Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease
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|ClinicalTrials.gov Identifier: NCT02743702|
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Diseases||Other: RESPIRATORY PHYSIOTHERAPY Other: USUAL THERAPIES||Not Applicable|
Many authors have demonstrated the efficacy of Physiotherapy in Respiratory attending respiratory difficulties associated with different types of pathologies (Chronic Obstructive Pulmonary Disease, cystic fibrosis, tumors), however the investigators did not find studies with scientific evidence demonstrating the effectiveness of these programs in children with Neuromuscular Diseases (NMD), whose quality and life expectancy depends largely on the proper handling of Bronchial secretions and delay the deterioration of respiratory function.
The main objective of this study focuses on determining the effectiveness of physiotherapy for the treatment of respiratory breathing difficulties in children with NMD. Deducing other aspects such as the impact of this program on the number of visits to hospital emergencies department each year, hospital admissions and respiratory infections suffered by these children, and the need or not of antibiotics.
Material and method:
This research is an analytical, longitudinal, prospective, experimental, evaluator blinded study. It is controlled with two parallel groups, randomized clinical trial.
The sample consisted of children diagnosed with NMD. For the evolution of different variables spirometric test was used for variables related to the function respiratory, and a tracking sheet designed by the researchers to collect the number hospital emergency visits each year, as well as hospital admissions, respiratory infections and need of antibiotics. These assessments were made before and after the start of program and during every four months.
Patients were randomized to control or experimental group, no apply any Respiratory Physical Therapy treatment in subjects in the first group and performing a Respiratory Physical Therapy program in the second. This program was carried out once in week by the physiotherapist, and four times weekly at home, by family, during one year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effectiveness of a Protocol of Respiratory Physiotherapy for Improvement or Maintenance of Respiratory Function, and Incidence of Respiratory Infections in Children With Neuromuscular Diseases, Compared With no Approach by Respiratory Physiotherapy of Respiratory Difficulties: A Randomized Clinical Trial With Two Groups in Parallel With Blinded Evaluator.|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||December 2014|
Experimental: GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY
Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30 and 45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.
Other: RESPIRATORY PHYSIOTHERAPY
The protocol designed was composed of the following exercises:
Other: USUAL THERAPIES
Experimental: GROUP RECEIVING THEIR USUAL THERAPIES
This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.
Other: USUAL THERAPIES
- Change From Baseline Vital Capacity at One Year. [ Time Frame: At baseline and at 1 year ]Change from Baseline vital capacity at one year evaluated by spirometer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743702
|Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla|
|Sevilla, Spain, 41009|