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Trial record 7 of 5221 for:    neuromuscular disease

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
Sponsor:
Information provided by (Responsible Party):
JJ JIMENEZ-REJANO, University of Seville

Brief Summary:
The main objective of this study is to determine whether the Respiratory Physiotherapy allows improvement or maintenance of respiratory function in children with Neuromuscular Diseases, against respiratory deterioration that occurs in the group of subjects who did not receive this treatment. And to determine whether decreasing the number of respiratory infections and secondly the need for antibiotics and the number of emergency room visits and hospital admissions related to these.

Condition or disease Intervention/treatment Phase
Neuromuscular Diseases Other: RESPIRATORY PHYSIOTHERAPY Other: USUAL THERAPIES Not Applicable

Detailed Description:

Background:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:

  • supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times
  • lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side
  • sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing
  • diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mouth slightly open. 3 replications
  • in a sitting position, with help of an ambu bag, we made inflations. Repeated 3 times
  • exercises of upper member coupled to respiratory rhythm: shoulder flexion and extension was carried out during the inspiratory phase and the extension and adduction of them during expiration. 3 times

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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being diagnosed with a Disease of the Neuromuscular junction, according to International Classification of Diseases 10.
  • Be aged between 3 and 18 years.

Exclusion Criteria:

  • Being unable to perform spirometry, for physical or psychological difficulties.
  • Be involved in another program Respiratory Physiotherapy.
  • Present some kind of associated pathology (such as broken ribs, state epilepticus ...) in which it is contraindicated any maneuvers of the respiratory therapy protocol designed.
  • If researchers are informed of the existence of a serious illness of the father / mother / tutor that preclude to carrying out the program of respiratory Physiotherapy at home.

Information from the National Library of Medicine

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


Locations
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Spain
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Sevilla, Spain, 41009
Sponsors and Collaborators
University of Seville

Publications:
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Responsible Party: JJ JIMENEZ-REJANO, PhD, University of Seville
ClinicalTrials.gov Identifier: NCT02743702     History of Changes
Other Study ID Numbers: USeville-JJIMENEZ-REJANO
First Posted: April 19, 2016    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016
Last Verified: May 2016
Keywords provided by JJ JIMENEZ-REJANO, University of Seville:
Effectiveness
Physical therapy modalities
neuromuscular diseases
Additional relevant MeSH terms:
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Neuromuscular Diseases
Nervous System Diseases