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临床试验/NCT07622875
NCT07622875Enrolling By Invitation不适用

Effects of Transcutaneous Diaphragmatic Electrical Stimulation Added to a Multimodal Rehabilitation Program on Pulmonary Functions in Non-Ambulatory Children With Cerebral Palsy

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1

研究概览

简要总结

Does transcutaneous diaphragmatic electrical stimulation (TDES), added to a 6-week structured multimodal rehabilitation program, improve diaphragm function, head-neck control, and sitting balance in children with cerebral palsy at GMFCS Level IV-V?

详细描述

Baseline clinical and demographic data of patients meeting the inclusion criteria will be recorded in detail. Subsequently, participants will be randomly assigned into two groups using a computer-generated randomization method. All patients will receive a 6-week multimodal rehabilitation program consisting of conventional exercises and electrical stimulation to the lower extremity muscles five days per week, in addition to 45-minute sessions of robotic rehabilitation, 45-minute occupational therapy, 45-minute hydrotherapy, and a 45-minute pulmonary rehabilitation program twice weekly. The pulmonary rehabilitation program will include diaphragmatic breathing training, chest wall mobilization, respiratory muscle-supportive exercises, and interventions aimed at postural alignment and sitting positioning. In addition to these treatments, patients in the intervention group will receive transcutaneous diaphragmatic electrical stimulation (TDES).

TDES will be administered by a blinded researcher using a four-channel, low-frequency biphasic neuromuscular electrical stimulator (Compex SP 4.0, Mouguerre, France). Rectangular electrodes will be positioned in the parasternal region adjacent to the xiphoid process and at the sixth and seventh intercostal spaces along the midaxillary line. Stimulation will be delivered using biphasic waves at a frequency of 30 Hz, a pulse width of 400 μs, and a ramp-up time of 0.7 seconds. Current intensity will be gradually increased, in accordance with established protocols, until visible diaphragmatic contractions are achieved. Intervention sessions will be administered twice weekly for 30 minutes per session over a 6-week period.

Assessments will be performed before rehabilitation (week 0) and after completion of the program (week 6) by a blinded researcher other than the investigator administering TDES. In children using braces due to scoliosis, all measurements will be performed without the brace.

The effects of TDES added to a multimodal rehabilitation program on pulmonary function, head-neck control, and sitting balance, as well as related factors, will be investigated in non-ambulatory children with cerebral palsy.

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
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Cerebral Palsy (GMFCS Level IV-V)
  • Aged 5-18 years

排除标准

  • Clinically unstable condition,
  • Tracheostomy, home-based non-invasive mechanical ventilation (CPAP/BIPAP), continuous oxygen therapy

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zeynep Kıraç Ünal

Associated Proffessor

Ankara Etlik City Hospital

研究点 (1)

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