SAPA Study (Seated Posture Analysis System) : Reliability and Validity Evaluation of the BePoW Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,
研究概览
简要总结
The aim of this clinical investigation is to develop a reliable and valid device to instantly measure the subject's sitting posture in a wheelchair, without using the MCPAA scale.
详细描述
Each subject will be invited to a single experimental session lasting approximately one hour, during which all assessments will be performed.
During the visit, the patient will complete an autonomy questionnaire and assess wheelchair fatigue. A spirometry test will be performed.
The measurements will then be recorded by the BePoW software and the occupational therapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Over 18 years of age,
- •Having freely consented to participate in the study (or their legal representative in the case of guardianship, in agreement with the patient),
- •In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his/her free and informed consent for the person for whom he/she is responsible to participate in the study (in agreement with the patient).
- •Temporarily or permanently wheelchair-bound,
- •Affiliated with a social security scheme or beneficiary of such a scheme.
排除标准
- •Has comprehension problems that prevent him/her from giving free and informed consent and from completing the investigation (following instructions, answering questionnaires),
- •Suffering from a pathology (Huntington's disease, Sydenham's Chorea) preventing stable sitting posture during participation in the investigation,
- •Have undergone an amputation that prevents the BePoW device from taking measurements,
- •having undergone a tracheotomy preventing spirometry.
- •Pregnant, parturient or breast-feeding women,
- •Person deprived of liberty by a judicial decision (except guardianship or curatorship) or or administrative decision, a person under psychiatric care or admitted to a or social establishment for purposes other than research,
- •Person in an emergency situation unable to give prior consent.
研究组 & 干预措施
position measurement with BePoW device compared with MCPAA scale measurements
Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements
干预措施: Position measurement with BePow (Device)
position measurement with BePoW device compared with MCPAA scale measurements
Each patient will have position measurement with BePoW device and, at the same time, will have MCPAA scale measurements
干预措施: Position measurement with MCPAA scale (Other)
结局指标
主要结局
Validity assessment: correlation coefficient r between raw goniometric measurements and BePoW measurements,
时间窗: Immediately after inclusion
kappa coefficient between recoded measurements : BePow / MCPAA
Reliability assessment: intraclass correlation coefficient (ICC) between BePoW measurements
时间窗: Immediately after inclusion
12 data records for each measurement for intra ICC
次要结局
- Assess the validity of BePoW measurements in relation to fatigability.(Immediately after inclusion)
- Assess the validity of BePoW measurements in relation to autonomy.(Immediately after inclusion)
- Determining the minimum detectable change (MDC) on angular measurements taken by BePoW(Immediately after inclusion)
- Assessing the validity of BePoW measurements in relation to respiratory capacity(Immediately after inclusion)
- Determine the standard error measurement (SEM) on angular measurements taken by BePoW(Immediately after inclusion)