| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurologic Disorder Respiratory Complication Child | Other: Chest Therapy Other: Postural Hygiene | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 30 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Chest Therapy and Postural Control in Children With Crhonic Neurological Patology |
| Study Start Date : | September 2013 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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. |
Other: Chest Therapy
The sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)
Other Name: Airways clearance techniques
Other: 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 Name: Postural hygiene workshop
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| Ages Eligible for Study: | up to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Principal Investigator: | Inmaculada M Moreno, Doctora | Sociedad Española de Cirugía y neumología Torácica |
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date ICMJE | April 23, 2019 | |||
| First Posted Date ICMJE | May 10, 2019 | |||
| Last Update Posted Date | May 10, 2019 | |||
| Study Start Date ICMJE | September 2013 | |||
| Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | |||
| Current Other Pre-specified Outcome Measures |
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.
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| Original Other Pre-specified Outcome Measures | Same as current | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Chest Therapy and Postural Education in Children With Cerebral Palsy | |||
| Official Title ICMJE | Chest Therapy and Postural Control in Children With Crhonic Neurological Patology | |||
| 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. | |||
| 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
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. |
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| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Not Applicable | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention 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)Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE | Experimental: 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. Interventions:
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE |
30 | |||
| Original Actual Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | May 2015 | |||
| Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | up to 6 Years (Child) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT03946137 | |||
| Other Study ID Numbers ICMJE | Complutense University | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Moreno Bermejo, Universidad Complutense de Madrid | |||
| Study Sponsor ICMJE | Universidad Complutense de Madrid | |||
| Collaborators ICMJE | Sociedad Española de Neumología y Cirugía Torácica | |||
| Investigators ICMJE |
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| PRS Account | Universidad Complutense de Madrid | |||
| Verification Date | May 2019 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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