Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

26 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Estimado)

55

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 112
        • Recrutamento
        • National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
        • Contato:
          • Po-Yin Chen, Assistant Professor, PhD
          • Número de telefone: 67166 +886-2-2826-7000
          • E-mail: poyin1128@nycu.edu.tw
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Dispositivo: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Gait speed
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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 (%)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Yang Ming Chiao Tung University

Investigadores

  • Investigador principal: Po-Yin Chen, PhD, National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de fevereiro de 2025

Conclusão Primária (Estimado)

31 de julho de 2026

Conclusão do estudo (Estimado)

11 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de julho de 2026

Primeira postagem (Real)

29 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de julho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NYCU114022AF

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de 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.

Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever