Cross-over Study of Three Modular Devices for Aid in Patient Standing and Transfer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
研究概览
简要总结
The main objective of this study is to evaluate via a physiological analysis of the movements involved in standing, the level of forward flexion of the spine (in cm on the horizontal axis) obtained with the apparatus "Tina" and to compare levels obtained in the same patients with stander/transfer devices "Turner" and "Vertic'Easy".
详细描述
Secondary objectives of this study are to compare the three devices in terms of:
- the level recovery of the spine on the vertical axis (vertical displacement C7, cm)
- standing time, defined by the time between the start of the forward flexion and the beginning of the vertical stabilization phase (seconds)
- the success rate of the verticalization of the patient (the attempt is considered successful when the vertical position is held for 10 seconds).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is in stable medical condition (no complications in the last 10 days)
- •The patient is unable to stand up by his/her self and requires help during transfers
- •The patient has muscular force (quadriceps) > 3 out of 5.
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a limited support from at least one lower limb
- •The patient has an unstable fracture
- •The patient has a fragile heart
- •The patient has joint pain localized in the knee, hip or ankle.
- •The patient has already used one of three mechanisms to help with standing and transfer used in this study
- •Behavioral problems (opposition, agitation)
研究组 & 干预措施
Tina-Turner-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
干预措施: Standing attempts with the "Vertic'Easy" Device (Device)
Tina-Turner-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
干预措施: Standing attempts with the "Turner" Device (Device)
Tina-Turner-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Turner; (3) Vertic'Easy.
干预措施: Standing attempts with the "Tina" device (Device)
Turner-Vertic'Easy-Tina
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
干预措施: Standing attempts with the "Vertic'Easy" Device (Device)
Turner-Vertic'Easy-Tina
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
干预措施: Standing attempts with the "Turner" Device (Device)
Turner-Vertic'Easy-Tina
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Vertic'Easy; (3) Tina.
干预措施: Standing attempts with the "Tina" device (Device)
Turner-Tina-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
干预措施: Standing attempts with the "Vertic'Easy" Device (Device)
Turner-Tina-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
干预措施: Standing attempts with the "Turner" Device (Device)
Turner-Tina-Vertic'Easy
Standing will be attempted with the three devices in the following order: (1) Turner; (2) Tina; (3) Vertic'Easy.
干预措施: Standing attempts with the "Tina" device (Device)
Vertic'Easy-Turner-Tina
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
干预措施: Standing attempts with the "Vertic'Easy" Device (Device)
Vertic'Easy-Turner-Tina
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
干预措施: Standing attempts with the "Turner" Device (Device)
Vertic'Easy-Turner-Tina
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Turner; (3) Tina.
干预措施: Standing attempts with the "Tina" device (Device)
Vertic'Easy-Tina-Turner
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
干预措施: Standing attempts with the "Vertic'Easy" Device (Device)
Vertic'Easy-Tina-Turner
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
干预措施: Standing attempts with the "Turner" Device (Device)
Vertic'Easy-Tina-Turner
Standing will be attempted with the three devices in the following order: (1) Vertic'Easy; (2) Tina; (3) Turner.
干预措施: Standing attempts with the "Tina" device (Device)
Tina-Vertic'Easy-Turner
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
干预措施: Standing attempts with the "Vertic'Easy" Device (Device)
Tina-Vertic'Easy-Turner
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
干预措施: Standing attempts with the "Turner" Device (Device)
Tina-Vertic'Easy-Turner
Standing will be attempted with the three devices in the following order: (1) Tina; (2) Vertic'Easy; (3) Turner.
干预措施: Standing attempts with the "Tina" device (Device)
结局指标
主要结局
Level of forward flexion of the spine (position of maximum horizontal displacement of C7)
时间窗: Baseline (Day 0; cross-sectional study)
cm
次要结局
- Angle of hip flexion (angle formed by the line connecting the acromion and the greater trochanter with the line connecting the greater trochanter and the lateral femoral condyle)(Baseline (Day 0; transversal study))
- Level of standing (maximum vertical displacement C7)(Baseline (Day 0; transversal study))
- Standing time (time from start of forward flexion and the beginning of the vertical stabilization phase)(Baseline (Day 0; transversal study))
- Verticalization achieved (yes/no)(Baseline (Day 0; transversal study))