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enrolling by invitation

Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker

key information

study id #: NCT03879304

condition: Muscular Dystrophy, Duchenne and Becker Types

status: enrolling by invitation

purpose:

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.

intervention: multimodal physiotherapy program with RV, multimodal physiotherapy program

mechanism of action: No pharmaceutical intervention

results: https://clinicaltrials.gov/ct2/show/results/NCT03879304

last updated: April 18, 2019

study details

start date: April 2019

estimated completion: September 2019

phase of development: N/A

size / enrollment: 11

study 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.

primary outcomes:

  • 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 outcomes:

  • 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.

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%.

study contacts

sponsor: University of Malaga

investigators: Rocío Martín Valero, PhD; Maria Teresa Labajos Manzanares, PhD

locations: Spain