An interventional study of multimodal physiotherapy program with RV and traditional physiotherapy program in Muscular Dystrophy, Duchenne and Becker Types, sponsored by University of Malaga. Completed at 1 site in Spain. Open to participants aged 4 Years to 15 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by University of Malaga · Not applicable, Interventional, and Treatment
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.
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 or one per week, along six weeks. Also they are going to training walking with with virtual games.
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 in zoom session.
At the end of the multimodal physiotherapy program, variables will be evaluated by the principal examiner.
548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.
This study's enrollment of 12 is below the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.
Browse Muscular Dystrophies studies →University of Malaga is the lead sponsor of 118 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The RV intervention group receives a tele multimodal physiotherapy program with tradicional exercises of physiotherapy like stretching, aerobic, training through videos and gamification with VR glasses.
Other: multimodal physiotherapy program with RV
Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.
Other: traditional physiotherapy program
Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.
Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.
Changes in six meter walking test (6-MWT) score
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.
Time frame: Baseline, up to six weeks
EPInfant
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.
Time frame: through study completion, average 6 weeks
NSAA o North Star Ambulatory Assessment
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.
Time frame: Baseline, up to 6 weeks
MFM o Motor Function Measure
measure motor performance
Time frame: Baseline, up to 6 weeks
Kids Screen-52
quality of life test
Time frame: Baseline.
Plan to share: No — an average of 2 years
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Malaga