Evaluation of Positioning Protocols with an Adapted Equipment on a Wheelchair in Hemiplegic Patients Following a Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 14
- 主要终点
- Degree of pelvic posterior tilt
研究概览
简要总结
The main purpose of this study is to assess the interest of using wheelchair positioning equipment on the decrease of postural disorders, compared to the standard use of a wheelchair
详细描述
The stroke is the main cause of hemiplegia in developed countries. Fifteen percent of people who say they have a stroke need, at home, a wheelchair to get from one room to another. The use of a wheelchair can cause postural disorders which can lead to pain, orthopedic deformity and pressure ulcers.
This study aims to assess the interest of using wheelchair positioning equipment (Seat back, Positioning cushion and Belt) on the decrease of postural disorders.
This decrease will be assessed after a standardized course, performed under three different conditions: with the positioning equipment (Positioning cushion and Seat back), with the positioning equipment and the belt and with the wheelchair alone.
Clinical tool used to assess the decrease is the Seated Postural Control Measure for Adults 2.0 (SPCMA 2.0).
This study, which will be the first prospective, interventional, multicenter, controlled and randomized study, could pave the way for guidelines of good practice, for wheelchair positioning of hemiplegic patients in France
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 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
- •Hemiplegic patient following a stroke
- •Hospitalized in a follow-up and rehabilitative care service, after hospital stays in a MCO service (neurology, neurosurgery or reanimation)
- •With a planned exit from hospital (homecoming, residential care facilities, nursing home, Long Term Care Unit ...)
- •Patient whose wheelchair choice should be already done
- •Patient who propels the wheelchair with the valid hand and/or valid foot
- •Written informed consent (IC) obtained
- •Patients with affiliation to the social security system
排除标准
- •Good walk recovery (FAC scale >3)
- •Wheelchair with a double hand rim
- •Patient who cannot use his2 wheelchair independently
- •Cognitive disorders which prevent the ability to well understanding the instructions
- •Other pathology which can interfere with this protocol (Spinal disorder, morbid overweight (BMI>40...)
结局指标
主要结局
Degree of pelvic posterior tilt
时间窗: Immediately after the end of the procedure, an average of 1 day
The Primary Outcome Measure is the variation of the Degree of pelvic posterior tilt at the end of the three standardized course. These courses were performed with Standard Wheelchair, Standard Wheelchair + Seat back + Positioning cushion + Belt or with Standard Wheelchair + Seat back + Positioning cushion. The Degree of pelvic posterior tilt was measured using the SPCMA 2.0 score (0 = normal, 1 = mild, 2 = moderate and 3 = severe retroversion)
次要结局
- Variation of the degree of Pelvis obliquity(Baseline and immediately after the end of the procedure, an average of 1 day)
- Degree of lateral inclination of the torso(Immediately after the end of the procedure, an average of 1 day)
- Degree of Pelvis obliquity(Immediately after the end of the procedure, an average of 1 day)
- Measure of patient's satisfaction(Immediately after the end of the procedure, an average of 1 day)
- Variation of Degree of pelvic posterior tilt(Baseline and immediately after the end of the procedure, an average of 1 day)
- Variation of degree of lateral inclination of the torso(Baseline and immediately after the end of the procedure, an average of 1 day)
- Adverse event collect(Immediately after the end of the procedure, an average of 1 day)
- Ability to achieve the whole course(Immediately after the end of the procedure, an average of 1 day)