Effectiveness of Non-Invasive Neuromodulation in Children With Neurodevelopmental Disorders to Improve Constipation and Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change in stool characteristics from baseline at a month and a half
研究概览
简要总结
Children with neurodevelopmental disorders have a delay in acquiring the skills that are assumed considering the phases of typical psychomotor development. Added to this difficulty and main element of concern on the part of their families, there are another series of signs that appear with some frequency and that, despite being unnoticed against other major problems represent basic and fundamental factors in the correct development and performance such as constipation problems and sleep disorders.
The aim of the study consists of to evaluate the effectiveness and safety of the non-invasive neuromodulation device applied in people with neurodevelopmental disorders, in relation to constipation problems and in the quality of sleep.
详细描述
While the application is being sent to the ethics committee, we will hold a series of informative talks for the centre's staff who, in one way or another, will be involved in the development of the project.
At the same time, information letters will be sent to the parents or legal representatives of the children who will a priori be part of the project, as well as the corresponding informed consent. In addition, they will be sent the screening documents that will allow us to confirm if the selected subject has constipation problems and/or sleep disorders.
The intervention period per subject will be 12 sessions, distributed in three sessions per week (Monday, Wednesday, and Friday), estimating that the intervention can be completed after one month.
During school hours, the participants will receive their own treatment, agreed by their multidisciplinary team with common and personal objectives for the subjects, so that there will be no interruption of their usual routine.
Two weeks after the intervention, a new assessment will be carried out to assess whether the possible changes recorded during the intervention phase have been maintained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sensory-motor alteration.
- •Be schooled in the Center of the City San Juan de Dios of Las Palmas de Gran Canaria.
- •Meet the criteria established by the Rome IV constipation scale.
- •Informed consent signed by the family, guardian or legal representative.
排除标准
- •No contraindications to treatment with NXSignal: Pacemaker, internal bleeding, do not apply electrodes on skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia to electricity.
- •Epilepsia.
- •Subjects who modify eating habits and/or water intake.
结局指标
主要结局
Change in stool characteristics from baseline at a month and a half
时间窗: Baseline and up to 1 month, and two weeks after intervention
A daily evaluation will be carried out both number of stools, as well as the type of stools following the criteria established by the Bristol Stool Form Scale. It is widely used as a research tool to assess the efficacy of treatments for various diseases of the intestine. The chart is used to describe the shapes and types of stool. It is also used as a tool to diagnose constipation, diarrhea, and irritable bowel syndrome. It is a medical aid designed to classify faeces into seven groups: Types 1 and 2 indicate constipation, types 3 and 4 are considered healthy stool, while types 5 to 7 suggest diarrhea and urgency. Each person will have different bowel habits, but the important thing is that your stools are soft and easy to pass, like types 3 and 4.
Change in sleep diary from baseline at a month and a half
时间窗: Baseline and up to 1 month, and two weeks after intervention
The sleep diary is easy to complete and gives us a global vision of sleep for several days. It facilitates the calculation of hours of sleep and nocturnal awakenings. The person who registers indicates the number of hours of sleep
次要结局
- Frequency of defecation from baseline at a month and a half(Baseline and up to 1 month, and two weeks after intervention)
研究者
Aníbal Báez Suárez
Principal Investigator
University of Las Palmas de Gran Canaria