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

• ClinicalTrials.gov Identifier: NCT03452059
• Recruitment Status: Completed
• First Posted: March 2, 2018
• Last Update Posted: July 30, 2018
• Sponsor: AI-Robotics Technology Co., Ltd
• Information provided by (Responsible Party): AI-Robotics Technology Co., Ltd

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Lower Extremity Motor Dysfunction, Spinal Cord Injury	Device: AiLegs, AiWalker and HKAFO	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot
• Actual Study Start Date: July 11, 2017
• Actual Primary Completion Date: January 13, 2018
• Actual Study Completion Date: January 13, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: AiLegs/AiWalker; use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)	Device: 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
Active Comparator: HKAFO/RGO; use hip and knee ankle foot orthosis (HKAFO) assisted walking	Device: 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

Outcome Measures

Primary Outcome Measures :

1. Walking efficiency [ Time Frame: 6 minute ]
   6 minute walk distance,measured by meters
2. Walking efficiency [ Time Frame: 6 minute ]
   average heart increasing rate,measured by times/min

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Jiangsu

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Sponsors and Collaborators

AI-Robotics Technology Co., Ltd

More Information

• Responsible Party: AI-Robotics Technology Co., Ltd
• ClinicalTrials.gov Identifier: NCT03452059
• Other Study ID Numbers: ART-1
• First Posted: March 2, 2018
• Last Update Posted: July 30, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AI-Robotics Technology Co., Ltd:

Paralysis; Lower Extremities; Ai-Robotics

Additional relevant MeSH terms:

Spinal Cord Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries