Cognitive Decline Clinical Trial
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
Verified date | May 2023 |
Source | Taipei Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Medical University | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Medical University |
Taiwan,
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 all — Click here to view all references
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. |
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 |