Ivor Wynne Center
Hamilton, Ontario, L8S 4L8, Canada
NCT Number: NCT07781995
Falls are a common problem in adults within the age of 55-80 years and can lead to injury and loss of independence. This study is testing a new type of balance training using augmented reality (AR). In this intervention, participants will see virtual objects, such as obstacles, placed in their environment and will practice stepping over or moving around them. The system will adjust the difficulty based on each person's performance. Participants will complete training sessions over several weeks. We will measure changes in balance, walking ability, and confidence before and after the program. The goal is to see if this training can help improve balance and reduce the risk of falls in older adults.
Trial opening soon.
Get Notified55 year–80 year
All sexes
Interventional
Not applicable
Hamilton, Ontario, L8S 4L8, Canada
Falls are a significant health concern among older adults and can contribute to injury, fear of falling, reduced physical activity, functional decline, and loss of independence. Exercise-based interventions that target balance, gait, strength, and functional mobility can reduce fall risk in older adults. However, implementation outside supervised clinical settings may be limited by insufficient training dose, lack of individualized progression, and difficulty maintaining engagement.
Augmented reality (AR) provides an opportunity to deliver balance and mobility training while allowing participants to interact with virtual training elements within their physical environment. Previous studies have investigated AR-assisted exercise and rehabilitation approaches in older adults, including balance, gait, and mobility training. Although these approaches have demonstrated potential benefits, further research is needed to determine how AR-based training can be individualized and implemented effectively in community-dwelling older adults. Incorporating machine learning-based adaptation may enable training difficulty to be adjusted according to individual performance and provide an appropriate and progressive level of challenge.
This study will evaluate the feasibility and preliminary effects of an artificial intelligence (AI)-enhanced AR balance and mobility training program in community-dwelling older adults aged 55-80 years. The study will use a single-arm, open-label, repeated-measures design. Participants will complete a baseline assessment (T1), followed by an 8-week AR training intervention and an immediate post-intervention assessment (T2).
The intervention will consist of 3-5 training sessions per week for 8 weeks, with each session lasting approximately 30 minutes. Participants will perform standing- and walking-based activities presented through wearable AR smart glasses. Training activities will include obstacle negotiation, path following, step targeting, turning, and directional-change tasks designed to challenge functional balance and mobility. Training sessions may be completed at McMaster University or, for eligible participants, in the participant's home. Before beginning home-based training, the home environment will be assessed for suitability, and the participant will complete an initial on-site training session under direct supervision.
The AR training application was developed by the McMaster University research team and runs on a dedicated smartphone connected to the AR glasses. The application incorporates a machine learning model that adapts task difficulty according to individual participant performance using a challenge-point framework designed to maintain an approximately 80% task success rate. When performance exceeds this target, the system iteratively increases task difficulty, for example by increasing target speed or decreasing target size. When performance falls below the target, the system reduces task difficulty, for example by decreasing target speed or increasing target size. The model uses positional and movement data collected through the AR glasses together with training performance metrics, including target success rate, accuracy, response time, and movement speed, to evaluate participant performance and inform adjustments to training difficulty.
The primary objective is to evaluate the feasibility of the intervention based on participant retention, adherence to the prescribed training program, and weekly session completion. Secondary outcomes will characterize preliminary within-participant changes in balance, functional mobility, and balance confidence from baseline to immediately following the intervention. Assessments will include the Mini Balance Evaluation Systems Test (Mini-BESTest), Timed Up and Go (TUG), Activities-specific Balance Confidence (ABC) Scale, BTrack force plate assessments, and instrumented movement assessments using inertial measurement units (IMUs).
Findings from this feasibility study will inform the implementation and design of future studies evaluating individualized AR-based balance and mobility training in older adults.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will complete an 8-week AI-enhanced augmented reality (AR) balance and mobility training program, consisting of 3-5 sessions per week of approximately 30 minutes each. Using AR smart glasses connected to a dedicated smartphone, participants will perform standing- and walking-based tasks, including obstacle negotiation, path following, step targeting, turning, and directional changes. A machine learning model adapts task difficulty based on individual performance using a challenge-point framework targeting approximately 80% task success. Difficulty is iteratively increased or decreased based on performance, including adjustments to target speed and target size. Training may be completed at McMaster University or, following an initial supervised session and home safety assessment, at the participant's home.
Time frame: From baseline (T1) through post-intervention assessment (T2), approximately 8 weeks
Retention will be calculated as the percentage of enrolled participants who complete the post-intervention assessment (T2): number completing T2 divided by the number enrolled at baseline (T1), multiplied by 100.
Time frame: Throughout the 8-week intervention
Adherence will be calculated for each participant as the percentage of prescribed AR training sessions completed during the 8-week intervention. Participants are prescribed 3-5 sessions per week, with each session lasting approximately 30 minutes.
Time frame: Weekly throughout the 8-week intervention
Weekly training participation will be assessed based on the number of AR training sessions completed each week. Completion of 3-5 sessions per week will be used to characterize adherence to the intended training frequency.
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
The Mini-BESTest assesses dynamic balance across anticipatory postural control, reactive postural responses, sensory orientation, and gait stability. Total scores range from 0 to 28, with higher scores indicating better balance performance.
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Functional mobility will be assessed using the Timed Up and Go test. Participants stand from a seated position, walk 3 metres, turn, return, and sit down. Performance is measured in seconds, with shorter completion times indicating better functional mobility.
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
The Activities-specific Balance Confidence (ABC) Scale will assess perceived confidence in maintaining balance during everyday activities. Scores are expressed as a percentage, with higher scores indicating greater balance confidence.
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Limits of Stability will assess the participant's ability to voluntarily control center of pressure within the base of support. Participants move a cursor representing center of pressure across a computer display while standing on the BTrackS force plate. Performance is quantified by the area covered in square centimetres (cm²).
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Postural stability during quiet standing will be assessed using the BTrackS Fall Risk Assessment. Center-of-pressure path length is measured while participants stand with eyes closed and hands on their hips. The outcome is expressed as total center-of-pressure path length in centimetres.
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
The BTrackS Weight Distribution Test will assess left-right and front-back weight-bearing symmetry and center-of-pressure alignment while participants stand with their feet shoulder-width apart.
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Wearable inertial measurement units (IMUs) equipped with accelerometers and gyroscopes will be used during standardized walking and turning tasks to quantify spatiotemporal gait and turning characteristics, including gait timing, variability, and movement stability.
Contact information is provided by the study sponsor or research team.
McMaster University
Other
Artificial Intelligence-Enhanced Augmented Reality Training to Improve Mobility, Balance, and Prevent Falls in Older Adults: A Feasibility Study
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