Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients

A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training

A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Experimental group receives robot-assisted-gait-training and conventional gait training.

Active comparator group receives conventional gait training only as the same number as the experimental group.

Inclusion Criteria:

• Age more than 19 and under 80
• Weight under 100kg
• Height less than 200cm
• Able to walk independently before onset of stroke
• Ischemic or hemorrhagic stroke patients
• Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
• FAC(Functional Ambulation Category) under 3 (0~2)
• Subacute stroke patients after 3 days and before 3 months of onset
• Be informed of the nature of the study and agreed on written consent voluntarily
• Patients taking medications or scheduled medications due to stroke

Exclusion Criteria:

• Patients with contraindications to weight bearing such as fractures, etc.
• Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
• Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
• Patients with severe skin damage and bedsore on wearing part of the trial device
• Pregnant or breast-feeding
• Participation within 30 days of the other clinical trials
• Patients whom the investigator considers inappropriate to participate in the study