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

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

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

Study Overview

• Status: Completed
• Conditions: Lower Extremity Motor Dysfunction, Spinal Cord Injury
• Intervention / Treatment: Device: AiLegs, AiWalker and HKAFO

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AI-Robotics Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): January 13, 2018
• Study Completion (Actual): January 13, 2018

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Paralysis; Lower Extremities; Ai-Robotics
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: ART-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No