Skip to main content
OpenTrials
Completed

NCT Number: NCT03946137

Chest Therapy and Postural Education in Children With Cerebral Palsy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chest Therapy

Other

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

Other

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

Primary outcomes

  1. Change from Quality of Life Related to Health (HRQoL) at 6 month

    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.

  2. Change from number of hospitalizations

    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.

Secondary outcomes

  1. Pulmonary auscultation

    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.

  2. Pulsoximetry

    Time frame: It was evaluated through study completion, an average of 6 month .

    It was measured by the finger Pulsioximetro, M-Pulse ™ pediatric.

  3. Heart rate

    Time frame: It was measured through study completion, an average of 6 month.

    It was evaluated using the finger Pulse Oximeter, M-Pulse ™ pediatric

  4. Respiratory Rate

    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.

  5. Sputum

    Time frame: It was measured through study completion, an average of 6 month .

    It was measured in millimeters of secretions with a millimetric glass.

  6. Number of emergency visits

    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.

  7. Number of visits to pediatrician

    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.

Other outcomes

  1. Thoracic mobility

    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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Sociedad Española de Neumología y Cirugía Torácica

Registry information

Official study title

Chest Therapy and Postural Control in Children With Crhonic Neurological Patology

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
May 10, 2019
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.