Status:
COMPLETED
Evaluation of the Effectiveness and Safety of AI-Robotics
Lead Sponsor:
AI-Robotics Technology Co., Ltd
Conditions:
Lower Extremity Motor Dysfunction, Spinal Cord Injury
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot
Detailed Description
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot developed by AI-Robotics Technology Co., Ltd., Beijing for who had lower limb paralysis
Eligibility Criteria
Inclusion
- more than18 but less than 60 years old，less than 80 kilos of weight，Gender is not limited
- Confirmed by MR/CT，AIS spinal cord injury grade: A-C level (without walking ability)：Damage plane T6-L2
- The muscle tension of the modified Ashworth grade level is less than or equal to 2
- The range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint Neutral position
- Upper limb strength and physical strength are sufficient to stabilize the crutches
- Patients are able to understand and actively participate in the training program, agree and sign the informed consent form
Exclusion
- The range of motion of the joints is severely limited and the walking action is limited
- Spinal fractures are not completely healed, the clinical situation is unstable; if not fully confirmed,please go department of orthopedics or other clinical departments for diagnosing
- Skin injury or infection of the lower extremities or the part of wearing robot
- Unstable angina, severe arrhythmia and other heart diseases
- Severe chronic obstructive pulmonary disease
- Unilateral neglect
- Severe cognitive or visual impairment
- Other contraindications or complications that may affect walking training
- Pregnant or lactating women
- The investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements
Key Trial Info
Start Date :
July 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03452059
Start Date
July 11 2017
End Date
January 13 2018
Last Update
July 30 2018
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029