Vestibular Function DisorderNCT05990023
The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task
A study testing Traditional vestibule rehabilitation training and Dual-task vestibule rehabilitation training in people with Vestibular Function Disorder and Cognitive Decline, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This study aims to investigate the effect of computerized vestibular function assessment and interactive training system, combined with cognitive/motor dual-task for the elderly with dizziness. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Function Disorder, Cognitive Decline, Dizziness
- What is being tested?
- Traditional vestibule rehabilitation training and Dual-task vestibule rehabilitation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2023to 14 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Year 1 (Study A):
- Could walk more than 30 meters with or without walking aids independently.
- Able to comprehend and communicate in Mandarin or Taiwanese.
- Sufficient corrected vision that allows independent outdoor mobility.
- Year 2 (Study B):
- Could walk more than 30 meters with or without walking aids independently.
Show all 15Show fewer
- Able to comprehend and communicate in Mandarin or Taiwanese.
- Sufficient corrected vision that allows independent outdoor mobility.
- Healthy participants and those who have experienced dizziness or falls within the past two years.
- Year 3 (Study C):
- Could walk more than 30 meters with or without walking aids independently.
- Able to comprehend and communicate in Mandarin or Taiwanese.
- Sufficient corrected vision that allows independent outdoor mobility.
- Willing to engage in moderate-intensity exercise for 45 minutes per session.
- Participants who have experienced dizziness or falls within the past two years.
Who cannot join
- Year 1 (Study A):
- Severe central or peripheral nervous system disorders.
- Participants who are blind or deaf.
- Individuals who cannot communicate or understand instructions.
- Current fractures or significant joint injuries.
- Year 2 (Study B):
Show all 15Show fewer
- Severe central or peripheral nervous system disorders.
- Participants who are blind or deaf.
- Individuals who cannot communicate or understand instructions.
- Current fractures or significant joint injuries.
- Year 3 (Study C):
- Severe central or peripheral nervous system disorders.
- Participants who are blind or deaf.
- Individuals who cannot communicate or understand instructions.
- Current fractures or significant joint injuries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effect of Computerized Vestibular Function Assessment and Interactive Training System, Combined With Cognitive/Motor Dual-task for the Elderly With Dizziness
This study aims to investigate the effect of computerized vestibular function assessment and interactive training system, combined with cognitive/motor dual-task for the elderly with dizziness. The investigators will compare the movement abilities among older adults with different cognitive level, and further establish an assessment module that can evaluate participants' dual-task performance in both vestibular and cognitive tasks. Finally, leveraging the advantages of sensor detection technology and computerized feedback, an appropriate dual-task rehabilitation approach for vestibular function and cognition will be developed.
Read the detailed description
Dizziness is one of the most common complaints among older adults and often a concern within healthcare systems. It leads to distressing sensations, reduced mobility, and decreased quality of life. Dizziness is also closely associated with falls, which are a major cause of comorbidities and mortality in older adults. During clinical rehabilitation training, it has been observed that some elderly patients with vestibular dizziness often experience difficulties with speech clarity, lack of attention, poor direction control, or easy forgetfulness of rehabilitation training content. Similar observations have been made by scholars who interacted with dizzy patients, noting difficulties in maintaining attention, deficits in attention and spatial memory, speech expression impairments, and impacts on spatial memory, fluency of speech, thinking abilities, calculation impairments, and other forms of numerical cognition. Clinical studies have already noted the association between vestibular dysfunction and cognitive impairment. However, there is limited research that can clarify the intricacies and complexities of this issue. Currently, there is scarce knowledge regarding the relationship between the vestibular system and specific cognitive aspects, as well as its correlation with balance deficits.
This study aims to investigate the effect of computerized vestibular function assessment and interactive training system, combined with cognitive/motor dual-task for the elderly with dizziness. Drawing from previous clinical rehabilitation experiences, a method for assessing vestibular function and balance performance will be designed to compare the movement differences among older adults with different cognitive performances. Subsequently, through scientific and objective motion capture analysis, a comprehensive assessment module will be established to evaluate the dual-task performance of participants in both vestibular and cognitive tasks. The performance differences attributed to cognition will be analyzed, and the correlation with vestibular function performance will be integrated to serve as a prescription reference for computer-assisted rehabilitation interventions. Finally, leveraging the advantages of sensor detection technology and computerized feedback, an appropriate dual-task rehabilitation approach for vestibular function and cognition will be developed. Methods: First year, the study will recruit 60 elderly people and integrate the use of inertial sensors and force plates with vestibular and balance tests to establish a vertigo assessment system for the elderly. In the second year, the subjects were divided into two groups: a control group of 25 healthy elderly people, and an experimental group of 25 elderly people who had experienced dizziness and falls in the past two years. Data were collected using a motion analysis system combined with a computerized assisted assessment. The main analysis is whether the experience of dizziness or fall affects the balance, vestibular and cognitive related activities. In the third year, 40 vestibular hypofunction patients will be randomized into either traditional or dual-task group. Both groups will receive 2~3 times per week for 4 weeks of computerized vestibular interventions with and without dual-task training protocols. Expected achievements: Combining safe stochastic dual-task training and computer-assisted rehabilitation interventions in this 3-year project, the mechanisms of cognition related to vestibular training will be elucidated. The optimal strategy for vestibular rehabilitation can thus be established.
- Being tested
- Traditional vestibule rehabilitation training, Dual-task vestibule rehabilitation training
- Keywords
- Vestibular function, Elderly cognition, Vestibular functional assessment, Vestibular vertigo
- Medical subject headings
- Vestibular Diseases, Cognitive Dysfunction, Dizziness, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional vestibule rehabilitation trainingOther
- Standing, using a gaze tracking system on a force plate to track a continuously moving target, with alerts when body sway exceeds a certain threshold.
- Standing, wearing an inertial sensor on the head and performing left-right or up-down head movements while maintaining gaze on a target, with a screen providing feedback on head movement speed.
- Standing, controlling body weight distribution on the force plate to reach a target position, with a screen displaying the current center of gravity position.
- Walking, synchronizing head movements with a rhythm or performing up-down head nods, with auditory cues indicating the desired head movement frequency.
- During continuous head rotations, stepping in a regular sequence of forward, backward, left, and right movements.
Dual-task vestibule rehabilitation trainingOther
- Adding a dual task of digit countdown and recitation to clinical balance training exercises.
- Incorporating a numerical calculation task into interactive screens during clinical balance training, with the participant's responses input by the researchers.
- Introducing upper limb exercises, such as button pressing or arm swinging, during clinical balance training.
- During continuous head rotations, following visual prompts on the display to perform forward, backward, left, and right displacements.
| Study group | Role | What they receive |
|---|---|---|
| Traditional vestibule rehabilitation training | Active comparator | The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project. Receives: Other: Traditional vestibule rehabilitation training |
| Dual-task vestibule rehabilitation training | Experimental | The intervention for the experimental group is based on the intervention for the control group, with additional components based on the findings from the second year of the study. These dual-task exercises are integrated into the training using the computerized training system and provided to the experimental group. Receives: Other: Dual-task vestibule rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotation of head, chest, and pelvis.
Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include rotational angles (degrees) of the head, chest, and waist.
Measured: 3 year.
Inclination of head, chest, and pelvis.
Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include angular velocities (degrees per second) of the head, chest, and waist.
Measured: 3 year.
Acceleration of head, chest, and pelvis.
Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include accelerations (meters per second squared) of the head, chest, and waist.
Measured: 3 year.
Static Visual acuity.
Parameters recorded by a screen with optotype chart and eyeglass system.
Measured: 3 year.
Dynamic Visual acuity.
Parameters recorded by a screen with optotype chart and eyeglass system during movements.
Measured: 3 year.
Static vestibulo-ocular reflex (VOR gain)
The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head.
Measured: 3 year.
Dynamic vestibulo-ocular reflex. (VOR gain)
The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head during movements.
Measured: 3 year.
