NCT06141642

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. 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. 2.Enhance the understanding of how motor skill learning in immersive virtual reality translates to older adults' activities of daily living.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

5 months

First QC Date

November 15, 2023

Last Update Submit

October 8, 2024

Conditions

Keywords

Aged

Outcome Measures

Primary Outcomes (4)

  • Motor function - Upper limb movement smoothness in immersive virtual reality

    Spectral Arc Length (SPARC) of the normalized instant velocity signal

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Motor function - Upper limb speed-accuracy trade-off in immersive virtual reality

    This index is calculated by dividing the speed of performance by the accuracy of performance

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Cognition - Response time in immersive virtual reality

    Time between the target mole appearance and the and the successful hitting of the mole (in REAsmash VR evaluation module)

    Day 1 (before intervention) and day 3 (at the end of the intervention)

  • Cognition - Inhibition cost of response time in immersive virtual reality

    Difference of response time between levels where the target mole is presented among non-salient distractors (levels 3 and 4), salient distractors (levels 1 and 2) and no-distractors (level 0) in REAsmashVR (evaluation module)

    Day 1 (before intervention) and day 3 (at the end of the intervention)

Secondary Outcomes (12)

  • Motor function - Coefficient of linearity in immersive virtual reality

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Motor function - Mean velocity in immersive virtual reality

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Motor function - Peak velocity in immersive virtual reality

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Motor function - Coefficient of variation of the velocity in immersive virtual reality

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Motor function - Lpath in immersive virtual reality

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • +7 more secondary outcomes

Other Outcomes (4)

  • Feasibility - Number of drop-outs

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Feasibility - Number of adverse events

    Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)

  • Effectiveness of participants masking

    Day 3 (at the end of the intervention)

  • +1 more other outcomes

Study Arms (2)

Self-adaptive serious game

EXPERIMENTAL

Participants in this arm will follow, during three consecutive days, a serious game (REAsmashVR) intervention whose difficulty is automatically and progressively adapted to their motor and cognitive performance. REAsmashVR involves finding a target as fast as possible. The virtual target (a mole wearing a red miner's helmet) is presented with distractors (moles wearing different helmets). Participants use a controller to hit the target mole with a virtual hammer. In this arm, the REAsmashVR version uses a regulator to continuously moderate the location and timing of appearance of the target mole, the number and type of distractors and the working area. This regulator enables users to score 75% successful performance (driving motivation to play / learn).

Device: Self-adaptive serious game

Non-adaptive serious game

SHAM COMPARATOR

Participants in this arm will follow, during three consecutive days, a serious game (REAsmashVR) intervention whose difficulty is not automatically adapted to their motor and cognitive performance. In this arm, the REAsmashVR version does not use a regulator to continuously adapt exercise difficulty according to user performance. Instead, the game randomly moderates the location of the target mole, the working area and the type of distractors. The appearance timing remains constant at 7 seconds, while the number of distractors gradually increases over time to simulate an adaptive game environment, ensuring participants are kept unaware of the intervention.

Device: Non-adaptive serious game

Interventions

A self-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2

Self-adaptive serious game

A non-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2

Non-adaptive serious game

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Laval

Québec, Quebec, G1V 0A6, Canada

Location

Related Publications (1)

  • Everard G, Vermette M, Dumas-Longpre E, Hoang T, Robitaille M, Sorrentino G, Edwards MG, Lejeune T, Batcho CS. Self-adaptive over progressive non-adaptive immersive virtual reality serious game to promote motor learning in older adults - A double blind randomized controlled trial. Neuroscience. 2025 Apr 6;571:7-18. doi: 10.1016/j.neuroscience.2025.02.053. Epub 2025 Feb 26.

Study Officials

  • Charles Sebiyo Batcho, PT, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

January 9, 2024

Primary Completion

June 6, 2024

Study Completion

June 6, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Locations