioral therapy.
干预措施: Oral Motor Therapy (Behavioral)
Oral Motor Therapy Plus Sham NMES
Participants assigned to this arm will receive oral motor therapy combined with sham NMES that does not deliver active stimulation.
干预措施: Sham Neuromuscular Electrical Stimulation (Sham NMES) (Device)
结局指标
主要结局
Change in Drooling Severity and Frequency Scale (DSFS) Score
时间窗: At Baseline and at 4th Week (after completion of 12 therapy sessions)
The Drooling Severity and Frequency Scale (DSFS) is a validated clinical tool that assesses drooling in two domains: severity and frequency. Severity is rated on a 5-point scale from 1 (dry; never drools) to 5 (profuse; clothing, hands, tray, and objects wet). Frequency is rated on a 4-point scale from 1 (never) to 4 (constantly). Higher scores in each subscale indicate more severe and frequent drooling. The total score reflects the combined impact of both dimensions.
Change in Drooling Impact Scale (DIS) Score
时间窗: At Baseline and at 4th Week (after completion of 12 therapy sessions)
The Drooling Impact Scale (DIS) assesses the impact of drooling on daily life. It consists of 10 items, each scored from 1 (barely) to 10 (extremely), resulting in a total score range of 10 to 100. Higher scores indicate a greater negative impact of drooling on quality of life.
次要结局
- Change in Orofacial Muscle Thickness Measured by Ultrasound(At Baseline and at 4th Week (after completion of 12 therapy sessions))
- Change in Visual Analog Scale (VAS) Drooling Severity Score(At Baseline and at 4th Week (after completion of 12 therapy sessions))
- Change in Drooling Quotient (DQ5)(At Baseline and at 4th Week (after completion of 12 therapy sessions))
- Change in Karaduman Chewing Performance Scale (KCPS) Score(At Baseline and at 4th Week (after completion of 12 therapy sessions))
- Change in Tongue Thrust Rating Scale (TTRS) Score(At Baseline and at 4th Week (after completion of 12 therapy sessions))
- Change in Daily Number of Wet Bibs and Cloths(At Baseline and at 4th Week (after completion of 12 therapy sessions))
研究者
Aslinur Keles Ercisli, MD, PhD
Investigator
Fatih Sultan Mehmet Training and Research Hospital