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Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker. (RVDuchenne)

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ClinicalTrials.gov Identifier: NCT03879304
Recruitment Status : Enrolling by invitation
First Posted : March 18, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Rosa Baeza Barragán, University of Malaga

Tracking Information
First Submitted Date  ICMJE March 9, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date September 25, 2019
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Changes in six meter walking test (6-MWT) score [ Time Frame: Baseline, up to five weeks ]
Six-meter walking test is a a well-established outcome measure in a variety of diseases. It is accurate, reproducible, simple to administer, and well tolerated. The 6MWT is a robust assessment tool for use in clinical trials given its ability to quantitatively evaluate ambulation in a controlled environment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03879304 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Forced vital capacity or (FVC) [ Time Frame: baseline, up to 5 weeks ]
    Represents the maximum volume of air that is exhaled, with a maximum effort, after a maximum inspiration.
  • FEV1 [ Time Frame: baseline, up to 5 weeks ]
    FEV1: is the maximum volume of air that is released in the first second during the FVC.
  • Peak Expiratory Flow (PEF) [ Time Frame: baseline, up to 5 weeks ]
    Represents the maximum amount of air expired abruptly and gives maximum inspiration. Litres per minute.
  • Maximum inspiratory flow or (PIF) [ Time Frame: baseline, up to 5 weeks ]
    Maximum inspired amount of air quickly after maximum expiration.
  • Inspiratory Capacity or (CI) [ Time Frame: baseline, up to 5 weeks ]
    Which is the maximum inspired air after a current expiration.
  • Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) [ Time Frame: Baseline, up 5 weeks ]
    Change in respiratory muscle function strength with transducer measuring maximal inspiratory (MIP) and expiratory pressures (MEP)
  • Sniff Nasal Inspiratory Pressure (SNIP) [ Time Frame: Baseline, up to 5 weeks ]
    Change in index of the strength of the diaphragm
  • Heart rate [ Time Frame: Baseline, 10 minutes from the start of Multimodal Physiotherapy program. ]
    numbers of beats per minute
  • EPInfant [ Time Frame: baseline, up to 5 weeks ]
    Scale of perceived child effort measurement EPInfant. It shows 11 numerical descriptors (0 to 10), 5 verbal descriptors located every 2 levels of intensity, and a set of illustrations that represent a child running at increasing intensities along a scale of bars of incremental height following a exponential type slope from left to right. The higher value represent a worse outcome.
  • NSAA o North Star Ambulatory Assessment [ Time Frame: Baseline, up to 5 weeks ]
    Functional scale for children with DMD. It is expressed in points and evidences the acquisition of functions or the loss of them. Whilst DMD children may generally present with recognizable adaptations to activity due to the underlying progressive muscular weakness, they may modify their activity to achieve functional goals in slightly differing ways. Generally, activities are graded in the following manner: 2 - 'Normal' - no obvious modification of activity 1 - Modified method but achieves goal independent of physical assistance from another 0 - Unable to achieve independently. The better punctuation is 34 point, what mean the higher outcome.
  • Oxygen saturation [ Time Frame: Baseline, 10 minutes from the start of Multimodal Physiotherapy program. ]
    measures the amount of oxygen in the blood.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Changes in spirometral measures [ Time Frame: baseline, up to 5 weeks ]
    Respiratory function. It is done through spirometry. Spirometry tells us the data about the child's respiratory function. It will be done with the spirometer before and after training. The spirometer that will use will be Datospir 120, according to the method described by Black and Hyant in 1971.
  • Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) [ Time Frame: Baseline, up 5 weeks ]
    Change in respiratory muscle function strength with transducer measuring maximal inspiratory (MIP) and expiratory pressures (MEP)
  • Sniff Nasal Inspiratory Pressure (SNIP) [ Time Frame: Baseline, up to 5 weeks ]
    Change in index of the strength of the diaphragm
  • Heart rate [ Time Frame: Baseline, 10 minutes from the start of Multimodal Physiotherapy program. ]
    numbers of beats per minute
  • EPInfant [ Time Frame: baseline, up to 5 weeks ]
    Scale of perceived child effort measurement EPInfant. It shows 11 numerical descriptors (0 to 10), 5 verbal descriptors located every 2 levels of intensity, and a set of illustrations that represent a child running at increasing intensities along a scale of bars of incremental height following a exponential type slope from left to right.
  • NSAA o North Star Ambulatory Assessment [ Time Frame: baseline, up to 5 weeks ]
    Functional scale for children with DMD. It is expressed in points and evidences the acquisition of functions or the loss of them.
  • Oxygen saturation [ Time Frame: Baseline, 10 minutes from the start of Multimodal Physiotherapy program. ]
    measures the amount of oxygen in the blood.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Official Title  ICMJE Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Brief Summary Duchenne's Muscular Dystrophy and Becker Dystrophy, hereafter DMD and BMD, is a serious and progressive disease that affects 1 in 3,500-6,000 males born alive. Scale 6-minute walking test, is used for determine the inclusion of children with DMD in pharmacological studies. Furthemore, is used to verify a training effectiveness assessing muscular endurance and cardio-respiratory functions. This Research evaluates the feasibility and effectiveness of a multimodal physiotherapist program with virtual reality glasses.
Detailed Description

