Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal physiotherapy program with RV | Experimental | 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. |
|
| Traditional physiotherapy program | Active Comparator | Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| RocÃo MartÃn Valero, PhD | Universidad de Málaga | Study Director |
| Maria Teresa Labajos Manzanares, PhD | Universidad de Málaga | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Málaga | Málaga | 29071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33289679 | Background | 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. | |
| 37990809 | Result | 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-Experimental Study. JMIR Serious Games. 2023 Nov 15;11:e48022. doi: 10.2196/48022. |
Not provided
Not provided
an average of 2 years
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Twelve participants were randomized to follow a multimodal physiotherapy program for 6 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.
Not provided
Not provided
Not provided
| traditional physiotherapy program | Other | Multimodal physiotherapy Programm includes: traditional physiotherapy, stretching, massage. |
|
| 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 |
| MFM o Motor Function Measure | measure motor performance | Baseline, up to 6 weeks |
| Kids Screen-52 | quality of life test | Baseline. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |