Clinical trial NCT03946137: Chest Therapy and Postural Education in Children With Cerebral Palsy
Official title: Chest Therapy and Postural Control in Children With Crhonic Neurological Patology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Disorder
Respiratory Complication
Child
Keywords: Neurological chronic disorder
Child
Chest therapy
Educational intervention
Postural hygiene
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2019-05-10
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentric experimental study before-after with intervention of Chest physiotherapy and workshops of postural hygiene in 30 children from 0 to 6 years with chronic neurological diseases and respiratory complications.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Quality of Life Related to Health (HRQoL) at 6 month
timeFrame: The PedsQL questionnaires were completed at the beginning of the study, at 6 months after the start of the study.
measure: Change from number of hospitalizations
timeFrame: 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.
Secondary outcomes:
measure: Pulmonary auscultation
timeFrame: It was assessed through study completion, an average of 6 month .
measure: Pulsoximetry
timeFrame: It was evaluated through study completion, an average of 6 month .
measure: Heart rate
timeFrame: It was measured through study completion, an average of 6 month.
measure: Respiratory Rate
timeFrame: It was measured through study completion, an average of 6 month.
measure: Sputum
timeFrame: It was measured through study completion, an average of 6 month .
measure: Number of emergency visits
timeFrame: 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.
measure: Number of visits to pediatrician
timeFrame: The number of pediatric visits for respiratory complications that each participant had during the six months before and after of the study was recorded.
Other outcomes:
measure: Thoracic mobility
timeFrame: It was measured through study completion, an average of 6 month.
Locations:
Study officials:
affiliation: Sociedad Española de Cirugía y neumología Torácica
name: Inmaculada M Moreno, Doctora
role: PRINCIPAL_INVESTIGATOR
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