跳至主要内容
临床试验/NCT04730817
NCT04730817Unknown不适用

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

The Hong Kong Polytechnic University6 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
6
主要终点
Global cognitive function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors at both pre- and post-observations will be blinded to the group label.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Global cognitive function

时间窗: 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.

Frailty

时间窗: 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

次要结局

  • Verbal and visuo-spatial short-term memory(Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart)
  • Walking speed(Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart)
  • Hand grip strength(Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart)
  • Inhibition of cognitive interference(Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart)
  • Executive function(Change is being assessed at "baseline" (T0) and "immediately after the completion" (T1), being 8 weeks apart)

研究者

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

Dr Rick Kwan

Assistant Professor

The Hong Kong Polytechnic University

研究点 (6)

Loading locations...

相似试验