Lower Extremity Motor Dysfunction, Spinal Cord InjuryARTNCT03452059
Evaluation of the Effectiveness and Safety of AI-Robotics
A study testing AiLegs, AiWalker and HKAFO in people with Lower Extremity Motor Dysfunction, Spinal Cord Injury, run by AI-Robotics Technology Co., Ltd at 1 site in China.
Trial summary
Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Extremity Motor Dysfunction, Spinal Cord Injury
- What is being tested?
- AiLegs, AiWalker and HKAFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2017to 13 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
About this study
Official title: 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
Read the 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
- Being tested
- AiLegs, AiWalker and HKAFO
- Keywords
- Paralysis, Lower Extremities, Ai-Robotics
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AiLegs, AiWalker and HKAFODevice
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
| Study group | Role | What they receive |
|---|---|---|
| AiLegs/AiWalker | Experimental | use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker) Receives: Device: AiLegs, AiWalker and HKAFO |
| HKAFO/RGO | Active comparator | use hip and knee ankle foot orthosis (HKAFO) assisted walking Receives: Device: AiLegs, AiWalker and HKAFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking efficiency
6 minute walk distance,measured by meters
Measured: 6 minute
Walking efficiency
average heart increasing rate,measured by times/min
Measured: 6 minute
Secondary outcomes (3)
Cardiovascular response
heart rate during and after 6 minute walk test
Measured: 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
Measured: 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
Measured: after 6 minute walk test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start11 Jul 2017
- Primary completion13 Jan 2018
- Study completion13 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Motor Dysfunction, Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AI-Robotics Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452059
- Sponsor's protocol ID
- ART-1
- Acronym
- ART
- Status last verified
- Jul 2018
- First submitted
- 23 May 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot
- ClinicalTrials.gov ID
- NCT03452059
- Acronym / sponsor ID
- ART / ART-1
- Keywords
- Paralysis, Lower Extremities, Ai-Robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AI-Robotics Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 13 Jan 2018 (actual)
- Study completion
- 13 Jan 2018 (actual)
- First posted
- 2 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AiLegs/AiWalker | Experimental | Device: AiLegs, AiWalker and HKAFOuse of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker) |
| HKAFO/RGO | Active comparator | Device: AiLegs, AiWalker and HKAFOuse hip and knee ankle foot orthosis (HKAFO) assisted walking |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AiLegs, AiWalker and HKAFO5 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 | Device | AiLegs/AiWalker, HKAFO/RGO |
Primary outcome
Walking efficiency
Time frame: 6 minute
6 minute walk distance,measured by meters
Walking efficiency
Time frame: 6 minute
average heart increasing rate,measured by times/min
3 secondary outcomes
Cardiovascular response
Time frame: during 6 minute walk test and right before the 6MWT
efficiency of put on or take off the Ailegs/Aiwalker/HKAFO
Time frame: immediately before beginning (pre-) and immediately after finishing (post-) each of 6 minute walk test
RPE questionaire
Time frame: after 6 minute walk test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
Related trials for Lower Extremity Motor Dysfunction, Spinal Cord Injury
Recruiting
ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)
Stroke, Incomplete Spinal Cord Injury (SCI)
Recruiting
ZEPU-AI Series Limb Feedback Robot Training Study (ZEPUAISRCT)
Stroke, Spinal Cord Injuries
Recruiting
ZEPU AI9 Exoskeleton Rehabilitation Robot
Stroke, Gait Disorders, Neurologic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AiLegs, AiWalker and HKAFO in people with Lower Extremity Motor Dysfunction, Spinal Cord Injury, run by AI-Robotics Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking efficiency (time frame: 6 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2018.