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Self-adaptive serious game for Aging (SAVinGs Trial)

N/A
Recruiting
Led By Charles Sebiyo Batcho, PT, PhD
Research Sponsored by Laval University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal-to-corrected vision
Age > or = 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
Awards & highlights

SAVinGs Trial Summary

This trial aims to investigate the impact of self-adaptive serious games, compared to traditional serious games, on motor skill learning and attention in older adults. The study will also explore how motor skill learning in

Who is the study for?
This trial is for older adults aged 65 or above with normal-to-corrected vision and a Montreal Cognitive Assessment score over 24, indicating they have no significant cognitive impairment. It's designed to help those who are generally healthy but may be experiencing the effects of aging on motor skills and attention.Check my eligibility
What is being tested?
The study compares two types of serious games: one that self-adapts to the player's ability (self-adaptive) and another that does not change difficulty (non-adaptive). The goal is to see which game better improves motor skills learning and attention in older adults.See study design
What are the potential side effects?
Since this trial involves playing virtual reality games, potential side effects might include dizziness, nausea, eye strain or headaches due to VR use. However, these are typically mild and temporary.

SAVinGs Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My vision is normal or corrected to normal.
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I am 65 years old or older.

SAVinGs Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (before intervention), day 2 and day 3 (at the end of the intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (before intervention), day 2 and day 3 (at the end of the intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognition - Inhibition cost of response time in immersive virtual reality
Cognition - Response time in immersive virtual reality
Motor function - Upper limb movement smoothness in immersive virtual reality
+1 more
Secondary outcome measures
Activity transfer - Box and Block Test
Activity transfer - TEMPA_glass
Cognition - Number of false positive in immersive virtual reality
+9 more
Other outcome measures
Effectiveness of participants masking
Feasibility - Number of adverse events
Feasibility - Number of drop-outs
+1 more

SAVinGs Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Self-adaptive serious gameExperimental Treatment1 Intervention
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).
Group II: Non-adaptive serious gamePlacebo Group1 Intervention
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.

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Who is running the clinical trial?

Laval UniversityLead Sponsor
420 Previous Clinical Trials
172,685 Total Patients Enrolled
2 Trials studying Aging
341 Patients Enrolled for Aging
Université Catholique de LouvainOTHER
157 Previous Clinical Trials
47,549 Total Patients Enrolled
1 Trials studying Aging
24 Patients Enrolled for Aging
Charles Sebiyo Batcho, PT, PhDPrincipal InvestigatorLaval University
~16 spots leftby Sep 2024
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