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

NCT07735078 | Recruiting DMC

• 1 other identifier: NYCU114022AF
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vestibular Dysfunction; Dizziness; Falls (Accidents) in Old Age; Balance Assessment; Cognitive Function Decline; Dual-Task Performance

Outcome Measures

Primary Outcomes (9)

• Gait speed

  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)

  Linear distance between two consecutive initial contacts of the same foot.

  Baseline laboratory assessment (single visit in year 1)

• Step width (m)

  Mediolateral distance between consecutive foot placements, representing base of support during gait.

  Baseline laboratory assessment (single visit in year 1)

• Cadence (steps/min)

  Number of steps taken per minute during walking.

  Baseline laboratory assessment (single visit in year 1)

• Step-to-step variability (%)

  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)

  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)

  Magnitude of trunk segment rotation relative to a reference orientation.

  Baseline laboratory assessment (single visit in year 1)

• Center-of-mass displacement (m)

  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)

  Time elapsed between stimulus onset and initiation of a motor response.

  Baseline laboratory assessment (single visit in year 1)

Secondary Outcomes (13)

• Montreal Cognitive Assessment-Taiwan version score (0-30points)

  Baseline laboratory assessment

• Path tracing completion time (s)

  Baseline laboratory assessment

• Stroop test score (count as PR1-99%)

  Baseline laboratory assessment

• Working memory completion time (s)

  Baseline laboratory assessment

• Mental rotation accuracy (number of correct responses)(0-16)

  Baseline laboratory assessment

Study Arms (1)

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.

Device: Instrumented balance and gait assessment using wearable inertial sensors; Other: Questionnaires and paper-based cognitive tests

Interventions

Instrumented balance and gait assessment using wearable inertial sensors DEVICE

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.

Healthy Older Adults

Questionnaires and paper-based cognitive tests OTHER

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.

Healthy Older Adults

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Severe central or peripheral neurological diseases.
• Blindness or deafness.
• Inability to communicate verbally or to understand simple instructions.
• Current fractures or major joint injuries.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

Taipei, Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Dizziness

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Po-Yin Chen, PhD

  National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Po-Yin Chen, PhD

CONTACT

+886-2-2826-7000; poyin1128@nycu.edu.tw

Quan-Chen Wu, MS

CONTACT

+886-2-2826-7000; kc1211.be14@nycu.edu.tw

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 29, 2026
• Study Start: February 10, 2025
• Primary Completion: July 31, 2026
• Study Completion (Estimated): March 11, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

TW (1)