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Completed

NCT Number: NCT03452059

Evaluation of the Effectiveness and Safety of AI-Robotics

Evaluation of the effectiveness and safety of the lower extremity exoskeleton rehabilitation training robot

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Key information

Conditions

Lower Extremity Motor Dysfunction, Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Walking efficiency

    Time frame: 6 minute

    6 minute walk distance,measured by meters

  2. Walking efficiency

    Time frame: 6 minute

    average heart increasing rate,measured by times/min

Secondary outcomes

  1. Cardiovascular response

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

    heart rate during and after 6 minute walk test

  2. 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

    to measure the time of putting on or taking off the Ailegs/Aiwalker/HKAFO before or after 6 min walk test

  3. RPE questionaire

    Time frame: after 6 minute walk test

    the RPE is recorded after the 6 min walk test

Sponsors and collaborators

Lead sponsor

AI-Robotics Technology Co., Ltd

Industry

Registry information

Official study title

Prospective, Multicenter, Self Controlled Evaluation of the Effectiveness and Safety of Lower Limb Exoskeleton Rehabilitation Training Robot

Acronym: ART

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 2, 2018
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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