跳至主要内容
临床试验/NCT05327335
NCT05327335招募中不适用

Intelligent Robotics for Elderly Assistance in Hong Kong

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
2
主要终点
Lower extremity functioning

研究概览

简要总结

Hong Kong is facing a significant societal challenge - a rapidly aging society. The proportion of the population aged 65 and over in Hong Kong increased from 16.6% in 2005 to 20.1% in 2020. The number of people aged 65 or older worldwide is estimated to reach 1.6 billion by 2050. In terms of quality of life, a major difficulty that many older people experience is a severe limitation in mobility and manipulability in their daily life, resulting in tremendous social and economic challenges. Hence, the investigators propose to develop innovative intelligent robotics systems to improve mobility and manipulability, prevent falls, enhance independence, and improve the quality of life of older adults. In particular, the investigators propose a User-Centric Co-creation (UC3) approach to developing novel intelligent wearable robots to enhance mobility and manipulability. The UC3 approach will start with a psycho-social study to identify the individual needs of older adults for achieving mobility and manipulability, which then leads to determining kinesiology-based design parameters for personalized wearable robots. The robots will be developed based on novel hybrid soft/rigid structures integrated with intelligent sensors, distributed actuators, and cooperative control methods. The robotic devices will be tested with elderly users in a user- user-centric environment for evaluation and continuous improvement. The investigators have conducted preliminary studies of the proposed approach. The results of the preliminary studies have clearly shown the feasibility as well as the novelty of the proposed approach. It can be stated confidently that our multidisciplinary team of experts in engineering, gerontology and medicine will be able to work with the elderly community and potential users to successfully deliver the project objectives. Furthermore, an Impact Committee, consisting of leaders in Hong Kong's elder community, elderly care organizations and related industries, has been proposed. It will advise and facilitate the research team to ensure the maximum impact of the research results and successful technology transfer. Commercialization efforts will be embedded in every phase of the project to ensure that the results will both benefit the elderly community and contribute to the economic development of Hong Kong. The outcomes of this project will place Hong Kong at the frontier of global robotics research and technology, provide critical technology to transform the elderly care services in Hong Kong, and create opportunities for training the next generation of scientists and engineers in robotics technology in Hong Kong.

详细描述

This study aims to provide an intelligent robotic solution for assisting older adults' mobility and manipulability. Using a novel UC3 development approach, the investigators will systematically study the requirements of elderly users to formulate technical specifications for designing personalized wearable robotic systems. Specifically, we will develop: (1) a novel UC3 development approach to identify the requirements and constraints for the elderly's mobility and manipulability based on gerontechnological and physiological studies; (2) a personalized sensor-driven wearable robot for elderly assistance; (3) an integrated interactive testing system to support the development of intelligent robot-enabled elderly assistance, and to significantly improve performance and safety; and (4) an experimental environment to test, evaluate and demonstrate the developed systems, emphasizing significantly improvement of the mobility and manipulability of older adults.

In order to improve human mobility and manipulability, a wearable robotic device is required to have certain rigidity to support the human body or sustain an external load. Inspired by the flexibility of multiple muscle bundles in biological muscle tissues, the investigators propose to use multiple servomotors to form distributed driving joints of the wearable robot of a hybrid structure and to regulate the driving force and speed of joints by coordinating the output of each motor in real-time. The UC3 approach starts with a psycho-social study and leads to the identification of the critical needs of older adults described by kinesiology-based design parameters. This will provide the guidelines for developing intelligent elderly assistive robots by integrating novel hybrid soft/rigid soft wearable robots, an intelligent sensing system and control methods. The robots will then be tested and evaluated in a user-centric environment to enable the next phase of improvement. Our systems will be developed based on requirements at three levels: (1) the physiology level, involving individual active elements; (2) the function level of action; and (3) the behaviour level of performing tasks.

