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

Muscular Dystrophy, Duchenne and Becker Types Clinical Trial

— RVDuchenne  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879304
• Other study ID #: UMalagaRV
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: March 11, 2023

Study information

• Verified date: May 2024
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 11, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Duchenne
• Muscular Dystrophy, Duchenne and Becker Types

Intervention

Other:
• multimodal physiotherapy program with RV
Physiotherapy Programm includes: respiratory physiotherapy, stretching, resistance training, aerobic training and adaptation and training with virtual reality glasses and relaxation.
• traditional physiotherapy program
Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage.

Locations

Country	Name	City	State
Spain	Universidad de Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Baeza-Barragan MR, Labajos Manzanares MT, Amaya-Alvarez MC, Morales Vega F, Rodriguez Ruiz J, Martin-Valero R. Effectiveness of a 5-Week Virtual Reality Telerehabilitation Program for Children With Duchenne and Becker Muscular Dystrophy: Prospective Quasi — View Citation

Baeza-Barragan MR, Labajos Manzanares MT, Ruiz Vergara C, Casuso-Holgado MJ, Martin-Valero R. The Use of Virtual Reality Technologies in the Treatment of Duchenne Muscular Dystrophy: Systematic Review. JMIR Mhealth Uhealth. 2020 Dec 8;8(12):e21576. doi: 10.2196/21576. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, up to six weeks
Secondary	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.	through study completion, average 6 weeks
Secondary	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.	Baseline, up to 6 weeks
Secondary	MFM o Motor Function Measure	measure motor performance	Baseline, up to 6 weeks
Secondary	Kids Screen-52	quality of life test	Baseline.