Vestibular Balance-Cognition Dual-Task Digital System: Development of a Smart Rehabilitation Platform for the Elderly and Prediction of Balance Function Risks
2026년 7월 26일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
관찰
등록 (추정된)
등록
55
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Po-Yin Chen, PhD
- 전화번호: 67166 +886-2-2826-7000
- 이메일: poyin1128@nycu.edu.tw
연구 연락처 백업
- 이름: Quan-Chen Wu, MS
- 전화번호: 65925 +886-2-2826-7000
- 이메일: kc1211.be14@nycu.edu.tw
연구 장소
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Taipei
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Taipei, Taipei, 대만, 112
- 모병
- National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
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연락하다:
- Po-Yin Chen, Assistant Professor, PhD
- 전화번호: 67166 +886-2-2826-7000
- 이메일: poyin1128@nycu.edu.tw
-
연락하다:
- Quan-Chen Wu, Research Assistant, MS
- 전화번호: 65925 +886-2-2826-7000
- 이메일: kc1211.be14@nycu.edu.tw
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
비확률 샘플
연구 인구
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.
설명
Inclusion Criteria:
- Community-dwelling adults aged 55 years or older.
- Able to walk at least 30 meters independently or with the use of a walking aid.
- Able to understand the study procedures and communicate in Mandarin or Taiwanese.
- Adequate corrected vision to go out independently.
- Able to participate in 45-minute sessions of moderate-intensity exercise once per week.
Exclusion Criteria:
- Severe central or peripheral neurological diseases.
- Blindness or deafness.
- Inability to communicate verbally or to understand simple instructions.
- Current fractures or major joint injuries.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
1
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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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.
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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.
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gait speed
기간: Baseline laboratory assessment (single visit in year 1)
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Average forward velocity of whole-body progression during walking, calculated as total distance divided by time.
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Baseline laboratory assessment (single visit in year 1)
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Stride length (m)
기간: Baseline laboratory assessment (single visit in year 1)
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Linear distance between two consecutive initial contacts of the same foot.
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Baseline laboratory assessment (single visit in year 1)
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Step width (m)
기간: Baseline laboratory assessment (single visit in year 1)
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Mediolateral distance between consecutive foot placements, representing base of support during gait.
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Baseline laboratory assessment (single visit in year 1)
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Cadence (steps/min)
기간: Baseline laboratory assessment (single visit in year 1)
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Number of steps taken per minute during walking.
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Baseline laboratory assessment (single visit in year 1)
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Step-to-step variability (%)
기간: Baseline laboratory assessment (single visit in year 1)
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Variability of consecutive steps, typically quantified as the coefficient of variation of stride time or step length.
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Baseline laboratory assessment (single visit in year 1)
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Trunk angular velocity (degrees/s)
기간: Baseline laboratory assessment (single visit in year 1)
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Rate of change in trunk segment orientation over time, derived from rotational kinematics.
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Baseline laboratory assessment (single visit in year 1)
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Trunk angular displacement (degrees)
기간: Baseline laboratory assessment (single visit in year 1)
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Magnitude of trunk segment rotation relative to a reference orientation.
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Baseline laboratory assessment (single visit in year 1)
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Center-of-mass displacement (m)
기간: Baseline laboratory assessment (single visit in year 1)
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Spatial excursion of the body's center of mass, typically analyzed in anterior-posterior and mediolateral directions during standing.
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Baseline laboratory assessment (single visit in year 1)
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Response time (s or ms)
기간: Baseline laboratory assessment (single visit in year 1)
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Time elapsed between stimulus onset and initiation of a motor response.
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Baseline laboratory assessment (single visit in year 1)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Montreal Cognitive Assessment-Taiwan version score (0-30points)
기간: Baseline laboratory assessment
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Total score on the Montreal Cognitive Assessment-Taiwan version, representing global cognitive function.
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Baseline laboratory assessment
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Path tracing completion time (s)
기간: Baseline laboratory assessment
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Time required to complete the Color Trails Test-1 task.
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Baseline laboratory assessment
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Stroop test score (count as PR1-99%)
기간: Baseline laboratory assessment
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Score of Stroop-type task, indicating inhibitory control and selective attention.
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Baseline laboratory assessment
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Working memory completion time (s)
기간: Baseline laboratory assessment
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Time required to complete the Color Trails Test-2 task.
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Baseline laboratory assessment
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Mental rotation accuracy (number of correct responses)(0-16)
기간: Baseline laboratory assessment
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Number of correct responses in the mental rotation task, reflecting visuospatial processing ability.
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Baseline laboratory assessment
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Mental rotation completion time (s)
기간: Baseline laboratory assessment
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Time required to complete the mental rotation task.
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Baseline laboratory assessment
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Activities-specific Balance Confidence score (0-100 points)
기간: Baseline laboratory assessment
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Total score on the Activities-specific Balance Confidence (ABC) scale, reflecting perceived balance confidence during daily activities; higher scores indicate greater confidence.
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Baseline laboratory assessment
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Dizziness Handicap Inventory score (0-100points)
기간: Baseline laboratory assessment
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Total score on the Dizziness Handicap Inventory (DHI), representing self-perceived handicap due to dizziness; higher scores indicate greater disability.
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Baseline laboratory assessment
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Hospital Anxiety and Depression Scale - Anxiety score (0-21 points)
기간: Baseline laboratory assessment
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Subscale score of the HADS assessing anxiety symptoms; higher scores indicate greater anxiety.
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Baseline laboratory assessment
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Hospital Anxiety and Depression Scale - Depression score (0-21 points)
기간: Baseline laboratory assessment
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Subscale score of the HADS assessing depressive symptoms; higher scores indicate greater depression.
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Baseline laboratory assessment
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Visual Vertigo Analogue Scale score ( 0-90points)
기간: Baseline laboratory assessment
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Self-reported severity of visually induced dizziness measured using a visual analogue scale; higher scores indicate greater symptom severity.
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Baseline laboratory assessment
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Dynamic Gait Index score (0-24 points)
기간: Baseline laboratory assessment
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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
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Tinetti total score (0-28 points)
기간: Baseline laboratory assessment
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Combined score of balance and gait subscales in the Tinetti assessment; lower scores indicate higher overall fall risk.
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Baseline laboratory assessment
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Po-Yin Chen, PhD, National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2025년 2월 10일
기본 완료 (추정된)
기본 완료
2026년 7월 31일
연구 완료 (추정된)
연구 완료
2027년 3월 11일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 8일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 26일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 29일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 26일
마지막으로 확인됨
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NYCU114022AF
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .