Evaluation of the Effectiveness and Safety of AI-Robotics

Study Overview
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Brief Summary
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Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot

Detailed Description
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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

Official Title
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Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot

Conditions
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Lower Extremity Motor Dysfunction, Spinal Cord Injury

Intervention / Treatment
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* Device: AiLegs, AiWalker and HKAFO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AiLegs/AiWalker<br>use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker) | Device: AiLegs, AiWalker and HKAFO<br>* 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<br>|
| Active Comparator: HKAFO/RGO<br>use hip and knee ankle foot orthosis (HKAFO) assisted walking | Device: AiLegs, AiWalker and HKAFO<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking efficiency | 6 minute walk distance,measured by meters | 6 minute | 
| Walking efficiency | average heart increasing rate,measured by times/min | 6 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular response | heart rate during and after 6 minute walk test | during 6 minute walk test and right before the 6MWT | 
| efficiency of put on or take off the Ailegs/Aiwalker/HKAFO | to measure the time of putting on or taking off the Ailegs/Aiwalker/HKAFO before or after 6 min walk test | immediately before beginning (pre-) and immediately after finishing (post-) each of 6 minute walk test | 
| RPE questionaire | the RPE is recorded after the 6 min walk test | after 6 minute walk test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paralysis, Lower Extremities, Ai-Robotics