Step length (centimeter) during walking
Step length (centimeter) recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Measured: 3 year.
Step frequency
Steps and times recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Measured: 3 year.
Walking trajectory (centimeter)
The shift(centimeter) of light and motion markers on subjects recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Measured: 3 year.
Step width (centimeter) during walking
The medial-lateral distance(centimeter) of light and motion markers on subject's feet recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation among the testing session.
Measured: 3 year.
Step variability of step length (standard deviation) during walking
The standard deviation of step length(centimeter) among the testing session. The step length(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
Measured: 3 year.
Step variability of step width (standard deviation) during walking
The standard deviation of step width(centimeter) among the testing session. The step width(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
Measured: 3 year.
Speed (meter per second) during walking
Speed (meter per second) calculated by dividing walking distances by total walking times. The walking distances and times are recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Measured: 3 year.
Lower limb Joint force (Newton)
Joint force is calculated by joint position(millimeter) and ground reaction force(Newton). The joint position(millimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera), and ground reaction force(Newton) is recorded by forceplates.
Measured: 3 year.
Lower limb Joint moment (Newton-metre)
Joint moment (Newton-metre) is calculated by multiplying ground reaction force(Newton) by limb length(meter). The limb length(meter) is recorded by meters or optical motion sensors(camera).
Measured: 3 year.
Lower limb Joint power (Watt)
Joint Power(watt) is calculated as the "scalar product" of joint moment and joint angular velocity(degree per second). The joint angular velocity (degree per second) is recorded by wearable sensors (inertial movement units) or optical motion sensors (camera).
Measured: 3 year.
Joint movement (degree)
Joint movement (degree) of subjects is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
Measured: 3 year.
Body center of mass sway (millimeter) during testing session
The shift (millimeter)) of light and motion markers on subject's pelvis recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) and forceplae during flat ground walking and up/down stairs situation.
Measured: 3 year.
Secondary outcomes (9)
Activities-Specific Balance Confidence Scale (ABC scale).
Clinical assessment scales to identify individuals with a fall risk. The minimum and maximum values are 0% and 100%, and whether higher scores mean a better outcome.
Measured: 3 year.
Dizziness Handicap Inventory (DHI).
Clinical assessment scales that quantifies the impact of dizziness on daily life. The minimum and maximum values are 0 and 100, and whether higher scores mean a worse outcome.
Measured: 3 year.
Hospital Anxiety and Depression Scale (HADS).
Clinical assessment scales to measure anxiety and depression in a general medical population of patients. The minimum and maximum values are 0 and 42, and whether higher scores mean a worse outcome.
Measured: 3 year.
Dynamic Gait Index (DGI).
Clinical assessment scales to test the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. The minimum and maximum values are 0 and 24, and whether higher scores mean a better outcome.
Measured: 3 year.
Tinetti Fall Risk Assessment Tool (Tinetti Scale).
Clinical assessment scales to test the walking and balance ability to valuate the falling risk. The minimum and maximum values are 0 and 28, and whether higher scores mean a better outcome.
Measured: 3 year.
Montreal Cognitive Assessment Taiwanese version (MoCA).
Cognitive-related assessments. The minimum and maximum values are 0 and 30, and whether higher scores mean a better outcome. The minimum and maximum values are 0 and 24, and whether higher scores mean a better outcome.
Measured: 3 year.
Trail Making Test.
Clinical assessment scales which provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning. Longer time consumed means worse performance. An average score for TMT-A is 29 seconds and a deficient score is greater than 78 seconds. For TMT-B, an average score is 75 seconds and a deficient score is greater than 273 seconds.
Measured: 3 year.
Digit Span Test.
Clinical assessment scales to test subject's ability to remember a sequence of numbers that appear on the screen, one at a time. The minimum and maximum values are 0 and 21, and whether higher scores mean a better outcome.
Measured: 3 year.
Stroop Test.
Clinical assessment scales for color recognize.The minimum and maximum values are 1% and 100%, and whether the higher percentage rates mean better performance
Measured: 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Nov 2023
- Primary completion14 Feb 2026 (estimated)
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Vestibular Function DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen Po-Yin, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990023
- Sponsor's protocol ID
- N202212070
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith PF. Why dizziness is likely to increase the risk of cognitive dysfunction and dementia in elderly adults. N Z Med J. 2020 Sep 25;133(1522):112-127.
PubMed 32994621Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
PubMed 16926202Brandt T, Daroff RB. The multisensory physiological and pathological vertigo syndromes. Ann Neurol. 1980 Mar;7(3):195-203. doi: 10.1002/ana.410070302. No abstract available.
PubMed 6999976Aguirre GK, D'Esposito M. Topographical disorientation: a synthesis and taxonomy. Brain. 1999 Sep;122 ( Pt 9):1613-28. doi: 10.1093/brain/122.9.1613.
PubMed 10468502Stijntjes M, Pasma JH, van Vuuren M, Blauw GJ, Meskers CG, Maier AB. Low cognitive status is associated with a lower ability to maintain standing balance in elderly outpatients. Gerontology. 2015;61(2):124-30. doi: 10.1159/000364916. Epub 2014 Sep 2.
PubMed 25196019Roberts JC, Cohen HS, Sangi-Haghpeykar H. Vestibular disorders and dual task performance: impairment when walking a straight path. J Vestib Res. 2011;21(3):167-74. doi: 10.3233/VES-2011-0415.
PubMed 21558642Camicioli R, Oken BS, Sexton G, Kaye JA, Nutt JG. Verbal fluency task affects gait in Parkinson's disease with motor freezing. J Geriatr Psychiatry Neurol. 1998 Winter;11(4):181-5. doi: 10.1177/089198879901100403.
PubMed 10230996O'Shea S, Morris ME, Iansek R. Dual task interference during gait in people with Parkinson disease: effects of motor versus cognitive secondary tasks. Phys Ther. 2002 Sep;82(9):888-97.
PubMed 12201803Sheridan PL, Solomont J, Kowall N, Hausdorff JM. Influence of executive function on locomotor function: divided attention increases gait variability in Alzheimer's disease. J Am Geriatr Soc. 2003 Nov;51(11):1633-7. doi: 10.1046/j.1532-5415.2003.51516.x.
PubMed 14687395Toulotte C, Thevenon A, Fabre C. Effects of training and detraining on the static and dynamic balance in elderly fallers and non-fallers: a pilot study. Disabil Rehabil. 2006 Jan 30;28(2):125-33. doi: 10.1080/09638280500163653.
PubMed 16393843Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.
PubMed 21593013Chen PY, Wei SH, Hsieh WL, Cheen JR, Chen LK, Kao CL. Lower limb power rehabilitation (LLPR) using interactive video game for improvement of balance function in older people. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):677-82. doi: 10.1016/j.archger.2012.05.012. Epub 2012 Jul 15.
PubMed 22795360Borges SM, Radanovic M, Forlenza OV. Correlation between functional mobility and cognitive performance in older adults with cognitive impairment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2018 Jan;25(1):23-32. doi: 10.1080/13825585.2016.1258035. Epub 2016 Dec 9.
PubMed 27934540Koh DH, Lee JD, Lee HJ. Relationships among hearing loss, cognition and balance ability in community-dwelling older adults. J Phys Ther Sci. 2015 May;27(5):1539-42. doi: 10.1589/jpts.27.1539. Epub 2015 May 26.
PubMed 26157259Iwasaki S, Yamamoto Y, Togo F, Kinoshita M, Yoshifuji Y, Fujimoto C, Yamasoba T. Noisy vestibular stimulation improves body balance in bilateral vestibulopathy. Neurology. 2014 Mar 18;82(11):969-75. doi: 10.1212/WNL.0000000000000215. Epub 2014 Feb 14.
