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The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task

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ClinicalTrials.gov Identifier: NCT05990023
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2023
Last Update Posted : November 15, 2023
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University

Tracking Information
First Submitted Date  ICMJE May 22, 2023
First Posted Date  ICMJE August 14, 2023
Last Update Posted Date November 15, 2023
Actual Study Start Date  ICMJE November 1, 2023
Estimated Primary Completion Date February 14, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2023)
  • Rotation of head, chest, and pelvis. [ Time Frame: 3 year. ]
    Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include rotational angles (degrees) of the head, chest, and waist.
  • Inclination of head, chest, and pelvis. [ Time Frame: 3 year. ]
    Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include angular velocities (degrees per second) of the head, chest, and waist.
  • Acceleration of head, chest, and pelvis. [ Time Frame: 3 year. ]
    Parameters from inertial sensors placed on the head, chest, and pelvis will be extracted. The parameters include accelerations (meters per second squared) of the head, chest, and waist.
  • Static Visual acuity. [ Time Frame: 3 year. ]
    Parameters recorded by a screen with optotype chart and eyeglass system.
  • Dynamic Visual acuity. [ Time Frame: 3 year. ]
    Parameters recorded by a screen with optotype chart and eyeglass system during movements.
  • Static vestibulo-ocular reflex (VOR gain) [ Time Frame: 3 year. ]
    The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head.
  • Dynamic vestibulo-ocular reflex. (VOR gain) [ Time Frame: 3 year. ]
    The VOR gain calculated by dividing eye movement velocity by head rotation velocity. The eye movement velocity(degree per second) and head rotation velocity(degree per second) are recorded by a screen, eyeglass system, and inertial sensor on subject's head during movements.
  • Step length (centimeter) during walking [ Time Frame: 3 year. ]
    Step length (centimeter) recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
  • Step frequency [ Time Frame: 3 year. ]
    Steps and times recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
  • Walking trajectory (centimeter) [ Time Frame: 3 year. ]
    The shift(centimeter) of light and motion markers on subjects recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
  • Step width (centimeter) during walking [ Time Frame: 3 year. ]
    The medial-lateral distance(centimeter) of light and motion markers on subject's feet recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation among the testing session.
  • Step variability of step length (standard deviation) during walking [ Time Frame: 3 year. ]
    The standard deviation of step length(centimeter) among the testing session. The step length(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
  • Step variability of step width (standard deviation) during walking [ Time Frame: 3 year. ]
    The standard deviation of step width(centimeter) among the testing session. The step width(centimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
  • Speed (meter per second) during walking [ Time Frame: 3 year. ]
    Speed (meter per second) calculated by dividing walking distances by total walking times. The walking distances and times are recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation from the starting location.
  • Lower limb Joint force (Newton) [ Time Frame: 3 year. ]
    Joint force is calculated by joint position(millimeter) and ground reaction force(Newton). The joint position(millimeter) is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera), and ground reaction force(Newton) is recorded by forceplates.
  • Lower limb Joint moment (Newton-metre) [ Time Frame: 3 year. ]
    Joint moment (Newton-metre) is calculated by multiplying ground reaction force(Newton) by limb length(meter). The limb length(meter) is recorded by meters or optical motion sensors(camera).
  • Lower limb Joint power (Watt) [ Time Frame: 3 year. ]
    Joint Power(watt) is calculated as the "scalar product" of joint moment and joint angular velocity(degree per second). The joint angular velocity (degree per second) is recorded by wearable sensors (inertial movement units) or optical motion sensors (camera).
  • Joint movement (degree) [ Time Frame: 3 year. ]
    Joint movement (degree) of subjects is recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) during flat ground walking and up/down stairs situation.
  • Body center of mass sway (millimeter) during testing session [ Time Frame: 3 year. ]
    The shift (millimeter)) of light and motion markers on subject's pelvis recorded by wearable sensors (inertial movement unit) or optical motion sensors (camera) and forceplae during flat ground walking and up/down stairs situation.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2023)
  • Activities-Specific Balance Confidence Scale (ABC scale). [ Time Frame: 3 year. ]
    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.
  • Dizziness Handicap Inventory (DHI). [ Time Frame: 3 year. ]
    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.
  • Hospital Anxiety and Depression Scale (HADS). [ Time Frame: 3 year. ]
    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.
  • Dynamic Gait Index (DGI). [ Time Frame: 3 year. ]
    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.
  • Tinetti Fall Risk Assessment Tool (Tinetti Scale). [ Time Frame: 3 year. ]
    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.
  • Montreal Cognitive Assessment Taiwanese version (MoCA). [ Time Frame: 3 year. ]
    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.
  • Trail Making Test. [ Time Frame: 3 year. ]
    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.
  • Digit Span Test. [ Time Frame: 3 year. ]
    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.
  • Stroop Test. [ Time Frame: 3 year. ]
    Clinical assessment scales for color recognize.The minimum and maximum values are 1% and 100%, and whether the higher percentage rates mean better performance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Computerized Vestibular Function Assessment and Training System Combined With Cognitive/Motor Dual-task
Official Title  ICMJE Investigating the Effect of Computerized Vestibular Function Assessment and Interactive Training System, Combined With Cognitive/Motor Dual-task for the Elderly With Dizziness
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Vestibular Function Disorder
  • Cognitive Decline
  • Dizziness
  • Vestibular Abnormality
Intervention  ICMJE
  • 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.
  • Other: 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.
Study Arms  ICMJE
  • Active Comparator: Traditional vestibule rehabilitation training
    The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.
    Intervention: Other: Traditional vestibule rehabilitation training
  • Experimental: Dual-task vestibule rehabilitation training
    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: Other: Dual-task vestibule rehabilitation training
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 4, 2023)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 14, 2026
Estimated Primary Completion Date February 14, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05990023
Other Study ID Numbers  ICMJE N202212070
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Taipei Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Taipei Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chen Po-Yin Taipei Medical University
PRS Account Taipei Medical University
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP