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Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AiLegs/AiWalker | Experimental | use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker) |
|
| HKAFO/RGO | Active Comparator | use hip and knee ankle foot orthosis (HKAFO) assisted walking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AiLegs, AiWalker and HKAFO | Device | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
| D014947 | Wounds and Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |