"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Percentage of patients per group for whom a pressure ulcer occurred.
研究概览
简要总结
The investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) This study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. The main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. A qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury
- •Motor level < C6
- •Complete or incomplete injury (AIS A, B and C impairment scale)
- •Primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility
- •At least 18 years of age
- •At any time after the occurrence of the spinal cord injury
- •Patients discharged from the center, with a first post-injury rehabilitation completed
- •Having participated in a specific therapeutic patient education on pressure ulcer prevention
- •No pelvic pressure sores under medical or surgical treatment at the time of inclusion
- •No aorto-iliac arterial disease that may promote pelvic ischemia (arterial Doppler <6 months)
- •Patient using a cushion approved by the HAS
- •Patients with a smartphone
排除标准
- •Congenital spinal cord injury
- •Motor level of the lesion > or = C6
- •Incomplete motor lesion (AIS D and E)
- •Patients who walk as their primary mode of ambulation
- •Use of an electric wheelchair
研究组 & 干预措施
Experimental Group (GASPARD®)
Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment
干预措施: GASPARD® (Device)
Control group:
Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care
结局指标
主要结局
Percentage of patients per group for whom a pressure ulcer occurred.
时间窗: 1 year
次要结局
- Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)(1 year)
- Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)(1 year)
- Cross-analysis and thematic analysis of the comments made during the focus groups, particularly with regard to the perception of one's ability to take charge of one's health and the connected dimension of the device.(1 year)
- Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)(1 year)
- Number of pressure sores per patient(1 year)
- Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.(1 year)