Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

VR Motor-cognitive Training for Cognitive Frailty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04467216
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Rick Kwan, The Hong Kong Polytechnic University

Brief Summary:

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. This pilot trial aims to examine the preliminary effects on cognitive function and frailty syndrome, as well as examine the feasibility.


Condition or disease Intervention/treatment Phase
Cognitive Frailty Device: Computerised cognitive training using virtual reality Not Applicable

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. They can simultaneously talk about and share their gaming experiences.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A total of 16 subjects with cognitive frailty will be assigned into 2 groups. Eight participants will be assigned to the intervention group in which they will undertake VR simultaneous motor-cognitive training and eight participants will be assigned to the control group in which existing forms of non-VR sequential motor-cognitive training will be provided.

Both intervention and control groups will employ the same intervention dosage including course, session duration and frequency. The following dosage is employed because they are also the same dosage used in the VR simultaneous motor-cognitive training that we proposed. I.e.,

  • Course: eight weeks
  • Session duration: 30 minutes
  • Frequency: twice per week
Masking: Single (Outcomes Assessor)
Masking Description: Outcome assessors at both pre- and post-observations will be blinded to the group label
Primary Purpose: Treatment
Official Title: Virtual Reality Motor-cognitive Training for Older People With Cognitive Frailty: A Pilot Trial
Estimated Study Start Date : July 15, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020

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: Computerised cognitive training using virtual reality
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 systems available in the market for older people are only for non-interactive activities (e.g., watching movies) to provide unusual experiences for disabled older people who cannot travel too far from home.

No Intervention: Control Group
This arm will be doing existing forms of motor-cognitive training in 30 minutes session, twice a week for 8 weeks



Primary Outcome Measures :
  1. Global cognitive function [ Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months) ]
    MoCA (score)

  2. Selective attention [ Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months) ]
    Stroop test (score)

  3. Visual-spatial perception [ Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months) ]
    Visual Object Space Perception test (score)


Secondary Outcome Measures :
  1. Frailty [ Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months) ]
    Fried Frailty Phenotype (score)

  2. Walking [ Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months) ]
    Timed up and go test (seconds)

  3. Strength [ Time Frame: Change is being assessed: "baseline" and "immediately after the completion" (2 months) ]
    Grip strength by dynamometer (kg)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Age ≥ 60 years,
  2. Community dwelling, as defined by living at home without staying in long-term care facilities (e.g., nursing home) in the last 12 months, and
  3. Cognitive frailty, as defined by co-existence of mild cognitive impairment and physical frailty,

    1. Mild cognitive impairment, measured by Montreal Cognitive Assessment (MoCA) ≤ 25 and Clinical Dementia Rating (CDR) = 0.5, and
    2. Frailty status from pre-frail to frail, measured by Fried Frailty Phenotype score ≥ 1.

Exclusion criteria

  1. Diagnosed dementia, according to subjects' medical record, or
  2. Probable dementia, as defined by MoCA ≤ 18, or
  3. Mobility restriction, as defined by Modified Functional Ambulatory Classification (MFAC) < Category 7 (i.e., Outdoor walker), or

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04467216


Contacts
Layout table for location contacts
Contact: Rick Kwan 96690420 ext 6456 rick.kwan@polyu.edu.hk

Locations
Layout table for location information
Hong Kong
Pok Oi Hospital Neighbourhood Elderly Centre
Hong Kong, Hong Kong
Contact: Olive Sin    98519917    khkic@pokoi.org.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
Layout table for investigator information
Study Chair: Rick Kwan The Hong Kong Polytechnic University
Publications:
Rosanna Chau MW, Chan SP, Wong YW, Lau MYP. Reliability and validity of the Modified Functional Ambulation Classification in patients with hip fracture. Hong Kong Physiotherapy Journal. 2013;31(1):41-44.

Layout table for additonal information
Responsible Party: Dr Rick Kwan, Dr, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04467216    
Other Study ID Numbers: ZB1H
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Rick Kwan, The Hong Kong Polytechnic University:
Cognitive frailty
Motor-cognitive training
Virtual reality
Gamification
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes