NCT05327335

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

4.7 years

First QC Date

March 25, 2022

Last Update Submit

April 24, 2022

Conditions

Keywords

intelligent roboticsuse-centric co-creationelderly assistancesarcopeniamobilitymanipulabilityacceptancesensor

Outcome Measures

Primary Outcomes (1)

  • Lower extremity functioning

    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).

    6 months

Secondary Outcomes (4)

  • Maximum handgrip strength

    6 months

  • Knee Maximum Voluntary Contraction (MVC)

    6 months

  • Gait motion analysis - cadence, step length, stride length, opposite foot contact and foot off

    6 months

  • Balance ability

    6 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

Older adults without mobility and/or manipulability difficulties will be treated as reference group while older adults with mobility and/or manipulability difficulties will use the robotics system and integrated environment to perform daily self-care.

Device: Intelligent robotics for elderly assistance - sarcopenia

Interventions

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.

Intervention Group

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Osteoporosis
  • A history of the spine, knee, hip, and ankle joint surgery
  • Intervention group participants:
  • 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
  • Osteoporosis
  • A history of the spine, knee, hip, and ankle joint surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, 999777, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Vivian W.Q. Lou, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Reference group: A total of 60 older adults without mobility difficulties will be recruited for need assessment, robot adoption, mobility assessment, and manipulability assessment. Each session will last for around 3 hours. Intervention group: A total of 120 older adults from out-patient clinic 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. 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Professor of Robotics and Automation; Director of Emerging Technologies Institute

Study Record Dates

First Submitted

March 25, 2022

First Posted

April 14, 2022

Study Start

November 1, 2020

Primary Completion

June 30, 2025

Study Completion

October 30, 2025

Last Updated

May 2, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Data collected in this study will be published and submitted to academic journals to share with other researchers.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
No limitations on the publications
Access Criteria
No limitations on the publications

Locations