PubMed 24532279
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Computerized Vestibular Function Assessment and Interactive Training System, Combined With Cognitive/Motor Dual-task for the Elderly With Dizziness
- ClinicalTrials.gov ID
- NCT05990023
- Acronym / sponsor ID
- N202212070
- Keywords
- Vestibular function, Elderly cognition, Vestibular functional assessment, Vestibular vertigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 14 Aug 2023 (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 aims to investigate the effect of computerized vestibular function assessment and interactive training system, combined with cognitive/motor dual-task for the elderly with dizziness. The investigators will compare the movement abilities among older adults with different cognitive level, and further establish an assessment module that can evaluate participants' dual-task performance in both vestibular and cognitive tasks. Finally, leveraging the advantages of sensor detection technology and computerized feedback, an appropriate dual-task rehabilitation approach for vestibular function and cognition will be developed.
Detailed description
Dizziness is one of the most common complaints among older adults and often a concern within healthcare systems. It leads to distressing sensations, reduced mobility, and decreased quality of life. Dizziness is also closely associated with falls, which are a major cause of comorbidities and mortality in older adults. During clinical rehabilitation training, it has been observed that some elderly patients with vestibular dizziness often experience difficulties with speech clarity, lack of attention, poor direction control, or easy forgetfulness of rehabilitation training content. Similar observations have been made by scholars who interacted with dizzy patients, noting difficulties in maintaining attention, deficits in attention and spatial memory, speech expression impairments, and impacts on spatial memory, fluency of speech, thinking abilities, calculation impairments, and other forms of numerical cognition. Clinical studies have already noted the association between vestibular dysfunction and cognitive impairment. However, there is limited research that can clarify the intricacies and complexities of this issue. Currently, there is scarce knowledge regarding the relationship between the vestibular system and specific cognitive aspects, as well as its correlation with balance deficits.
This study aims to investigate the effect of computerized vestibular function assessment and interactive training system, combined with cognitive/motor dual-task for the elderly with dizziness. Drawing from previous clinical rehabilitation experiences, a method for assessing vestibular function and balance performance will be designed to compare the movement differences among older adults with different cognitive performances. Subsequently, through scientific and objective motion capture analysis, a comprehensive assessment module will be established to evaluate the dual-task performance of participants in both vestibular and cognitive tasks. The performance differences attributed to cognition will be analyzed, and the correlation with vestibular function performance will be integrated to serve as a prescription reference for computer-assisted rehabilitation interventions. Finally, leveraging the advantages of sensor detection technology and computerized feedback, an appropriate dual-task rehabilitation approach for vestibular function and cognition will be developed. Methods: First year, the study will recruit 60 elderly people and integrate the use of inertial sensors and force plates with vestibular and balance tests to establish a vertigo assessment system for the elderly. In the second year, the subjects were divided into two groups: a control group of 25 healthy elderly people, and an experimental group of 25 elderly people who had experienced dizziness and falls in the past two years. Data were collected using a motion analysis system combined with a computerized assisted assessment. The main analysis is whether the experience of dizziness or fall affects the balance, vestibular and cognitive related activities. In the third year, 40 vestibular hypofunction patients will be randomized into either traditional or dual-task group. Both groups will receive 2~3 times per week for 4 weeks of computerized vestibular interventions with and without dual-task training protocols. Expected achievements: Combining safe stochastic dual-task training and computer-assisted rehabilitation interventions in this 3-year project, the mechanisms of cognition related to vestibular training will be elucidated. The optimal strategy for vestibular rehabilitation can thus be established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional vestibule rehabilitation training | Active comparator | Other: Traditional vestibule rehabilitation trainingThe intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project. |
| Dual-task vestibule rehabilitation training | Experimental | Other: Dual-task vestibule rehabilitation trainingThe intervention for the experimental group is based on the intervention for the control group, with additional components based on the findings from the second year of the study. These dual-task exercises are integrated into the training using the computerized training system and provided to the experimental group. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Year 1 (Study A):
- Year 2 (Study B):
- Year 3 (Study C):
Key exclusion criteria (15 listed)
- Year 1 (Study A):
- Year 2 (Study B):
- Year 3 (Study C):
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 |
|---|---|---|
| Traditional vestibule rehabilitation training* Standing, using a gaze tracking system on a force plate to track a continuously moving target, with alerts when body sway exceeds a certain threshold. * Standing, wearing an inertial sensor on the head and performing left-right or up-down head movements while maintaining gaze on a target, with a screen providing feedback on head movement speed. * Standing, controlling body weight distribution on the force plate to reach a target position, with a screen displaying the current center of gravity position. * Walking, synchronizing head movements with a rhythm or performing up-down head nods, with auditory cues indicating the desired head movement frequency. * During continuous head rotations, stepping in a regular sequence of forward, backward, left, and right movements. | Other | Traditional vestibule rehabilitation training |
| Dual-task vestibule rehabilitation training* Adding a dual task of digit countdown and recitation to clinical balance training exercises. * Incorporating a numerical calculation task into interactive screens during clinical balance training, with the participant's responses input by the researchers. * Introducing upper limb exercises, such as button pressing or arm swinging, during clinical balance training. * During continuous head rotations, following visual prompts on the display to perform forward, backward, left, and right displacements. | Other | Dual-task vestibule rehabilitation training |
Primary outcome
Rotation of head, chest, and pelvis.
Time frame: 3 year.
Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include rotational angles (degrees) of the head, chest, and waist.
Inclination of head, chest, and pelvis.
Time frame: 3 year.
Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include angular velocities (degrees per second) of the head, chest, and waist.
Acceleration of head, chest, and pelvis.
Time frame: 3 year.
Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include accelerations (meters per second squared) of the head, chest, and waist.
Static Visual acuity.
Time frame: 3 year.
Parameters recorded by a screen with optotype chart and eyeglass system.
Dynamic Visual acuity.
Time frame: 3 year.
Parameters recorded by a screen with optotype chart and eyeglass system during movements.
Static vestibulo-ocular reflex (VOR gain)
Time frame: 3 year.
The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head.
Dynamic vestibulo-ocular reflex. (VOR gain)
Time frame: 3 year.
The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head during movements.
Step length (centimeter) during walking
Time frame: 3 year.
Step length (centimeter) recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Step frequency
Time frame: 3 year.
Steps and times recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Walking trajectory (centimeter)
Time frame: 3 year.
The shift(centimeter) of light and motion markers on subjects recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Step width (centimeter) during walking
Time frame: 3 year.
The medial-lateral distance(centimeter) of light and motion markers on subject's feet recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation among the testing session.
Step variability of step length (standard deviation) during walking
Time frame: 3 year.
The standard deviation of step length(centimeter) among the testing session. The step length(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
Step variability of step width (standard deviation) during walking
Time frame: 3 year.
The standard deviation of step width(centimeter) among the testing session. The step width(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
Speed (meter per second) during walking
Time frame: 3 year.
Speed (meter per second) calculated by dividing walking distances by total walking times. The walking distances and times are recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
Lower limb Joint force (Newton)
Time frame: 3 year.
Joint force is calculated by joint position(millimeter) and ground reaction force(Newton). The joint position(millimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera), and ground reaction force(Newton) is recorded by forceplates.
Lower limb Joint moment (Newton-metre)
Time frame: 3 year.
Joint moment (Newton-metre) is calculated by multiplying ground reaction force(Newton) by limb length(meter). The limb length(meter) is recorded by meters or optical motion sensors(camera).
Lower limb Joint power (Watt)
Time frame: 3 year.
Joint Power(watt) is calculated as the "scalar product" of joint moment and joint angular velocity(degree per second). The joint angular velocity (degree per second) is recorded by wearable sensors (inertial movement units) or optical motion sensors (camera).
Joint movement (degree)
Time frame: 3 year.
Joint movement (degree) of subjects is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
Body center of mass sway (millimeter) during testing session
Time frame: 3 year.
The shift (millimeter)) of light and motion markers on subject's pelvis recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) and forceplae during flat ground walking and up/down stairs situation.
9 secondary outcomes
Activities-Specific Balance Confidence Scale (ABC scale).
Time frame: 3 year.
