Evaluation of the Effectiveness and Safety of AI-Robotics

Not Applicable

Completed

• Conditions: Lower Extremity Motor Dysfunction, Spinal Cord Injury
• Interventions: Device: AiLegs, AiWalker and HKAFO

• Registration Number: NCT03452059
• Lead Sponsor: AI-Robotics Technology Co., Ltd

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

Study Timeline

• Study First Submitted: 2017-05-23
• Study Start: 2017-07-11
• Primary Completion: 2018-01-13
• Study Completion: 2018-01-13
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HKAFO/RGO	AiLegs, AiWalker and HKAFO	use hip and knee ankle foot orthosis (HKAFO) assisted walking
AiLegs/AiWalker	AiLegs, AiWalker and HKAFO	use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)

Primary Outcome Measures

Name	Time	Method
Walking efficiency	6 minute	average heart increasing rate,measured by times/min

Secondary Outcome Measures

Name	Time	Method
Cardiovascular response	during 6 minute walk test and right before the 6MWT	heart rate during and after 6 minute walk test
efficiency of put on or take off the Ailegs/Aiwalker/HKAFO	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
RPE questionaire	after 6 minute walk test	the RPE is recorded after the 6 min walk test

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China