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RecruitingNCT07735078Updated Jul 29, 2026

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

An observational study in Vestibular Dysfunction, Dizziness and Falls (Accidents) in Old Age, sponsored by National Yang Ming Chiao Tung University. Recruiting at 1 site in Taiwan. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by National Yang Ming Chiao Tung University · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
55
Ages
55 Years and older
Sex
All
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Study 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.

02

Conditions studied

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

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03

In context

Dizziness

226 studies on the registry are indexed under Dizziness; 56 are open to participants now.

This study's planned enrollment of 55 is below the median of 126 across 44 observational studies indexed under Dizziness.

Browse Dizziness studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 208 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
55 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceInstrumented 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.

  • OtherQuestionnaires 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.

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What researchers measure

Primary outcomes

  1. Gait speed

    Average forward velocity of whole-body progression during walking, calculated as total distance divided by time.

    Time frame: Baseline laboratory assessment (single visit in year 1)

  2. Stride length (m)

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

    Time frame: Baseline laboratory assessment (single visit in year 1)

  3. Step width (m)

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

    Time frame: Baseline laboratory assessment (single visit in year 1)

  4. Cadence (steps/min)

    Number of steps taken per minute during walking.

    Time frame: Baseline laboratory assessment (single visit in year 1)

  5. Step-to-step variability (%)

    Variability of consecutive steps, typically quantified as the coefficient of variation of stride time or step length.

    Time frame: Baseline laboratory assessment (single visit in year 1)

  6. Trunk angular velocity (degrees/s)

    Rate of change in trunk segment orientation over time, derived from rotational kinematics.

    Time frame: Baseline laboratory assessment (single visit in year 1)

  7. Trunk angular displacement (degrees)

    Magnitude of trunk segment rotation relative to a reference orientation.

    Time frame: Baseline laboratory assessment (single visit in year 1)

  8. Center-of-mass displacement (m)

    Spatial excursion of the body's center of mass, typically analyzed in anterior-posterior and mediolateral directions during standing.

    Time frame: Baseline laboratory assessment (single visit in year 1)

  9. Response time (s or ms)

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

    Time frame: Baseline laboratory assessment (single visit in year 1)

Secondary outcomes

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

    Total score on the Montreal Cognitive Assessment-Taiwan version, representing global cognitive function.

    Time frame: Baseline laboratory assessment

  2. Path tracing completion time (s)

    Time required to complete the Color Trails Test-1 task.

    Time frame: Baseline laboratory assessment

  3. Stroop test score (count as PR1-99%)

    Score of Stroop-type task, indicating inhibitory control and selective attention.

    Time frame: Baseline laboratory assessment

  4. Working memory completion time (s)

    Time required to complete the Color Trails Test-2 task.

    Time frame: Baseline laboratory assessment

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

    Number of correct responses in the mental rotation task, reflecting visuospatial processing ability.

    Time frame: Baseline laboratory assessment

  6. Mental rotation completion time (s)

    Time required to complete the mental rotation task.

    Time frame: Baseline laboratory assessment

  7. 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.

    Time frame: Baseline laboratory assessment

  8. 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.

    Time frame: Baseline laboratory assessment

  9. Hospital Anxiety and Depression Scale - Anxiety score (0-21 points)

    Subscale score of the HADS assessing anxiety symptoms; higher scores indicate greater anxiety.

    Time frame: Baseline laboratory assessment

  10. Hospital Anxiety and Depression Scale - Depression score (0-21 points)

    Subscale score of the HADS assessing depressive symptoms; higher scores indicate greater depression.

    Time frame: Baseline laboratory assessment

  11. 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.

    Time frame: Baseline laboratory assessment

  12. 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.

    Time frame: Baseline laboratory assessment

  13. Tinetti total score (0-28 points)

    Combined score of balance and gait subscales in the Tinetti assessment; lower scores indicate higher overall fall risk.

    Time frame: Baseline laboratory assessment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07735078
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Feb 10, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Mar 11, 2027 (estimated)
Last update
Jul 29, 2026

Study contacts

Po-Yin Chen, PhD
Contact
poyin1128@nycu.edu.tw
+886-2-2826-7000 ext. 67166
Quan-Chen Wu, MS
Contact
kc1211.be14@nycu.edu.tw
+886-2-2826-7000 ext. 65925
Po-Yin Chen, PhD
principal investigator · National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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