xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05990023</url>
    </required_header>
    <id_info>
      <org_study_id>N202212070</org_study_id>
      <nct_id>NCT05990023</nct_id>
    </id_info>
    <brief_title>The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Medical University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aims to investigate the effect of computerized vestibular function assessment and&#xD;
        interactive training system, combined with cognitive/motor dual-task for the elderly with&#xD;
        dizziness. The investigators will compare the movement abilities among older adults with&#xD;
        different cognitive level, and further establish an assessment module that can evaluate&#xD;
        participants' dual-task performance in both vestibular and cognitive tasks. Finally,&#xD;
        leveraging the advantages of sensor detection technology and computerized feedback, an&#xD;
        appropriate dual-task rehabilitation approach for vestibular function and cognition will be&#xD;
        developed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dizziness is one of the most common complaints among older adults and often a concern within&#xD;
        healthcare systems. It leads to distressing sensations, reduced mobility, and decreased&#xD;
        quality of life. Dizziness is also closely associated with falls, which are a major cause of&#xD;
        comorbidities and mortality in older adults. During clinical rehabilitation training, it has&#xD;
        been observed that some elderly patients with vestibular dizziness often experience&#xD;
        difficulties with speech clarity, lack of attention, poor direction control, or easy&#xD;
        forgetfulness of rehabilitation training content. Similar observations have been made by&#xD;
        scholars who interacted with dizzy patients, noting difficulties in maintaining attention,&#xD;
        deficits in attention and spatial memory, speech expression impairments, and impacts on&#xD;
        spatial memory, fluency of speech, thinking abilities, calculation impairments, and other&#xD;
        forms of numerical cognition. Clinical studies have already noted the association between&#xD;
        vestibular dysfunction and cognitive impairment. However, there is limited research that can&#xD;
        clarify the intricacies and complexities of this issue. Currently, there is scarce knowledge&#xD;
        regarding the relationship between the vestibular system and specific cognitive aspects, as&#xD;
        well as its correlation with balance deficits.&#xD;
  &#xD;
        This study aims to investigate the effect of computerized vestibular function assessment and&#xD;
        interactive training system, combined with cognitive/motor dual-task for the elderly with&#xD;
        dizziness. Drawing from previous clinical rehabilitation experiences, a method for assessing&#xD;
        vestibular function and balance performance will be designed to compare the movement&#xD;
        differences among older adults with different cognitive performances. Subsequently, through&#xD;
        scientific and objective motion capture analysis, a comprehensive assessment module will be&#xD;
        established to evaluate the dual-task performance of participants in both vestibular and&#xD;
        cognitive tasks. The performance differences attributed to cognition will be analyzed, and&#xD;
        the correlation with vestibular function performance will be integrated to serve as a&#xD;
        prescription reference for computer-assisted rehabilitation interventions. Finally,&#xD;
        leveraging the advantages of sensor detection technology and computerized feedback, an&#xD;
        appropriate dual-task rehabilitation approach for vestibular function and cognition will be&#xD;
        developed. Methods: First year, the study will recruit 60 elderly people and integrate the&#xD;
        use of inertial sensors and force plates with vestibular and balance tests to establish a&#xD;
        vertigo assessment system for the elderly. In the second year, the subjects were divided into&#xD;
        two groups: a control group of 25 healthy elderly people, and an experimental group of 25&#xD;
        elderly people who had experienced dizziness and falls in the past two years. Data were&#xD;
        collected using a motion analysis system combined with a computerized assisted assessment.&#xD;
        The main analysis is whether the experience of dizziness or fall affects the balance,&#xD;
        vestibular and cognitive related activities. In the third year, 40 vestibular hypofunction&#xD;
        patients will be randomized into either traditional or dual-task group. Both groups will&#xD;
        receive 2~3 times per week for 4 weeks of computerized vestibular interventions with and&#xD;
        without dual-task training protocols. Expected achievements: Combining safe stochastic&#xD;
        dual-task training and computer-assisted rehabilitation interventions in this 3-year project,&#xD;
        the mechanisms of cognition related to vestibular training will be elucidated. The optimal&#xD;
        strategy for vestibular rehabilitation can thus be established.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">May 14, 2026</completion_date>
    <primary_completion_date type="Anticipated">February 14, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rotation of head, chest, and pelvis.</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Inclination of head, chest, and pelvis.</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceleration of head, chest, and pelvis.</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static Visual acuity.</measure>
      <time_frame>3 year.</time_frame>
      <description>Parameters recorded by a screen with optotype chart and eyeglass system.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic Visual acuity.</measure>
      <time_frame>3 year.</time_frame>
      <description>Parameters recorded by a screen with optotype chart and eyeglass system during movements.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Static vestibulo-ocular reflex (VOR gain)</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dynamic vestibulo-ocular reflex. (VOR gain)</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Step length (centimeter) during walking</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Step frequency</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Walking trajectory (centimeter)</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Step width (centimeter) during walking</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Step variability of step length (standard deviation) during walking</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Step variability of step width (standard deviation) during walking</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Speed (meter per second) during walking</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower limb Joint force (Newton)</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower limb Joint moment (Newton-metre)</measure>
      <time_frame>3 year.</time_frame>
      <description>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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lower limb Joint power (Watt)</measure>
      <time_frame>3 year.</time_frame>
      <description>Joint Power(watt) is calculated as the &quot;scalar product&quot; 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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Joint movement (degree)</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Body center of mass sway (millimeter) during testing session</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Activities-Specific Balance Confidence Scale (ABC scale).</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dizziness Handicap Inventory (DHI).</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Anxiety and Depression Scale (HADS).</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dynamic Gait Index (DGI).</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinetti Fall Risk Assessment Tool (Tinetti Scale).</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment Taiwanese version (MoCA).</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trail Making Test.</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digit Span Test.</measure>
      <time_frame>3 year.</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroop Test.</measure>
      <time_frame>3 year.</time_frame>
      <description>Clinical assessment scales for color recognize.The minimum and maximum values are 1% and 100%, and whether the higher percentage rates mean better performance</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Vestibular Function Disorder</condition>
    <condition>Cognitive Decline</condition>
    <condition>Dizziness</condition>
    <condition>Vestibular Abnormality</condition>
    <arm_group>
      <arm_group_label>Traditional vestibule rehabilitation training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual-task vestibule rehabilitation training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional vestibule rehabilitation training</intervention_name>
      <description>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.&#xD;
  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.&#xD;
  Standing, controlling body weight distribution on the force plate to reach a target position, with a screen displaying the current center of gravity position.&#xD;
  Walking, synchronizing head movements with a rhythm or performing up-down head nods, with auditory cues indicating the desired head movement frequency.&#xD;
  During continuous head rotations, stepping in a regular sequence of forward, backward, left, and right movements.</description>
      <arm_group_label>Traditional vestibule rehabilitation training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dual-task vestibule rehabilitation training</intervention_name>
      <description>Adding a dual task of digit countdown and recitation to clinical balance training exercises.&#xD;
  Incorporating a numerical calculation task into interactive screens during clinical balance training, with the participant's responses input by the researchers.&#xD;
  Introducing upper limb exercises, such as button pressing or arm swinging, during clinical balance training.&#xD;
  During continuous head rotations, following visual prompts on the display to perform forward, backward, left, and right displacements.</description>
      <arm_group_label>Dual-task vestibule rehabilitation training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Year 1 (Study A):&#xD;
  &#xD;
                 1. Could walk more than 30 meters with or without walking aids independently.&#xD;
  &#xD;
                 2. Able to comprehend and communicate in Mandarin or Taiwanese.&#xD;
  &#xD;
                 3. Sufficient corrected vision that allows independent outdoor mobility.&#xD;
  &#xD;
            -  Year 2 (Study B):&#xD;
  &#xD;
                 1. Could walk more than 30 meters with or without walking aids independently.&#xD;
