Vestibular Balance-Cognition Dual-Task Digital System: Development of a Smart Rehabilitation Platform for the Elderly and Prediction of Balance Function Risks
26 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
55
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Po-Yin Chen, PhD
- Número de teléfono: 67166 +886-2-2826-7000
- Correo electrónico: poyin1128@nycu.edu.tw
Copia de seguridad de contactos de estudio
- Nombre: Quan-Chen Wu, MS
- Número de teléfono: 65925 +886-2-2826-7000
- Correo electrónico: kc1211.be14@nycu.edu.tw
Ubicaciones de estudio
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Taipei
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Taipei, Taipei, Taiwán, 112
- Reclutamiento
- National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
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Contacto:
- Po-Yin Chen, Assistant Professor, PhD
- Número de teléfono: 67166 +886-2-2826-7000
- Correo electrónico: poyin1128@nycu.edu.tw
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Contacto:
- Quan-Chen Wu, Research Assistant, MS
- Número de teléfono: 65925 +886-2-2826-7000
- Correo electrónico: kc1211.be14@nycu.edu.tw
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gait speed
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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 (%)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Montreal Cognitive Assessment-Taiwan version score (0-30points)
Periodo de tiempo: 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)
Periodo de tiempo: 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%)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline laboratory assessment
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Tinetti total score (0-28 points)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Po-Yin Chen, PhD, National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de febrero de 2025
Finalización primaria (Estimado)
31 de julio de 2026
Finalización del estudio (Estimado)
11 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de julio de 2026
Publicado por primera vez (Actual)
29 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Trastornos sensoriales
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Mareo
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Encuestas y cuestionarios
Otros números de identificación del estudio
- NYCU114022AF
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .