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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 : Recruiting
First Posted : March 18, 2019
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Rosa Baeza Barragán, University of Malaga

Study Description
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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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophy, Duchenne and Becker Types Other: multimodal physiotherapy program with RV Other: multimodal physiotherapy program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 11 participants
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
Official Title: Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Actual Study Start Date : April 15, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
Active Comparator: Multimodal physiotherapy program
Traditional intervention group receives assistance of a multimodal program of physiotherapy without virtual reality glasses.
 Other: multimodal physiotherapy program
Multimodal physiotherapy Programm includes: respiratory physiotherapy, stretching, massage, aerobic training and resistance training.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Maximum inspiratory flow or (PIF) [ Time Frame: baseline, up to 5 weeks ]
    Maximum inspired amount of air quickly after maximum expiration.

  5. Inspiratory Capacity or (CI) [ Time Frame: baseline, up to 5 weeks ]
    Which is the maximum inspired air after a current expiration.

  6. 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)

  7. Sniff Nasal Inspiratory Pressure (SNIP) [ Time Frame: Baseline, up to 5 weeks ]
    Change in index of the strength of the diaphragm

  8. Heart rate [ Time Frame: Baseline, 10 minutes from the start of Multimodal Physiotherapy program. ]
    numbers of beats per minute

  9. 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.

  10. 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.


  11. Oxygen saturation [ Time Frame: Baseline, 10 minutes from the start of Multimodal Physiotherapy program. ]
    measures the amount of oxygen in the blood.


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%.
Contacts and Locations
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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): NCT03879304


Contacts
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Contact: Rosa Baeza 636400094 ext +34 m.rosabaeza@gmail.com

Locations
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Spain
Universidad de Málaga Recruiting
Málaga, Spain, 29071
Contact: Rosa Baeza Barragán    636400094 ext +34    m.rosabaeza@gmail.com   
Sponsors and Collaborators
University of Malaga
Investigators
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Study Director: Rocío Martín Valero, PhD Universidad de Málaga
Study Director: Maria Teresa Labajos Manzanares, PhD Universidad de Málaga
More Information
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Responsible Party: Rosa Baeza Barragán, Principal Investigator, University of Malaga
ClinicalTrials.gov Identifier: NCT03879304    
Other Study ID Numbers: UMalagaRV
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: an average of 2 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosa Baeza Barragán, University of Malaga:
Virtual Reality [L01.224.160.875], [L01.296.555]
Physical Therapy Modalities [E02.779], [E02.831.535]
Respiratory Therapy [E02.880]
Dystrophin [D12.776.210.500.250]
 Becker Muscular Dystrophy [C10.668.491.175.500.300]
Resistance training [E02.831.535.483.875]
Muscular Stretching Therapy [E02.831.535.483.750]
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked