Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05990023
Other study ID # N202212070
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date May 14, 2026

Study information

Verified date May 2023
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date May 14, 2026
Est. primary completion date February 14, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 85 Years
Eligibility Inclusion Criteria: - Year 1 (Study A): 1. Could walk more than 30 meters with or without walking aids independently. 2. Able to comprehend and communicate in Mandarin or Taiwanese. 3. Sufficient corrected vision that allows independent outdoor mobility. - Year 2 (Study B): 1. Could walk more than 30 meters with or without walking aids independently. 2. Able to comprehend and communicate in Mandarin or Taiwanese. 3. Sufficient corrected vision that allows independent outdoor mobility. 4. Healthy participants and those who have experienced dizziness or falls within the past two years. - Year 3 (Study C): 1. Could walk more than 30 meters with or without walking aids independently. 2. Able to comprehend and communicate in Mandarin or Taiwanese. 3. Sufficient corrected vision that allows independent outdoor mobility. 4. Willing to engage in moderate-intensity exercise for 45 minutes per session. 5. Participants who have experienced dizziness or falls within the past two years. Exclusion Criteria: - Year 1 (Study A): 1. Severe central or peripheral nervous system disorders. 2. Participants who are blind or deaf. 3. Individuals who cannot communicate or understand instructions. 4. Current fractures or significant joint injuries. - Year 2 (Study B): 1. Severe central or peripheral nervous system disorders. 2. Participants who are blind or deaf. 3. Individuals who cannot communicate or understand instructions. 4. Current fractures or significant joint injuries. - Year 3 (Study C): 1. Severe central or peripheral nervous system disorders. 2. Participants who are blind or deaf. 3. Individuals who cannot communicate or understand instructions. 4. Current fractures or significant joint injuries.

Study Design


Intervention

Other:
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.
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.

Locations

Country Name City State
Taiwan Taipei Medical University Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (29)

Aguirre 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. — View Citation

Borges 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. — View Citation

Brandt 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. — View Citation

Camicioli 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. — View Citation

Chen KL, Xu Y, Chu AQ, Ding D, Liang XN, Nasreddine ZS, Dong Q, Hong Z, Zhao QH, Guo QH. Validation of the Chinese Version of Montreal Cognitive Assessment Basic for Screening Mild Cognitive Impairment. J Am Geriatr Soc. 2016 Dec;64(12):e285-e290. doi: 10.1111/jgs.14530. Epub 2016 Nov 7. — View Citation

Chen PY, Jheng YC, Wang CC, Huang SE, Yang TH, Hsu PC, Kuo CH, Lin YY, Lai WY, Kao CL. Effect of noisy galvanic vestibular stimulation on dynamic posture sway under visual deprivation in patients with bilateral vestibular hypofunction. Sci Rep. 2021 Feb 19;11(1):4229. doi: 10.1038/s41598-021-83206-z. — View Citation

Chen 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. — View Citation

Fujimoto C, Yamamoto Y, Kamogashira T, Kinoshita M, Egami N, Uemura Y, Togo F, Yamasoba T, Iwasaki S. Noisy galvanic vestibular stimulation induces a sustained improvement in body balance in elderly adults. Sci Rep. 2016 Nov 21;6:37575. doi: 10.1038/srep37575. — View Citation

Gill-Body KM, Beninato M, Krebs DE. Relationship among balance impairments, functional performance, and disability in people with peripheral vestibular hypofunction. Phys Ther. 2000 Aug;80(8):748-58. — View Citation

Herdman SJ, Tusa RJ, Blatt P, Suzuki A, Venuto PJ, Roberts D. Computerized dynamic visual acuity test in the assessment of vestibular deficits. Am J Otol. 1998 Nov;19(6):790-6. — View Citation

Holtzer 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. — View Citation

Iwasaki 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. — View Citation

Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011. — View Citation

Koh 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. — View Citation

Myers AM, Fletcher PC, Myers AH, Sherk W. Discriminative and evaluative properties of the activities-specific balance confidence (ABC) scale. J Gerontol A Biol Sci Med Sci. 1998 Jul;53(4):M287-94. doi: 10.1093/gerona/53a.4.m287. — View Citation

Myers AM, Powell LE, Maki BE, Holliday PJ, Brawley LR, Sherk W. Psychological indicators of balance confidence: relationship to actual and perceived abilities. J Gerontol A Biol Sci Med Sci. 1996 Jan;51(1):M37-43. doi: 10.1093/gerona/51a.1.m37. — View Citation

O'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. — View Citation

Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28. — View Citation

Roberts 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. — View Citation

Rubenstein 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. — View Citation

Sheridan 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. — View Citation

Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812. — View Citation

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. — View Citation

Stijntjes 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. — View Citation

Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239. — View Citation

Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available. — View Citation

Toulotte 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. — View Citation

Whitney SL, Wrisley DM, Brown KE, Furman JM. Is perception of handicap related to functional performance in persons with vestibular dysfunction? Otol Neurotol. 2004 Mar;25(2):139-43. doi: 10.1097/00129492-200403000-00010. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation

* Note: There are 29 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary Static Visual acuity. Parameters recorded by a screen with optotype chart and eyeglass system. 3 year.
Primary Dynamic Visual acuity. Parameters recorded by a screen with optotype chart and eyeglass system during movements. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Primary 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). 3 year.
Primary 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). 3 year.
Primary 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. 3 year.
Primary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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. 3 year.
Secondary 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 3 year.
See also
  Status Clinical Trial Phase
Completed NCT03228446 - The Effects of Attentional Filter Training on Working Memory N/A
Completed NCT04033419 - Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer Phase 2
Terminated NCT05199142 - A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participants With Cognitive Decline Phase 1
Active, not recruiting NCT05290233 - Time Restricted Eating Plus Exercise for Weight Management N/A
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Unknown status NCT00696514 - Vitamin B12 and Folic Acid Supplementation for Preventing Fractures in Elderly People Phase 1
Completed NCT00110604 - The Effect of Folic Acid on Atherosclerosis, Cognitive Performance and Hearing N/A
Recruiting NCT06245005 - Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Recruiting NCT05014399 - Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Active, not recruiting NCT05586750 - Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy Phase 4
Completed NCT04386902 - Evaluation of Cognitive State Using Neurosteer EEG System
Recruiting NCT06070818 - Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline N/A
Completed NCT01669915 - A Large Randomized Trial of Vitamin D, Omega-3 Fatty Acids and Cognitive Decline N/A
Completed NCT02814526 - Exercise in Adults With Mild Memory Problems N/A
Not yet recruiting NCT06252376 - Effects of Blood Pressure on Cognition and Cerebral Hemodynamics in PD N/A
Not yet recruiting NCT05928078 - A Home-based e-Health Intervention in the Elderly: MOVI-ageing N/A
Recruiting NCT06318377 - Peanuts and Neurocognitive / Cardiovascular Health in Black Individuals N/A
Recruiting NCT03839784 - Building a Platform for Precision Anesthesia in the Geriatric Surgical Patient
Completed NCT04537728 - My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices N/A
Active, not recruiting NCT03370796 - Group Reminiscence Therapy for Elderly People With Cognitive Decline in Institutional Context N/A