In addition a physiotherapy program, virtual reality have a lot of importance advantages for train while motivated the kids.

A cross over study will be applied. In the control time, patient will received a initial evaluation and a final without making the physiotherapy program and without virtual reality glasses. The data will be collected by principal examiner.

In the intervention time the group will received 10 multimodal physiotherapy sessions, two per week, along five weeks. Also they are going to training walking in a treadmill with virtual reality glasses.

Multimodal physiotherapist program describes the exercises to be performed, how long it will take, the number of repetitions and the way to do it with the physiotherapist.

At the end of the multimodal physiotherapy program, variables will be evaluated by the principal examiner.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Eleven participants were randomized to follow a multimodal physiotherapy program for 5 weeks. At the end of this period the participants will be crossed to another intervention without virtual reality glasses. The results will be measured before and after each intervention during the study.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Muscular Dystrophy, Duchenne and Becker Types
Intervention  ICMJE
  • Other: multimodal physiotherapy program with RV
    Physiotherapy Programm includes: respiratory physiotherapy, stretching, massage, resistance training, aerobic training and adaptation and training with virtual reality glasses.
  • Other: multimodal physiotherapy program
    Multimodal physiotherapy Programm includes: respiratory physiotherapy, stretching, massage, aerobic training and resistance training.
Study Arms  ICMJE
  • Experimental: Multimodal physiotherapy program with RV
    The RV intervention group receives a multimodal physiotherapy program with tradicional exercises of physiotherapy and also a training with virtual reality glasses to complete de 6-MWT also with the glasses on.
    Intervention: Other: multimodal physiotherapy program with RV
  • Active Comparator: Multimodal physiotherapy program
    Traditional intervention group receives assistance of a multimodal program of physiotherapy without virtual reality glasses.
    Intervention: Other: multimodal physiotherapy program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
11
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children between 4 and 10 years
  • Duchenne and Becker Diagnosis ICD-10 issued by specialist in neurology.
  • Associated in Duchenne Parent Project.
  • Children who can walk 10 m at last 120 seconds.
  • First punctuation of North Start Ambulatory assessment bigger than 20 points.

Exclusion Criteria:

  • An other Dystrophies.
  • Older than 10 years.
  • Not Physiotherapy. Not walk.
  • Asociated heart disease Sprains, fractures. FC >120, Sat O2 <89%.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03879304
Other Study ID Numbers  ICMJE UMalagaRV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: an average of 2 years
Responsible Party Rosa Baeza Barragán, University of Malaga
Study Sponsor  ICMJE University of Malaga
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rocío Martín Valero, PhD Universidad de Málaga
Study Director: Maria Teresa Labajos Manzanares, PhD Universidad de Málaga
PRS Account University of Malaga
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP