Evaluation of the Effectiveness and Safety of AI-Robotics

NCT ID: NCT03452059

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-11
• Study Completion Date: 2018-01-13

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

Conditions

Lower Extremity Motor Dysfunction, Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AiLegs/AiWalker

use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)

Group Type: EXPERIMENTAL

AiLegs, AiWalker and HKAFO

Intervention Type: DEVICE

5 days. Using their own control method, each morning using AiLegs, AiWalker AiWalker and HKAFO for 6 minutes walk test, three kinds of appliance between at least 30 minutes to determine heart rate, blood pressure and breathing back to quiet level. Repeat the same procedure in the afternoon ，the order is also random. Each participant will complete 10 groups of lower limb exoskeleton rehabilitation Training robot (including AiLegs, AiWalker two models) and HKAFO 6 minutes walking test

HKAFO/RGO

use hip and knee ankle foot orthosis (HKAFO) assisted walking

Group Type: ACTIVE_COMPARATOR

AiLegs, AiWalker and HKAFO

Intervention Type: DEVICE

5 days. Using their own control method, each morning using AiLegs, AiWalker AiWalker and HKAFO for 6 minutes walk test, three kinds of appliance between at least 30 minutes to determine heart rate, blood pressure and breathing back to quiet level. Repeat the same procedure in the afternoon ，the order is also random. Each participant will complete 10 groups of lower limb exoskeleton rehabilitation Training robot (including AiLegs, AiWalker two models) and HKAFO 6 minutes walking test

Interventions

AiLegs, AiWalker and HKAFO

5 days. Using their own control method, each morning using AiLegs, AiWalker AiWalker and HKAFO for 6 minutes walk test, three kinds of appliance between at least 30 minutes to determine heart rate, blood pressure and breathing back to quiet level. Repeat the same procedure in the afternoon ，the order is also random. Each participant will complete 10 groups of lower limb exoskeleton rehabilitation Training robot (including AiLegs, AiWalker two models) and HKAFO 6 minutes walking test

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. more than18 but less than 60 years old，less than 80 kilos of weight，Gender is not limited

2. Confirmed by MR/CT，AIS spinal cord injury grade: A-C level (without walking ability)：Damage plane T6-L2

3. The muscle tension of the modified Ashworth grade level is less than or equal to 2

4. The range of passive motion of the hip and knee joint of the patient is approximately normal in the ankle joint Neutral position

5. Upper limb strength and physical strength are sufficient to stabilize the crutches

6. Patients are able to understand and actively participate in the training program, agree and sign the informed consent form

Exclusion Criteria

1. The range of motion of the joints is severely limited and the walking action is limited

2. 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

3. Skin injury or infection of the lower extremities or the part of wearing robot

4. Unstable angina, severe arrhythmia and other heart diseases

5. Severe chronic obstructive pulmonary disease

6. Unilateral neglect

7. Severe cognitive or visual impairment

8. Other contraindications or complications that may affect walking training

9. Pregnant or lactating women

10. The investigators find that patients with poor compliance, unable to complete the study in accordance with the requirements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AI-Robotics Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

ART-1

Identifier Type: -

Identifier Source: org_study_id