Back to resultsEvaluation of the Effectiveness and Safety of AI-Robotics (ART)
Primary Purpose
Lower Extremity Motor Dysfunction, Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AiLegs, AiWalker and HKAFO
Sponsored by
About this trial
This is an interventional treatment trial for Lower Extremity Motor Dysfunction, Spinal Cord Injury focused on measuring Paralysis, Lower Extremities, Ai-Robotics
Eligibility Criteria
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
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AiLegs/AiWalker
HKAFO/RGO
Arm Description
use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)
use hip and knee ankle foot orthosis (HKAFO) assisted walking
Outcomes
Primary Outcome Measures
Walking efficiency
6 minute walk distance,measured by meters
Walking efficiency
average heart increasing rate,measured by times/min
Secondary Outcome Measures
Cardiovascular response
heart rate during and after 6 minute walk test
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
RPE questionaire
the RPE is recorded after the 6 min walk test
Full Information
NCT ID
NCT03452059
First Posted
May 23, 2017
Last Updated
July 27, 2018
Sponsor
AI-Robotics Technology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03452059
Brief Title
Evaluation of the Effectiveness and Safety of AI-Robotics
Acronym
ART
Official Title
Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
January 13, 2018 (Actual)
Study Completion Date
January 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AI-Robotics Technology Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Motor Dysfunction, Spinal Cord Injury
Keywords
Paralysis, Lower Extremities, Ai-Robotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AiLegs/AiWalker
Arm Type
Experimental
Arm Description
use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)
Arm Title
HKAFO/RGO
Arm Type
Active Comparator
Arm Description
use hip and knee ankle foot orthosis (HKAFO) assisted walking
Intervention Type
Device
Intervention Name(s)
AiLegs, AiWalker and HKAFO
Intervention Description
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
Primary Outcome Measure Information:
Title
Walking efficiency
Description
6 minute walk distance,measured by meters
Time Frame
6 minute
Title
Walking efficiency
Description
average heart increasing rate,measured by times/min
Time Frame
6 minute
Secondary Outcome Measure Information:
Title
Cardiovascular response
Description
heart rate during and after 6 minute walk test
Time Frame
during 6 minute walk test and right before the 6MWT
Title
efficiency of put on or take off the Ailegs/Aiwalker/HKAFO
Description
to measure the time of putting on or taking off the Ailegs/Aiwalker/HKAFO before or after 6 min walk test
Time Frame
immediately before beginning (pre-) and immediately after finishing (post-) each of 6 minute walk test
Title
RPE questionaire
Description
the RPE is recorded after the 6 min walk test
Time Frame
after 6 minute walk test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effectiveness and Safety of AI-Robotics
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