NCT07781995

Brief 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). 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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
21mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

November 30, 2026

Expected
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

August 19, 2026

Last Update Submit

August 21, 2026

Conditions

Keywords

Augmented RealityGaitBalanceFalls Prevention

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Weekly throughout the 8-week intervention

Secondary Outcomes (7)

  • Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Score

    Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks

  • Change in Timed Up and Go (TUG) Performance

    Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks

  • Change in Activities-specific Balance Confidence (ABC) Scale Score

    Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks

  • Change in BTrackS Limits of Stability

    Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks

  • Change in BTrackS Fall Risk Assessment

    Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks

  • +2 more secondary outcomes

Study Arms (1)

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.

Device: AI-Enhanced Augmented Reality Balance and Mobility Training

Interventions

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.

Participants receive the 8-week AI-enhanced AR balance and mobility training, 3-5 sessions per week.

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivor Wynne Center

Hamilton, Ontario, L8S 4L8, Canada

Location

Related Links

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Single-arm open-label feasibility study where all participants will receive intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start (Estimated)

November 30, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations