Efficacy of End-Effector Robot-Assisted Gait Training in Subacute Stroke Patients: Clinical and Gait Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Change in Six-Minute Walking Test (6MWT)
研究概览
简要总结
To date, no studies seems to compare conventional gait rehabilitation program with end-effector RAGT in subacute stroke patients by analysing the variations of gait kinematics beyond clinical multi prospective outcomes.
The aim of this pilot study is to evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program.
详细描述
To evaluate the efficacy of end-effector RAGT in subacute stroke patients in terms of clinical outcomes and gait kinematics, comparing them with conventional gait rehabilitation program, patients following first ever stroke in sub-acute phase will be recruited and assessed both clinically and instrumentally (Gait Analysis) at baseline (T0) and at the end of training program (T1). The patients will be divided into 2 groups and will conduct two different types of gait training: one group will be recruited by IRCCS San Raffaele Pisana of Rome and will perform, in addition to conventional therapy, gait training using an end-effector robotic device for RAGT(Robotic Group, RG); and another group will be recruited by the Don Carlo Gnocchi Foundation Onlus of Rome, and will perform conventional gait rehabilitation program(Conventional Group, CG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All the clinical assessments are routinely administered by both participating centers, and the outcome assessors are blinded to the study protocols.
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
- •first cerebral stroke
- •2 weeks up to 6 months post the acute event (subacute patients)
- •age between 18-80 years
- •ability to fit into the end-effector footplates
- •no significant limitation of joint range of motion
- •ability to tolerate upright standing for 60 seconds
- •ability to walk unassisted or with little assistance
- •ability to give written consent
- •compliance with the study procedures
排除标准
- •contractures of the hip, knee, or ankle joints that might limit the range of motion during gait
- •medical issue that precludes full weight bearing and ambulation (e.g. orthopaedic injuries, pain, severe osteoporosis, or severe spasticity)
- •cognitive and/or communicative disability (e.g. due to brain injury): inability to understand the instructions required for the study
- •cardiac pathologies, anxiety or psychosis that might interfere with the use of the equipment or testing
- •Written informed consent was obtained from each subject.
结局指标
主要结局
Change in Six-Minute Walking Test (6MWT)
时间窗: Session 1 (baseline), and Session 20 (week 7)
The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.
次要结局
- Change in 10 Meter Walk Test (10MWT)(Session 1 (baseline), and Session 20 (week 7))
- Change in Fugl-Meyer Assessment (FMA) scale(Session 1 (baseline), and Session 20 (week 7))
- Change in Modified Ashworth Scale (MAS)(Session 1 (baseline), and Session 20 (week 7))
- Change in Tinetti Scale Balance (TIN-B)(Session 1 (baseline), and Session 20 (week 7))
- Change in Motricity Index (MI)(Session 1 (baseline), and Session 20 (week 7))
- Change in Tinetti Walking (TIN-W)(Session 1 (baseline), and Session 20 (week 7))
- Change in Time Up And Go (TUG)(Session 1 (baseline), and Session 20 (week 7))
- Change in Functional Ambulation Classification (FAC)(Session 1 (baseline), and Session 20 (week 7))
- Change in Trunk Control Test (TCT)(Session 1 (baseline), and Session 20 (week 7))
- Change in Walking Handicap Scale (WHS)(Session 1 (baseline), and Session 20 (week 7))