Evaluation of the Effectiveness and Safety of AI-Robotics (ART)

AI-Robotics Technology

Status: Completed

Conditions: Lower Extremity Motor Dysfunction, Spinal Cord Injury

Treatments: Device: AiLegs, AiWalker and HKAFO

Study type: Interventional

Funder types: Industry

Identifiers

NCT03452059

ART-1

Details and patient eligibility

About

Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

AiLegs/AiWalker

Experimental group

Description:

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

Treatment:

Device: AiLegs, AiWalker and HKAFO

HKAFO/RGO

Active Comparator group

Description:

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

Treatment:

Device: AiLegs, AiWalker and HKAFO