Effectiveness of a Multimodal Physiotherapy Program With Virtual Reality Glasses in Duchenne and Becker.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in six meter walking test (6-MWT) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •An other Dystrophies.
- •Older than 10 years.
- •Not Physiotherapy. Not walk.
- •Asociated heart disease Sprains, fractures. FC >120, Sat O2 <89%.
研究组 & 干预措施
Multimodal physiotherapy program with RV
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.
干预措施: multimodal physiotherapy program with RV (Other)
Traditional physiotherapy program
Traditional intervention group receives assistance of a program of physiotherapy traditional without virtual reality glasses.
干预措施: traditional physiotherapy program (Other)
结局指标
主要结局
Changes in six meter walking test (6-MWT) score
时间窗: 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.
次要结局
- EPInfant(through study completion, average 6 weeks)
- MFM o Motor Function Measure(Baseline, up to 6 weeks)
- Kids Screen-52(Baseline.)
- NSAA o North Star Ambulatory Assessment(Baseline, up to 6 weeks)
研究者
Rosa Baeza Barragán
Principal Investigator
University of Malaga