Chest Therapy and Postural Education in Children With Cerebral Palsy

Child Clinical Trial

Official title:

Chest Therapy and Postural Control in Children With Crhonic Neurological Patology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946137
• Other study ID #: Complutense University
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2019
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Nervous System Diseases
• Neurologic Disorder
• Respiratory Complication

Intervention

Other:
• Chest Therapy
The sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)
• Postural Hygiene
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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Sociedad Española de Neumología y Cirugía Torácica

References & Publications (15)

Al-Khaledi B, Lewis M, Maclean JE. Case 2: Recurrent lower respiratory tract infections in a child with Down syndrome. Paediatr Child Health. 2014 Jan;19(1):19-21. — View Citation

Barks L, Shaw P. Wheelchair positioning and breathing in children with cerebral palsy: study methods and lessons learned. Rehabil Nurs. 2011 Jul-Aug;36(4):146-52, 174. — View Citation

de Godoy VC, Zanetti NM, Johnston C. Manual hyperinflation in airway clearance in pediatric patients: a systematic review. Rev Bras Ter Intensiva. 2013 Jul-Sep;25(3):258-62. doi: 10.5935/0103-507X.20130043. Review. English, Portuguese. — View Citation

Fitzgerald DA, Follett J, Van Asperen PP. Assessing and managing lung disease and sleep disordered breathing in children with cerebral palsy. Paediatr Respir Rev. 2009 Mar;10(1):18-24. doi: 10.1016/j.prrv.2008.10.003. Epub 2009 Jan 23. Review. — View Citation

Flores JC, Carrillo D, Karzulovic L, Cerda J, Araya G, Matus MS, Llévenes G, Menchaca G, Vargas NA. [Children with special health care needs: prevalence in a pediatric hospital and associated risks]. Rev Med Chil. 2012 Apr;140(4):458-65. doi: 10.4067/S0034-98872012000400006. Spanish. — View Citation

Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6. — View Citation

Hill CM, Parker RC, Allen P, Paul A, Padoa KA. Sleep quality and respiratory function in children with severe cerebral palsy using night-time postural equipment: a pilot study. Acta Paediatr. 2009 Nov;98(11):1809-14. doi: 10.1111/j.1651-2227.2009.01441.x. — View Citation

Kwon YH, Lee HY. Differences of respiratory function in children with spastic diplegic and hemiplegic cerebral palsy, compared with normally developed children. J Pediatr Rehabil Med. 2013;6(2):113-7. doi: 10.3233/PRM-130246. — View Citation

Lagerkvist AL, Sten G, Westerberg B, Ericsson-Sagsjö A, Bjure J. Positive expiratory pressure (PEP) treatment in children with multiple severe disabilities. Acta Paediatr. 2005 May;94(5):538-42. — View Citation

Littleton SR, Heriza CB, Mullens PA, Moerchen VA, Bjornson K. Effects of positioning on respiratory measures in individuals with cerebral palsy and severe scoliosis. Pediatr Phys Ther. 2011 Summer;23(2):159-69. doi: 10.1097/PEP.0b013e318218e306. — View Citation

Marks JH. Pulmonary care of children and adolescents with developmental disabilities. Pediatr Clin North Am. 2008 Dec;55(6):1299-314, viii. doi: 10.1016/j.pcl.2008.08.006. — View Citation

McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):250S-259S. doi: 10.1378/chest.129.1_suppl.250S. Review. — View Citation

Ortiz Tde A, Forti G, Volpe MS, Carvalho CR, Amato MB, Tucci MR. Experimental study on the efficiency and safety of the manual hyperinflation maneuver as a secretion clearance technique. J Bras Pneumol. 2013 Mar-Apr;39(2):205-13. doi: 10.1590/S1806-371320 — View Citation

Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1. Review. — View Citation

Tenenbaum A, Hanna RN, Averbuch D, Wexler ID, Chavkin M, Merrick J. Hospitalization of children with down syndrome. Front Public Health. 2014 Mar 20;2:22. doi: 10.3389/fpubh.2014.00022. eCollection 2014. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Thoracic mobility	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.	It was measured through study completion, an average of 6 month.
Primary	Change from Quality of Life Related to Health (HRQoL) at 6 month	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.	The PedsQL questionnaires were completed at the beginning of the study, at 6 months after the start of the study.
Primary	Change from number of hospitalizations	Number of admissions due to respiratory complications. It was valued through a personal interview with the parents.	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	Pulmonary auscultation	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.	It was assessed through study completion, an average of 6 month .
Secondary	Pulsoximetry	It was measured by the finger Pulsioximetro, M-Pulse ™ pediatric.	It was evaluated through study completion, an average of 6 month .
Secondary	Heart rate	It was evaluated using the finger Pulse Oximeter, M-Pulse ™ pediatric	It was measured through study completion, an average of 6 month.
Secondary	Respiratory Rate	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.	It was measured through study completion, an average of 6 month.
Secondary	Sputum	It was measured in millimeters of secretions with a millimetric glass.	It was measured through study completion, an average of 6 month .
Secondary	Number of emergency visits	Number of emergency visits due to respiratory complications. It was valued through a personal interview with the parents.	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.
Secondary	Number of visits to pediatrician	Number of visits to pediatrician due to respiratory complications. It was valued through a personal interview with the parents.	The number of pediatric visits for respiratory complications that each participant had during the six months before and after of the study was recorded.

External Links

•   Al-Khaledi B, Lewis M, Maclean JE. Case 2: Recurrent lower respiratory tract infections in a child with Down syndrome. Paediatr Child Health. 2014 Jan;19(1):19-21.
•   Fitzgerald DA, Follett J, Van Asperen PP. Assessing and managing lung disease and sleep disordered breathing in children with cerebral palsy. Paediatr Respir Rev. 2009
•   McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):250S-259S. doi: 10.1378/chest.129.1_suppl.250S. Review.
•   Ortiz Tde A, Forti G, Volpe MS, Carvalho CR, Amato MB, Tucci MR. Experimental study on the efficiency and safety of the manual hyperinflation maneuver as a secretion clearance technique. J Bras Pneumol. 2013.
•   Tenenbaum A, Hanna RN, Averbuch D, Wexler ID, Chavkin M, Merrick J. Hospitalization of children with down syndrome. Front Public Health. 2014 Mar 20;2:22. doi: 10.3389/fpubh.2014.00022. eCollection 2014.