Older AdultsNCT07781995
AI-Adaptive AR Training for Balance and Falls Prevention in Older Adults
A study testing AI-Enhanced Augmented Reality Balance and Mobility Training in people with Older Adults and Older Adults, Balance, run by McMaster University at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Older Adults, Older Adults, Balance
- What is being tested?
- AI-Enhanced Augmented Reality Balance and Mobility Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 55 - 80 years
- Able to ambulate independently with or without an assistive device
- Able to understand and follow instructions unimpeded by significant cognitive barriers (MoCA score must be 24/30 or higher)
- Self-reported balance concerns or perceived risk of falls (e.g., reduced balance confidence)
- Must be able to provide a list of current medications to the experimenters and the changes in medications during the study
- Vision that normal or near normal with/without the use of glasses/lenses
- Able to understand and follow study instructions in English
Who cannot join
- Engaging in any additional balance or mobility training programs while participating in the study
- Diagnosed neurological conditions that substantially impair balance or mobility (e.g., stroke, Parkinson's disease, Traumatic Brain Injury)
- Medical conditions that contraindicate moderate physical activity
- Vision impairment that cannot be corrected by glasses or lenses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiru Wang contact
Canada1 site
Ivor Wynne Center
Hamilton, Ontario, L8S 4L8
Aimee Nelson, 9055259140 ext. 28053, nelsonaj@mcmaster.ca
About this study
Official title: Artificial Intelligence-Enhanced Augmented Reality Training to Improve Mobility, Balance, and Prevent Falls in Older Adults: A Feasibility Study
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.
Read the detailed description
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.
- Conditions
- Older Adults, Older Adults, Balance
- Being tested
- AI-Enhanced Augmented Reality Balance and Mobility Training
- Keywords
- Augmented Reality, Gait, Balance, Falls Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Enhanced Augmented Reality Balance and Mobility TrainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants receive the 8-week AI-enhanced AR balance and mobility training, 3-5 sessions per week. | Experimental | Participants will complete an 8-week AI-enhanced augmented reality balance and mobility training program, with 3-5 sessions per week lasting approximately 30 minutes each. Training includes standing- and walking-based tasks such as obstacle negotiation, path following, step targeting, turning, and directional changes. Task difficulty is adaptively adjusted based on participant performance using a machine learning model designed to maintain an approximately 80% task success rate. Receives: Device: AI-Enhanced Augmented Reality Balance and Mobility Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention Rate
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.
Measured: From baseline (T1) through post-intervention assessment (T2), approximately 8 weeks
Adherence to the Augmented Reality Training Program
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.
Measured: Throughout the 8-week intervention
Weekly Augmented Reality Training Session Completion
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.
Measured: Weekly throughout the 8-week intervention
Secondary outcomes (7)
Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Score
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.
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in Timed Up and Go (TUG) Performance
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.
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in Activities-specific Balance Confidence (ABC) Scale Score
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.
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in BTrackS Limits of Stability
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).
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in BTrackS Fall Risk Assessment
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.
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in BTrackS Weight Distribution
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.
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in Inertial Measurement Unit (IMU)-derived Gait and Turning Measures
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.
Measured: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by McMaster 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm open-label feasibility study where all participants will receive intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee Nelson, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781995
- Sponsor's protocol ID
- 20142
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Enhanced Augmented Reality Training to Improve Mobility, Balance, and Prevent Falls in Older Adults: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07781995
- Acronym / sponsor ID
- 20142
- Conditions
- Older Adults, Older Adults, Balance
- Keywords
- Augmented Reality, Gait, Balance, Falls Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 24 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm open-label feasibility study where all participants will receive intervention.
| Arm | Type | Receives |
|---|---|---|
| Participants receive the 8-week AI-enhanced AR balance and mobility training, 3-5 sessions per week. | Experimental | Device: AI-Enhanced Augmented Reality Balance and Mobility TrainingParticipants will complete an 8-week AI-enhanced augmented reality balance and mobility training program, with 3-5 sessions per week lasting approximately 30 minutes each. Training includes standing- and walking-based tasks such as obstacle negotiation, path following, step targeting, turning, and directional changes. Task difficulty is adaptively adjusted based on participant performance using a machine learning model designed to maintain an approximately 80% task success rate. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 55 - 80 years
- Able to ambulate independently with or without an assistive device
- Able to understand and follow instructions unimpeded by significant cognitive barriers (MoCA score must be 24/30 or higher)
- Self-reported balance concerns or perceived risk of falls (e.g., reduced balance confidence)
- Must be able to provide a list of current medications to the experimenters and the changes in medications during the study
Key exclusion criteria (4 listed)
- Engaging in any additional balance or mobility training programs while participating in the study
- Diagnosed neurological conditions that substantially impair balance or mobility (e.g., stroke, Parkinson's disease, Traumatic Brain Injury)
- Medical conditions that contraindicate moderate physical activity
- Vision impairment that cannot be corrected by glasses or lenses
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 |
|---|---|---|
| AI-Enhanced Augmented Reality Balance and Mobility TrainingParticipants 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. | Device | Participants receive the 8-week AI-enhanced AR balance and mobility training, 3-5 sessions per week. |
Primary outcome
Participant Retention Rate
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.
Adherence to the Augmented Reality Training Program
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.
Weekly Augmented Reality Training Session Completion
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.
7 secondary outcomes
Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Score
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in Timed Up and Go (TUG) Performance
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in Activities-specific Balance Confidence (ABC) Scale Score
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in BTrackS Limits of Stability
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in BTrackS Fall Risk Assessment
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in BTrackS Weight Distribution
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Change in Inertial Measurement Unit (IMU)-derived Gait and Turning Measures
Time frame: Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Chen W, Li M, Li H, Lin Y and Feng Z (2023) Tai Chi for fall prevention and balance improvement in older adults: a systematic review and meta-analysis of randomized controlled trials. Front.Link provided by the sponsor.
- Pillay, J., Gaudet, L.A., Saba, S. et al. Falls prevention interventions for community-dwelling older adults: systematic review and meta-analysis of benefits, harms, and patient values and preferences.Link provided by the sponsor.
- Yoo HN, Chung E, Lee BH. The Effects of Augmented Reality-based Otago Exercise on Balance, Gait, and Falls Efficacy of Elderly Women. J Phys Ther Sci.Link provided by the sponsor.
- Chen PJ, Penn IW, Wei SH, Chuang LR, Sung WH. Augmented reality-assisted training with selected Tai-Chi movements improves balance control and increases lower limb muscle strength in older adults: A prospective randomized trial. J Exerc Sci Fit.Link provided by the sponsor.
- Im DJ, Ku J, Kim YJ, Cho S, Cho YK, Lim T, Lee HS, Kim HJ, Kang YJ. Utility of a Three-Dimensional Interactive Augmented Reality Program for Balance and Mobility Rehabilitation in the Elderly: A Feasibility Study. Ann Rehabil Med.Link provided by the sponsor.
- Vieira ER, Civitella F, Carreno J, Junior MG, Amorim CF, D'Souza N, Ozer E, Ortega F, Estrázulas JA. Using Augmented Reality with Older Adults in the Community to Select Design Features for an Age-Friendly Park: A Pilot Study. J Aging Res.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Xiru Wang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Enhanced Augmented Reality Balance and Mobility Training in people with Older Adults and Older Adults, Balance, run by McMaster 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimee Nelson ((905) 525-9140 ext. 28053, nelsonaj@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Rate (time frame: From baseline (T1) through post-intervention assessment (T2), approximately 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2026.