Neurologic DisorderNCT03946137
Chest Therapy and Postural Education in Children With Cerebral Palsy
A study testing Chest Therapy and Postural Hygiene in people with Neurologic Disorder and Respiratory Complication, run by Universidad Complutense de Madrid.
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… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Neurologic Disorder, Respiratory Complication, Child
- What is being tested?
- Chest Therapy and Postural Hygiene
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Chest Therapy and Postural Control in Children With Crhonic Neurological Patology
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.
Read the detailed 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.
- Conditions
- Neurologic Disorder, Respiratory Complication, Child
- Being tested
- Chest Therapy, Postural Hygiene
- Keywords
- Neurological chronic disorder, Child, Chest therapy, Educational intervention, Postural hygiene
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest TherapyOther
Also called Airways clearance techniques
The sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)
Postural HygieneOther
Also called Postural hygiene workshop
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chest Therapy; Other: Postural Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: It was assessed through study completion, an average of 6 month .
Pulsoximetry
It was measured by the finger Pulsioximetro, M-Pulse ™ pediatric.
Measured: It was evaluated through study completion, an average of 6 month .
Heart rate
It was evaluated using the finger Pulse Oximeter, M-Pulse ™ pediatric
Measured: It was measured through study completion, an average of 6 month.
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.
Measured: It was measured through study completion, an average of 6 month.
Sputum
It was measured in millimeters of secretions with a millimetric glass.
Measured: It was measured through study completion, an average of 6 month .
Number of emergency visits
Number of emergency visits due to respiratory complications. It was valued through a personal interview with the parents.
Measured: 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 visits to pediatrician
Number of visits to pediatrician due to respiratory complications. It was valued through a personal interview with the parents.
Measured: The number of pediatric visits for respiratory complications that each participant had during the six months before and after of the study was recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study startSep 2013
- Primary completionMar 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, Moreno Bermejo, Universidad Complutense de Madrid
- Investigators
- Inmaculada M Moreno, Doctora, Principal investigator, Sociedad Española de Cirugía y neumología Torácica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946137
- Sponsor's protocol ID
- Complutense University
- Status last verified
- May 2019
- First submitted
- 23 Apr 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22854691Marks 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.
PubMed 19041459Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1.
PubMed 17894905Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
PubMed 17894906Tenenbaum 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.
PubMed 24688981Hill 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.
PubMed 19627261Littleton 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.
PubMed 21552079Al-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.
PubMed 24627649Kwon 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.
PubMed 23803344McCool 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.
PubMed 16428718Lagerkvist 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.
PubMed 16188740Ortiz 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.
PubMed 23670506de 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.
PubMed 24213091Barks 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.
PubMed 21721395Fitzgerald 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.
PubMed 19203740
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Therapy and Postural Control in Children With Crhonic Neurological Patology
- ClinicalTrials.gov ID
- NCT03946137
- Acronym / sponsor ID
- Complutense University
- Conditions
- Neurologic Disorder, Respiratory Complication, Child
- Keywords
- Neurological chronic disorder, Child, Chest therapy, Educational intervention, Postural hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sample | Experimental | Other: Chest Therapy, Other: Postural Hygiene30 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. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest TherapyAlso: Airways clearance techniquesThe sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough) | Other | Sample |
| Postural HygieneAlso: Postural hygiene workshopPostural 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 | Sample |
Primary outcome
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.
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.
7 secondary outcomes
Pulmonary auscultation
Time frame: It was assessed through study completion, an average of 6 month .
Pulsoximetry
Time frame: It was evaluated through study completion, an average of 6 month .
Heart rate
Time frame: It was measured through study completion, an average of 6 month.
Respiratory Rate
Time frame: It was measured through study completion, an average of 6 month.
Sputum
Time frame: It was measured through study completion, an average of 6 month .
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Background: PubMed 22854691Flores 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.
- Background: PubMed 19041459Marks 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.
- Background: PubMed 17894905Schechter MS. Airway clearance applications in infants and children. Respir Care. 2007 Oct;52(10):1382-90; discussion 1390-1.
- Background: PubMed 17894906Hess DR. Airway clearance: physiology, pharmacology, techniques, and practice. Respir Care. 2007 Oct;52(10):1392-6.
- Results publication: PubMed 24688981Tenenbaum 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.
- Results publication: PubMed 19627261Hill 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.
- Results publication: PubMed 21552079Littleton 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.
- Results publication: PubMed 24627649Al-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.
- Results publication: PubMed 23803344Kwon 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.
- Results publication: PubMed 16428718McCool 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.
- Results publication: PubMed 16188740Lagerkvist 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.
- Results publication: PubMed 23670506Ortiz 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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Fitzgerald DA, Follett J, Van Asperen PP. Assessing and managing lung disease and sleep disordered breathing in children with cerebral palsy. Paediatr Respir Rev. 2009Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inmaculada M Moreno, Doctora principal investigator
Sociedad Española de Cirugía y neumología Torácica
Questions about this trial
What is this clinical trial studying?
A study testing Chest Therapy and Postural Hygiene in people with Neurologic Disorder and Respiratory Complication, run by Universidad Complutense de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03946137, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.