Идёт набор NCT07735078

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

— Наблюдательное Vestibular Dysfunction Dizziness Falls (Accidents) in Old Age Balance Assessment

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Instrumented balance and gait assessment using wearable inertial sensors, Questionnaires and paper-based cognitive tests.
Кому может быть актуально: Состояния в реестре: Vestibular Dysfunction, Dizziness, Falls (Accidents) in Old Age, Balance Assessment. Базовые параметры: от 55 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

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.

Вмешательства

Устройство 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.
Другое 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.

Первичные конечные точки

Gait speed [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Stride length (m) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Step width (m) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Cadence (steps/min) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Step-to-step variability (%) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Trunk angular velocity (degrees/s) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Trunk angular displacement (degrees) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Center-of-mass displacement (m) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]
Response time (s or ms) [Срок оценки: Baseline laboratory assessment (single visit in year 1)]

Вторичные конечные точки (12)

Montreal Cognitive Assessment-Taiwan version score (0-30points) [Срок оценки: Baseline laboratory assessment]
Path tracing completion time (s) [Срок оценки: Baseline laboratory assessment]
Stroop test score (count as PR1-99%) [Срок оценки: Baseline laboratory assessment]
Working memory completion time (s) [Срок оценки: Baseline laboratory assessment]
Mental rotation accuracy (number of correct responses)(0-16) [Срок оценки: Baseline laboratory assessment]
Mental rotation completion time (s) [Срок оценки: Baseline laboratory assessment]
Activities-specific Balance Confidence score (0-100 points) [Срок оценки: Baseline laboratory assessment]
Dizziness Handicap Inventory score (0-100points) [Срок оценки: Baseline laboratory assessment]
Hospital Anxiety and Depression Scale - Anxiety score (0-21 points) [Срок оценки: Baseline laboratory assessment]
Hospital Anxiety and Depression Scale - Depression score (0-21 points) [Срок оценки: Baseline laboratory assessment]
Visual Vertigo Analogue Scale score ( 0-90points) [Срок оценки: Baseline laboratory assessment]
Dynamic Gait Index score (0-24 points) [Срок оценки: Baseline laboratory assessment]

Критерии участия

Критерии включения

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.