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CompletedNCT03452059ARTUpdated Jul 30, 2018

Evaluation of the Effectiveness and Safety of AI-Robotics

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

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Lower Extremity Motor Dysfunction, Spinal Cord Injury

Keywords

  • Paralysis
  • Lower Extremities
  • Ai-Robotics
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    AiLegs/AiWalker

    use of lower extremity rehabilitation training robot assisted walking (including AiLegs, AiWalker)

    Device: AiLegs, AiWalker and HKAFO

  • Active comparator
    HKAFO/RGO

    use hip and knee ankle foot orthosis (HKAFO) assisted walking

    Device: AiLegs, AiWalker and HKAFO

Interventions

  • DeviceAiLegs, 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

05

What researchers measure

Primary outcomes

  1. Walking efficiency

    6 minute walk distance,measured by meters

    Time frame: 6 minute

  2. Walking efficiency

    average heart increasing rate,measured by times/min

    Time frame: 6 minute

Secondary outcomes

  1. Cardiovascular response

    heart rate during and after 6 minute walk test

    Time frame: during 6 minute walk test and right before the 6MWT

  2. 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

  3. RPE questionaire

    the RPE is recorded after the 6 min walk test

    Time frame: after 6 minute walk test

06

Study locations

1 site
  • The First Affiliated Hospital of Nanjing Medical University
    Nanjing, Jiangsu 210029, China
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03452059
Lead sponsor
AI-Robotics Technology Co., Ltd
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jul 11, 2017
Primary completion
Jan 13, 2018
Completion
Jan 13, 2018
Last update
Jul 30, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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