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Vestibular Balance-Cognition Dual-Task Digital System: Development of a Smart Rehabilitation Platform for the Elderly and Prediction of Balance Function Risks

2026年7月26日 更新者：National Yang Ming Chiao Tung University
This study is being done to better understand how vestibular problems and thinking abilities (such as attention and mental flexibility) are related in older adults, and how doing a balance task and a thinking task at the same time affects their performance. Older adults will first complete questionnaires and simple paper-and-pencil tests of attention, memory, and mental rotation while seated. They will then perform standing balance tasks on a portable force platform under different conditions (eyes open, eyes closed, standing on a foam surface) and will repeat some of the thinking tasks at the same time. Next, participants will walk on a treadmill while wearing small motion sensors, both with and without added thinking tasks such as serial subtraction and digit reordering. The total testing time is about 90 minutes. Two groups will be included: healthy older adults and older adults who have had dizziness or falls in the past two years. By comparing these groups, the study aims to provide a basis for designing future dual-task assessment and training programs to reduce balance problems and falls in older adults.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

55

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 台湾
    • Taipei
      • Taipei、Taipei、台湾、112
        • 招聘中
        • National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
        • 接触：
          • Po-Yin Chen, Assistant Professor, PhD
          • 电话号码：67166 +886-2-2826-7000
          • 邮箱：poyin1128@nycu.edu.tw
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Community-dwelling older adults aged 55 years and older without severe neurological, sensory, or musculoskeletal conditions, who can walk at least 30 meters independently or with a walking aid, communicate in Mandarin or Taiwanese, and safely participate in weekly moderate-intensity exercise sessions.

描述

Inclusion Criteria:

  1. Community-dwelling adults aged 55 years or older.
  2. Able to walk at least 30 meters independently or with the use of a walking aid.
  3. Able to understand the study procedures and communicate in Mandarin or Taiwanese.
  4. Adequate corrected vision to go out independently.
  5. Able to participate in 45-minute sessions of moderate-intensity exercise once per week.

Exclusion Criteria:

  1. Severe central or peripheral neurological diseases.
  2. Blindness or deafness.
  3. Inability to communicate verbally or to understand simple instructions.
  4. Current fractures or major joint injuries.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Healthy Older Adults
Community-dwelling older adults aged 55 years and older who are able to walk at least 30 meters independently or with a walking aid, can communicate in Mandarin or Taiwanese, have adequate corrected vision to go out independently, and can participate in 45-minute sessions of moderate-intensity exercise once per week. Individuals with severe central or peripheral neurological diseases, blindness or deafness, inability to communicate verbally or understand instructions, or current fractures or major joint injuries will be excluded.
设备：Instrumented balance and gait assessment using wearable inertial sensors
Participants undergo a series of static and dynamic balance and gait assessments in a motion analysis laboratory while wearing body-segment inertial measurement units (IMUs). The sensors provide real-time signals for interaction with the evaluation system during single-task and dual-task standing and walking tests.
其他：Questionnaires and paper-based cognitive tests
Participants complete a battery of self-report questionnaires and paper-based cognitive tests after explanation by a physical therapist. Instruments include dizziness and balance scales, the Activities-specific Balance Confidence (ABC) scale, and cognitive tests such as the WAIS-III Taiwan Digit Odd-Even Sequencing Test, Taiwan Stroop Word-Color Test, path judgment tasks, and mental rotation tasks. Questionnaires are administered verbally and responses recorded in writing.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Gait speed
大体时间：Baseline laboratory assessment (single visit in year 1)
Average forward velocity of whole-body progression during walking, calculated as total distance divided by time.
Baseline laboratory assessment (single visit in year 1)
Stride length (m)
大体时间：Baseline laboratory assessment (single visit in year 1)
Linear distance between two consecutive initial contacts of the same foot.
Baseline laboratory assessment (single visit in year 1)
Step width (m)
大体时间：Baseline laboratory assessment (single visit in year 1)
Mediolateral distance between consecutive foot placements, representing base of support during gait.
Baseline laboratory assessment (single visit in year 1)
Cadence (steps/min)
大体时间：Baseline laboratory assessment (single visit in year 1)
Number of steps taken per minute during walking.
Baseline laboratory assessment (single visit in year 1)
Step-to-step variability (%)
大体时间：Baseline laboratory assessment (single visit in year 1)
Variability of consecutive steps, typically quantified as the coefficient of variation of stride time or step length.
Baseline laboratory assessment (single visit in year 1)
Trunk angular velocity (degrees/s)
大体时间：Baseline laboratory assessment (single visit in year 1)
Rate of change in trunk segment orientation over time, derived from rotational kinematics.
Baseline laboratory assessment (single visit in year 1)
Trunk angular displacement (degrees)
大体时间：Baseline laboratory assessment (single visit in year 1)
Magnitude of trunk segment rotation relative to a reference orientation.
Baseline laboratory assessment (single visit in year 1)
Center-of-mass displacement (m)
大体时间：Baseline laboratory assessment (single visit in year 1)
Spatial excursion of the body's center of mass, typically analyzed in anterior-posterior and mediolateral directions during standing.
Baseline laboratory assessment (single visit in year 1)
Response time (s or ms)
大体时间：Baseline laboratory assessment (single visit in year 1)
Time elapsed between stimulus onset and initiation of a motor response.
Baseline laboratory assessment (single visit in year 1)

次要结果测量

结果测量
措施说明
大体时间
Montreal Cognitive Assessment-Taiwan version score (0-30points)
大体时间：Baseline laboratory assessment
Total score on the Montreal Cognitive Assessment-Taiwan version, representing global cognitive function.
Baseline laboratory assessment
Path tracing completion time (s)
大体时间：Baseline laboratory assessment
Time required to complete the Color Trails Test-1 task.
Baseline laboratory assessment
Stroop test score (count as PR1-99%)
大体时间：Baseline laboratory assessment
Score of Stroop-type task, indicating inhibitory control and selective attention.
Baseline laboratory assessment
Working memory completion time (s)
大体时间：Baseline laboratory assessment
Time required to complete the Color Trails Test-2 task.
Baseline laboratory assessment
Mental rotation accuracy (number of correct responses)(0-16)
大体时间：Baseline laboratory assessment
Number of correct responses in the mental rotation task, reflecting visuospatial processing ability.
Baseline laboratory assessment
Mental rotation completion time (s)
大体时间：Baseline laboratory assessment
Time required to complete the mental rotation task.
Baseline laboratory assessment
Activities-specific Balance Confidence score (0-100 points)
大体时间：Baseline laboratory assessment
Total score on the Activities-specific Balance Confidence (ABC) scale, reflecting perceived balance confidence during daily activities; higher scores indicate greater confidence.
Baseline laboratory assessment
Dizziness Handicap Inventory score (0-100points)
大体时间：Baseline laboratory assessment
Total score on the Dizziness Handicap Inventory (DHI), representing self-perceived handicap due to dizziness; higher scores indicate greater disability.
Baseline laboratory assessment
Hospital Anxiety and Depression Scale - Anxiety score (0-21 points)
大体时间：Baseline laboratory assessment
Subscale score of the HADS assessing anxiety symptoms; higher scores indicate greater anxiety.
Baseline laboratory assessment
Hospital Anxiety and Depression Scale - Depression score (0-21 points)
大体时间：Baseline laboratory assessment
Subscale score of the HADS assessing depressive symptoms; higher scores indicate greater depression.
Baseline laboratory assessment
Visual Vertigo Analogue Scale score ( 0-90points)
大体时间：Baseline laboratory assessment
Self-reported severity of visually induced dizziness measured using a visual analogue scale; higher scores indicate greater symptom severity.
Baseline laboratory assessment
Dynamic Gait Index score (0-24 points)
大体时间：Baseline laboratory assessment
Total score on the Dynamic Gait Index, based on performance across eight functional gait tasks; lower scores indicate poorer gait performance and increased fall risk.
Baseline laboratory assessment
Tinetti total score (0-28 points)
大体时间：Baseline laboratory assessment
Combined score of balance and gait subscales in the Tinetti assessment; lower scores indicate higher overall fall risk.
Baseline laboratory assessment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Yang Ming Chiao Tung University

调查人员

  • 首席研究员：Po-Yin Chen, PhD、National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月10日

初级完成 (估计的)

2026年7月31日

研究完成 (估计的)

2027年3月11日

研究注册日期

首次提交

2026年7月8日

首先提交符合 QC 标准的

2026年7月26日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月29日

上次提交的符合 QC 标准的更新

2026年7月26日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NYCU114022AF

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data (IPD) will be shared for research purposes. The data set will include key demographic variables, vestibular-related cognitive test scores, instrumented balance and gait parameters from wearable inertial sensors, static balance metrics, and questionnaire/scale scores (e.g., ABC, DHI, VVAS, HADS, DGI, Tinetti, MoCA-TW), with all direct identifiers removed. A detailed data dictionary and description of derived variables will be provided to support secondary analyses.

IPD 共享时间框架

IPD will be made available within 12 months after publication of the primary results manuscript and will remain accessible for at least 5 years thereafter.

IPD 共享访问标准

De-identified IPD will be shared with qualified researchers from academic or healthcare institutions for non-commercial research on vestibular, balance, gait, cognitive, or related geriatric health topics. Investigators must submit a brief proposal specifying objectives, planned analyses, and ethical approvals. Proposals will be reviewed by the study team, and, if approved, data will be provided via secure transfer following execution of a data use agreement that requires protection of confidentiality, prohibits re-identification, and mandates appropriate citation of the original trial in all publications.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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