EMMVIES : Walking Training at Home in VIrtual Reality for Children With Chronic Illnesses Impacting Physical Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Home rehabilitation program
研究概览
简要总结
Over the past 30 years, the prevalence of congenital or acquired chronic diseases in children has risen, affecting between 10 and 30% of them, or at least 100,000 children in France. Pathologies such as cerebral palsy (CP), neuromuscular diseases (NMD), obesity or congenital heart disease impact physical health by causing musculoskeletal, respiratory or cardiovascular deficiencies. These limitations influence their ability to participate in daily activities, affecting their quality of life and that of their families.To minimize these impacts, motor rehabilitation programs focusing on physical activity are proposed, but their effectiveness requires prolonged practice. However, these specific programs, often delivered in remote specialized centers, are difficult to access. Home programs have been developed to overcome these constraints. They enable children, with the support of their parents, to carry out therapeutic activities at home. Although their feasibility has been demonstrated, their effectiveness is relative. A multitude of protocols and tools have been tested, with no harmonization of practices.To support the implementation of home-based programs for children with CP or obesity, virtual reality has already been used, mainly on the basis of commercial solutions. This solution is therefore feasible and has proved relatively effective.With this in mind, and based on the user experience of children, parents and professionals, the investigators have initially co-developed with the French company EzyGain a connected treadmill specifically adapted to pediatric needs and the requirements of home programs. The AMY treadmill is a compact treadmill with on-board sensors and a safety system, communicating with a tablet application and a virtual reality headset.Taking into account the opportunities offered by this new technology, as well as building on the effects and features already known from home programs, the investigators have developed a new modality for home programs focusing on walking for children with CP, MNM and obesity, the EMMVIES program. The crucial step now is to investigate the feasibility, tolerance and clinical effects of this EMMVIES program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 6 to 17 years at date of inclusion;
- •Able to walk for 5 minutes on a treadmill with or without body weight support, with or without technical aids;
- •Be able to understand and play virtual reality games (immersive or non-immersive);
- •Be able to answer questionnaires;
- •Patient affiliated to or benefiting from a social security scheme;
- •Informed consent, dated and signed by parents or guardians (if minors), to participate in the study;
- •Included in a care program specific to their chronic condition for at least 6 months;
- •Meet the following criteria depending on the group:
- •Diagnosis of CP
- •Functional level classified II or III according to the Gross Motor Function Classification System (GMFCS)
- •Rehabilitation goal: improvement of gait and/or gross motor function
- •Overweight or obese, defined by a BMI above the IOTF-25 percentile
- •Aim to increase daily physical activity
- •No history of hip pathology
- •Diagnosis of one of the following neuromuscular pathologies: spinal muscular atrophy type 3, Duchenne disease, congenital myopathy or Charcot Marie Tooth.
- •Functional level of grade 2 to 6 on the Walton scale, or grade 3 to 7 on the Vignos scale
- •Rehabilitation goal: improvement of walking and/or gross motor skills
排除标准
- •Patients weighing over 100 kg (due to the technical constraints of using the AMY mat).
- •For children aged 6 to 11: in connection with the immersive virtual reality device: problems with stereoscopic vision (perception of images in 3 dimensions), unstabilized epilepsy, facial trauma < 3 months, hearing or visual impairment, pain, dizziness or nausea caused by using immersive virtual reality.
- •Patients who have undergone surgery in the last 3 months;
- •Patients who have received intramuscular botulinum toxin injections in the lower limbs or intensive therapy in the 3 months prior to inclusion;
- •Patient with a non-routine therapeutic program planned within 5 months that could lead to confusion with the tested program;
- •Patient with insufficient understanding of the French language;
- •Patient opposition (child or adolescent);
- •Persons deprived of liberty by judicial or administrative decision;
- •Persons under compulsory psychiatric care;
- •Persons under legal protection;
结局指标
主要结局
Home rehabilitation program
时间窗: 3 x 30-minute sessions over 10 weeks
The treadmill walking training program comprises a minimum of 3 sessions per week, with one day of rest between each session. Each session comprises around 30 minutes of physical exercise on a mat, alternating between walking and balance exercises.
次要结局
- Assessment of lower limb muscle strength(Inclusion, 10 weeks and 20 weeks)
- 10-meter walk test(Inclusion, 10 weeks and 20 weeks)
- 6-minute walk test(Inclusion, 10 weeks and 20 weeks)
- Motion control assessment(Inclusion, 10 weeks and 20 weeks)
- Balance assessment(Inclusion, 10 weeks and 20 weeks)
- Assessment of gross motor functions for children with CP(Inclusion, 10 weeks and 20 weeks)
- Assessment of gross motor functions for children with MNM(Inclusion, 10 weeks and 20 weeks)
- Quality of life assessment(Inclusion, 10 weeks and 20 weeks)
- Assessment of daily activities and mobility(Inclusion, 10 weeks and 20 weeks)
- Actimetry(Inclusion, 10 weeks and 20 weeks)
- User experience - User Experience Questionnaire(once at 20 weeks)
- User experience - Usability Metric for User Experience(once at 20 weeks)
- User experience - Mobile Applications Rating Scale version utilisateur(once at 20 weeks)