Applicability of Robotic Devices, Virtual and Augmented Reality in the Rehabilitation of People With Stroke During Treadmill Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
- Objective assessment of clinical symptoms, mobility and quality of life changes resulting from stroke and determination of changes resulting from therapies.
- Assessment of the rehabilitation effectiveness of traditional high intensity training.
- Assessment of the rehabilitation effectiveness of gait training performed on a treadmill with a robot-assisted soft-exoskeleton.
- Assessment of the rehabilitation effectiveness of treadmill training supplemented with virtual and augmented reality.
- Determination of the joint application possibilities of robot-assisted and virtual and augmented reality treadmill training in order to further increase the effectiveness.
- Comparison of the effectiveness of different trainings.
- Mapping of changes in gait patterns due to therapies using 3D motion analysis.
- Mapping of changes in postural stability due to therapies using posturography.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •has had a first ischemic stroke diagnosed by a neurologist based on CT or MRI;
- •neurological examination shows mobility and postural limitations;
- •mRS score of 2 or higher;
排除标准
- •multiple strokes in the medical history;
- •systolic blood pressure less than 120 or greater than 160 mmHg;
- •orthostatic hypotension;
- •carotid artery stenosis;
- •severe heart disease;
- •hemophilia;
- •traumatic brain injury;
- •seizure disorder; untreated diabetes;
- •abnormal electroencephalography;
- •Mini Mental Test score < 22;
- •abnormal blood panel;
- •use of sedatives; irregular medication;
- •severe aphasia (Western Aphasia Battery ≤ 25);
- •severe vision or hearing impairment;
- •severe sensory dysfunction;
- •severe orthopedic problem;
- •other neurological condition affecting motor function;
- •alcoholism;
- •drug use;
- •smoking after stroke diagnosis;
- •inability to walk at least 100 m with or without assistive devices in 6 minutes;
- •BBS score ≤ 32;
- •BI score ≤ 70;
- •inability to understand verbal instructions or signals on a television screen;
- •current participation in an individual or group exercise program outside of standard physiotherapy;
研究组 & 干预措施
VR&AR-TT
Receiving treadmill training with C-Mill, a special treadmill that provides virtual and augmented reality.
干预措施: Treadmill Training with Virtual and Augmented Reality (Other)
C-TT
Receiving treadmill training with the combination of the ReStore and C-Mill system.
干预措施: Combined Treadmill Training (Other)
HIT
Receiving high intensity training
干预措施: High Intensity Training (Other)
R-TT
Receiving high intensity treadmill training with ReStore robotic device.
干预措施: Robot Assisted Treadmill Training (Other)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 3 weeks
The modified Rankin Scale (mRS) indicates the degree of independence in daily activities and the severity of disability. The method for assessing mRs is a guided interview. . The scoring is divided as follows: 0-No symptoms; 1-No significant disability. Able to carry out activities of daily living despite some symptoms; 2-Mild disability. Able to look after himself without assistance but not able to carry out all previous activities; 3-Moderate disability. Needs some assistance with activities of daily living but can walk without assistance; 4-Moderately severe disability. Unassisted, unable to meet his/her own physical needs, unable to walk without assistance; 5-Severe disability. Bedridden, incontinent, requires constant nursing care; 6-Dead
次要结局
- 36-Item Short Form Survey (SF-36)(3 weeks)
- Stroke Impact Scale-16 (SIS-16)(3 weeks)
- Berg Balance Scale (BBS)(3 weeks)
- Tinetti test(3 weeks)
- 6 minute walking test (6MWT)(3 weeks)
- 10 meter walking test(3 weeks)
- Posturographic examination(3 weeks)
- 3D gait analysis - Spatiotemporal parameters(3 weeks)
- 3D gait analysis - Spatial parameters(3 weeks)
- 10. 3D gait analysis - Temporal parameters(3 weeks)
- Barthel Index (BI)(3 weeks)
- Functional Independence Measure scale (FIM)(3 weeks)
研究者
Tollár József
Head of Department
Somogy Megyei Kaposi Mór Teaching Hospital