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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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

観察的

入学 (推定)

55

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • 台湾
    • Taipei
      • Taipei、Taipei、台湾、112
        • 募集
        • National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
        • コンタクト：
          • Po-Yin Chen, Assistant Professor, PhD
          • 電話番号：67166 +886-2-2826-7000
          • メール：poyin1128@nycu.edu.tw
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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.
デバイス：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Gait speed
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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 (%)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Montreal Cognitive Assessment-Taiwan version score (0-30points)
時間枠：Baseline laboratory assessment
Total score on the Montreal Cognitive Assessment-Taiwan version, representing global cognitive function.
Baseline laboratory assessment
Path tracing completion time (s)
時間枠：Baseline laboratory assessment
Time required to complete the Color Trails Test-1 task.
Baseline laboratory assessment
Stroop test score (count as PR1-99%)
時間枠：Baseline laboratory assessment
Score of Stroop-type task, indicating inhibitory control and selective attention.
Baseline laboratory assessment
Working memory completion time (s)
時間枠：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)
時間枠：Baseline laboratory assessment
Number of correct responses in the mental rotation task, reflecting visuospatial processing ability.
Baseline laboratory assessment
Mental rotation completion time (s)
時間枠：Baseline laboratory assessment
Time required to complete the mental rotation task.
Baseline laboratory assessment
Activities-specific Balance Confidence score (0-100 points)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Baseline laboratory assessment
Combined score of balance and gait subscales in the Tinetti assessment; lower scores indicate higher overall fall risk.
Baseline laboratory assessment

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

National Yang Ming Chiao Tung University

捜査官

  • 主任研究者：Po-Yin Chen, PhD、National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年2月10日

一次修了 (推定)

2026年7月31日

研究の完了 (推定)

2027年3月11日

試験登録日

最初に提出

2026年7月8日

QC基準を満たした最初の提出物

2026年7月26日

最初の投稿 (実際)

2026年7月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月29日

QC基準を満たした最後の更新が送信されました

2026年7月26日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • NYCU114022AF

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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