Wheelchair Seating Users With Neuromuscular Diseases: Elaboration of a Pronostic Score of Changes on the Seating System of the Wheelchair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- Change in the seating system of the user's wheelchair
研究概览
简要总结
Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort).
详细描述
Progressive muscle weakness in neuromuscular diseases leads to motor disabilities leading to permanentfull-time wheelchair use. This is the case for infantile spinal muscular atrophy type II (SMA II), where people are dependent on a permanent sitting position from early childhood, at 2 years of age, or for Duchenne muscular dystrophy, when they lose their ability to walk around 10 years without corticosteroid therapy or around 13 years with treatment. These wheelchair users, weakened by the disease, are subject to musculotendinous retractions, osteo-articular stiffness, spinal deformities and pain. In addition, they use the wheelchair on a daily basis, on average 12 hours a day, whose permanent sitting position also conditions the performance of achieving life habits.
The analysis of the static and dynamic seated postural installation in the wheelchair makes it possible to avoid harmful consequences on the health and quality of life of users on a daily basis. When performed early enough, regularly and optimally, it also contributes to the prevention of complications.
In France, these assessments are carried out by occupational therapists, accompanied by doctors of Physical Medicine and Rehabilitation.
The weakness of the literature in this area and the absence of recommendations do not allow the user or any health professional to identify the need and the level of urgency to benefit from a dedicated consultation.
Faced with this observation, the development of a prognostic score for a change in positioning in the wheelchair, based on a prospective multicenter cohort and its validation on an external prospective cohort, will allow any healthcare professional to guide the user to a necessary positioning consultation. The hypothesis is that this score has discriminating qualities and that it is calibrated to predict a change in the seat of the RF and therefore the need to reassess the seated postural installation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over the age of 18
- •Daily wheelchair user (more than 4 hours per day)
- •Having a neuromuscular disease such as Duchenne Muscular Dystrophy or Infantile Spinal Muscular Atrophy type II
- •Accompanied by an identified medical equipment provider, able to respond to the recommendations of the clinical team
- •Patient informed and having signed consent.
排除标准
- •Person who already has a seat change or FR prescription at the time of inclusion
- •Having undergone surgery less than 1 year ago or a fracture
- •Pregnant or breastfeeding women
- •Patient under guardianship or curatorship.
结局指标
主要结局
Change in the seating system of the user's wheelchair
时间窗: through study completion, to 12 months
Any change in the seating system of the user's wheelchair within 12 months will be noted. A change in the seating system is defined by the occurrence of at least one of these situations: * one or more seat/back adjustments: depth, width, height * addition/removal of postural elements * replacement of the cushion, or backrest or headrest * Use of electric functions of the wheelchair or on-board standing * modification of control device of the WC.
次要结局
- adverse event(through study completion, an average of 12 month)
- Pressure ulcer topography (stage and location )(at baseline and 12 months)
- Pain Visual Analogue Scale(at baseline and 12 months)
- Comfort perception scale (Visual Analogue Scale)(at baseline and 12 months)
- Seated Postural Control Measure (SPCM)(at baseline and 12 months)
- Postural stability perception scale (in antero-posterior and lateral stability)(at baseline and 12 months)