Dizziness Handicap Inventory (DHI).
Time frame: 3 year.
Hospital Anxiety and Depression Scale (HADS).
Time frame: 3 year.
Dynamic Gait Index (DGI).
Time frame: 3 year.
Tinetti Fall Risk Assessment Tool (Tinetti Scale).
Time frame: 3 year.
Montreal Cognitive Assessment Taiwanese version (MoCA).
Time frame: 3 year.
Trail Making Test.
Time frame: 3 year.
Digit Span Test.
Time frame: 3 year.
Stroop Test.
Time frame: 3 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Background: PubMed 32994621Smith PF. Why dizziness is likely to increase the risk of cognitive dysfunction and dementia in elderly adults. N Z Med J. 2020 Sep 25;133(1522):112-127.
- Background: PubMed 16926202Rubenstein LZ. Falls in older people: epidemiology, risk factors and strategies for prevention. Age Ageing. 2006 Sep;35 Suppl 2:ii37-ii41. doi: 10.1093/ageing/afl084.
- Background: PubMed 6999976Brandt T, Daroff RB. The multisensory physiological and pathological vertigo syndromes. Ann Neurol. 1980 Mar;7(3):195-203. doi: 10.1002/ana.410070302. No abstract available.
- Background: PubMed 10468502Aguirre GK, D'Esposito M. Topographical disorientation: a synthesis and taxonomy. Brain. 1999 Sep;122 ( Pt 9):1613-28. doi: 10.1093/brain/122.9.1613.
- Background: PubMed 25196019Stijntjes M, Pasma JH, van Vuuren M, Blauw GJ, Meskers CG, Maier AB. Low cognitive status is associated with a lower ability to maintain standing balance in elderly outpatients. Gerontology. 2015;61(2):124-30. doi: 10.1159/000364916. Epub 2014 Sep 2.
- Background: PubMed 21558642Roberts JC, Cohen HS, Sangi-Haghpeykar H. Vestibular disorders and dual task performance: impairment when walking a straight path. J Vestib Res. 2011;21(3):167-74. doi: 10.3233/VES-2011-0415.
- Background: PubMed 10230996Camicioli R, Oken BS, Sexton G, Kaye JA, Nutt JG. Verbal fluency task affects gait in Parkinson's disease with motor freezing. J Geriatr Psychiatry Neurol. 1998 Winter;11(4):181-5. doi: 10.1177/089198879901100403.
- Background: PubMed 12201803O'Shea S, Morris ME, Iansek R. Dual task interference during gait in people with Parkinson disease: effects of motor versus cognitive secondary tasks. Phys Ther. 2002 Sep;82(9):888-97.
- Background: PubMed 14687395Sheridan PL, Solomont J, Kowall N, Hausdorff JM. Influence of executive function on locomotor function: divided attention increases gait variability in Alzheimer's disease. J Am Geriatr Soc. 2003 Nov;51(11):1633-7. doi: 10.1046/j.1532-5415.2003.51516.x.
- Background: PubMed 16393843Toulotte C, Thevenon A, Fabre C. Effects of training and detraining on the static and dynamic balance in elderly fallers and non-fallers: a pilot study. Disabil Rehabil. 2006 Jan 30;28(2):125-33. doi: 10.1080/09638280500163653.
- Background: PubMed 21593013Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17.
- Background: PubMed 22795360Chen PY, Wei SH, Hsieh WL, Cheen JR, Chen LK, Kao CL. Lower limb power rehabilitation (LLPR) using interactive video game for improvement of balance function in older people. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):677-82. doi: 10.1016/j.archger.2012.05.012. Epub 2012 Jul 15.
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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. This study is not recruiting at the moment.
Chen Po-Yin study chair
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional vestibule rehabilitation training and Dual-task vestibule rehabilitation training in people with Vestibular Function Disorder and Cognitive Decline, run by Taipei Medical 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 15 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 15 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotation of head, chest, and pelvis. (time frame: 3 year.). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990023, which also lists 29 linked publications.
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 15 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.