Vestibular DysfunctionNCT07735078
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 of Vestibular Dysfunction and Dizziness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vestibular Dysfunction, Dizziness, Falls (Accidents) in Old Age
- What is being tested?
- Instrumented balance and gait assessment using wearable inertial sensors and Questionnaires and paper-based cognitive tests
- Type of treatment
- Medical device
- How many people
- 55 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Feb 2025to 11 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Severe central or peripheral neurological diseases.
- Blindness or deafness.
- Inability to communicate verbally or to understand simple instructions.
- Current fractures or major joint injuries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
Taipei, Taipei, 112
Po-Yin Chen, Assistant Professor, PhD, +886-2-2826-7000 ext. 67166, poyin1128@nycu.edu.tw
Quan-Chen Wu, Research Assistant, MS, +886-2-2826-7000 ext. 65925, kc1211.be14@nycu.edu.tw
About this study
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
- Being tested
- Instrumented balance and gait assessment using wearable inertial sensors, Questionnaires and paper-based cognitive tests
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented balance and gait assessment using wearable inertial sensorsDevice
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.
Questionnaires and paper-based cognitive testsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Instrumented balance and gait assessment using wearable inertial sensors; Other: Questionnaires and paper-based cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
Average forward velocity of whole-body progression during walking, calculated as total distance divided by time.
Measured: Baseline laboratory assessment (single visit in year 1)
Stride length (m)
Linear distance between two consecutive initial contacts of the same foot.
Measured: Baseline laboratory assessment (single visit in year 1)
Step width (m)
Mediolateral distance between consecutive foot placements, representing base of support during gait.
Measured: Baseline laboratory assessment (single visit in year 1)
Cadence (steps/min)
Number of steps taken per minute during walking.
Measured: 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.
Measured: 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.
Measured: Baseline laboratory assessment (single visit in year 1)
Trunk angular displacement (degrees)
Magnitude of trunk segment rotation relative to a reference orientation.
Measured: 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.
Measured: Baseline laboratory assessment (single visit in year 1)
Response time (s or ms)
Time elapsed between stimulus onset and initiation of a motor response.
Measured: Baseline laboratory assessment (single visit in year 1)
Secondary outcomes (13)
Montreal Cognitive Assessment-Taiwan version score (0-30points)
Total score on the Montreal Cognitive Assessment-Taiwan version, representing global cognitive function.
Measured: Baseline laboratory assessment
Path tracing completion time (s)
Time required to complete the Color Trails Test-1 task.
Measured: Baseline laboratory assessment
Stroop test score (count as PR1-99%)
Score of Stroop-type task, indicating inhibitory control and selective attention.
Measured: Baseline laboratory assessment
Working memory completion time (s)
Time required to complete the Color Trails Test-2 task.
Measured: 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.
Measured: Baseline laboratory assessment
Mental rotation completion time (s)
Time required to complete the mental rotation task.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline laboratory assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start10 Feb 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion11 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DysfunctionStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Yin Chen, PhD, Principal investigator, National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735078
- Sponsor's protocol ID
- NYCU114022AF
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular Balance-Cognition Dual-Task Digital System: Development of a Smart Rehabilitation Platform for the Elderly and Prediction of Balance Function Risks
- ClinicalTrials.gov ID
- NCT07735078
- Acronym / sponsor ID
- NYCU114022AF
- Conditions
- Vestibular Dysfunction, Dizziness, Falls (Accidents) in Old Age, Balance Assessment, Cognitive Function Decline, Dual-Task Performance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 11 Mar 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Older Adults | – | Device: Instrumented balance and gait assessment using wearable inertial sensors, Other: Questionnaires and paper-based cognitive testsCommunity-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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Severe central or peripheral neurological diseases.
- Blindness or deafness.
- Inability to communicate verbally or to understand simple instructions.
- Current fractures or major joint injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumented balance and gait assessment using wearable inertial sensorsParticipants 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. | Device | Healthy Older Adults |
| Questionnaires and paper-based cognitive testsParticipants 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. | Other | Healthy Older Adults |
Primary outcome
Gait speed
Time frame: Baseline laboratory assessment (single visit in year 1)
Average forward velocity of whole-body progression during walking, calculated as total distance divided by time.
Stride length (m)
Time frame: Baseline laboratory assessment (single visit in year 1)
Linear distance between two consecutive initial contacts of the same foot.
Step width (m)
Time frame: Baseline laboratory assessment (single visit in year 1)
Mediolateral distance between consecutive foot placements, representing base of support during gait.
Cadence (steps/min)
Time frame: Baseline laboratory assessment (single visit in year 1)
Number of steps taken per minute during walking.
Step-to-step variability (%)
Time frame: 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.
Trunk angular velocity (degrees/s)
Time frame: Baseline laboratory assessment (single visit in year 1)
Rate of change in trunk segment orientation over time, derived from rotational kinematics.
Trunk angular displacement (degrees)
Time frame: Baseline laboratory assessment (single visit in year 1)
Magnitude of trunk segment rotation relative to a reference orientation.
Center-of-mass displacement (m)
Time frame: 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.
Response time (s or ms)
Time frame: Baseline laboratory assessment (single visit in year 1)
Time elapsed between stimulus onset and initiation of a motor response.
13 secondary outcomes
Montreal Cognitive Assessment-Taiwan version score (0-30points)
Time frame: Baseline laboratory assessment
Path tracing completion time (s)
Time frame: Baseline laboratory assessment
Stroop test score (count as PR1-99%)
Time frame: Baseline laboratory assessment
Working memory completion time (s)
Time frame: Baseline laboratory assessment
Mental rotation accuracy (number of correct responses)(0-16)
Time frame: Baseline laboratory assessment
Mental rotation completion time (s)
Time frame: Baseline laboratory assessment
Activities-specific Balance Confidence score (0-100 points)
Time frame: Baseline laboratory assessment
Dizziness Handicap Inventory score (0-100points)
Time frame: Baseline laboratory assessment
Hospital Anxiety and Depression Scale - Anxiety score (0-21 points)
Time frame: Baseline laboratory assessment
Hospital Anxiety and Depression Scale - Depression score (0-21 points)
Time frame: Baseline laboratory assessment
Visual Vertigo Analogue Scale score ( 0-90points)
Time frame: Baseline laboratory assessment
Dynamic Gait Index score (0-24 points)
Time frame: Baseline laboratory assessment
Tinetti total score (0-28 points)
Time frame: Baseline laboratory assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Vestibular Dysfunction
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
F-GYN for Vaginal Dryness and Vulvovaginal Atrophy
Atrophic Vaginitis, Atrophic Vulvovaginitis
RecruitingObservational study
Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss
Children, Only, Vestibular Disorder
RecruitingObservational study
Vestibular and Postural Function in Children Suspected of Balance Disorders
Children, Only, Vestibular Disorder
RecruitingObservational study
Normative Data of Vestibular and Postural Function in Danish Children
Children, Only, Vestibular Function
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Po-Yin Chen, PhD principal investigator
National Yang Ming Chiao Tung University, Department of Physical Therapy and Assistive Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Dysfunction and Dizziness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Po-Yin Chen, PhD (+886-2-2826-7000 ext. 67166, poyin1128@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Baseline laboratory assessment (single visit in year 1)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.