Chest Therapy and Postural Education in Children With Cerebral Palsy

NCT03946137 | Completed DMC

• 1 other identifier: Complutense University
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurologic Disorder; Respiratory Complication; Child

Keywords

Neurological chronic disorder; Child; Chest therapy; Educational intervention; Postural hygiene

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (7)

• Pulmonary auscultation

  It was assessed through study completion, an average of 6 month .

• Pulsoximetry

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

• Heart rate

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

• Respiratory Rate

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

• Sputum

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

Other Outcomes (1)

• Thoracic mobility

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

Study Arms (1)

Sample

EXPERIMENTAL

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.

Other: Chest Therapy; Other: Postural Hygiene

Interventions

Chest Therapy OTHER

The sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)

Also known as: Airways clearance techniques

Sample

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).

Also known as: Postural hygiene workshop

Sample

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Sociedad Española de Neumología y Cirugía Torácica: collaborator

Related Publications (15)

• 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.

  PMID: 22854691 BACKGROUND

• 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.

  PMID: 19041459 BACKGROUND

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

  PMID: 17894905 BACKGROUND

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

  PMID: 17894906 BACKGROUND

• 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.

  PMID: 24688981 RESULT

• 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.

  PMID: 19627261 RESULT

• 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.

  PMID: 21552079 RESULT

• 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.

  PMID: 24627649 RESULT

• 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.

  PMID: 23803344 RESULT

• 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.

  PMID: 16428718 RESULT

• 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.

  PMID: 16188740 RESULT

• 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.

  PMID: 23670506 RESULT

• 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.

  PMID: 24213091 RESULT

• 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.

  PMID: 21721395 RESULT

• 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.

  PMID: 19203740 RESULT

Related Links

• 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

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Inmaculada M Moreno, Doctora

  Sociedad Española de Cirugía y neumología Torácica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 10, 2019
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share