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OpenTrials
Completed

NCT Number: NCT03879304

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

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.

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Key information

Conditions

Muscular Dystrophy, Duchenne and Becker Types Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Málaga

Málaga, 29071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children between 4 and 15 years
  • Duchenne and Becker Diagnosis ICD-10 issued by specialist in neurology.
  • 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%.

Treatment and study plan

multimodal physiotherapy program with RV

Other

Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.

traditional physiotherapy program

Other

Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.

Primary outcomes

  1. Changes in six meter walking test (6-MWT) score

    Time frame: Baseline, up to six 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

  1. EPInfant

    Time frame: through study completion, average 6 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.

  2. NSAA o North Star Ambulatory Assessment

    Time frame: Baseline, up to 6 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.

  3. MFM o Motor Function Measure

    Time frame: Baseline, up to 6 weeks

    measure motor performance

  4. Kids Screen-52

    Time frame: Baseline.

    quality of life test

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Acronym: RVDuchenne

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Mar 18, 2019
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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