  &#xD;
                 2. Able to comprehend and communicate in Mandarin or Taiwanese.&#xD;
  &#xD;
                 3. Sufficient corrected vision that allows independent outdoor mobility.&#xD;
  &#xD;
                 4. Healthy participants and those who have experienced dizziness or falls within the&#xD;
                    past two years.&#xD;
  &#xD;
            -  Year 3 (Study C):&#xD;
  &#xD;
                 1. Could walk more than 30 meters with or without walking aids independently.&#xD;
  &#xD;
                 2. Able to comprehend and communicate in Mandarin or Taiwanese.&#xD;
  &#xD;
                 3. Sufficient corrected vision that allows independent outdoor mobility.&#xD;
  &#xD;
                 4. Willing to engage in moderate-intensity exercise for 45 minutes per session.&#xD;
  &#xD;
                 5. Participants who have experienced dizziness or falls within the past two years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Year 1 (Study A):&#xD;
  &#xD;
                 1. Severe central or peripheral nervous system disorders.&#xD;
  &#xD;
                 2. Participants who are blind or deaf.&#xD;
  &#xD;
                 3. Individuals who cannot communicate or understand instructions.&#xD;
  &#xD;
                 4. Current fractures or significant joint injuries.&#xD;
  &#xD;
            -  Year 2 (Study B):&#xD;
  &#xD;
                 1. Severe central or peripheral nervous system disorders.&#xD;
  &#xD;
                 2. Participants who are blind or deaf.&#xD;
  &#xD;
                 3. Individuals who cannot communicate or understand instructions.&#xD;
  &#xD;
                 4. Current fractures or significant joint injuries.&#xD;
  &#xD;
            -  Year 3 (Study C):&#xD;
  &#xD;
                 1. Severe central or peripheral nervous system disorders.&#xD;
  &#xD;
                 2. Participants who are blind or deaf.&#xD;
  &#xD;
                 3. Individuals who cannot communicate or understand instructions.&#xD;
  &#xD;
                 4. Current fractures or significant joint injuries.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chen Po-Yin</last_name>
      <role>Study Chair</role>
      <affiliation>Taipei Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Chen Po-Yin, PhD</last_name>
      <phone>(02)27361661</phone>
      <phone_ext>6311</phone_ext>
      <email>poyin1128@tmu.edu.tw</email>
    </overall_contact>
    <location>
      <facility>
        <name>Taipei Medical University</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <contact>
        <last_name>Po-Yin Chen, PhD</last_name>
        <phone>(02)27361661</phone>
        <phone_ext>6311</phone_ext>
        <email>poyin1128@tmu.edu.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
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    </reference>
    <reference>
      <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>
      <PMID>9831156</PMID>
    </reference>
    <reference>
      <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>
      <PMID>15021773</PMID>
    </reference>
    <reference>
      <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>
      <PMID>7814786</PMID>
    </reference>
    <reference>
      <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>
      <PMID>18314568</PMID>
    </reference>
    <reference>
      <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>
      <PMID>8548512</PMID>
    </reference>
    <reference>
      <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>
      <PMID>2229948</PMID>
    </reference>
    <reference>
      <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>
      <PMID>2317323</PMID>
    </reference>
    <reference>
      <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>
      <PMID>6880820</PMID>
    </reference>
    <reference>
      <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>
      <PMID>9256869</PMID>
    </reference>
    <reference>
      <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>
      <PMID>3944402</PMID>
    </reference>
    <reference>
      <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>
      <PMID>27996103</PMID>
    </reference>
    <reference>
      <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>
      <PMID>10911413</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>33608568</PMID>
    </reference>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>May 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Vestibular function</keyword>
    <keyword>Elderly cognition</keyword>
    <keyword>Vestibular functional assessment</keyword>
    <keyword>Vestibular vertigo</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vertigo</mesh_term>
      <mesh_term>Vestibular Diseases</mesh_term>
      <mesh_term>Dizziness</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05990023
  org study id: N202212070
  nct id: NCT05990023
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Rotation of head, chest, and pelvis.
  time frame: 3 year.
  description: 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.
  measure: Inclination of head, chest, and pelvis.
  time frame: 3 year.
  description: 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.
  measure: Acceleration of head, chest, and pelvis.
  time frame: 3 year.
  description: 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.
  measure: Static Visual acuity.
  time frame: 3 year.
  description: Parameters recorded by a screen with optotype chart and eyeglass system.
  measure: Dynamic Visual acuity.
  time frame: 3 year.
