Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Gain in Berg Balance Scale score
研究概览
简要总结
The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed. Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . This project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The aim of the study is to study the effectiveness of the prototype (interactive walking mobile robot).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, aged at least 18 years and at most 80 years old
- •Size at least equal to 150 cm and less than or equal to 190 cm (robot design)
- •Having signed free informed consent in writing,
- •Personal history of stroke with ischemic or hemorrhagic cause, right or left hemispherical, localized in addition or under tentorial
- •Single or multiple stroke.
- •Post stroke period: acute sub (2 weeks 6 months)
- •Left or right hemiparesis resulting from stroke
- •Gait or balance disorders related to the consequences of stroke
- •Minimum Berg Score: 3
- •Hospitalization in a CPR service in complete hospitalization, week or day
- •Medical stability, ie not presenting a cardiovascular, biological or other imbalance against the rehabilitation of walking
- •Patient affiliated to a social security scheme
排除标准
- •Patient with a pacemaker
- •Patient with a very open wound
- •Weight less than 40 kg
- •Weight greater than 105 kg (total maximum weight supported by the robot: 120 kg)
- •- FAC > 4 and lack of technical aids for walking (e.g., single cane, tripod cane, rollator).
- •Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty
- •Patients currently included in another research protocol with an influence on balance and walking
- •Refusal of the patient to participate in the study
- •Pregnant and lactating women,
- •with major cognitive or mood disorders, - Being unable to give their consent.
研究组 & 干预措施
Robot in combination with traditional reeducation
干预措施: An assessment of patient acceptance of robotic rehabilitation (Other)
Robot in combination with traditional reeducation
干预措施: Clinical evaluation (Other)
Robot in combination with traditional reeducation
干预措施: quality of life assessment (Other)
Robot in combination with traditional reeducation
干预措施: An evaluation of how to use the robot (Other)
Standard rehabilitation
干预措施: Clinical evaluation (Other)
Standard rehabilitation
干预措施: Intervention - without Robot (Other)
Standard rehabilitation
干预措施: quality of life assessment (Other)
Robot in combination with traditional reeducation
干预措施: Intervention - with Robot (Other)
Robot in combination with traditional reeducation
干预措施: cognitive assessment (Other)
Standard rehabilitation
干预措施: cognitive assessment (Other)
结局指标
主要结局
Gain in Berg Balance Scale score
时间窗: at 1 month
It consists of 14 items, with a maximum score of 56. Static and dynamic balance tasks of increasing difficulty are performed, with a score per item ranging from 0 to 4, depending on the ability to perform the task evaluated. This equilibrium scale was initially conceived as a quantitative measure of the balance and the risk of falling in non-institutionalized elderly people (Berg 1989). The psychometric qualities of this scale were then demonstrated in patients after stroke, including fidelity, validity and internal consistency (Berg 1992, Berg 1995, Mao 2002, Wang 2004, Hiengkaew 2012). Sensitivity to change was considered moderate to wide according to the studies (Wood-Dauphinee 1996, Mao 2002, Chou 2006). The Standard Error of Measurement (SEM) varies from 1.5 to 2.9 points depending on the studies (Liston and Brouwer 1996, Stevensen 2001, Flansbjer 2012, Hiengkaew 2012).
次要结局
- FAC(at 1 month and at 3 months)
- Evaluation of the robot's modalities of use - Breaks(At 1 month)
- Evaluation of the robot's modalities of use - Speed(At 1 month)
- SIS(at 1 month and at 3 months)
- TUG(at 1 month and at 3 months)
- Evaluation of cognitive functions(At 1 month)
- Evaluation of the robot's modalities of use - Distance(At 1 month)
- Evaluation of the robot's modalities of use - Duration(At 1 month)
- Evaluation of the robot's modalities of use - Suspension(At 1 month)
- Evaluation of the robot's modalities of use - duration breaks(At 1 month)
- Evaluation of cognitive functions - Bell barrage test(At 1 month)
- Evaluation of cognitive functions - Bergego(At 1 month)
- motor skills scores: Motricity Index(at 1 month and at 3 months)
- PASS(at 1 month and at 3 months)
- Walking Test(at 1 month and at 3 months)
- Berg Balance Scale score(at 3 months)
- Evaluation of the robot's modalities of use - Time(At 1 month)
- WADE(at 1 month and at 3 months)
- Evaluation of patient acceptance of robotic gait rehabilitation(At 3 months)
- Evaluation of cognitive functions - BREF(At 1 month)
- Evaluation of the robot's modalities of use - Lengh(At 1 month)
- Evaluation of cognitive functions- Memory Test(At 1 month)
- Evolution of spatial reference frames - SSA(At 1 month and at 3 months)
- Evolution of spatial reference frames - SSV(At 1 month and at 3 months)
- Evaluation of cognitive functions - TMT(At 1 month)
- Evaluation of cognitive functions - VAP-S(At 1 month)
- Evolution of spatial reference frames - LBA(At 1 month and at 3 months)