Child Clinical Trial
Official title:
Chest Therapy and Postural Control in Children With Crhonic Neurological Patology
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.
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).
ESTIMATION OF SAMPLE SIZE The sample size necessary to obtain a good internal validity was
calculated, considering a normal distribution of the data, making a population estimate
according to Granmo for paired means (repeated in a group). And the Bonferroni correction was
taken into account, that is, the significance of at least 0.05 divided by the number of
comparisons (in this case 8) was considered for each contrast.
So, estimating a significance of 0.00625 (0.05 / 8) and a power of 0.8, in a bilateral
contrast, 27 subjects are required to detect a difference equal to or greater than 3.5 units.
A standard deviation of 5 is assumed.
The participants were recruited from four centres of early care and foundations of the
Community of Madrid. From their respective centres, all the parents of children with chronic
neurological syndromes, who could enter the study according to the inclusion and exclusion
criteria previously described, participated in the project.
The informed consent of the parents or guardians of each participant was filed outside their
medical history and they were informed of the confidentiality of the data according to the
Organic Law 15/99 of December 13 of Data Protection of personal character.
Subsequently, a first evaluation of the participants was performed, in which the descriptive
data, the clinical exams, the number of exacerbations that each participant underwent during
the 6 months prior to the beginning of the study were collected and the PedsQL quality of
life questionnaires Through a personal interview with the parents.
After this first evaluation, the clinical evaluations were performed, including the clinical
exams of the participants before and after each session. And, after each session, the volume
of secretions expectorated by each participant was measured. In the last session (session 6)
the PedsQL quality of life questionnaires were completed again.
Finally, in the evaluation of evolutionary control, clinical examinations were performed, the
PedsQL quality of life questionnaires were again completed and the number of exacerbations
due to respiratory complications that each participant had during the six months after the
study was started.
Chest therapy was performed twice a month. The intervention of the workshops was done every 3
months.
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