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

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.

Study Overview

• Status: Recruiting
• Conditions: Dizziness; Falls (Accidents) in Old Age; Balance Assessment; Vestibular Dysfunction; Cognitive Function Decline; Dual-Task Performance
• Intervention / Treatment: Device: Instrumented balance and gait assessment using wearable inertial sensors; Other: Questionnaires and paper-based cognitive tests

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Po-Yin Chen, PhD; Phone Number: 67166 +886-2-2826-7000; Email: poyin1128@nycu.edu.tw
• Study Contact Backup: Name: Quan-Chen Wu, MS; Phone Number: 65925 +886-2-2826-7000; Email: kc1211.be14@nycu.edu.tw

Study Locations

• Taiwan
  • Taipei
    • Taipei, Taipei, Taiwan, 112
      • Recruiting
      • National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
      • Contact: Po-Yin Chen, Assistant Professor, PhD; Phone Number: 67166 +886-2-2826-7000; Email: poyin1128@nycu.edu.tw
      • Contact: Quan-Chen Wu, Research Assistant, MS; Phone Number: 65925 +886-2-2826-7000; Email: kc1211.be14@nycu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment-Taiwan version score (0-30points)	Total score on the Montreal Cognitive Assessment-Taiwan version, representing global cognitive function.	Baseline laboratory assessment
Path tracing completion time (s)	Time required to complete the Color Trails Test-1 task.	Baseline laboratory assessment
Stroop test score (count as PR1-99%)	Score of Stroop-type task, indicating inhibitory control and selective attention.	Baseline laboratory assessment
Working memory completion time (s)	Time required to complete the Color Trails Test-2 task.	Baseline laboratory assessment
Mental rotation accuracy (number of correct responses)(0-16)	Number of correct responses in the mental rotation task, reflecting visuospatial processing ability.	Baseline laboratory assessment
Mental rotation completion time (s)	Time required to complete the mental rotation task.	Baseline laboratory assessment
Activities-specific Balance Confidence score (0-100 points)	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)	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)	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)	Subscale score of the HADS assessing depressive symptoms; higher scores indicate greater depression.	Baseline laboratory assessment
Visual Vertigo Analogue Scale score ( 0-90points)	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)	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)	Combined score of balance and gait subscales in the Tinetti assessment; lower scores indicate higher overall fall risk.	Baseline laboratory assessment

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University
• Investigators: Principal Investigator: Po-Yin Chen, PhD, National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): March 11, 2027

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 26, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): July 29, 2026
• Last Update Submitted That Met QC Criteria: July 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dizziness; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: NYCU114022AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No