Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change from baseline in laryngeal movement during swallowing
研究概览
简要总结
When the seat is a vehicle for disabled person, postural adaptation methodology is known and, on prescription, there is possibility of financial support for technical posture assists. For people who use a standard seat, a chair for example, there is no satisfactory existing hardware.
A transportable customisable and scalable sitting positioning device (DATP device), to be placed on a standard seat, is a solution that might fit in the home, in specialized foster homes or in institutions for the elderly. Such a device has been developed but earnings on swallowing disorders have to be validated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- •Postural disorder requiring the use of only one type of installation (wheelchair or hull)
- •Spinal stiffness or non-reducible hips (spondylitis, osteosynthesis rod)
- •Not included anthropometric dimensions between:
- •Basin with between 39 and 50 cm
- •femoral length between 42 and 52 cm
- •tibial length between 39 and 44 cm (46.5 with femoral recharge), measured with the shoes.
- •Pregnant or lactating women
研究组 & 干预措施
DATP -
No introduction of a device allowing a custom sitting to help patients with swallowing disorders .
DATP +
Introduction of a device allowing a custom sitting to help patients with swallowing disorders .
干预措施: DATP (Device)
结局指标
主要结局
Change from baseline in laryngeal movement during swallowing
时间窗: One month
Compare the laryngeal movement during swallowing in dysphagic population with DATP device compare to a population without device after one month of care. At Visit 1, patients were included and randomized 1 month later the patients in both groups will be invited for specific education session positioning. The introduction of the device will be carried out before the meeting for patients DATP + group, which will include a training session in the use of DATP. Patients who have the DATP will be contacted by telephone within the first 15 days to verify compliance with the use of the device. All patients returned 1 month for the last visit.
次要结局
- Adult sitting postural control measure (MCPAA)(One month)
- Functional oral intake scale (FOIS)(One month)
- NIH Swallowing Safety Scale(One month)
- Quality questionnaire of patient's life(One month)