In order to inform the design of our wearable robotic device, it is essential to understand the needs and compensation requirements of the elderly users in their daily life at physiology, function, and behaviour levels. 60 elderly subjects will be recruited for examination. The user needs assessment will result in a list of categories of "movement, tasks, and behaviour" with the scenarios of "mobility problems in the home and the community" that older people think important and necessary to complete independently daily life. Based on the psycho-social studies and physical and physiological tests done in laboratory testing and evaluation platform, the investigators will conduct needs and compensation assessments quantitatively to formulate technical requirements for system design and development. Furthermore, as the measured data continue to accumulate, the investigators will develop machine learning methods to efficiently estimate reliable compensation schemes based on a small set of measured data on a new user. This will greatly accelerate the efficiency of compensation studies when the number of users increases.

To evaluate our wearable devices for improvement, the investigators will quantitatively assess the enhancement of the mobility and manipulability of the targeted elderly using a pre-and post-implementation experiment. A total of 180 older people from the out-patient clinics and/or elderly community service units will be recruited for user studies in three phases, with 60 people in each phase. Subjects to be recruited in Phase 2 and Phase 3 need to meet the following inclusion and exclusion criteria: (1) aged 65 or older; (2) SARC-F score (measurement of sarcopenia) equal to or over 4; (3) SPPB score less than 11; (4) moderate mobility impairment, i.e., ADL between 6 and 12; (5) capable of clear communication; and (6) no cognitive impairment. The participants will use the robotics system and integrated environment to perform daily self-care to uncover problems in functionality, usability, and acceptance of the robotic device prototype. The system, connected to mobile apps and the Internet, will serve as a platform to measure and record data on how the participants engage in pre-specified activities. The experiment will last six months, and the outcome will be assessed pre-and post-implementation for comparison and validation. The major testing criteria include the design specifications for functionalities and reliability, user experiences, system security and privacy. Participants' perceived ability and confidence to perform daily self-care activities, quality of life, and acceptance of the system will also be measured. The first stage of evaluation will focus on the functionality and reliability of the individual system, measuring the gait stability using walker tipping index, fatigability by handle reaction vector (HRV), and centre of gravity. The second stage will focus on evaluating the system performance and usability of the IAE.

The participation of the older adults recruited from the out-patient clinics and/or elderly community service units in the tests, surveys, and/or interviews will not affect the quality of care they are receiving. No drug usage and medical treatment will be involved in the study. Intervention, surveys, and/or interviews do not impose any physical or medical risk to participants. The only concern is that participants may feel a little tired after the tests. Participants can voluntarily withdraw from the study at any time, without giving any reasons, their medical care or original rights will not be affected.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 65 or older
  • SARC-F score (measurement of sarcopenia) below 4
  • Capable of clear communication
  • No cognitive impairment

排除标准

  • Osteoporosis
  • A history of the spine, knee, hip, and ankle joint surgery
  • Intervention group participants:
  • Inclusion Criteria:
  • Aged 65 or older
  • SARC-F score (measurement of sarcopenia) equal to or over 4
  • Able to perform the experiment in a laboratory setting independently
  • Capable of clear communication
  • No cognitive impairment
  • Exclusion Criteria:
  • Osteoporosis
  • A history of the spine, knee, hip, and ankle joint surgery.

结局指标

主要结局

Lower extremity functioning

时间窗: 6 months

Lower extremity functioning will be assessed by the short physical performance battery (SPPB). SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The scores range from 0 (worst performance) to 12 (best performance). The total score of the gait speed test ranged from 0 (unable to walk) to 4 (if time is less than 4.82 sec). The total score of the chair stand test ranged from 0 (unable to complete 5 chair stands or completes stand in \> 60 sec) to 4 (if chair stand time is 11.19 sec or less). In the balance test, the participants will perform a total of three balance tests. First, the side-by-side stand, ranging from 0 (not attempted / not held for 10 sec) to 1 (held for 10 sec). Second, the semi-tandem stand, ranging from 0 (not attempted / not held for 10 sec) to 1 (held for 10 sec). Third, the tandem stand, ranging from 0 (not attempted / held \< 3 sec) to 2 (held for 10 sec).

次要结局

  • Maximum handgrip strength(6 months)
  • Gait motion analysis - cadence, step length, stride length, opposite foot contact and foot off(6 months)
  • Balance ability(6 months)
  • Knee Maximum Voluntary Contraction (MVC)(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Xi Ning

Chair Professor of Robotics and Automation; Director of Emerging Technologies Institute

The University of Hong Kong

研究点 (2)

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