Clinical trial NCT03879304: Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Official title: Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophy, Duchenne and Becker Types
Keywords: Virtual Reality [L01.224.160.875], [L01.296.555]
Physical Therapy Modalities [E02.779], [E02.831.535]
Respiratory Therapy [E02.880]
Dystrophin [D12.776.210.500.250]
Becker Muscular Dystrophy [C10.668.491.175.500.300]
Resistance training [E02.831.535.483.875]
Muscular Stretching Therapy [E02.831.535.483.750]
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Changes in six meter walking test (6-MWT) score
timeFrame: Baseline, up to six weeks
Secondary outcomes:
measure: EPInfant
timeFrame: through study completion, average 6 weeks
measure: NSAA o North Star Ambulatory Assessment
timeFrame: Baseline, up to 6 weeks
measure: MFM o Motor Function Measure
timeFrame: Baseline, up to 6 weeks
measure: Kids Screen-52
timeFrame: Baseline.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Universidad de Málaga
Study officials:
affiliation: Universidad de Málaga
name: Rocío Martín Valero, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Málaga
name: Maria Teresa Labajos Manzanares, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.