An interventional study of AiLegs, AiWalker and HKAFO in Lower Extremity Motor Dysfunction, Spinal Cord Injury, sponsored by AI-Robotics Technology Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-30.
Sponsored by AI-Robotics Technology Co., Ltd · Not applicable, Interventional, and Treatment
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
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's enrollment of 40 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →This is the only study on the registry with AI-Robotics Technology Co., Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)
Device: AiLegs, AiWalker and HKAFO
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
Walking efficiency
6 minute walk distance,measured by meters
Time frame: 6 minute
Walking efficiency
average heart increasing rate,measured by times/min
Time frame: 6 minute
Cardiovascular response
heart rate during and after 6 minute walk test
Time frame: 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
Time frame: 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
Time frame: after 6 minute walk test
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Jan 2018, 6 months.
Of 49 industry-sponsored interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 6 months is below that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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