Clinical trial NCT05990023: The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Vestibular Function Disorder
Cognitive Decline
Dizziness
Vestibular Abnormality
Keywords: Vestibular function
Elderly cognition
Vestibular functional assessment
Vestibular vertigo
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rotation of head, chest, and pelvis.
timeFrame: 3 year.
measure: Inclination of head, chest, and pelvis.
timeFrame: 3 year.
measure: Acceleration of head, chest, and pelvis.
timeFrame: 3 year.
measure: Static Visual acuity.
timeFrame: 3 year.
measure: Dynamic Visual acuity.
timeFrame: 3 year.
measure: Static vestibulo-ocular reflex (VOR gain)
timeFrame: 3 year.
measure: Dynamic vestibulo-ocular reflex. (VOR gain)
timeFrame: 3 year.
measure: Step length (centimeter) during walking
timeFrame: 3 year.
measure: Step frequency
timeFrame: 3 year.
measure: Walking trajectory (centimeter)
timeFrame: 3 year.
measure: Step width (centimeter) during walking
timeFrame: 3 year.
measure: Step variability of step length (standard deviation) during walking
timeFrame: 3 year.
measure: Step variability of step width (standard deviation) during walking
timeFrame: 3 year.
measure: Speed (meter per second) during walking
timeFrame: 3 year.
measure: Lower limb Joint force (Newton)
timeFrame: 3 year.
measure: Lower limb Joint moment (Newton-metre)
timeFrame: 3 year.
measure: Lower limb Joint power (Watt)
timeFrame: 3 year.
measure: Joint movement (degree)
timeFrame: 3 year.
measure: Body center of mass sway (millimeter) during testing session
timeFrame: 3 year.
Secondary outcomes:
measure: Activities-Specific Balance Confidence Scale (ABC scale).
timeFrame: 3 year.
measure: Dizziness Handicap Inventory (DHI).
timeFrame: 3 year.
measure: Hospital Anxiety and Depression Scale (HADS).
timeFrame: 3 year.
measure: Dynamic Gait Index (DGI).
timeFrame: 3 year.
measure: Tinetti Fall Risk Assessment Tool (Tinetti Scale).
timeFrame: 3 year.
measure: Montreal Cognitive Assessment Taiwanese version (MoCA).
timeFrame: 3 year.
measure: Trail Making Test.
timeFrame: 3 year.
measure: Digit Span Test.
timeFrame: 3 year.
measure: Stroop Test.
timeFrame: 3 year.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Chen Po-Yin
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.