Clinical trial NCT06141642: Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults
Official title: Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults - A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Aging Well
Aging
Keywords: Aged
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Université Catholique de Louvain
First posted: 2023-11-21
Enrollment: 33
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: While scientific evidence emphasizes the detrimental effect of sedentary behavior on health, the literature suggests that, on average, older adults spend 75% of their days in a sedentary manner, and often isolated (Petrusevski 2020). This lack of physical activity and social interaction not only leads to an increase in functional limitations and the risk of worsening an existing chronic disease but also elevates the risk of mortality. Furthermore, older adults face progressive functional decline, both in motor and cognitive aspects, as a result of aging, contributing to inactivity and sedentary behavior (Botö 2021).

The literature suggests that new technologies such as immersive virtual reality (iVR) and serious games serve as effective means to promote active leisure, thereby breaking isolation and reducing sedentary behavior. The development of these new technologies is also promising for objectively and quantitatively measuring motor and cognitive activity (e.g., kinematics, reaction time).

Serious games are defined as games whose primary objective is more focused on learning than entertainment. For instance, they allow the integration of physical and cognitive activity programs into a playful activity, conducive to long-term adherence. Their effectiveness is starting to be studied in hospitalized older adults (Cuevas-Lara 2021), especially as they also help combat age-related functional decline. Indeed, they provide the opportunity to promote and measure activity through enjoyable and self-administered exercises.

However, despite the growing interest in serious games, the impact of self-adaptive serious games, compared to traditional (non-adaptive) serious games, on motor skill learning and attention function in older adults remains unclear. This gap in knowledge necessitates a rigorous investigation. Therefore, this randomized controlled trial seeks to address this gap and achieve the following objectives:

1. Compare the effect of a self-adaptive serious game to a non-adaptive serious game on motor skill learning and attention in older adults.
2. Enhance the understanding of how motor skill learning in immersive virtual reality translates to older adults' activities of daily living.


Eligibility criteria: Inclusion Criteria:

* Normal-to-corrected vision
* Score \> 24 in the Montreal Cognitive Assessment
* Age \> or = 65 years old

Exclusion Criteria:

* Severe comprehension issues
* History of seizures
* Prior experience with serious games in immersive virtual reality

Primary outcomes:
measure: Motor function - Upper limb movement smoothness in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function - Upper limb speed-accuracy trade-off in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Cognition - Response time in immersive virtual reality
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
measure: Cognition - Inhibition cost of response time in immersive virtual reality
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Secondary outcomes:
measure: Motor function - Coefficient of linearity in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function - Mean velocity in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function - Peak velocity in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function - Coefficient of variation of the velocity in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function - Lpath in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function - Headpath in immersive virtual reality
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Motor function transfer - Finger Nose Test
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
measure: Activity transfer - TEMPA_glass
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
measure: Activity transfer - Box and Block Test
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
measure: Cognition - Number of false positive in immersive virtual reality
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
measure: Cognition - Number of omissions in immersive virtual reality
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
measure: Cognition transfer - Deary-Liewald reaction time task
timeFrame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Other outcomes:
measure: Feasibility - Number of drop-outs
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Feasibility - Number of adverse events
timeFrame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
measure: Effectiveness of participants masking
timeFrame: Day 3 (at the end of the intervention)
measure: Participants' perception of immersive virtual reality and serious games
timeFrame: Day 3 (at the end of the intervention)
Locations:
city: Québec
country: Canada
facility: University Laval
state: Quebec
Study officials:
affiliation: Laval University
name: Charles Sebiyo Batcho, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: