search
Back to results

Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease

Primary Purpose

Neuromuscular Diseases

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
RESPIRATORY PHYSIOTHERAPY
USUAL THERAPIES
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases focused on measuring Effectiveness, Physical therapy modalities, neuromuscular diseases

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY

GROUP RECEIVING THEIR USUAL THERAPIES

Arm Description

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.

This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.

Outcomes

Primary Outcome Measures

Change From Baseline Vital Capacity at One Year.
Change from Baseline vital capacity at one year evaluated by spirometer.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2016
Last Updated
May 30, 2016
Sponsor
University of Seville
search

1. Study Identification

Unique Protocol Identification Number
NCT02743702
Brief Title
Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease
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 Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases
Keywords
Effectiveness, Physical therapy modalities, neuromuscular diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY
Arm Type
Experimental
Arm Description
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.
Arm Title
GROUP RECEIVING THEIR USUAL THERAPIES
Arm Type
Experimental
Arm Description
This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.
Intervention Type
Other
Intervention Name(s)
RESPIRATORY PHYSIOTHERAPY
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
USUAL THERAPIES
Primary Outcome Measure Information:
Title
Change From Baseline Vital Capacity at One Year.
Description
Change from Baseline vital capacity at one year evaluated by spirometer.
Time Frame
At baseline and at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
7550210
Citation
Ambrosino N, Vitacca M, Rampulla C. Standards for rehabilitative strategies in respiratory diseases. Monaldi Arch Chest Dis. 1995 Aug;50(4):293-318. No abstract available.
Results Reference
background
PubMed Identifier
21162485
Citation
Danov Z, Schroth MK. Respiratory management of pediatric patients with neuromuscular disease. Pediatr Ann. 2010 Dec;39(12):769-76. doi: 10.3928/00904481-20101116-07. No abstract available.
Results Reference
background
PubMed Identifier
9377912
Citation
Bach JR, Ishikawa Y, Kim H. Prevention of pulmonary morbidity for patients with Duchenne muscular dystrophy. Chest. 1997 Oct;112(4):1024-8. doi: 10.1378/chest.112.4.1024.
Results Reference
background
PubMed Identifier
12662009
Citation
Chatwin M, Ross E, Hart N, Nickol AH, Polkey MI, Simonds AK. Cough augmentation with mechanical insufflation/exsufflation in patients with neuromuscular weakness. Eur Respir J. 2003 Mar;21(3):502-8. doi: 10.1183/09031936.03.00048102.
Results Reference
background
PubMed Identifier
15668554
Citation
Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91. doi: 10.1097/01.phm.0000151941.97266.96.
Results Reference
background
PubMed Identifier
18317980
Citation
Watzek I, Winterholler M. [Basic principles of non-respiratory physiotherapy for neuromuscular diseases]. Pneumologie. 2008 Mar;62 Suppl 1:S28-30. doi: 10.1055/s-2007-1016426. German.
Results Reference
background

Learn more about this trial

Effectiveness of Respiratory Physiotherapy in Children With Neuromuscular Disease

We'll reach out to this number within 24 hrs