Evaluation of the Impact of a Rehabilitation Intervention Based on Cycling With Virtual Park on Slowing the Functional Motor Decline of Neuromuscular Patients in Developmental Age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 7
研究概览
简要总结
The goal of this clinical trial is to assess the effects of a dual-task, multimodal training program on slowing functional motor decline in children and adolescents with neuromuscular disorders. The main questions it aims to answer are:
Does Virtual Park slow functional motor decline in children and adolescents with neuromuscular diseases compared with standard therapy?
Does Virtual Park contribute to increased engagement and improved neuropsychological function?
If there is a comparison group, Researchers will compare dual-task cycling supported by the Virtual Park application to standard therapy to see whether it improves motor and neuropsychological functions and engagement.
Participants will undergo two phases:
- Phase 1: 3 months of standard therapy;
- Phase 2: 3 months of experimental conditions in which patients undergo a rehabilitative intervention with Virtual Park, 3 times a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •availability of a definitive clinical or molecular genetic diagnosis of a neuromuscular disease;
- •age between 6 years and 17 years and 11 months (inclusive);
- •height compatible with the use of the Thera-Trainer (minimum 120 cm);
- •performance Upper Limb Module 2.0 assessment: Entry level >= 2
排除标准
- •other concomitant genetic diseases;
- •presence of visual impairments that prevent access to the experimental virtual reality protocol;
- •concomitant compromised cardio-respiratory function that contraindicates cycle ergometer training;
- •severe osteoporosis.
研究组 & 干预措施
Two-phase arm
- Phase 1: 3 months of standard therapy;
- Phase 2: 3 months of experimental conditions in which patients undergo a rehabilitative intervention with Virtual Park, 3 times a week for 20 minutes (plus 5-10 minutes of warm-up and 5-10 minutes of cool down).
干预措施: Standard therapy (Other)
Two-phase arm
- Phase 1: 3 months of standard therapy;
- Phase 2: 3 months of experimental conditions in which patients undergo a rehabilitative intervention with Virtual Park, 3 times a week for 20 minutes (plus 5-10 minutes of warm-up and 5-10 minutes of cool down).
干预措施: Dual-task cycling (Device)