Characterization of the Postural Habits of Wheelchair Users in an Ecological Situation and Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor Integrating an Artificial Intelligence Algorithm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Evaluate the impact of a device, monitoring the wheelchair user's risk of pressure sores and issuing alerts based on international recommendations, on the support reliefs provided by the subject in an ecological situation
研究概览
简要总结
Spinal cord injuries and people with Duchenne Muscular Dystrophy or Infant Spinal Muscular Atrophy (ISA) are prone to pain and pressure sores associated with prolonged sitting. For this reason, it is recommended that people with spinal cord injuries release pressure every 15 to 30 minutes and motorized wheelchair users use the electric positioning functions at least 1 minute every hour.
The aim is to prevent and/or reduce pain and pressure sores. These devices could help to observe daily the variability of users' pressure maps, their impact on occupational performance, the link with pain and redness and could propose customized adjustments.
详细描述
The main objective of this study is to evaluate the impact of an algorithm that characterizes the cruro-ischiatic fingerprints used in daily life and that issues an alert in case of detection of a pressure sore risk defined by the literature on the occupational performance of the subjects.
The resulting assumption is based on the following points:
- The algorithms implemented in this device are able to calculate and isolate a number of cruro-ischiatic fingerprints used during the day during priority activities and active or passive position changes.
- They may, in the event of a risk position, issue alerts based on the recommendations.
This will allow us to analyze the impact of these alerts on the changes in position and relief actually performed by the subject, analyze the consequences on the MCRO score (psychosocial impact on occupational performance) and verify the impact of visual biofeedback on chair positioning.
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
- •Men or women over 18 years of age,
- •Daily user of a FR (more than 3 hours per day):
- •Persons with Duchenne Muscular Dystrophy (DMD) or DMB using an FRE,
- •People with Infant Spinal Muscular Atrophy (ISA) using an FRE,
- •WB persons using an MRA with sensitivity disorders (ASIA A).
- •FRE allowing a switchover of at least:
- •25° of the seat and 120° of the backrest,
- •45° of sitting in one block,
- •Patient who has signed an informed and written consent,
- •Affiliation to a social security scheme (beneficiary or beneficiary).
排除标准
- •Refusal of the patient to participate in the study,
- •School level lower than cycle 3 not allowing to understand the use of the embedded device,
- •Severe incontinence,
- •BM without sensitivity disorders,
- •Participant in another study or therapeutic trial,
- •Patient under guardianship or curatorship,
- •Pregnant women.
结局指标
主要结局
Evaluate the impact of a device, monitoring the wheelchair user's risk of pressure sores and issuing alerts based on international recommendations, on the support reliefs provided by the subject in an ecological situation
时间窗: 14 days
Primary outcome will be evaluated with the number of modification of relief or changing of position with or without alert. The metric used will be the number of average reliefs per hour performed by the patient. This number of reliefs will be compared with and without an alert system.
次要结局
- Feasibility study of integrating international recommendations to reduce the risk of pressure ulcers in a medical device(14 days)
- the impact of visual biofeedback of the pressure print on chair(14 days)
- the study of the acceptability by the patient of alerts in relation with international recommendations(14 days)
- the differences in occupational performance at the MCRO (Mesure canadienne du rendement occupationnel) score(14 days)