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

Sponsor

University of Malaga (Other)

Overall Status

Recruiting

CT.gov ID

NCT03879304

Collaborator

(none)

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Apr 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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.

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

Primary Outcome Measures

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

Forced vital capacity or (FVC) [baseline, up to 5 weeks]
Represents the maximum volume of air that is exhaled, with a maximum effort, after a maximum inspiration.
FEV1 [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) [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) [baseline, up to 5 weeks]
Maximum inspired amount of air quickly after maximum expiration.
Inspiratory Capacity or (CI) [baseline, up to 5 weeks]
Which is the maximum inspired air after a current expiration.
Maximal inspiratory pressures (MIP) and maximal expiratory pressures (MEP) [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) [Baseline, up to 5 weeks]
Change in index of the strength of the diaphragm
Heart rate [Baseline, 10 minutes from the start of Multimodal Physiotherapy program.]
numbers of beats per minute
EPInfant [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 [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 [Baseline, 10 minutes from the start of Multimodal Physiotherapy program.]
measures the amount of oxygen in the blood.