Chest Therapy
OtherThe sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)
Other names: Airways clearance techniques
NCT Number: NCT03946137
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.
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Notify MeUp to 6 year
All sexes
Interventional
Not applicable
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)
Other names: Airways clearance techniques
Postural hygiene workshops were taught through a theoretical presentation with the help of slides and practical exercises in small groups (2-4 parents per group).
Other names: Postural hygiene workshop
Time frame: 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.
Time frame: 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.
Time frame: It was assessed through study completion, an average of 6 month .
The presence or absence of adventitious noises was assessed. The conserved vesicular murmur corresponds to normal respiratory noise and indicates good pulmonary ventilation. The adventitious sounds assessed are crackles, wheezing and hypoventilation, indicating poor pulmonary ventilation and bronchial obstruction. The auscultation was assessed using the 3M ™ Littmann® Classic II Pediatric Stethoscope.
Time frame: It was evaluated through study completion, an average of 6 month .
It was measured by the finger Pulsioximetro, M-Pulse ™ pediatric.
Time frame: It was measured through study completion, an average of 6 month.
It was evaluated using the finger Pulse Oximeter, M-Pulse ™ pediatric
Time frame: It was measured through study completion, an average of 6 month.
The number of breathing cycles was valued with the help of a crono for 60 seconds in the rest of the participants, in a noise-free environment.
Time frame: It was measured through study completion, an average of 6 month .
It was measured in millimeters of secretions with a millimetric glass.
Time frame: 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.
Number of emergency visits due to respiratory complications. It was valued through a personal interview with the parents.
Time frame: The number of pediatric visits for respiratory complications that each participant had during the six months before and after of the study was recorded.
Number of visits to pediatrician due to respiratory complications. It was valued through a personal interview with the parents.
Time frame: It was measured through study completion, an average of 6 month.
The measurement of maximal inspiration, maximal expiration and the difference between both (thoracic expansion) in the sitting position was made using a tape measure marked in increments of 0.1 cm at the level of the fourth intercostal space.
Universidad Complutense de Madrid
Other
Chest Therapy and Postural Control in Children With Crhonic Neurological Patology
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