Robot-assisted Locomotor Training After Severe Stroke: Discrete Versus Rhythmic Movement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Functional Ambulation Scale (FAC)
研究概览
简要总结
The objective of this study is to compare the effects of novel versus standard locomotor training using a robotic gait orthosis (LT-RGO) after stroke. The hypothesis is that the novel LT-RGO protocol, by establishing a progressive decrease in gait velocity and guidance force, may facilitate greater motor recovery compared to the use of a standard protocol.
详细描述
Standard (rhythmic) robot-assisted locomotor training on a bodyweight-supported treadmill (LT-BWST) used progressively increased speed each week. Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. The novel approach of slowing down the treadmill reduced momentum. If speed had been increased (standard approach), momentum would have increased (momentum = mass * velocity); and the resulting, passive propulsion of momentum would have diminished the role of cortical skills needed to plan, initiate, and overtly control gait. In sum, the novel protocol used a slower-than-standard treadmill speed in order to provide a window of time sufficient for the corticomotor system to process information, learn, and adjust its response to internal and external feedback (eg, proprioceptive input; therapist input) during robot-assisted LT-BWST.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of stroke and image with hemiparesis left or right;
- •No more that one ischemic or hemorrhagic stroke episode;
- •06 months post-stroke;
- •Verified clinical stability on medical evaluation;
- •Spasticity level I or II in the Ashworth scale;
- •Score 1-2 in the Functional Ambulation Scale (FAC);
- •Signed informed consent.
排除标准
- •Dependence to perform activities of daily living before the stroke;
- •Lack of clinical indications for exercises (such as cardiopulmonary instability and uncontrolled diabetes);
- •Severe cognitive impairment;
- •Serious psychiatric change that needs psychiatric care;
- •Severe osteoporosis;
- •Severe spasticity of the lower limbs, deformities or fixed contractures that prevent the achievement of movements;
- •Lack of resistance or disabling fatigue;
- •Body weight greater than 150 kg;
- •Unstable angina or other untreated heart disease;
- •Chronic obstructive pulmonary disease;
- •Unconsolidated fractures, pressure sores;
- •Other neurological diseases.
结局指标
主要结局
Functional Ambulation Scale (FAC)
时间窗: Baseline and 6 weeks
The Functional Ambulation Scale (FAC) assesses an individual's independence during gait and follows a six-level scale: 0 - Patient can not walk or ask for help from two or more people; 1 - Patient requires continuous support from a person who assists with weight and balance; 2 - Patient needs continuous or intermittent support from a person to help with balance and coordination; 3 - Patient required for a person without physical contact; 4 - Patient can walk independently on the floor, but requires help on stairs and ramps; 5 - Patient can walk independently. This study compared the gait independence by the FAC between the two Arms, after intervention as compared to baseline.
次要结局
- Time Up and Go (TUG)(Baseline and 6 weeks)
- Ten-meters Walking Test (10MWT)(Baseline and 6 weeks)
- Six-minute Walking Test (6MWT)(Baseline and 6 weeks)
- Lower Limbs Fugl-Meyer(Baseline and 6 weeks)
- Berg Scale(Baseline and 6 weeks)
研究者
Thais Amanda Rodrigues
Physiotherapist
University of Sao Paulo