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Completed

NCT Number: NCT06141642

Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults

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.

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Key information

Conditions

Older Adults Aging Aging Well

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Laval

Québec, Quebec, G1V 0A6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-adaptive serious game

Device

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

Non-adaptive serious game

Device

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

Primary outcomes

  1. Motor function - Upper limb movement smoothness in immersive virtual reality

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

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

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

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

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

  3. Cognition - Response time in immersive virtual reality

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

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

  4. Cognition - Inhibition cost of response time in immersive virtual reality

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

    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)

Secondary outcomes

  1. Motor function - Coefficient of linearity in immersive virtual reality

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

    Ratio between the ideal path (the length of the ideal route) and the distance covered by the controller

  2. Motor function - Mean velocity in immersive virtual reality

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

    Ratio between the distance covered by the controller and the duration of the task

  3. Motor function - Peak velocity in immersive virtual reality

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

    Highest instant velocity observed during the movement

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

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

    Ratio between the standard deviation of the instant velocity and the mean velocity

  5. Motor function - Lpath in immersive virtual reality

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

    Total distance covered by the controller during the task

  6. Motor function - Headpath in immersive virtual reality

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

    Total distance covered by the headset during the task

  7. Motor function transfer - Finger Nose Test

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

    Motor-coordination test where participants are asked to touch their nose and a circular target (3 cm diameter) disposed on a wall 30cm away in the horizontal plane. Participants must realize as many repetitions as possible in 20s without missing the nose or the target.

  8. Activity transfer - TEMPA_glass

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

    The TEMPA (Test Évaluatif des Membres Supérieurs de Personnes Âgées) is an assessment designed to evaluate upper limb function in older adults, encompassing the performance of nine routine upper limb activities. Within the scope of this study, the investigators intend to assess participants' performance specifically in one of these tasks: pouring a glass of liquid and subsequently drinking it. The measurement will focus on the time taken by participants to complete this particular activity.

  9. Activity transfer - Box and Block Test

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

    The Box and Block Test (BBT) is a standardized performance-based assessment used to evaluate manual dexterity and upper extremity function, particularly in the context of gross motor skills. The test involves a wooden box divided into two compartments by a partition. Within one compartment, there are a certain number of wooden blocks. The objective of the test is to move as many blocks as possible from one side of the box to the other within 60s.

  10. Cognition - Number of false positive in immersive virtual reality

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

    The count of erroneously hit distractor moles in the VR evaluation module of REAsmash.

  11. Cognition - Number of omissions in immersive virtual reality

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

    The count of omitted target moles in the VR evaluation module of REAsmash.

  12. Cognition transfer - Deary-Liewald reaction time task

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

    A computerized test wherein participants are prompted to accurately respond to stimuli presented in either one or four squares at randomized intervals.

Other outcomes

  1. Feasibility - Number of drop-outs

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

    The count of participants that will not finish the experiment

  2. Feasibility - Number of adverse events

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

    The count of adverse events

  3. Effectiveness of participants masking

    Time frame: Day 3 (at the end of the intervention)

    A Likert scale incorporating a confidence ratio, wherein participants are required to estimate and express their confidence level regarding the arm in which they were allocated

  4. Participants' perception of immersive virtual reality and serious games

    Time frame: Day 3 (at the end of the intervention)

    Semi-structured interviews

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Université Catholique de Louvain

Registry information

Official study title

Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults - A Double Blind Randomized Controlled Trial

Acronym: SAVinGs

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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