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临床试验/NCT07781995
NCT07781995尚未招募不适用

Artificial Intelligence-Enhanced Augmented Reality Training to Improve Mobility, Balance, and Prevent Falls in Older Adults: A Feasibility Study

McMaster University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Participant Retention Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Participant Retention Rate

时间窗: 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 AR Training Program

时间窗: 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 AR Training Session Completion

时间窗: 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.

Adherence to the Augmented Reality Training Program

时间窗: 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

时间窗: 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.

次要结局

  • Change in 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 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)
  • Change in BTrackS Weight Distribution(Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks)
  • Change in IMU-derived Gait and Turning Measures(Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks)
  • Change in Mini Balance Evaluation Systems Test (Mini-BESTest) Score(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 Inertial Measurement Unit (IMU)-derived Gait and Turning Measures(Baseline (T1) and immediately post-intervention (T2), approximately 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aimee Nelson

Professor

McMaster University

研究点 (1)

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