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

Aging Clinical Trial

— SAVinGs  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141642
• Other study ID #: #2020-1909
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: January 2024
• Source: Laval University
• Contact: Charles Sebiyo Batcho, PT, PhD
• Phone: (418) 529 9141
• Email: charles.batcho[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Aging Well
• Older Adults

Intervention

Device:
• Self-adaptive serious game
A self-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2
• Non-adaptive serious game
A non-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2

Locations

Country	Name	City	State
Canada	University Laval	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Université Catholique de Louvain

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility - Number of drop-outs	The count of participants that will not finish the experiment	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Other	Feasibility - Number of adverse events	The count of adverse events	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Other	Effectiveness of participants masking	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	Day 3 (at the end of the intervention)
Other	Participants' perception of immersive virtual reality and serious games	Semi-structured interviews	Day 3 (at the end of the intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Motor function - Coefficient of linearity in immersive virtual reality	Ratio between the ideal path (the length of the ideal route) and the distance covered by the controller	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Secondary	Motor function - Mean velocity in immersive virtual reality	Ratio between the distance covered by the controller and the duration of the task	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Secondary	Motor function - Peak velocity in immersive virtual reality	Highest instant velocity observed during the movement	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Secondary	Motor function - Coefficient of variation of the velocity in immersive virtual reality	Ratio between the standard deviation of the instant velocity and the mean velocity	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Secondary	Motor function - Lpath in immersive virtual reality	Total distance covered by the controller during the task	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Secondary	Motor function - Headpath in immersive virtual reality	Total distance covered by the headset during the task	Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Secondary	Motor function transfer - Finger Nose Test	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.	Day 1 (before intervention) and day 3 (at the end of the intervention)
Secondary	Activity transfer - TEMPA_glass	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.	Day 1 (before intervention) and day 3 (at the end of the intervention)
Secondary	Activity transfer - Box and Block Test	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.	Day 1 (before intervention) and day 3 (at the end of the intervention)
Secondary	Cognition - Number of false positive in immersive virtual reality	The count of erroneously hit distractor moles in the VR evaluation module of REAsmash.	Day 1 (before intervention) and day 3 (at the end of the intervention)
Secondary	Cognition - Number of omissions in immersive virtual reality	The count of omitted target moles in the VR evaluation module of REAsmash.	Day 1 (before intervention) and day 3 (at the end of the intervention)
Secondary	Cognition transfer - Deary-Liewald reaction time task	A computerized test wherein participants are prompted to accurately respond to stimuli presented in either one or four squares at randomized intervals.	Day 1 (before intervention) and day 3 (at the end of the intervention)