Chest Therapy and Postural Control in Children With Crhonic Neurological Patology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change from Quality of Life Related to Health (HRQoL) at 6 month
研究概览
简要总结
INTRODUCTION: Neurological Chronic disease leads to motor disability and associated pathologies. Numerous studies agree that the lack of prevention and treatment in pulmonary health in children with disabilities results in increased morbidity and mortality, increased medical care and costs in care, and, for patients and their caregivers, decrease in their quality of life OBJECTIVE: The objective of this study is to assess if children with chronic neurological disease and respiratory disease benefit from airway clearance techniques and postural hygiene workshops to optimize their respiratory status and quality of life. PATIENTS AND METHODS: Multicenter experimental study before-after with intervention of chest therapy and workshops of postural hygiene in 30 children from 0 to 6 years with chronic neurological affectation and respiratory complications. Respiratory clinical variables, volume of expectorated secretions, PedsQL pediatric quality of life questionnaires were evaluated and the number of exacerbations due to respiratory complications was recorded.
详细描述
There are few studies that apply and evaluate respiratory physiotherapy and / or postural hygiene in children with neurological affections. This study aims to improve the quality and effectiveness of physiotherapy interventions in paediatric patients with neurological problems and respiratory symptomatology, providing scientific evidence to respiratory physiotherapy protocols that are carried out in daily clinical practice and implementing the practice of therapeutic education on postural hygiene.
HYPOTHESIS: Children with neurological chronic disease and respiratory affection benefit from mucociliary clearance techniques and workshops on postural hygiene to optimize respiratory status and quality of life.
OBJECTIVES
- To evaluate the effectiveness of mucociliary clearance techniques in improving respiratory clinical signs and to increase expectoration of bronchial secretions in children with chronic neurological disease.
- To analyse the effectiveness of mucociliary clearance techniques combined with workshops to improve the quality of life of children with chronic neurological disease with respiratory complications.
- Establish the effectiveness of mucociliary clearance techniques and workshops to reduce the number of exacerbations due to respiratory infection in children with chronic neurological disease.
- To determine the effectiveness of mucociliary clearance techniques and workshops to reduce hospital admissions for respiratory complications in children with chronic neurological disease.
- MATERIAL AND METHODS It is an experimental study before - after a single group of children with non-progressive chronic neurological affectation (Cerebral Palsy, Down Syndrome, encephalopathies, ...) and respiratory involvement with intervention of chest therapy and workshops of postural hygiene directed to their parents or guardians Each individual has been their own control in the successive evaluations. The physiotherapist who has performed the techniques of chest therapy and workshops has been the same as the physiotherapist evaluator, so that there has been neither simple nor double blind.
The project was previously approved by the Clinical Research Ethics Committee of the San Carlos Clinical University Hospital (internal code nº 15/152-E); He was awarded the 2014 Research Fellowship of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR).
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
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose parents or guardians have signed informed consent.
- •Patients of both sexes whose ages are between 0 and 6 years.
- •Diagnosis of PC, encephalopathies and syndromes with non-progressive chronic neurological involvement, with respiratory complications (Pneumonias or Bronchitis).
排除标准
- •Patients affected by immunodeficiency or hemato-oncological process.
- •Previous respiratory pathology in itself (not consistent with its underlying pathology)
- •Patients with cardiovascular instability.
- •Patients with drained pneumothorax.
- •Patients with recent pneumonectomy.
- •Patients with severe bullae.
- •Patients with hemoptysis.
研究组 & 干预措施
Sample
30 patients of both sexes aged between 0 and 6 years with chronic neurological involvement with respiratory complications.
Individual sessions of chest therapy every fifteen days for three months, in total 6 respiratory physiotherapy sessions of 30 minutes each were performed. And the postural hygiene workshops were given to the parents, this educational intervention was carried out at the beginning of the study, at 3 months and at 6 months from the beginning. Each intervention lasted 4 hours with theoretical and practical part.
干预措施: Chest Therapy (Other)
Sample
30 patients of both sexes aged between 0 and 6 years with chronic neurological involvement with respiratory complications.
Individual sessions of chest therapy every fifteen days for three months, in total 6 respiratory physiotherapy sessions of 30 minutes each were performed. And the postural hygiene workshops were given to the parents, this educational intervention was carried out at the beginning of the study, at 3 months and at 6 months from the beginning. Each intervention lasted 4 hours with theoretical and practical part.
干预措施: Postural Hygiene (Other)
结局指标
主要结局
Change from Quality of Life Related to Health (HRQoL) at 6 month
时间窗: The PedsQL questionnaires were completed at the beginning of the study, at 6 months after the start of the study.
It was objectified through a personal interview with the parents, the PedsQL ™ Questionnaire on Pediatric Life Quality in Spanish version was used with the corresponding permission of use. The PedsQL ™ Generic Module investigates four areas or dimensions of the child's HRQoL: Physical, Emotional, Social and School Functioning. To calculate the HRQoL measure, the items were linearly transformed using a five-point Likert scale, on a scale of 0-100.
Change from number of hospitalizations
时间窗: The number of hospitalizations for respiratory complications that each participant had during the six months before and after the start of the study was recorded.
Number of admissions due to respiratory complications. It was valued through a personal interview with the parents.
次要结局
- Respiratory Rate(It was measured through study completion, an average of 6 month.)
- Number of emergency visits(The number of visits to the emergency department due to respiratory complications that each participant had during the six months before and after the study was recorded.)
- Pulsoximetry(It was evaluated through study completion, an average of 6 month .)
- Pulmonary auscultation(It was assessed through study completion, an average of 6 month .)
- Sputum(It was measured through study completion, an average of 6 month .)
- Number of visits to pediatrician(The number of pediatric visits for respiratory complications that each participant had during the six months before and after of the study was recorded.)
- Heart rate(It was measured through study completion, an average of 6 month.)
研究者
Moreno Bermejo
Physiotherapist
Universidad Complutense de Madrid