Chest Therapy and Postural Education in Children With Cerebral Palsy
NCT ID: NCT03946137
Last Updated: 2019-05-10
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2013-09-30
2015-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sample
30 patients of both sexes aged between 0 and 6 years with chronic neurological involvement with respiratory complications.
Individual sessions of chest therapy every fifteen days for three months, in total 6 respiratory physiotherapy sessions of 30 minutes each were performed. And the postural hygiene workshops were given to the parents, this educational intervention was carried out at the beginning of the study, at 3 months and at 6 months from the beginning. Each intervention lasted 4 hours with theoretical and practical part.
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
ALL
No
Sponsors
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Sociedad Española de Neumología y Cirugía Torácica
OTHER
Universidad Complutense de Madrid
OTHER
Responsible Party
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Moreno Bermejo
Physiotherapist
Principal Investigators
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Inmaculada M Moreno, Doctora
Role: PRINCIPAL_INVESTIGATOR
Sociedad Española de Cirugía y neumología Torácica
References
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Flores JC, Carrillo D, Karzulovic L, Cerda J, Araya G, Matus MS, Llevenes 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.
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.
Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1.
Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
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.
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. Epub 2009 Jul 22.
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.
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. doi: 10.1093/pch/19.1.19a. No abstract available.
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.
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.
Lagerkvist AL, Sten G, Westerberg B, Ericsson-Sagsjo A, Bjure J. Positive expiratory pressure (PEP) treatment in children with multiple severe disabilities. Acta Paediatr. 2005 May;94(5):538-42. doi: 10.1111/j.1651-2227.2005.tb01935.x.
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/S1806-37132013000200012.
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.
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. doi: 10.1002/j.2048-7940.2011.tb00082.x.
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.
Related Links
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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.
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.
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.
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
Other Identifiers
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Complutense University
Identifier Type: -
Identifier Source: org_study_id
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