  description: Parameters recorded by a screen with optotype chart and eyeglass system during movements.
  measure: Static vestibulo-ocular reflex (VOR gain)
  time frame: 3 year.
  description: 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.
  measure: Dynamic vestibulo-ocular reflex. (VOR gain)
  time frame: 3 year.
  description: 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.
  measure: Step length (centimeter) during walking
  time frame: 3 year.
  description: 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.
  measure: Step frequency
  time frame: 3 year.
  description: 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.
  measure: Walking trajectory (centimeter)
  time frame: 3 year.
  description: 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.
  measure: Step width (centimeter) during walking
  time frame: 3 year.
  description: 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.
  measure: Step variability of step length (standard deviation) during walking
  time frame: 3 year.
  description: 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.
  measure: Step variability of step width (standard deviation) during walking
  time frame: 3 year.
  description: 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.
  measure: Speed (meter per second) during walking
  time frame: 3 year.
  description: 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.
  measure: Lower limb Joint force (Newton)
  time frame: 3 year.
  description: 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.
  measure: Lower limb Joint moment (Newton-metre)
  time frame: 3 year.
  description: 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).
  measure: Lower limb Joint power (Watt)
  time frame: 3 year.
  description: 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).
  measure: Joint movement (degree)
  time frame: 3 year.
  description: 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.
  measure: Body center of mass sway (millimeter) during testing session
  time frame: 3 year.
  description: 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.
  measure: Activities-Specific Balance Confidence Scale (ABC scale).
  time frame: 3 year.
  description: 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.
  measure: Dizziness Handicap Inventory (DHI).
  time frame: 3 year.
  description: 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.
  measure: Hospital Anxiety and Depression Scale (HADS).
  time frame: 3 year.
  description: 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.
  measure: Dynamic Gait Index (DGI).
  time frame: 3 year.
  description: 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.
  measure: Tinetti Fall Risk Assessment Tool (Tinetti Scale).
  time frame: 3 year.
  description: 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.
  measure: Montreal Cognitive Assessment Taiwanese version (MoCA).
  time frame: 3 year.
  description: 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.
  measure: Trail Making Test.
  time frame: 3 year.
  description: 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.
  measure: Digit Span Test.
  time frame: 3 year.
  description: 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.
  measure: Stroop Test.
  time frame: 3 year.
  description: Clinical assessment scales for color recognize.The minimum and maximum values are 1% and 100%, and whether the higher percentage rates mean better performance
  arm group label: Traditional vestibule rehabilitation training
  arm group type: Active Comparator
  description: The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.
  arm group label: Dual-task vestibule rehabilitation training
  arm group type: Experimental
  description: 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.
  intervention type: Other
  intervention name: Traditional vestibule rehabilitation training
  description: 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.
  arm group label: Traditional vestibule rehabilitation training
  intervention type: Other
  intervention name: Dual-task vestibule rehabilitation training
  description: 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.
  arm group label: Dual-task vestibule rehabilitation training
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chen Po-Yin
  role: Study Chair
  affiliation: Taipei Medical University
  last name: Chen Po-Yin, PhD
  phone: (02)27361661
  phone ext: 6311
  email: poyin1128@tmu.edu.tw
  facility: 
  contact: 
  country: Taiwan
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  PMID: 16926202
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  PMID: 25196019
  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.
  PMID: 21558642
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  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.
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  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.
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  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.
  PMID: 21593013
  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.
  PMID: 22795360
  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.
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  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.
  PMID: 26157259
  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.
  PMID: 24532279
  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.
  PMID: 27869225
  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.
  PMID: 9831156
  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.
  PMID: 15021773
  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.
  PMID: 7814786
  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.
  PMID: 18314568
  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.
  PMID: 8548512
  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.
  PMID: 2229948
  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.
  PMID: 2317323
  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.
  PMID: 6880820
  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.
  PMID: 9256869
  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.
  PMID: 3944402
  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.
  PMID: 27996103
  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.
  PMID: 10911413
  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.
  PMID: 33608568
  responsible party type: Sponsor
  mesh term: Vertigo
  mesh term: Vestibular Diseases
  mesh term: Dizziness
  mesh term: Cognitive Dysfunction