An interventional study of Traditional vestibule rehabilitation training and Dual-task vestibule rehabilitation training in Vestibular Function Disorder, Cognitive Decline and Dizziness, sponsored by Taipei Medical University. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 55 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-15.
Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment
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.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's planned enrollment of 150 is above the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →Taipei Medical University is the lead sponsor of 257 studies on the registry; 59 are open to participants now.
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Year 1 (Study A):
Year 2 (Study B):
Year 3 (Study C):
Exclusion Criteria:
Year 1 (Study A):
Year 2 (Study B):
Year 3 (Study C):
The intervention for the control group primarily follows conventional rehabilitation methods but incorporates the computerized training system developed in this project.
Other: Traditional 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.
Other: Dual-task 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.
* 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.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
Static Visual acuity.
Parameters recorded by a screen with optotype chart and eyeglass system.
Time frame: 3 year.
Dynamic Visual acuity.
Parameters recorded by a screen with optotype chart and eyeglass system during movements.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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).
Time frame: 3 year.
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).
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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.
Time frame: 3 year.
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
Time frame: 3 year.
Started Nov 2023 (actual). Primary completion is estimated for Feb 2026, 27 months after the start.
Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's planned 27 months is above that.
Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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