Older AdultsSAVinGsNCT06141642
Self-Adaptive Immersive Virtual Reality Serious Game to Enhance Motor Skill Learning and Attention in Older Adults
A study testing Self-adaptive serious game and Non-adaptive serious game in people with Older Adults and Aging Well, run by Laval University at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Aging Well, Aging
- What is being tested?
- Self-adaptive serious game and Non-adaptive serious game
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jan 2024to 6 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Normal-to-corrected vision
- Score > 24 in the Montreal Cognitive Assessment
- Age > or = 65 years old
Who cannot join
- Severe comprehension issues
- History of seizures
- Prior experience with serious games in immersive virtual reality
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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:
- Compare the effect of a self-adaptive serious game to a non-adaptive serious game on motor skill learning and attention in older adults.
- Enhance the understanding of how motor skill learning in immersive virtual reality translates to older adults' activities of daily living.
- Conditions
- Older Adults, Aging Well, Aging
- Being tested
- Self-adaptive serious game, Non-adaptive serious game
- Keywords
- Aged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-adaptive serious gameDevice
A self-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2
Non-adaptive serious gameDevice
A non-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Non-adaptive serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor function - Upper limb movement smoothness in immersive virtual reality
Spectral Arc Length (SPARC) of the normalized instant velocity signal
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Ratio between the ideal path (the length of the ideal route) and the distance covered by the controller
Measured: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Motor function - Mean velocity in immersive virtual reality
Ratio between the distance covered by the controller and the duration of the task
Measured: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Motor function - Peak velocity in immersive virtual reality
Highest instant velocity observed during the movement
Measured: 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
Ratio between the standard deviation of the instant velocity and the mean velocity
Measured: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Motor function - Lpath in immersive virtual reality
Total distance covered by the controller during the task
Measured: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Motor function - Headpath in immersive virtual reality
Total distance covered by the headset during the task
Measured: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
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.
Measured: Day 1 (before intervention) and day 3 (at the end of the intervention)
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.
Measured: Day 1 (before intervention) and day 3 (at the end of the intervention)
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.
Measured: Day 1 (before intervention) and day 3 (at the end of the intervention)
Cognition - Number of false positive in immersive virtual reality
The count of erroneously hit distractor moles in the VR evaluation module of REAsmash.
Measured: Day 1 (before intervention) and day 3 (at the end of the intervention)
Cognition - Number of omissions in immersive virtual reality
The count of omitted target moles in the VR evaluation module of REAsmash.
Measured: Day 1 (before intervention) and day 3 (at the end of the intervention)
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.
Measured: Day 1 (before intervention) and day 3 (at the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start9 Jan 2024
- Primary completion6 Jun 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Charles Sebiyo Batcho, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141642
- Sponsor's protocol ID
- #2020-1909
- Acronym
- SAVinGs
- Status last verified
- Oct 2024
- First submitted
- 15 Nov 2023
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40021077
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06141642
- Acronym / sponsor ID
- SAVinGs / #2020-1909
- Conditions
- Older Adults, Aging Well, Aging
- Keywords
- Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Université Catholique de Louvain
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the effect of a self-adaptive serious game to a non-adaptive serious game on motor skill learning and attention in older adults.
- Enhance the understanding of how motor skill learning in immersive virtual reality translates to older adults' activities of daily living.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-adaptive serious game | Experimental | Device: Self-adaptive serious gameParticipants 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). |
| Non-adaptive serious game | Sham comparator | Device: Non-adaptive serious gameParticipants 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. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Normal-to-corrected vision
- Score > 24 in the Montreal Cognitive Assessment
- Age > or = 65 years old
Key exclusion criteria (3 listed)
- Severe comprehension issues
- History of seizures
- Prior experience with serious games in immersive virtual reality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-adaptive serious gameA self-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2 | Device | Self-adaptive serious game |
| Non-adaptive serious gameA non-adaptive serious game in immersive virtual reality using the device MetaQuest 1 or 2 | Device | Non-adaptive serious game |
Primary outcome
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
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
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)
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)
12 secondary outcomes
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)
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)
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)
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)
Motor function - Lpath in immersive virtual reality
Time frame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Motor function - Headpath in immersive virtual reality
Time frame: Day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Motor function transfer - Finger Nose Test
Time frame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Activity transfer - TEMPA_glass
Time frame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Activity transfer - Box and Block Test
Time frame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Cognition - Number of false positive in immersive virtual reality
Time frame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Cognition - Number of omissions in immersive virtual reality
Time frame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Cognition transfer - Deary-Liewald reaction time task
Time frame: Day 1 (before intervention) and day 3 (at the end of the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 40021077Everard 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.
Related trials for Older Adults
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Sebiyo Batcho, PT, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-adaptive serious game and Non-adaptive serious game in people with Older Adults and Aging Well, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.