VR Motor-cognitive Training for Older People With Cognitive Frailty

August 23, 2021 updated by: Dr Rick Kwan, The Hong Kong Polytechnic University

Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: The Implementation of the Prototype

Cognitive frailty is a clinical syndrome in which cognitive impairment (e.g., poor memory, visuospatial function) and physical frailty (e.g., slowness, poor muscle strength, physical inactivity) co-exist. It is prevalent in community-dwelling older people. The progressive decline of cognitive and physical functions restricts older people from participating in activities (e.g., social get-togethers). Reduced participation further jeopardizes their life-space mobility (e.g., ability to travel to areas far away from home). Therefore, those with cognitive frailty are at risk of developing dementia and becoming dependent.

Simultaneous motor-cognitive training is more effective at promoting optimal functioning in older people than motor or cognitive training alone. Gaming is effective at promoting the motivation to participate. The contents of games in the market are unrelated to the context or daily living of the elderly. Currently, available training is non-simultaneous. This makes the training less transferable to the daily life of the elderly and reduces its effects.

Virtual reality (VR) technology can provide a virtual space that mimics the real environment. This allows clients to participate in daily activities in a virtual space. Older people can be trained to improve their cognitive and physical skills in a painless, fun way. However, the effect and feasibility of employing simultaneous motor-cognitive training launching on a VR platform mimicking the daily living environment in older people with cognitive frailty is poorly known.

Following the findings from the previous proof-of-concept test (registration number: NCT04467216), we proceed to implement the study to 400 participants from six different elderly centres between the period of March 2021 and December 2022.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the intervention, VR will be employed to simulate a daily living environment familiar to older people. Participants will wear a commercially available head-mounted VR system with hand-held controllers to experience the participation of daily activities in a virtual environment. Simultaneous physical and cognitive training will be embedded in the training system to promote optimal function. Participants will attend physical training in a sitting position through cycling on an ergometer and moving the hand-held controllers. Motion sensors built into the VR system and ergometer will track these movements to control everyday tasks in the virtual environment (e.g., moving around the city). Simultaneously, participants will undergo cognitive training by participating in various tasks demanding cognitive functions, such as visual-spatial (e.g., wayfinding) and problem-solving (e.g., wallet loss) functions. Gamification will be employed to promote the motivation to participate. All training activities will be gamified by blending in fun elements, such as difficulty-levelling, competition, and e-tokens. Co-participation is allowed to promote interpersonal interactions. The prototype enables real-time co-viewing among participants. Other elderly centre members and the activity facilitators can share the view of the participants in the game on either a large-screen monitor or a tablet computer, allowing them to simultaneously discuss and share about their gaming experiences.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Pok Oi Hospital Chan Shi Sau Memorial Social Service Centre
        • Contact:
      • Lai Chi Kok, Hong Kong
        • Recruiting
        • Pok Oi Hospital Mei Foo Lai Wan Kaifong Association Mr. and Mrs. Leung Chi Chim Elderly Health Support and Learning Centre
        • Contact:
      • Lai Chi Kok, Hong Kong
        • Recruiting
        • Pok Oi Hospital Mr. Kwok Hing Kwan Neighbourhood Elderly Centre
        • Contact:
      • Tin Shui Wai, Hong Kong
        • Recruiting
        • Pok Oi Hospital Chan Ping Memorial Neighbourhood Elderly Centre
        • Contact:
      • Tuen Mun, Hong Kong
        • Recruiting
        • Pok Oi Hospital Wong Muk Fung Memorial Elderly Health Support and Learning Centre
        • Contact:
      • Yuen Long, Hong Kong
        • Recruiting
        • Pok Oi Hospital Mrs. Wong Tung Yuen District Elderly Community Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 60 years,
  • Self-reported or informant-reported cognitive complaints
  • Objective cognitive impairment, as defined by a Clinical Dementia Rating of 0.5 and a Montreal Cognitive Assessment (MoCA) score of <25
  • Preservation of one's independence, as defined by the Lawton's Instrumental Activity of Daily Living score of >14
  • No diagnosed dementia, as observed in the medical record
  • Physical frailty from being pre-frail to frail, as defined by a Fried Frailty Index (FFI) score of 1-5.

Exclusion Criteria:

  • Participants who have impaired mobility, as defined by Modified Functional Ambulatory Classification (MFAC) < Category 7 (i.e., Outdoor walker),
  • or probable dementia, i.e., MoCA < 17 or clinical dementia rating ≥ 1.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
This arm will undertake VR simultaneous motor-cognitive training in 30 minutes session, twice a week for 8 weeks.
Device: Virtual Reality Motor-Cognitive Training System
Immersive VR training system tailor-made for the daily living experiences in the Hong Kong context to provide interactive experiences for older people in Hong Kong. The VR training system is designed as a game with 16 progressive levels (anticipating intervention group participants to complete 2 levels per week for 8 weeks) which aim to train their motor and cognitive functions.
No Intervention: Control group
This arm will not be given any kind of treatment and will act as a passive control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global cognitive function
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Score on the Montreal Cognitive Assessment Hong Kong Version (HK-MoCA), ranging from 0 to 30.
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Frailty
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Score on the Fried Frailty Phenotype, ranging from 0 to 5
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibition of cognitive interference
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Stroop Color-Word Test (SCWT) Global Index score, calculated by I=CW-((W+C)/2)
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Executive function
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Time taken to complete the trail making test (TMA & TMB), ranges from 0 to 300 seconds (when maximum time is reached)
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Verbal and visuo-spatial short-term memory
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Score on the Digit Span Test, ranges from 0 to 9
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Walking speed
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Timed up and go test (seconds)
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Hand grip strength
Time Frame: Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart
Hand grip strength by dynamometer (kg)
Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Pok Oi Hospital

Investigators

  • Principal Investigator: Rick Kwan, Dr, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

May 31, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

January 29, 2021

Study Record Updates

Last Update Posted (Actual)

August 27, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-ZB1H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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