Effect of Robot Assisted Treatment on Gait Performace in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 28
- 试验地点
- 3
- 主要终点
- 6 minuts walking test.
研究概览
简要总结
Stroke are the main causes of motor disability among adults and are expected to impose an increasing social and economic burden for our Country. The impact of stroke on patients is enormous, with negative ramifications on the persons participation in social, vocational, and recreational activities. It is the primary cause of long-term disability in these countries. At the present stage, it is well known that control of balance during upright standing depends upon the central integration of afferent information from vestibular, somatosensory (proprioceptive, tactile), and visual systems, which constitute a multilink neural network for the control of neck, hip, and ankle joints. More recently, it has been studied at the level of cerebral cortex; vestibular inputs would reach face/neck representation of primary somatosensory cortex and would be then integrated with visual and somatosensory inputs in intraparietal, posterior end of the insula and medial superior temporal cortices. Remarkably, balance impairment and the associated risk of falling represent one of the most prominent and potentially disabling features in stroke subjects. The specific aims of this project are: to verify whether the robotics lower limb treatment with body weight support is more effective than the treadmill treatment in the reduction of motor impairment in Stroke patients, and to improve the quality of the gait and the endurance and to analyze possible improvements in terms of physiological biomechanical gait through analysis of spatio-temporal parameters.
详细描述
Objective: to assess the lower limb recovery after the gait rehabilitation training exercises in acute and chronic stroke patients.
The proposed project, through a Randomized controlled observer-blind trial aimed at evaluating the effectiveness of end-effector robot assisted therapy vs the treadmill and ground treatment in sub-acute and chronic stroke subjects. 90 inpatients and out-patients with a stroke will be recruited. We will randomize the patients on 3 groups [15 sub-acute (ischemic and hemorrhagic) stroke patients (after 30±7 days from injury) and 15 chronic (ischemic and hemorrhagic) patients (after 3/6 months days from injury) for all groups]:
- sub-acute and chronic stroke patients robot treatment.
- sub-acute and chronic patients treadmill treatment.
- sub-acute and chronic patients ground treatment.
The specific aims of this project are:
- to verify whether the robotics end-effector GEO lower limb treatment with body weight support is more effective than the treadmill treatment or ground treatment in the reduction of motor impairment in sub-acute and Chronic stroke patients, and to improve the quality of the gait and the endurance;
- to analyse possible improvements in terms of physiological biomechanical gait through analysis of kinematics , kinetics and EMG evaluation;
- to analyse possible improvements in terms of reduction of instable posture and movements, which can represent a reduction of the risk of fall typical of these subjects;
- to evaluate the kinematic, kinetic and EMG quantitative data during selected movements (gait, posture, ) compared with age matched reference data;
- to investigate the stability of the effects of robot-assisted treatment at 4/6 months follow-up in terms of Quality of Life (QoL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •between the ages of 18-95 years;
- •able to walk 25 feet unassisted or with assistance
- •truck control
- •first acute event of cerebrovascular stroke
- •unilateral paresis,
- •ability to understand and follow simple instructions
- •ability to walk without assistance prior to stroke
- •endurance sufficient to stand at least 20 minutes unassisted per patient report.
排除标准
- •unable to understand instructions required by the study (Informed Consent Test of Comprehension).
- •medical or neurological comorbidities that might contribute to significant gait dysfunction.
- •uncontrolled hypertension > 190/110 mmHg.
- •significant symptoms of orthostasis when standing up.
- •circulatory problems, history of vascular claudication or significant (+3) pitting edema.
- •lower extremity injuries or joint problems (hip or leg) that limit range of motion or function, or cause pain with movement
- •bilateral impairment,
- •severe sensory deficits in the paretic upper limb,
- •cognitive impairment or behavioral dysfunction that would influence the ability to comprehend or participate in the study.
- •Women who are pregnant and/or lactating.
结局指标
主要结局
6 minuts walking test.
时间窗: Change from Baseline in gait speed at 6 months follow up.
The 6 minuts walking test as primary outcome assessments will be collected at baseline (inclusion)(T0) and endpoint (after 15 robot sesion) (T1) (no later than 1 day \> last training session) at the follow-up examination after 3/6 months from the treatments conclusion (T2).
次要结局
- Fugl Meyer (lower limb section)(Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.)
- Gait Parameters with EMG(baseline, weekly during intervention, 6 months follow up)
- Borg scale(Change from Baseline in Borg scale at 6 months follow up.)
- Functional Ambulation Classification(Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.)
- Walk Handicap Scale (WHS)(Change from Baseline in Fugl Meyer scrores at 6 months follow up months follow up.)